Today's letter to the Tick-Borne Disease Working Group...

---------- Original Message ----------
From: CARL TUTTLE <runagain@comcast.net>
To: "tickbornedisease@hhs.gov" <tickbornedisease@hhs.gov>
Cc: (97 Undisclosed recipients)
Date: 10/28/2020 9:18 AM
Subject: Re: Effect of dapsone alone and in combination with intracellular antibiotics against the biofilm form of B. burgdorferi

To The Tick-Borne Disease Working Group,

Please see the letter below from Dr. Richard Horowitz regarding a follow-up in vivo clinical study, Efficacy of Double-Dose Dapsone Combination Therapy for Chronic Lyme Disease.

."..tick-borne symptom improvements in 98% of patients, with 45% remaining in remission for 1 year or longer"

Carl Tuttle
Lyme Endemic Hudson, NH

Letter from Dr. Richard Horowitz to Professor Gillian Leng, Chief Executive at The National Institute for Health and Care Excellence (NICE)

----Original Message-----
From: Richard Horowitz
To: Gillian Leng 
Sent: Wed, Oct 28, 2020 8:06 am
Subject: New study published on Lyme disease in the journal Antibiotics, has important implications for CLD/PTLDS

Dear Ms. Leng,

Finding a 'cure' for chronic Lyme disease/PTLDS has been an elusive goal for decades by researchers and clinicians. I just published this case study and retrospective chart review of 40 patients in the journal Antibiotics with Dr Phyllis Freeman on double dose dapsone combination therapy:

Horowitz, R.I.; Freeman, P.R. 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

What is new about this and why am I so excited?
The etiology of chronic Lyme disease/PTLDS has been a source of debate in the medical field for decades. University of New Haven researchers Dr Eva Sapi, G. Guar and K. Murali working with myself and Dr Freeman recently published a groundbreaking in vitro culture study in the Springer journal BMC, that definitively shows that Borrelia burgdorferi, the bacteria that causes Lyme disease, forms biofilms that protect the organism, and that combining antibiotics with older leprosy drugs like dapsone effectively kills the bacteria by disrupting the biofilm.
Horowitz, R.I., Murali, K., Gaur, G. et al. Effect of dapsone alone and in combination with intracellular antibiotics against the bio-film form of B. burgdorferi. BMC Res Notes 13, 455 (2020).  https://doi.org/10.1186/s13104-020-05298-6

A follow-up in vivo clinical study is now published in the journal Antibiotics. It found that an 8-week course of the leprosy drug dapsone combined with doxycycline and rifampin was effective in improving symptoms in 98% of patients and led to long-term remission in 45% of patients despite most individuals being ill for a decade or longer! These studies help elucidate the underlying cause of resistant symptoms in chronic Lyme disease (e.g. the importance of biofilm and 'persister' forms of the bacteria), while the study published in the Journal Antibiotics also illustrates the importance of associated tickborne co-infections, including Babesia and Bartonella, responsible for resistant long-term illness.

How does it affect patients?
As you know, Lyme borreliosis is a spreading worldwide epidemic, which can result in disabling chronic fatigue, musculoskeletal pain, and neuropsychiatric complaints. Between 300,000 and 500,000 new Lyme disease cases are diagnosed in the United States every year, with an estimated 2 million individuals suffering with Post Treatment Lyme Disease Syndrome (PTLDS). Until now, no treatment has been available for PTLDS. In this recent study, 58% percent of those with a history of PTLDS remained in remission after using this novel oral, generic 8-week antibiotic protocol, providing new hope for those suffering with chronic Lyme disease. Up until now, there has been no published effective treatment for PTLDS, much less a potential cure.

What are the implications for patients?
Prior NIH trials have shown that symptoms of chronic Lyme disease can be as severe as those with chronic congestive heart failure, leading to long-term suffering and disability, elevated healthcare costs and financial insecurity. This innovative 8-week antibiotic protocol provides an answer for those who have suffered for decades. The next step is to perform a randomized, placebo-controlled trial using double dose dapsone combination therapy (DDS CT), done in parallel with studies to find answers for resistant tickborne co-infections. This should decisively prove that the elusive “cure” for Lyme disease that has evaded researchers and clinicians for decades may now finally within reach, ending a medical debate that has caused suffering in millions of patients worldwide.

