Virulence of Borrelia involves multiple channels for transmission and establishment in multiple tissues, as well as evasion of the host immune responses. The bacteria undergo significant changes in gene expression and multiply and spread once transmitted to the host. These changes induce inflammatory responses that, in humans, result in clinical signs and symptoms of disease. In this review, the authors provide an overview on the ability of Borrelia burgdorferi to infect a host and the factors which decisively affect the nature or outcome of this infection that have been demonstrated in vivo, primarily in mouse models.
Jenifer Coburn, Brandon Garcia, Linden T. Hu, Mollie W. Jewett, Peter Kraiczy, Steven J. Norris and Jon Skare Curr. Issues Mol. Biol. (2022) 42: 473-518.https://doi.org/10.21775/cimb.042.473
LDA Announces Lyme Project Webinar: Bransfield & Pat Smith Discuss IDSA Guidelines
UPDATE 12.22.20: Bransfield & P. Smith on What’s the Scoop on IDSA Guidelines?
Dr. Robert Bransfield and LDA President Pat Smith spent two hours discussing all aspects of the new IDSA Lyme Guidelines from how they were developed, differences from prior guidelines and how they impact patients and treating physicians. The Zoom program was hosted by Project Lyme, a NYC non profit who will be posting the entire program on You Tube soon.
In response to the question asked by moderator Noah Johnson to Pat Smith “How do these guidelines affect clinicians and practitioners?,” she responded
Doctors who treat using ILADS guidelines are often investigated by medical boards and charged with malpractice.
Over decades, treating doctors have lost licenses, have been fined, been monitored, or have not been allowed to diagnose and treat Lyme disease.
Hospitals have threatened their privileges, insurers have threatened them from removal from plans if they treated long-term.
Doctors who practice under IDSA guidelines have reported doctors treating with antibiotics long-term to medical boards and testified against them in insurance cases.
Many of the treating physicians are no longer in any insurance plans, and some have spent hundreds of thousands of dollars to defend their right to treat Lyme patients long-term when they determine it is necessary.
In response to the question asked by moderator Noah Johnson to Dr. Bransfield “How do these guidelines compare to standards of care?,” he responded
Standard of care is established by the physicians who actually treat the illness, not the physicians who dismiss the illness. The disclaimer is critical in pointing out guidelines assist, but do not dictate assessment, treatment.
More information on content of program to follow soon!
View entire Zoom program hosted by Project Lyme with Noah Johnson as moderator.
Project Lyme will host renowned psychiatrist Dr. Robert Bransfield, M.D. (Bio) and well-known advocate Patricia Smith, President of Lyme Disease Association, Inc. (Bio)
They will offer opinions on the restrictive and selective nature of the updated Infectious Disease Society of America’s guidelines for treating Lyme disease and discuss key insights such as IDSA’s refusal to acknowledge persistent infection, lax treatment protocols that ignore patient’s needs, as well as maintaining outdated definitions for Lyme presentations.
Noah Johnston, Administrative Director of Project Lyme will moderate the discussion and take live Q&A from the virtual crowd.
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.
Credentials: Peter A. McCullough, M.D., M.P.H.; Vice Chief of Internal Medicine: Baylor University Medical Center; Baylor University Medical Center, Dallas, TX; Baylor Heart and Vascular Institute, Dallas, TX; Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas, TX
Summary: Acute COVID-19 has a great range of clinical severity from asymptomatic to fatal. In the absence of clinical trials and guidelines, with hospitalizations and mortality mounting, it is prudent to deploy treatment for COVID-19 based on pathophysiological principles. We have proposed an algorithm based on age and comorbidities that allows for a large proportion to be monitored and treated at home during self-isolation with the aim of reducing the risks of hospitalization and death.
Video on His Treatment Publication: October 11, 2020, see video of Dr. McCullough providing a critical update: Ambulatory Treatment of COVID-19.(Association of American Physicians and Surgeons)
His Testimony to US Senate Committee Hearing: See video from November 19th, 2020 – Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, in which Dr. McCullough and other witnesses give testimony at a US Senate Committee Hearing (Dept. of Homeland Security and Governmental Affairs), Chairman: Sen. Ron Johnson (R-WI) and Ranking Member: Sen. Gary C. Peters (D-MI)
Horowitz Blog Honoring Congressman Smith’s Efforts to Save a CLD Pt. with COVID
Richard Horowitz, MD, PLLC – LDA Guest Blogger.
Dr. Richard I. Horowitz, MD, PLLC, is a board-certified internist and medical director of the Hudson Valley Healing Arts Center, where he has treated over 13,000 Lyme and tick-borne disease patients during the past 30 years. He is the author of two best-selling books, Why Can’t I Get Better? & How Can I Get Better? An Action Plan for Treating Resistant Lyme and Chronic Disease. Dr Horowitz was also a member of the HHS Tick-borne Disease Working Group and Co-chair of the “Other Tick-borne Diseases and Co-infections” subcommittee which provided recommendations to Congress to improve the care of those suffering with tick-borne disorders.
The Lyme Disease Association thanks Congressman Chris Smith,
US House Lyme Disease Caucus Co-Chair, & Richard Horowitz, MD, for their valiant efforts to help a chronic Lyme patient
hospitalized with COVID-19.
