Success in 2020/IDSA Guidelines/Pat Smith Last WG Remarks/Disulfiram/Attempt to Save a Lyme/COVID Patient/Lyme Pathogenesis/COVID
Lyme Disease Pathogenesis- A Review
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.
Read the full review article: Lyme Disease Pathogenesis
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.
Date: Thursday, December 17, 2020
Time: 5:30pm – 7:00pm
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.
Read more about WG from LDA:
Peter A. McCullough, MD, MPH COVID-19 Treatment Protocols
Treatment Publication: Peter A. McCullough, M.D., M.P.H., Vice Chief of Internal Medicine, Baylor University Medical Center, et al. published an article in the American Journal of Medicine, August 2020: Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection.
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.
Congressman Smith contacted me several nights ago asking for my assistance. A chronic Lyme disease patient was extremely ill in a NJ hospital on a ventilator with COVID-19, and was on dialysis after failing traditional therapies. He called me late on Thursday evening, as he had known about my success with glutathione and ivermectin, thanks to Pat Smith, head of the LDA. He asked if I could contact the hospital and discuss with the ICU team the therapeutics that had helped my patients, as well as speak to the patient’s wife. I promptly sent over 10 email attachments to Congressman Smith highlighting the role of glutathione and ivermectin in COVID-19, as well as links to the two articles that I published in the peer-reviewed medical literature (R.I. Horowitz, P.R. Freeman, Three Novel Prevention, Diagnostic and Treatment Options for COVID-19 Urgently Necessitating Controlled Randomized Trials, Medical Hypotheses (2020)
Horowitz, R.I., Freeman P, Bruzzese, J. Efficacy of glutathione therapy in relieving dyspnea associated with COVID-19 pneu-monia: A report of 2 cases. Respiratory Medicine Case Reports, April 21, 2020. Article Number: 101063)
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.
Read review here: Gao, J.; Gong, Z.; Montesano, D.; Glazer, E.; Liegner, K. “Repurposing” Disulfiram in the Treatment of Lyme Disease and Babesiosis: Retrospective Review of First 3 Years’ Experience in One Medical Practice. Antibiotics 2020, 9, 868.
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. ”