Thank goodness 2020 is behind us! However, believe it or not, some good things took place in the Lyme community during 2020 for which we should all be grateful. Here’s my list of positive progress that will boost our efforts in 2021!
Successful treatments for persistent/chronic Lyme and tick-borne diseases are emerging rapidly
Stanford University has been screening existing drugs for more effective treatment of chronic Lyme disease since 2011. In 2016, they published a list of 20 top (already available) drugs that far exceed the effectiveness of current treatments. They moved these drugs into animal studies. Over the last few years, two drugs have surfaced – Disulfiram and Azlocillin. Disulfiram is available now. Azlocillin is approved, but not yet available in the U.S. Azlocillin has been effective in killing drug-tolerant forms of B. burgdorferi in lab dishes. The side effects of this drug are minimal. Stanford patented the compound and is working with a company to develop an oral form of the drug. Researchers plan to conduct a clinical trial. This could be a real breakthrough!
Ken Liegner, MD, took Stanford research into clinical practice in 2020 – publishing his research with 70 patients. While the regimen is VERY difficult (any exposure to alcohol can create serious effects), many patients have resolved their symptoms, especially cognitive, and been able to live antibiotic-free with restored quality of life. Facebook groups tracking patient responses have emerged to support the patient journey with disulfiram. Here is one such group. Here is another.
Dapsone Combination Therapy:
Johns Hopkins Ying Zhang (MD, Ph.D.) has been very busy investigating better treatment strategies for persistent Lyme disease, finding that treatments for persistent tuberculosis have potential in chronic Lyme. Clinical studies were published this year revealing successful outcomes. This is a viable treatment option available now.
The inflammatory aspect of Lyme and tick-borne diseases has been known for a long time, but only recently has Mast Cell Activation Syndrome/Disorder landed on the map for most Lyme practitioners. Addressing MCAS has been life-changing for many Lyme patients and has created a pathway to improved quality of life, improving tolerance and effectiveness of treatment.
US Health & Human Services 20th Century Cures Act “Tick-borne Disease Working Group”
The Tick-borne Disease Working Group completes its second two-year session and publishes the second series of reports with significant recommendations. The third and last session is 2021-2022 (unless extended). Summary and excerpts below with the full reports here.
This report significantly expanded the understanding of “Lyme” Disease as multipathogenic (multiple babesia including duncani, multiple borrelia strains including miyamotoi, tularemia, rickettsias and more), calling for improved tests, understanding of sequelae and education of healthcare practitioners. For example, targeted education for OB/GYNs was called for in Babesiosis impacts in pregnancy and congenital transmission. In addition, the issues of treatment resistance were documented (especially with Babesia) calling for improved treatments.
This report affirms that persistence of infection has been established in animal models and human cases and therefore, “based on accumulating evidence from the results of studies in animal models, it appears likely that the continuing symptoms in some patients who have or have not been previously treated with certain antibiotic regimens are due to persisting, metabolically active B. burgdorferi. Recognizing some of the shortfalls of previously conducted controlled antibiotic treatment trials, along with recognition that persistent B. burgdorferi are capable of altering and evading host immune responses, and capable of forming persister cells following certain antibiotic treatments, there is the real possibility and opportunity to utilize other antibiotic regimens to prevent the formation of persistent B. burgdorferi, as well as to successfully treat patients with persistent Lyme disease.“
The report calls for targeted research and indicates that until further studies are done, “health care providers may have to exercise their clinical judgment as to how to best diagnose and treat patients with persistent Lyme disease.” Specific actions recommended include:
Clinical Treatment Trials Network
Establish a clinical treatment trials network to evaluate the potential of various antibiotic and non-antibiotic treatment regimens in patients with persistent Lyme disease. This network would participate in studies that include the use of antibiotic regimens differing from those used in previously conducted studies and of longer duration in patients with persistent Lyme disease.
Targeted Test/Biomarker Research Funding
Target research funding for the development of specific detection tests/biomarkers to determine whether persistent disease is due to ongoing infection and to monitor results of treatment.
Practitioner Education on Testing/Diagnosis
Educate clinicians as to the limitations of currently available tests in the diagnosis and in the monitoring of treatment of patients with persistent Lyme disease.
Further evaluate human-to-human sexual transmission of Lyme disease.
Maternal/Fetal and Congenital
Further evaluate maternal-fetal transmission and congenital Lyme disease.