The following Blog, posted on his Facebook, is reprinted with permission from Dr. Richard Horowitz. The LDA applauds these two courageous individuals trying to buck the system to save a life.
Dr. Richard Horowitz November 2 at 7:43 AM ·
I feel inspired to write a blog this am, which I would like to entitle “What it truly means to be a public servant.” It is in honor of Congressman Chris Smith from NJ. Please read the story below, and see if you agree that his action, going far above and beyond the call of duty, is why Congressman Smith is now currently serving his 20th term in Congress.
Fast forward to Sunday. I had not heard anything from the hospital and was getting ready to call the patients wife, as I was curious how he responded to the IV glutathione. Just as I was about to pick up the phone, I suddenly I got a call from Congressman Smith again. He let me know that the patient was deteriorating and that the hospital had not administered the IV glutathione. Why? It was not on formulary and was not a drug. Congressman Smith asked me if I could please call the hospital again and speak to the head of the pharmacy to sort things out. I did so and spoke to a woman we will call ‘Adele’. Adele let me know that she agreed to try it, since the patient had failed all traditional therapies. I gave her the name of the compounding pharmacy that I used and drove over to my office to see if I had some unused bottles of IV glutathione. Fortunately, I did. They were in the original box with the lot numbers, to ensure purity, and I called Adele back up, asking if a courier could come to my home and pick them up since the patient was rapidly deteriorating. She said she wasn’t sure a courier could come from NJ to NY to do so, at which point I offered to drive from my home across the border into NJ onto the first stop of the Garden State Parkway. A patient’s life was at stake. She said she would get back to me and let me know if that was a possibility.
Two hours later I got a call from Congressman Smith at 7 pm on Sunday night. He let me know that he and his chief of staff were going to drive 3 1/2 hours to my home to pick up the glutathione and the nutraceuticals that I had procured from my office. It was heavily raining outside, and would be a 7-hour trip back and forth. I asked him, was he sure, and that perhaps my meeting him halfway could help. He said no. He was already on his way.
While in the car driving to my home, Congressman Smith got on a three-way call, to contact Adele again, and be sure that the patient would be able to receive the IV glutathione stat Sunday night. It would otherwise be 48 hours to get an emergency FedEx shipment from a compounding pharmacy. She let us know that she spoke to the hospital administrators and legal team, who were not comfortable with using the glutathione from the compounding pharmacy that I used. They were not familiar with them (even though you could google the name of the pharmacy online, with their license number and history). Congressman Smith, the patient’s wife and I got on the three way call and begged them to please consider it, as the patient had failed all traditional therapies, and was rapidly deteriorating. I explained to Adele that glutathione was a natural substance made by the body and the liver, and that I had a 30-year experience using it for Herxheimer reactions in Lyme disease patients. I had always found it to safe and well tolerated unless someone had chemical sensitivity and a severe sulfa allergy. After listening to our arguments, Adele said she would re-contact the administration and legal team and get back to us.
Two hours later, we received notice from the wife that the patient had died. Congressman Chris called me with the news and turned around after having driven over 2 hours on a cold, wet, rainy night. He thanked me, and I said to him: “Chris, please don’t thank me. Thank you. I know very few public servants who would ever go out of the way you did for your constituents in their district. What you did is the true meaning of the highest form of public service. God bless you.”
Congressman Smith let me know that he was going to be on a call with Alex Azar, head of HHS today. I asked if there was any way to get a randomized, controlled trial done for glutathione and ivermectin, as cases were spiking in the US, with death rates continuing to rise. He said he would speak to him about it and get me on a call. As I got off the phone and turned to my wife, and explained what had just happened, I was struck by what it means to truly be a public servant and deeply care about your constituents. Very few individuals would hear the call of duty and rise to such heights. Congressman Smith is such a man. When you consider all that he has done for the Lyme community during the past 3 decades, it is no wonder that he has been in Congress since 1981.
It is ultimately not billions of dollars in money and advertising that gets you that type of loyal support that has followed him for decades in Congress. It is because Congressman Smith has the heart and soul of a man who cares and goes the extra mile to ensure that he is always doing his best, getting the best for his constituents. If everyone in Congress followed his lead, America would truly be great again.
Disulfiram for Lyme and Babesiosis Treatment: Retrospective 3 yr Review
In a retrospective review on the use of Disulfiram as a repurposed drug in the treatment of Lyme and Babesiosis, most patients experienced benefits with regard to their symptoms. It was found that although patients on high dose experienced higher risk for adverse reactions than the low dose patients, they were also more likely to show “enduring remission” which is defined as remaining clinically well for ≥6 months without further anti-infective treatment. Adverse reactions from disulfiram treatment observed in the high-dose group were fatigue (66.7%), psychiatric symptoms (48.5%), peripheral neuropathy (27.3%), and mild to moderate elevation of liver enzymes (15.2%). It was also found that patients with co-infection of babesiosis and bartonellosis tended to require higher doses of disulfiram to achieve clinical improvement of their symptoms.
The authors concluded that disulfiram monotherapy is useful in the treatment of Lyme disease through individualized and flexible approach with shared decision-making with patients. They also suggest that further study and treatment trials seems warranted. This article was co-authored by Dr. Kenneth Liegner, LLMD, who serves on the LDA Scientific and Professional Advisory Board.
