There have recently been a few changes to some major scientific guidelines by the American Heart Association/American College of Cardiology (AHA/ACC), along with a new book on Lyme disease by IDSA members. I will address these today and leave the discussion of insurance coverage in the US and the new NIH vaccine guidelines for part 2, with a brief discussion of emerging infections.
Most of us in medicine follow guidelines as long as they are scientifically valid, make sense, and clinically work in the real world helping patients. Let’s examine some recent guidelines (and grade them) to see how they may or may not provide crucial information to improve patients’ lives. Then lets discuss some of the flaws in our present healthcare system guidelines with a patient of mine who was just denied care by a major insurance company in what I consider to be a life or death situation. That was the initial impetus for me to write this Medical Detective Substack on guidelines and how useful (or not) they actually were.
The New AHA/ACC Guidelines
For some of us practicing internal medicine for decades, it came as no surprise that a new BP target was announced by the AHA/ACC considering that cardiovascular disease is one of the top 10 killers in the US and the world. Their biggest new recommendation was that the overarching blood pressure treatment goal is now less than 130/80 mmHg for all adults, which is a revision of the 2017 recommendations that often used 140/90 mmHg as a treatment starting point. It appears that many people have read these guidelines and will adopt them, as the number of downloads since its release 6 weeks ago is a whopping 42,734!
Top Take home Messages:
“HBP is the most prevalent and modifiable risk factor for the development of CVDs, including coronary artery disease, heart failure, atrial fibrillation, stroke, dementia, chronic kidney disease, and all-cause mortality. The overarching blood pressure treatment goal is <130/80 mm Hg for all adults, with additional considerations for those who require institutional care, have a limited predicted lifespan, or are pregnant.
“For all adults, lifestyle changes, including maintaining or achieving a healthy weight, following a heart-healthy eating pattern (such as DASH [Dietary Approaches to Stop Hypertension]), reducing sodium intake, increasing dietary potassium intake, adopting a moderate physical activity program, managing stress, and reducing or eliminating alcohol intake are strongly recommended to prevent or treat elevated blood pressure and hypertension.”
These guidelines are practical, and should benefit large numbers of individuals, providing an easy-to-follow schema to improve cardiovascular risks. I would grade this an A+.
The New Lyme Book/Guidelines by IDSA Members
A new Lyme book was just released by members of the IDSA that was edited by John Halpern. You can buy the book or see chapter excerpts by going online:
https://www.cabidigitallibrary.org/doi/book/10.1079/9781800626225.0000
Is there anything new in this book? I don’t know because I haven’t bought it, nor have many people if I am reading the metrics correctly, as it appears there have been 15 downloads of the chapter by Dr Wormser since its release almost two months ago. Compare that to the AHA/AHCC guidelines where 42,734 people downloaded it! Of course, to be fair, those guidelines were free. Dr Halpern’s book is $180 and is 360 pages. I’m curious why anyone would make such a book so expensive, so no one would buy it. Even IDSA members….
If anyone should buy this Lyme book and read it, please let me know if there are any groundbreaking insights. However based on a review of what was on line as a ‘teaser’ by Dr Gary Wormser that a single 200 mg dose of doxycycline is often effective for a tick bite within 72 hours, and that there is no proof that a chronic Borrelia infection persists, with post-treatment symptoms not improving by additional courses of antibiotic treatment, I am doubtful there is much that is new. That has been the stance of these authors for decades despite new science being published in the peer-reviewed literature.
Regarding the one dose of doxycycline: apart from the ILADS scientific guidelines debunking that myth, this is from an independent Canadian guideline on ‘One Dose of Doxycycline for the Prevention of Lyme Disease: A Review of Clinical Effectiveness and Guidelines
“Limitations
One of the main limitations of the body of evidence is it rests on the results of a single RCT published in 2001. The effectiveness estimate in the RCT has a wide confidence interval, and if one of the 26 patients lost to follow-up in the treatment group developed erythema migrans, effectiveness would no longer be statistically significant. The use of erythema migrans as a surrogate outcome for Lyme disease has not been validated. The length of follow-up was insufficient to detect late manifestations of Lyme disease. The trial is also ungeneralizable to patients bitten by other black-legged ticks, patients exposed to multiple tick-borne diseases, or manifestations of Lyme disease other than erythema migrans. Additionally, a medical entomologist was used to identify the tick as Ixodes scapularis, which requires a certain level of expertise not generalizable to the medical community as a whole.”