Access to Care:
This report summarizes the issues impacting access to knowledgeable care and recommends actions for government agencies including the development of curriculum and a CME requirement for clinicians which accurately represents the state of the science, including the multiple diagnostic and treatment approaches available and acknowledging the diagnostic limitations of clinically available laboratory tests for all stages of Lyme disease. In addition, it focuses on reducing psychiatric misdiagnoses through education/training of healthcare, neuropsychologists, clinical and school psychologists, social workers and other school personnel regarding the broad manifestations and complexity of tick-borne disease. Additional actions are recommended below:
Formation of Multi-disciplinary Treatment Teams
Including NIH funded in-patient units that can treat patients presenting with neuropsychiatric symptoms, often exacerbated in treatment.
Increasing public awareness that there are two divergent approaches to the diagnosis and treatment of Lyme disease by ensuring the disclosure of such are included on all State and Federal government websites that discuss Lyme disease or tick-borne diseases, including CDC, NIH, AHRQ and all government educational seminars, clinical materials and other educational materials for both health care providers and the public. Public information should also provide information about the occupational risks of tick-borne diseases, as well as blood transfusions and organ transplants.
Ensure that curriculum by CDC, NIH and other government agencies be developed by teams that reflect the differences in scientific perspectives.
Progression of Torrey et al v. Infectious Diseases Society of America et al – RICO (Racketeer Influenced and Corrupt Organizations) case.
This case was filed against 8 insurance companies, 7 physician-researchers (including Steere, Wormser, etc.) and the IDSA alleging the intentional collusion across these groups to deny diagnosis and treatment to sick patients resulting in harm. The law being applied in this case is used with mobsters and is a federal law that provides for extended criminal penalties and a civil cause of action for acts performed as part of an ongoing criminal organization.
All 8 Insurance Companies Settle
As of November 2020, all eight insurance companies have settled in Torrey v. IDSA et al. No details are known on the settlements, which have not been made available in public documents. The remaining defendants include six physician-researchers (the seventh, Robert Nadelman, passed away) and the IDSA. The trial is to be September 2021 and has been stated that the patients will not settle with these defendants.
When insurance companies settle, you can bet they perceived the case evidence as strong and best not aired in public. Insurance funding certainly exceeds that of patients in the lawsuit. If they wanted to, they could fight this. These settlements are telling.
Pennsylvania Legislative Progress
We made significant progress in advancing HB 629, which was fully expected to pass this past Spring with the support of the Chair of the Banking and Insurance Committee, Senator Scavello. Unfortunately, COVID-19 has rightly disrupted the attention of the legislators, and not so rightly, the Presidential election also undermined action on this bill. The good news is that there has already been action to reintroduce this bill and more Lyme bills in the 2021 session. With the above events in 2020, there is even more support for passing the insurance bill as well as the CME education and testing improvement bills that are underway. Thank you all for your tremendous support, actions, phone calls and letters to get HB 629 passed. Stay tuned for more on these 2021 bills.
Historic Federal Budget Passed Providing Highest Level of Funding for Tick-borne Disease Ever
The federal government plans to spend $91M in FY21 vs. $55M in FY20, a 65% increase in spending on Lyme disease, approved by the legislature and signed into law by the President. In such a tough budget year, this is a positive sign of improvement. More details can be found here and here.
Lyme Treatment Lessons for COVID-19
Given that Lyme/Tick-borne diseases have a significant inflammatory component, the lessons Lyme practitioners have learned have become quite useful in the prevention and treatment of COVID-19. Nutritional and immune prevention actions have been published, as well as treatments, which are adding to the tool-set we have to address COVID-19. If you haven’t reviewed these strategies, make sure you do, and talk to your health care practitioner about prevention strategies that may make sense for you. Share the news!
Resilience as a Strength of the Lyme Community
In closing, I want to recognize the strengths of the Lyme community and the lessons that we have all learned regarding resilience, advocacy and persistence.
These are all capabilities we’ve had to develop to address Lyme and other tick-borne infections, often without much community support and facing ignorance and resistance. I certainly felt the value of these lessons over the course of this last year and hope that you all did too.
We made so much progress on legislative change in PA – with all of your help. It was frustrating and disappointing to see that effort go unrewarded. I feel strongly that hope is on the way, with the support of all that has happened this year, to finally make progress on Lyme and Tick-borne diseases in Pennsylvania.
Stay tuned for our monthly updates in 2021 – and Happy New Year!
Julia Wagner, MBA, President of PA Lyme Resource Network