New IDSA Guidelines/Failure to Commandeer Patient Chapter/#GivingTues/New Test for Lyme/CO Ticks/Updated COVID Protocol/Canine-Human Lyme Data/Next WG Meeting/LDA Thanks 51 Groups/DoD: Funds Lyme Vaccine
IDSA Announces New Lyme Disease Guidelines
The Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR) announced on November 30, 2020, new guidelines for prevention, diagnosis, and treatment of Lyme disease.
Among the treatment recommendations, the guidelines recommend oral antibiotic therapy for most patients with Lyme disease. The recommended duration of therapy is 10 to 14 days for early Lyme disease, 14 days for Lyme carditis, 14 to 21 days for neurologic Lyme disease, and 28 days for late Lyme arthritis. Retreatment may be indicated for individuals with arthritis who have failed a first course of treatment.
From the Guidelines: “Each sponsoring organization elected a cochair to lead the guidelines panel”….A total of 36 panelists comprised the full panel….the panel included 3 patient representatives and 1 healthcare consumer representative. At the request of the patient representatives, we have not disclosed their names to maintain their confidentiality. ”
The House Lyme Disease Caucus is a bi-partisan group working together in Congress to take action on Lyme & tick-borne diseases. Under the leadership of Congressmen Chris Smith (NJ) and co-chair Colin Peterson (MN), it has initiated letters and actions to benefit Lyme patients, such as the inclusion of the monies for Lyme & tick-borne diseases into the Congressionally Directed Medical Research Program (CDMRP) and language and Lyme monies into Appropriations over the years and initiated favorable legislation. Additionally, it has queried government agencies over policies not favorable to patients. This has reminded the agencies that someone is looking over their shoulder. Many meetings have been held and educational sessions in DC for Congress.
If Representatives are interested in signing up they can contact the offices of Congressman Christopher Smith (NJ) or Colin Peterson (MN).
List of Current House Lyme Disease Caucus
Smith, Christopher H. (R-NJ-04), Co-chair
Peterson, Collin C. (D-MN-7), Co-chair
Cohen, Steve (D-TN-9)
Connolly, Gerald E. (D-VA-11)
Courtney, Joe (D-CT-2)
DeGette, Diana (D-CO-1)
Delgado, Antonio (D-NY-19)
Hartzler, Vicky (R-MO-04)
Higgins, Brian (D-NY-26)
Holmes Norton, Eleanor (D-DC)
Keating, William R. (D-MA-9)
Kennedy, Joseph P. (D-MA-4)
King, Pete (R-NY-02)
Krishnamoorthi, Raja (D-IL-08)
Langevin, James R. (D- RI-02)
Lofgren, Zoe (D-CA-19)
Malinowski, Tom (D-NJ-7)
Maloney, Sean Patrick (D-NY-18)
McGovern, James P. (D-MA-02)
Moulton, Seth (D-MA-06)
Peters, Scott (D-CA-52)
Pingree, Chellie (D-ME-01)
Pocan, Mark (D-WI-02)
Posey, Bill (R-FL-8)
Reed, Tom (R-NY)
Rose, Max (D-NY-11)
Stefanik, Elise (R-NY-21)
Steil, Bryan (R-WI-01)
Thompson, Glenn (R-PA-15)
Tonko, Paul (D-NY-20)
Wexton, Jennifer (R-VA-10)
Wittman, Robert J. (R-VA-01)
More about the Caucus
The bipartisan Congressional Lyme Disease Task Force, co-chaired by Rep. Chris Smith (R-NJ) and Rep. Collin Peterson (D-MN), is dedicated to educating Members of Congress and staff about Lyme and other tick-borne diseases, as well as advancing initiatives that are designed to help the estimated 400,000 Americans who develop Lyme disease each year and all of those living with the disease.
As co-chairs of the bipartisan Task Force, Rep. Smith and Rep. Peterson lead annual appropriations requests in support of Lyme disease research through the Department of Health and Human Services and for research funding at the Department of Defense. In 2015, the caucus secured for the first time ever, $5 million in funding in the House Appropriations Committee annual military spending legislation, which was adopted in the Fiscal Year 2016 funding bill which was signed into law, and will provide resources for Lyme disease research through DOD’s innovative, high-risk, high-reward program. Subsequently, the CDMRP continued to be funded, and $7 million was secured for 2020.
The caucus helped advocates secure another major win for Lyme disease. In December of 2016, the United States House of Representatives passed, and former-President Obama signed, the 21st Century Cures Act. The Cures Act included language – similar to a bill that Rep. Smith introduced previously – which created the interagency Tick-Borne Disease Working Group. Specifically, the Working Group (WG) under the auspices of HHS, is comprised of federal and non-federal members tasked with reporting to Congress on scientific advances, research questions, surveillance activities and emerging strains in species of pathogenic organisms. Patients, advocates and treating physicians sit at the same table with government officials. In 2018, the WG sent a report to Congress with recommendations on Lyme and other tick-borne diseases.