So scientifically, that study is highly flawed, and has the potential to harm patients. Interestingly, one of the last consultations I did two months ago failed the one dose of doxycycline. Regarding the ability of Borrelia to persist in the body, when I reviewed the cited references from Dr Wormser, none of my articles were listed below (I know, shocking). I have listed some of them for you with two documentaries and a podcast I did with other doctors (put in the correct passcode below) who can attest to the effectiveness of using dapsone combination therapy and the MSIDS model for those suffering from CLD/PTLDS. My findings are validated by a culture model from Eva Sapi’s group at the University of New Haven showing dapsone’s effectiveness against the biofilm/persister forms of Borellia; an animal model at Tufts showing rifampin and dapsone cured the mice with chronic Lyme disease; as well as approximately 400 chronically ill Lyme and TBD patients attesting to the effectiveness of this approach (in retrospective studies) with other doctors having tried it, finding the approach to be successful:
Dapsone documentary 2024:
https://players.brightcove.net/6314452011001/PAMDt93Yi_default/index.html?videoId=6353288590112
Dapsone documentary 2025:
https://drive.google.com/file/d/1pyenOMXjYGHCJaOAgwIH4psI-9Z5botN/view
Dr. H Podcast with Dr Alain Mass and Dr Charlie Bizilj on The Success of Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease. May 21, 2025
Passcode: &0yqten0
10 Dapsone Articles on The Effective Treatment of Chronic LD & Associated Co-infections Including Bartonella: As of May 11, 2024
Horowitz, R.I.; Fallon, J.; Freeman, P.R. Combining Double-Dose and High-Dose Pulsed Dapsone Combination Therapy for Chronic Lyme Disease/Post-Treatment Lyme Disease Syndrome and Co-Infections, Including Bartonella: A Report of 3 Cases and a Literature Review. Microorganisms 2024, 12, 909. https://doi.org/10.3390/microorganisms12050909
Horowitz, R.I.; Fallon, J.; Freeman, P.R. Comparison of the Efficacy of Longer versus Shorter Pulsed High Dose Dapsone Combination Therapy in the Treatment of Chronic Lyme Disease/Post Treatment Lyme Disease Syndrome with Bartonellosis and Associated Coinfections. Microorganisms 2023, 11, 2301. https://doi.org/10.3390/microorganisms11092301
Horowitz RI, Freeman PR. Efficacy of Short-Term High Dose Pulsed 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 Literature Review. Antibiotics. 2022; 11(7):912. https://doi.org/10.3390/antibiotics11070912
https://www.mdpi.com/2079-6382/11/7/912/htm
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
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
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, 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
Horowitz RI, Freeman PR (2016) Are Mycobacterium Drugs Effective for Treatment Resistant Lyme Disease, Tick-Borne Co-Infections, and Autoimmune Disease?. JSM Arthritis 1(2): 1008.