What is the disruption in how CLD/PTLDS typically has been handled?
Until now, insurance companies have denied the persistence of the Lyme bacteria after standard antibiotic therapies, based on the results of several prior NIH randomized trials done over a decade ago. This would oftentimes lead to denial of long-term treatment and lack of access to care for chronically ill patients, who were left without answers as to the etiology of their chronic illness. During the past decade, new research and answers emerged from Stanford, Johns Hopkins University, and the University of New Haven, which illustrated the presence of novel biofilm forms and ‘persister’ forms of Borrelia in culture, which could potentially explain treatment resistance and relapse. Prior NIH trials did not address these novel forms of the bacteria, but as other diseases in medicine had been shown to involve the presence of persister bacteria, including mycobacterium tuberculosis and leprae (TB/leprosy), I therefore decided to try dapsone, a leprosy drug, as my antibiotic of choice based on its scientific properties. Dapsone not only acts as a ‘persister’ drug, but also lowers inflammation, has anti-malarial effects and can be effective in autoimmune illness. These are all clinical manifestations that can be seen in chronic Lyme disease with associated co-infections like Babesia (a malarial-like parasite). Using dapsone at regular doses (100 mg/day), combined with a tetracycline and rifampin (another TB drug), the combo was shown to be effective in those failing traditional antibiotic therapy. I published two retrospective studies in the medical literature on 300 patients who improved on dapsone combination therapy:

Horowitz, R.I.; Freeman, P.R. Precision Medicine: retrospective chart review and data analysis of 200 patients on dapsone combination therapy for chronic Lyme disease/post-treatment Lyme disease syndrome: part 1. International Journal of General Medicine 2019:12 101–119,   https://www.ncbi.nlm.nih.gov/pubmed/30863136

Horowitz RI, Freeman PR (2016) The Use of Dapsone as a Novel “Persister” Drug in the Treatment of Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome. J Clin Exp Dermatol Res 7: 345. doi:10.4172/2155-9554.1000345

Although the standard dapsone regimen was effective in relieving 8 major Lyme symptoms in two retrospective studies of 300 patients, patients oftentimes relapsed at the discontinuation of therapy. The two new studies published in BMC Springer and the journal Antibiotics now explain why. The Springer study showed that higher doses of dapsone were more effective in culture against the biofilm forms of Borrelia. I tried a higher dose of dapsone in this recent paper published in Antibiotics, where I found the higher dose dapsone protocol to have significantly improved long term efficacy. These results point for the first time to a potential ‘cure’ for Lyme.

What are the broader implications of these studies for our ailing health care system?
Due to the insensitivity of present Lyme testing strategies, some persistently ill individuals are labeled as having Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME), Fibromyalgia (FM), Multiple Sclerosis (MS), non-specific autoimmune disorders or early dementia. Lyme is known as ‘the great imitator’ as it can mimic and be associated with these different conditions. Presently 5% of the US population (approximately 17 million individuals) suffer with CFS/ME and FM; Over 20 million Americans have been diagnosed with an autoimmune disorder, and 46.5 million Americans have been suspected of having early dementia, while chronic diseases account for 86% of our rising health care costs and 70% of the deaths in the US. The16-point chronic disease model known as MSIDS (Multiple Systemic Infectious Disease Syndrome) highlighted in this recent article in Antibiotics and in prior published Precision medicine studies (Horowitz, R.I.; Freeman, P.R. Precision Medicine: The Role of the MSIDS Model in Defining, Diagnosing, and Treating Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome and Other Chronic Illness: Part 2. Healthcare 2018, 6, 129.   https://www.ncbi.nlm.nih.gov/pubmed/30400667 ) provides a potential framework to address not only the epidemic of Lyme disease, but the growing chronic disease health care burden in the US.

I would like to thank the MSIDS Research Foundation (MRF) for their support in helping to publish this study, my colleagues at the University of New Haven, Stanford and Johns Hopkins University for their tireless work in finding answers for chronic LD, Dr Phyllis Freeman, my longtime friend and collaborator, who has supported me through publishing all of the above articles, and finally my medical staff, that has been supporting my work and the Lyme community for over 30 years.

If anyone would like to partner on performing a RCT on the above DDD CT protocol, or has questions about the study, please contact me. I look forward to working with you all on this important project.

Best wishes,

Rich Horowitz 

Disclaimer: The views expressed are those of Dr Richard Horowitz, and do not represent the views of the Tick-Borne Disease Working Group, HHS or the United States.