11th Hour Attempt to Commandeer & Rewrite Patient Chapter Fails
BACKGROUND: The 17th Working Group Meeting turned out to be a referendum on the Patient Chapter of the upcoming 2020 Working Group report. The previous 9 months of the WG had seen that chapter content consistently eroded by comments from just a few WG members which forced shortening of chapter, removal of material, rewriting of material, and moving around of material. The terms “chronic Lyme” and “persistent Lyme” could not be used and had already been removed. Now, more changes and even a complete chapter rewrite were called for. Differences in IDSA Guidelines, LDo’s patient registry information, shared decision making permitting doctors to tell patients about different treatments, and peer review that questioned conclusions of the NIH studies were all under attack and subject to removal/more revisions after 9 months of scrutiny and changes made to accommodate numerous objections each meeting.
Chapter Co-Writers Pat Smith & Scott Cooper refused to do any more changes. A Donta/Smith motion was made to accept the Chapter as written (with one clarification). It was voted on after about an hour of often contentious discussion including a rebuttal to the NIH objections (already previously addressed) to the chapter by Smith“…“the 11th hour and what is (a) surprise, you want to deep-six the report. The only report that addresses what happens with patients. I’m sorry that you think the NIH is sacrosanct. So much that the bodies of people that were charged with doing research and talking about what research should be done were not even willing to take in chronic Lyme disease research. That’s why we couldn’t get it done or published. That’s happened for years. … I happen to think that we have to do something for the hundreds and thousands of people over the years that have been affected. The government doesn’t want to do anything about it, so I don’t know why you’re sitting at this table if you don’t want to do something. We have compromised plenty and removed tons of stuff…. Compromising on the fact that Lyme disease is the most prevalent tick-borne disease affecting the most people, and it’s more people who aren’t able to get treated because the government doesn’t want to recognize they are sick. You want to send them all to psychiatrist.”
TECHNICAL DIFFICULTIES WITH TRANSCRIPT BELOW: The following article provides quotes from the automatically produced transcript downloaded during the WG meeting. The transcript often contains inaudible/ garbled material due to HHS meeting software/phone connections. Where possible, LDA has listened to the audio recording and supplied the actual word(s) in parenthesis. So that the dialogue presented makes sense, sometimes a sentence between quotes in italics is provided by LDA, indicating other WG discussion took place. The bolding in quotes has been done by the LDA to emphasize the most significant lines. You can listen to the actual audio transcript of Pat’s Smith Rebuttal at the bottom of this article. (click here)
Actual Dialogue of Pat Smith’s Rebuttal to Attempt to Rewrite/Remove More Material From the Chapter 7 Patient Report: The following section is from the audio/written transcripts downloaded from the Working Group meeting.
WALKER: You’ve taken advantage of being office (AUTHOR) of a chapter to launch into topics that have nothing to do with the chapter that you don’t want to put into the report. It has nothing to do with supporting the recommendations of the chapter.
COOPER: They do support it, plus as Jim noted with the charter of the working group, one of the things is affordable access for patients to care that stores health.
WALKER: You need to get that into recommendations. And I hope to do it because you have not done it effectively at all, anything to do with access to care for the recommendations of this chapter.
SMITH: I don’t think so David. We’ve done this for many hours. Hours and hours. More than probably the rest of the working group reports put together. We addressed these comments that don’t have any real specific asks, it doesn’t support, it’s been all the way through. I don’t think we need to go any further. I think we have done our part, and we are willing to move along because we don’t feel that we need to discuss this any longer.
WALKER: You took two and half hours to delay moving to the meeting and that is what took all the time from the last meeting.
SMITH: Excuse me, that was not my issue. Because you work behind the scenes to change protocols, and then you did not want that brought up in public. I brought it up, and I’m very happy that I did.
DIXON: Further discussion of individual comments is not going to get us any further. I think we have had ample communication and differences of opinion have been expressed, but we have not come to consensus, so we need to vote on the overall chapter, because it’s not the individual comments of the overall some of the balance of the chapter. I feel there’s not an overall balance of the chapter and I’m uncomfortable on the lack of balance and the misrepresentation or the depiction of the clinical trials overall. They are listed as preempts there is trials done and two additional trials done under grant it’s the overall focus on the minority finding of those studies rather than the overall preponderance of evidence adding to that the overall depiction I think that’s a good way to characterize. I think what we need to do is call to a vote and see how many people feel that way and how far apart we are before wasting additional time on individual comments that really aren’t the point.
SMITH: I would say Dennis, thank you for your honesty and I know you’re espousing what the party line is. The party line for 46 years has been let’s bury the patient’s.I’ve worked for 36 years and (AS) an advocate for those with chronic Lyme disease and I have never in my life seen the hatred that I’ve heard from some people in this group over providing information that is totally verifiable. We have sources coming up but you don’t want to accept them. David doesn’t want to accept the (THEM) or Schapiro. I don’t know who else want to accept them. Nobody else gets the same scrutiny.
This group was willing to accept a 1904 piece of citation in this report. But we have citations coming up in the best institutions over many years, and you don’t want to accept it.
…you can’t say chronic or persistent Lyme (EXISTS). I think the community is tired of it.
So now we get to the 11th hour and what is (a) surprise you want to deep-six the report. The only report that addresses what happens with patients. I’m sorry that you think the NIH is sacrosanct. So much, that the bodies of people that were charged with doing research and talking about what research should be done, were not even willing to take in chronic Lyme disease research. That’s why we couldn’t get it done or published. That’s happened for years…The NIH is not sacrosanct.