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
Tardo AC, McDaniel CE and Embers ME (2023). Superior efficacy of combination antibiotic therapy versus monotherapy in a mouse model of Lyme disease. Front. Microbiol. 14:1293300. doi: 10.3389/fmicb.2023.1293300
https://www.frontiersin.org/articles/10.3389/fmicb.2023.1293300/full
I listed in the 2023 Microorganism’s paper the entire dapsone protocol so that anyone can go to their doctor and use it and prove its efficacy. That is how science works. It should be open-access for the benefit of all. One of the people in the documentary above, who was sick for years, did just that and got help (I never met her personally). So when books or guidelines purposefully leave out science that doesn’t fit their world view, instead of just debating it and telling us why they don’t believe it, I can’t find a reason to support the conclusions in the rest of the book, despite the fact that many of the authors are smart people and may have valid things to say about ticks or other tick-borne diseases in general. I did send a copy of my R34 NIH grant to Paul G. Auwerter, who is one of the authors, hoping to get feedback and be inclusive. I did the same for Dr Alan Steere. They were kind in responding, but I never heard back regarding details of how to improve my NIH multi-center, placebo controlled, randomized controlled trial (RCT) of dapsone combination therapy. I know they want the ‘gold standard’ in medicine, a RCT, to prove my hypotheses, so I am starting that process to prove the world that what I have discovered works. Science needs to be open and inclusive of all viewpoints. Looking at the chapter from Dr Wormser, this book does not provide that, rehashing old news. I give it a D but admit my own bias. It appears all my scientific references and other showing Borrelia persists were left out.
Where Insurance Guidelines Fail Us
I have a woman in a major, world-renowned teaching hospital in the Northeast who was just diagnosed with MAI, Mycobacterium avium intracellulare. This is an opportunistic lung infection usually only seen in severely immunocompromised patients. I (not the doctors at this teaching hospital) evaluated her and found she was severely immunocompromised with Chronic Variable Immune Deficiency (CVID). She had low IgG levels and two subclass deficiencies. She also tested positive for mold toxins (gliotoxins) that are immunosuppressive. That helped explain how she got this severe infection. The ID doc put her on 6-7 antibiotics, most of which were IV for the first few months, which is the standard-of-care, but did not tell her to take biofilm agents, even though MAI is a biofilm/persister infection like Borrelia burgdorferi.
“Mycobacterium avium complex organisms and other nontuberculous mycobacteria (NTM) are waterborne opportunistic pathogens with a strong propensity for surface adherence and biofilm formation… Efforts to eradicate M. avium complex and NTM are thwarted by their preference for surface adherence and biofilm formation”
From: Falkinham JO. Mycobacterium avium complex: Adherence as a way of life. AIMS Microbiol. 2018 Jun 12;4(3):428-438. doi: 10.3934/microbiol.2018.3.428. PMID: 31294225; PMCID: PMC6604937.
“M. avium biofilm formation is enhanced by commonly used compounds and, in the sessile bacterial phenotype, is resistant to clarithromycin and ethambutol, in a reversible manner.”
From: McNabe M, Tennant R, Danelishvili L, Young L, Bermudez LE. Mycobacterium avium ssp. hominissuis biofilm is composed of distinct phenotypes and influenced by the presence of antimicrobials. Clin Microbiol Infect. 2011 May;17(5):697-703. doi: 10.1111/j.1469-0691.2010.03307.x. PMID: 20636426; PMCID: PMC2978799.
The guidelines being used to treat this sick individual did not include adding biofilm agents to the antibiotic regimen, to help increase the efficacy. It did not include looking for reasons why she got the infection in the first place, and when I went to her major insurance company, petitioning for immunoglobulin therapy, I was denied. Why? She made antibodies after a pneumococcal challenge. They ignored the fact that only severely immunosuppressed individuals get MAI, she had CVID, and toxins suppressing her immunity. Their guidelines would only allow it if she didn’t make antibodies. She is waiting to see an immunologist at her major teaching hospital, which is taking months to book, and doctors and nurses keep telling her (I’m not exaggerating) that everyone dies from this infection! This is a big OY. This is a major failure of guidelines. A nurse for the insurance company is reading what to do out of their guidelines book.
Many of you know of my prior fights with insurers over finding Babesia in the Hudson Valley in the 1990s, and being thrown out of insurance panels because I was spending money for an infection that “didn’t exist”, when they purposely ignored hundreds of positive titers, PCRs and FISH tests, with patients responding to my treatments. Money and medicine are bad bedfellows. The problem I saw 30 years ago still exists today.
Next week: the new NIH vaccine guidelines and healthcare gaps in the US.