I happen to think that we have to do something for the hundreds and thousands of people over the years that have been affected. The government doesn’t want to do anything about it, so I don’t know why you’re sitting at this table if you don’t want to do something. We have compromised plenty and removed tons of stuff.
Compromising on the fact that Lyme disease is the most prevalent tick-borne disease affecting the most people, and it’s more people who aren’t able to get treated because the government doesn’t want to recognize they are sick. You want to send them all to psychiatrist. I’ve had people who I know personally that have been put into institutions and weren’t able to be treated (for Lyme disease)…This includes children. I’m sick of it. I saw children seizing in the 90s from Lyme disease and hospitals…It’s a tragedy that’s gone on too long. Somebody has to do something.
I had higher hope that this group was going to be able to do something and I am disappointed. I shouldn’t be, because my hopes should not have been that high…I agree that we need to do something for these people who are suffering.
DIXON: That’s why I’m so committed to the resource section on how we need to explore and understand better the pathogenesis and suffering of the individuals, so that we can intervene with the most appropriate methods (in a scientifically rigorous fashion.)
SMITH: (You had 46 years to do the pathogenesis and get it solved. Let’s look at COVID. Let’s see what was done) in the 9 months time. (….Look what has been done just in that time period.) You had 46 years. And what did you do. You covered up a disease. I remember it from the 80s, from the 90s, you tried to cover it up as a disease you try to cover it up as a (IT) spread, then you went and covered up (Babesia) where it was. And it isn’t just CDC, it’s the NIH, too. It’s about time somebody stood up and said we have to do something that directly impacts getting help for these people.
DIXON: We are trying to uncover, not cover the mechanisms (of pathogenesis and understand the basic transmission) and clinical means to address that.
SMITH: And you didn’t have time enough or money enough. I saw the inventories. I know what you did. I know what you should’ve done. But no, that was not done. I only saw a couple of years of those inventories and so you’re never getting to the bottom line. People said it this morning. Where’s the help for the patient. There is none and now you want to remove their chapter? Well go ahead.
I’m going to tell you what — we’re going to do things with Congress that this group cannot do. Because it’s obvious that some of you don’t want to do it. And again please, the other people in the group, and you know you are, I’m not speaking to you right now. I’m speaking to these people who have prevented this from moving forward. It’s just unbelievable to me how a few pages of the chapter have been so attacked.
LDA comment: The below references MyLymeData registry…
WALKER: I believe the survey you did and there really is exemplary of a group of people, thousands of people that you’ve surveyed who are suffering and they definitely need to be helped and we don’t really know what’s wrong with them. The problem is they are self-reported saying that they believe they have persistent Lyme disease.
SMITH: If you would have listened to the prior meeting, (David you would have heard)
WALKER:They really don’t… they just say they’ve had Lyme disease, and the high rates of co-infection with respiratory illnesses like mycoplasma and (Bartonellosis)…These people definitely do need help but the help may not be Lyme disease. And if it is Lyme disease we need to understand how.
SMITH: We discussed this patient registry… The people in that registry were asked if they had the doctor diagnoses, and if they did not they were removed from the registry. There’s tons of patient registries and you just want to pick on this one because it doesn’t meet your needs. This is typical…But the rest of the patient registries of the world that the NIH have or that the CDC have or other agencies or other respected institutions have. You don’t come out and say anything about those. Those registries are used everywhere. You only care because this one shows the true extent of problems across the United States and across the world. You’ve had 46 years to do the research about what’s wrong with these people if this isn’t what they have.Not only have that (HAVEN’T YOU) done it, you’ve relied on mainstream medicine, which means they can’t get more treatment in any way shape or form. They are not permitted. They are told to go to a psychiatrist, even alternative medicines, (Nope, forget it you can’t.) That’s unconscionable, unconscionable.
DONTA: I move that this chapter be accepted with possible minor revisions.
WALKER: Sam would you be willing to break that into two sections on the recommendation and the content of the chapter?
SMITH: He cannot, because we’ve already voted on the recommendations.
DONTA: That is a part of the chapter David. So unless we want to hear from other members of the working group, my motion stands that we move to accept Chapter 7 into the report.
SMITH: I second that.
SOLTYSIAK:…So now is (AS) a working group at this 11th hour. We are supposed to compromise and decide (WHAT) we want to represent. And guess what. We have that opportunity for the minority report. If we voted something down, we can choose to still put them in our (MINORITY) report (GOING) forward. I think we just have to agree to the process…
SMITH: That’s correct. I would certainly be very happy that we proceed on this boat (VOTE). And if it goes down, I’d love to be able to present to Congress how this working group voted against a chapter, the one for the patient’s. And the one that the patient had that (THE) input into, and had it well-crafted and well done, and spent hours of discussion on, then I’d be very happy to do that, and we will do that (IF THAT HAPPENS). So let’s move on and get the boat (VOTE) going.
Some more procedural comments made by Donta, Soltysiak, Dixon, Berger
SMITH: I would like to say something about the fact that these comments that are put in here, were put in here by David. They are the same, (COMMENTS THAT HAVE BEEN) in there before, in the last meeting. And he didn’t put these comments in there (TODAY). So therefore, he cannot go back now and put these comments in and expect that we need to address them. We have addressed these 1000 times over and there was no reason for them to be put in here. It was on last time’s agenda, and it was pushed, in my opinion, to the end as it always was, so that we can be sacrificed and moved again and again until now we are at a critical point. And [ MUSIC ] about this chapter and whether it will stand or not. I mean, this is ludicrous to me and I would like, and at this point, I call the vote.
SOLTYSIAK:…let’s pay attention to our tone and it also is about respect….When the processes (PROCESS IS) we have had months to come to agreement on this chapter and we don’t agree. It’s a chapter that presents many opportunities for disagreement. Therefore, the solution is, if you don’t agree, present in your vote as a minority on either the hold (WHOLE) chapter or your vote on certain sections and provide a minority report.
SMITH: That’s (NOT) what we have on the floor. The motion on the floor is to accept the chapter. We will fix the first comment because it was legitimate, it was confusing and we will fix that comment. These are the (OTHER) comments should’ve been done at the last (MEETING).
[ Indiscernible – overlapping speakers ]
SMITH: Wait a minute, excuse me. As far as tone and respect, you have got to be kidding. Let me tell you. You’ve got to be getting (KIDDING).After all the things I have heard and seen how some people have reacted to patients, to our sick patients, they are the ones that deserve to have the respect. And they have not gotten it. And so, therefore, we have a motion on the floor. I called the vote.
SHAPIRO: First of all, the motion hasn’t been seconded. Secondly, I have a question. Could somebody please clarify what the requirement is for a minority report? Is one half (DOES ONE HAVE) to reject the chapter, can one accept the chapter but object to specific content, and how does that happen because it sounds like we have only had motions to accept or reject the chapter. So Jim, can you clarify what needs to happen to have a minority report included, please?
BERGER: Okay. It’s my understanding that for a minority response there can be either a rejection of the chapter or a rejection of comments.
SMITH:That (MINORITY REPORT) has to be in response to a vote. That has to be a vote on one particular sections and that has not been done. And therefore right now we have a motion on the floor to accept or reject the chapter. If someone – states not to accept the chapter they can do a minority report, but there’s nothing right now about any kinds of sections. And so, we have a motion, Sam, motion denies seconded it. (Sam motioned it and I seconded it)
COOPER:And I would add to what Pat is saying and what Jim said. When it comes down to a vote on an entire chapter, then the dissenting opinion that’s written everything in the chapter is fair game…
— [Inaudible – static ] (COOPER COMES BACK ON)
COOPER: What I was saying is in this case where we are voting on the entire chapter, whatever way the vote comes out if you or someone who has dissented…from the majority for the entire chapter, your opinion that’s written can cover that entire chapter. If we were voting on a specific section that would be different. The opinion would have to stick to that if you were in the minority. But in this case, that’s not relevant because the motion by salmon (SAM) seconded by Pat was…the entire (CHAPTER) as is, other than the first one (CHAPTER COMMENT) we talked about with the numbers and percentages, which we [Indiscernible ] (WILL) correct.
Below, Beard is addressing a number of Working Group Members’ comments from above…
BEARD: You know, this has been — I couldn’t agree with Dennis More. Certainly CDC is clearly supportive of recommendations, and honestly, I’m not so much against what’s written here. I think it’s what’s not here, and I think it’s the whole idea of showing the balance. I mean, I am fine with registry data. But I think David makes a good point and we should point out limitations of registry data. You know, there’s truly a point and counterpoint to this and this is a dilemma in which we live and we need to work out a way to answer these questions and resolve it. But I think the way the chapter is written and LeeAnn (LEIGH ANN), to your point, I don’t think that it’s there (FAIR) to say these were 11th hour comments.It was something brought up very, very, very early on and I think can support those who have been outspoken about this, that the balance just is not been put in there and in that sense the comments have never adequately been addressed.
Again, I’m supportive. I think was (WHAT’S) in here is good, and this is (AN) incredibly important chapter. And it doesn’t need to be deleted or even rewritten. It just needs to be balanced with the other side of some of these issues. That, to me, is really the issue of debate here.
COOPER: Thank you, Sam and thank you, Ben. I will say in defense of what Pat and I have done throughout this process, I feel like we have acted in good faith to address the comments that we have gotten, all of them, unless they were just criticisms without any constructive part to it. As Sam was saying, there was nothing offered and I will say this last round, the preponderance here is just to comment this is irrelevant. And with nothing to offer, so if that needs to be pointed out, particularly to the public listening in, because they might not be able to see these comments, and since we will not go through each one, a lot of them are just that… We have addressed even those in the past. You know, to explain why it’s not irrelevant. So I think we are at really a point here. With (WE’VE) acted in good faith. We have tried to respond and work together. I think we are at a point where Sam put the motion and Pat seconded it. To either accept the chapter as it is other than that one area or, you know, to not accept it and then we will proceed from there.
DIXON: …The overall tone of an entire page is hard to fix with one or two comments, so if you just focus on the text about the NIH trials and include the European trials, which are even bigger and did the same thing, you see such things as comments about the poor design, you see inconsistencies in result, you see controversies. The results are rather consistent. I think the disparity is in the to interpretation of the results. So if you look at the very fine European trial done by [ Name indiscernible ] Goldberg and colleagues I have known Bob since the early 90s when he came into the (INFECTIOUS DISEASES ???) effect it is the them the clinical trial network that I went for 15 years. He took on the challenge of Lyme because he noted previous randomized trials have not shown convincingly that prolonged antibody treatment has been beneficial to patients. Which is true. The trials are showing that additional drugs are not beneficial and yet there’s controversy over interpreting that…
SMITH: Excuse me, Dennis, but I believe you were most meetings and if you weren’t present Sam Perdue was, and to give you both credit, you made the meetings. However, we discussed that issue very clearly and in response to those comments many, many, months ago and we said, no, we are not talking here. We are talking about U.S. trials. We are not talking about trials in other countries.We were very clear about it. We said it, we stated it, we made changes to that whole section. Many, many rounds of changes throughout that whole section and no one ever put (BROUGHT) it up again. And now, now that you guys have pushed this till the 11th and a half hour and you want it rewritten again and you want to bring up all that old stuff again, well, sorry, Dennis, but we’re not going to do that. We are not going to bring this up again. That was already discussed. You can go back and find it in the transcripts and if that’s the case but it’s there and we are not going to do this again. And I call the question, we have a motion and a second on the floor.
DIXON: Another interpretation of that is the changes that were made did not have significant impact on the concerns that were registered.
SMITH: That is not true because no other concerns were registered on that aspect after that. The only concerns that have been continuously registered are concern(s) that don’t provide anything and just say that doesn’t belong in the chapter. And so, we’ve addressed everything and then some…I know we went above and beyond the call of duty to get this to a consensus state and, you know, and then to see now, here you are, and you’re going to shoot it down.Well, please be my guest. Shoot it down, because I’m going to tell you it’s about time that this nation understood where it’s government stands online (ON LYME) disease, in particular, chronic and persistent, and those patients. I think they need to see it clearly, and believe me, this will drive it home. I’m perfectly fine to go with this and we have a motion and a second on the floor. Let’s do it.
WALKER: I have a question for you. Does the (SHARED) decision making inception (OPTION), trying to force physicians to offer (IN)effective, dangerous options to the patients?
DONTA: I disagree. David you cannot make that kind of statement without more experience. And, Dennis, you know, we have talked about the European trial, and it had a big fatal flaw which was duration of treatment. A couple of others. Let’s not presume that appropriate duration of treatment, which is the key to the critique of all of the existing trials and whether that’s correct or not remains to be seen but needs to be supportive. We can’t be dancing around that there is another cause when it’s staring us in the face…
SMITH:… David, here’s my response. First of all, it’s not my judgment. I am not a physician. I have never pretended to be one. However, I can read and I can also assess information that is provided by the tens and tens of thousands of patients and physicians across the country. And I can look at [Indiscernible] (ILADS) guidelines which were the IOM approved the way the [Indiscernible] (ILADS) were developed. They were the last ones on the national guidelines clearinghouse as a matter of fact before the government defunded the clearinghouse. Those guidelines stand up. They give the doctor the right to make a clinical decision based on what they see and also based on the kinds of testing that they do and considerations of the background and the patient’s history and the differential diagnoses etc. etc.
WALKER: I agree with that, Pat.
SMITH:And that is what our chapter talks about, basically is that there are two sets of guidelines and that… clinical judgment shall (SHOULD BE) permitted, because for heaven sakes, otherwise let’s not bother sending those guys to med school because what good is it if they are not allowed to use the (THEIR) clinical judgment, and they are basing that on guidelines that were on the national guidelines clearinghouse approved by AHRQ.
WALKER: What if the decision is dangerous and ineffective? To (DO) they had (HAVE) to present the alternative treatment?
DONTA: David, you are telling me I have been giving dangerous medications for years excessively treating those patients. Sorry to hear you say that. Please, let’s vote.
BEARD:I just wish we could address sections of this and not the whole thing, because it’s just throwing the baby out with the bathwater.
SMITH: I think that, no offense, Ben, but the government longtime (AGO) through(THREW) out the baby in the bathwater, and those were our patients. You threw them out, you left them there, and this to me just stomping all over them, so I don’t think it could get much worse.I have never spoken this way at anything I have sat on before in this manner, but I just feel like this is — it’s so ludicrous, I can (CAN’T) imagine what the people are thinking out there, but I can be pretty sure of it and it’s disgraceful. It’s absolutely disgraceful, so let’s get it over with. If you’re going to cut us out, then (CUT US) out.
The Chapter 7 vote on the motion to approve the chapter, as written with one change, was as follows:
Scott Copper*, Patricia Smith, Beto Perez de Leon*, Angel Davey*, Scott Commins, Sam Donta, Leigh Ann Soltysiak, Leith States*
Ben Beard*, Dennis Dixon*, Kevin Macaluso, Todd Myers*, Eugene Shapiro, David Walker
LDA NOTE: There are 7 federal members* and 7 non-federal public members on the working group. Members wishing to write a minority report must vote NO to the chapter. The vote was taken and some individuals also made comments while they were voting. See official transcript. View list of TBDWG members present at meeting HERE.
OTHER WG REPORT BUSINESS CONDUCTED:
Chapter 1: Background
Chapter 2: Methods
Chapter 3: Tick Biology, Ecology, and Control
Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics
Chapter 5: Causes, Pathogenesis, and Pathophysiology
Chapter 6: Treatment review Chapter 7: Clinician and Public Education, Patient Access to Care
Chapter 8: Epidemiology and Surveillance
Chapter 9: Federal Inventory
Chapter 10: Public Input review
Chapter 11: Looking Forward
Chapter 12: Conclusion
Review of: Executive Summary
The section on RMSF and Ehrlichiosis states they are managed by antibiotic therapy to prevent patient debilitation, disability and death. No mention of death was made in the Lyme reference; therefore, Pat requested that the word death be included in the section for Lyme disease. Vote to approve Executive Summary with the changes agreed to, passed unanimously. Note: Shapiro left the meeting (as he has done during several past meetings) once again, delegating his proxy vote to Walker.
Chapter 4: Clinical Manifestations, Diagnosis, and Diagnostics
Vote to approve chapter 4 passed, with Leigh Ann abstaining. Shapiro was again absent for this vote.
Chapter 6: Treatment
After discussions regarding Powassan Virus references, vote to approve chapter 6 passed unanimously.
Chapter 8: Epidemiology and Surveillance
Vote to approve chapter 8 with the changes discussed, passed unanimously.
Chapter11: Looking Forward
This chapter was previously approved with minor editorial changes however, a minority report will be written by Pat Smith and Captain Scott Cooper, on the strong suggestion in here to include industry in the next WG process– concerns on conflicts of interest and legislative categories which do not include industry.
Chapters 1: Background; 2: Methods; 5: Causes, Pathogenesis, and Pathophysiology; 9: Federal Inventory– Pat requested addition of the link to access the Federal Inventory Questions be inserted in this section, this was approved without contest. All of these chapters were approved previously at the 16th meeting with minor editorial changes.
Chapters 3: Tick Biology, Ecology, and Control; 10: Public Input; and 12: Conclusionwere voted on after minor editorial changes. All passed unanimously.
Appendices: The 21st Century Cures Act delineates categories that WG members must be appointed to. Pat requested that the category of each WG member is to be listed in the report. The WG agreed to add to Appendix A. Report cover and back photos were discussed and decided upon. Smith discussed the need to promote the proper messaging in regard to tick repellent use. The front cover primary image will depict a family outdoors…the real “picture” of how Lyme and other tick-borne diseases are affecting patients across the country.
Verbal public comments were delivered by ten people, many of whom had presented at the previous meeting. Critical care nurse and mother of a child with Lyme, Janice Sutton; Lorraine Johnson, CEO of Lyme disease.org; Dorothy Leland, VP of Lymedisease.org and mother of a child with Lyme disease; Phyllis Mervine, President of Lymedisease.org; Patient advocate, Carl Tuttle; Patient advocate, Lucy Barnes.
View Dorothy Leland’s, Touched by Lyme, blog posts on LDo’s website HERE.
View LDo’s Opinion and Features posts for public commenters HERE.
Public Comments Subcommittee:
Subcommittee Co-chair, Angel Davey, presented tables from the Public Comments Subcommittee, which summarizes incoming written public comments: priority areas/key themes through October 2020. November comments were too numerous to publish publicly prior to the meeting. New comments as well as recurrent themes received in October 2020 included:
“Concern about expedited timing/deadline for call for new public WG members”
“Inquiry as to whether anyone was establishing labeling requirements for mammalian-containing products”
“Obstacles to medical care for LD while living abroad in Australia”
“Reference and supporting information submitted for a new, effective PTLDS treatment protocol”
Horowitz, R.; R. Freeman, P. Efficacy of Double-Dose Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome (PTLDS) and Associated Co-infections: A Report of Three Cases and Retrospective Chart Review. Antibiotics 2020, 9, 725.https://doi.org/10.3390/antibiotics9110725
“Reference provided for an in vitro culture study of dapsone combined with antibiotics effectively disrupting Bb biofilms and killing the bacteria”
Horowitz, R.I., Murali, K., Gaur, G. et al. Effect of dapsone alone and in combination with intracellular antibiotics against the biofilm form of B. burgdorferi. BMC Res Notes 13, 455 (2020). https://doi.org/10.1186/s13104-020-05298-6
DISCUSSION OF MINORITY REPORT: The meeting ended with discussion by those who voted against Chapter 7 of how minority reporting will be submitted in response to the large number of dissenting votes in the approval of Chapter 7. There seemed to be ongoing confusion regarding the process and requirement for minority reporting. It was decided that each minority voter for Chapter 7 may submit an individual minority report or there can be a collective report, and the writers will provide input on how to proceed once they have reviewed. View the discussion of minority reporting transcript HERE.
FINAL WG MEETING DATE: The next and final public meeting of the TBDWG for the 2020 report to Congress will take place on December 2nd. Pat requested an HHS presentation of the LymeX partnership, which Jim Berger agreed to provide at that time. Public comments on the meeting must be received by 11:59 p.m., ET, Tuesday, November 24.
LINKS TO OFFICIAL MEETING TRANSCRIPTS:
Registration and public comment instructions may be found on the HHS website HERE.
Click downloaded official written transcript of the complete Chapter 7 discussion HERE.
Watch/Listen to the actual recording of Pat’s Smith rebuttal by clicking below: