References for HB 660 and SB 557
Additional References
When it takes the DOH decades to start sporatically educating the public about Lyme disease and, for example, the first attempt after years of begging for their help in QAC, ends up to be less than adequate- can't even spell the name of the disease and have rabies brochures to hand out under the Lyme display- it is clear we haven't gotten and won't get any decent help from them.
How Do You Spell Lyme Disease?
NEVER With An "S" On The End.
1. Examples of Sharing & Educating-
The Maryland Department of Health (DOH) Center for Zoonotic and Vector Borne Diseases hosted a series of webinars last March and also regularly offer CME credit courses on Lyme and tick borne diseases (CDC), as well as Lyme Disease Case Study Courses (IDSA).
3. It continues: “The Working Group was authorized by Congress for a total of six years from the date that the Act became law. The current authorization extends until December 2022.”
4. . In fact, one donor recently provided $10 million via a 5 year grant for Lyme research at Johns Hopkins in 2016, in addition to the additional government and private funding they receive. Aucott and Soloski (Hopkins) received $6 million of the total grant for a 5 year study, while Zhang (Hopkins) received $2.5 million and Schwartz (Hopkins) received “over $1 million” for his Lyme related work that will extend from Maryland into Pennsylvania.
5. ... an experienced chronic Lyme treating doctor from New York; FDA Deputy Director; a representative from the Institutional Centers for Clinical and Translational Research, Boston Children’s Hospital; the Director of the Rickettsial [spotted fever] Diseases Research Program at the Naval Medical Research Center U.S. Department of Defense (DoD); Chief Medical Officer at the U.S. Department of Health and Human Services; Director of the Vector-Borne Disease Laboratory who is also the Director of the Division of Infectious Diseases; along with the TBDWG Chair, John Aucott, from Hopkins.
We do have support of the out-of-state national group leaders who are very busy with their organizations and are still trying to represent us by working with the federal TBDWG, so I am fairly sure they won’t want to come to Maryland for this effort.
Chronically ill tick borne disease patients and their doctors won’t, as usual, be fairly represented. Maryland doesn’t have a prominent Lyme organization not affiliated with Johns Hopkins to work on a TBDWG, and only a small handful of chronically ill volunteer patient advocates who are already stretched past their limits or have recently retired for health reasons. We also don’t have healthy, knowledgeable tick borne disease patients ready and waiting for this group to be formed so they can join in (most are trying to catch up and are moving on with their lives).
6. Additionally, many (if not all) do not have the time it would take due to their busy practices, the experience necessary to treat chronic forms of tick borne diseases, the scientific or medical knowledge needed to properly address prevention, surveillance, diagnostics, etc. or the desire to be placed in this situation.
Auwaerter trying to dismiss validated symptoms to lessen the severity of Lyme disease. This effort is to make Lyme fit into a "box" so the box contents can be used to pad their new guidelines with junk science, and be applied in the continuation and development of new tests and a new vaccine. It also pleases insurers who have a vested interest in keeping Lyme sympoms to a minimal to reduce their costs.
Source- https://www.ncbi.nlm.nih.gov/pubmed/27914746
8. BOTH sets of guidelines are to be accepted.
10. IDSA stated in its letter to the federal TBDWG that it has grave concerns about the content in the Access to Care chapter as related to patient treatment. QUOTE- “If the recommendations were implemented as written, they would essentially remove any accountability for physicians providing unproven treatments to patients who may or may not have Lyme disease. These treatments can be harmful, and the recommendations in this chapter would remove patients’ opportunity for redress and prohibit state medical boards from censuring these doctors or preventing them from harming additional patients. Increased federal funding for responses to tick-borne diseases is vital, but this funding cannot come at the expense of funding for other diseases, including HIV. … (continued)
The recommendations and policies outlined in this chapter would subject patients to faulty diagnostic procedures and dangerous, unproven treatments. We also oppose recommendations or laws designed to protect clinicians who provide harmful treatments. In addition, we oppose any attempts by the Working Group to undermine widely accepted medical guidelines for the treatment of Lyme disease that are rooted in scientific evidence or to promote clinical guidelines that are not evidence-based. We are apprehensive about the potential impact of the recommendation to provide protections for doctors who follow “recognized guidelines.” The term is exceedingly broad and could easily be applied to guideline recommendations that lack sufficient evidence or are based mainly on patient preference such as the ILADS guidelines that give physicians broad latitude regardless of documented efficacy or safety. (continued)
This recommendation was adopted by a margin of only one vote, by far the most contentious vote of the Working Group, yet due to the composition of the writing group, the report will contain no minority opinion on this issue. This is a highly significant oversight and defect.”
12. Money to be made... QUOTE- "All of the patents are jointly owned by CHOP and the Wistar Institute. Offit is one of the three listed inventors on the vaccine patents but holds 100% of CHOP’s inventor rights. The other two inventors, Fred Clark and Stanley Plotkin, are both affiliated with the Wistar Institute (in a December 2005 transaction that was similar to CHOP’s deal with Royalty Pharma, the Wistar Institute sold its royalty interest in Rotateq to Paul Capital for $45 million).
Additional Information/References
Paul Auwaerter at Johns Hopkins…
QUOTE- "Physicians and laypeople who believe in the existence of chronic Lyme disease have formed societies, created charitable foundations, started numerous support groups (even in locations in which B. burgdorferi infection is not endemic), and developed their own management guidelines." Source
QUOTE- "Patients are really buying into this pseudo science argument," he said. "Auwaerter is also with the Infectious Diseases Society of America. He dismissed the Connecticut attorney general's investigation as misguided, and its conclusions as a "smokescreen.”
QUOTE- “Although science has not supported the concept of chronic Lyme disease, the entity has continued to draw favor among some patients, healthcare providers, media, and politicians despite, or perhaps due to, the controversy. … It is of paramount importance that key decision makers for both patients and public alike understand that fairness and balance have no place in medicine…”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540629/
QUOTE- “A small set of practitioners have advanced the notion that patients with chronic, subjective symptoms, such as fatigue, musculoskeletal aches, and neurocognitive symptoms, have ever-present infection with B. burgdorferi that requires treatment, with months to years of antibiotics often prescribed in combination or by parenteral administration.”
QUOTE- “This highly vocal debate probably more reflects the unmet needs of many patients and the frustrations of our incomplete understanding of post–Lyme disease syndrome. Passions will likely run high until progress can assuage this uncertainty and provide proven, effective therapy for these patients.”
https://academic.oup.com/cid/article/45/2/143/419655
QUOTE- "Sometimes it's non-Hodgkin's Lymphoma. Sometimes it's Parkinson's disease. Sometimes it's simply sleep apnea, and that's why the patient has been walking around in an exhausted fog. Dr. Paul Auwaerter, clinical director for infectious diseases at Johns Hopkins University Hospital, has a whole list of such conditions, all of which turned out to be afflicting patients of his who thought they had chronic Lyme disease. "I think the criteria is a bit too loose by these doctors who consider themselves Lyme specialists," Auwaerter said.” [ABLS- Anything But Lyme Syndrome]
QUOTE- “It’s very rare that people will require a second course of an antibiotic to eradicate the actual bacteria that causes Lyme disease. That said, a small percentage of people have symptoms after the antibiotic treatment course, including muscle aches and pains and fatigue,” notes Auwaerter. “These post-infection symptoms will improve over time.”
June 2010- Baltimore's Child
QUOTE- “Infectious Diseases Society of America [IDSA] believes very strongly that the bill that passed in Connecticut is not a good bill,” says Paul Auwaerter, MD, IDSA spokesman and clinical director of infectious diseases at Johns Hopkins University School of Medicine in Baltimore. “It takes politicians and inserts them into the medical decision making arena. We do not think this kind of bill ends up in the patients’ best interest.” Lyme Disease Treatment Guidelines All Wrong? Zerbe, June 5, 2009 http://www.rodale.com/lyme-disease-treatment-legislation
QUOTE- "When I look here in academics and I train infectious disease fellows, fellows don't want to see Lyme patients," says Auwaerter. "They don't want to enter this controversial area because it seems like it's just a recipe for headaches. I think the debate, as it were, has gotten to such a level that it may stifle research." Tick Wars
http://www.baltimoremagazine.net/this-month/2008/06/tick-wars ]
QUOTE- "Those who advocate for “Chronic Lyme Disease” often use “specialty Lyme research laboratories” that diagnose the infection using unvalidated methods. This is confusing for patients.” (Hopkins Medicine Spring/Summer 2008- In the Spotlight)
QUOTE- "The continued vitriol (or political emphasis) that believers of chronic Lyme disease have taken to the state houses, to politicians, and others, do little to advance the cause in the long-term."
QUOTE- "I am afraid that the media and even the Internet and other sources easily amplify information that is not very soundly reached or based or even practiced widely."
QUOTE- "Blumenthal alleged that there were conflicts of interest and anti-trust violations. Due to significant legal costs, the Professional Society of the Infectious Disease Society of America elected to settle this.”
http://www.medscape.com/viewarticle/723539
QUOTE- "… “chronic Lyme disease.” This term is used by a small number of practitioners (often self-designated as “Lyme-literate physicians”) to describe patients whom they believe have persistent B. burgdorferi infection, a condition they suggest requires long-term antibiotic treatment and may even be incurable. Although chronic Lyme disease clearly encompasses post–Lyme disease syndrome, it also includes a broad array of illnesses or symptom complexes for which there is no reproducible or convincing scientific evidence of any relationship to B. burgdorferi infection." Source
QUOTE- "Although anecdotal evidence and findings from uncontrolled studies have been used to provide support for long-term treatment of chronic Lyme disease, a response to treatment alone is neither a reliable indicator that the diagnosis is accurate nor proof of an antimicrobial effect of treatment." Source
QUOTE- "It is highly unlikely that post–Lyme disease syndrome is a consequence of occult infection of the central nervous system.” Source
QUOTE- "How should clinicians handle the referral of symptomatic patients who are purported to have chronic Lyme disease? The scientific evidence against the concept of chronic Lyme disease should be discussed and the patient should be advised about the risks of unnecessary antibiotic therapy. ... If a diagnosis for which there is a specific treatment cannot be made, the goal should be to provide emotional support and management of pain, fatigue, or other symptoms as required. Explaining that there is no medication, such as an antibiotic, to cure the condition is one of the most difficult aspects of caring for such patients. Nevertheless, failure to do so in clear and empathetic language leaves the patient susceptible to those who would offer unproven and potentially dangerous therapies. Additional advice to clinicians is included in the Supplementary Appendix, available with the full text of this article at www.nejm.org.” Source
QUOTE- "Chronic Lyme disease is the latest in a series of syndromes that have been postulated in an attempt to attribute medically unexplained symptoms to particular infections. Other examples that have now lost credibility are “chronic candida syndrome” and “chronic Epstein–Barr virus infection. The assumption that chronic, subjective symptoms are caused by persistent infection with B. burgdorferi is not supported by carefully conducted laboratory studies or by controlled treatment trials. Chronic Lyme disease, which is equated with chronic B. burgdorferi infection, is a misnomer, and the use of prolonged, dangerous, and expensive antibiotic treatments for it is not warranted." Source
QUOTE- “Lastly, although advocates offer testimonials to the good works of LLMDs and chronic Lyme disease treatment outcomes, there is little published quality evidence to back their practices or support the hypothesis of ongoing infection. What is present either does not suggest response rates higher than the approximately one-third improvement noted in published placebo-controlled trials or is of low quality, with some of the more highly touted even lacking case definition methodology. This lack of good quality evidence and practices has not dimmed efforts to popularize chronic Lyme disease.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540629/
QUOTE- “Despite the disconnect between valid scientific data and the content of these internet writings, Lyme advocacy groups have flourished, including in states that do not have endemic B. burgdorferi infection such as Colorado (18). The appeal of these groups may lie in the information presented in Lyme blogs or on advocacy web sites espousing views that Lyme disease is difficult both to diagnose and to treat, and that mainstream medical opinions are biased due to undocumented conflicted interests or corrupt practices. Such conspiracy views appear to channel practices that have long been used by some movements in American politics, such as McCarthyism, trading on frustration and anger, plying fear of the unknown and paranoia to exploit their point of view (19). (NOTE- There is Lyme disease in Colorado.)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540629/
QUOTE- “In addition to maintaining a robust internet presence, these Lyme disease advocacy groups and activists have worked to develop a foundation of LLMDs, research and publications, and meetings to promulgate their theories. One of their intentions, for example, is to assert the existence of a vast and under-recognized epidemic of Lyme diseases. Advocates have taken this and other messages to the traditional media who, in turn, have perhaps unwittingly given significant time to the advocates' points of view; these mainstream publications appear to have blunted the rightful characterization of these groups' fringe philosophy and its pseudoscience underpinnings. Beyond undue fair balance, many media pieces trade on testimonials and human interest stories conveying a saga of chronic Lyme disease; those often outshine the counter arguments of sound science (if even presented). This phenomenon may well be exacerbated by the decline of scientific literacy within journalism generally (20). Pseudo-documentaries have been among the latest techniques to launch vitriol against established experts and practices.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540629/
QUOTE- “Given the veneer of legitimacy, advocates have amplified the effects of media campaigns by harnessing political routes. Both Connecticut and Rhode Island have passed legislation to protect practitioners from any disciplinary action in their treatment of Lyme disease, and similar bills have been introduced in at least 11 other states (Diana Olson, personal communication, December 2011). Mandated insurance coverage for long-term and parenteral antibiotics for Lyme disease is now law in New Jersey. Among the more unusual efforts, advocacy groups upset with the newly updated 2006 IDSA Lyme disease guideline have sought legal means to have it withdrawn or altered, largely because of the guideline recommendation against long-term antibiotic therapy for Lyme disease due to ineffectiveness and potentially harmful effects.”
QUOTE- “In his role as Connecticut Attorney General, Richard Blumenthal launched an investigation into the 2006 IDSA guideline with allegations of undisclosed conflicts of interest among the authors and the complaint that alternative therapies addressing chronic Lyme disease were not considered.”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540629/
QUOTE- “Aided and empowered by these web-based modalities, advocacy groups have secured celebrity endorsements, fundraising mechanisms, and political lobbies. In addition to the impacts described above, these advocacy groups are also affecting mainstream medicine. For example, some healthcare providers now come to understand Lyme disease in terms provided by patients who have investigated information on the internet, citing half-truths such as a need for long-term antibiotic therapy for treatment, or the poor sensitivity of B. burgdorferi serological testing. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540629/
QUOTE- “When clinical studies indicate no advantage with the use of long-term antibiotics, the ethical question of whether LLMDs are serving well their patients without conflict of interest might also be raised (31). When questioned, typical arguments offered by LLMDs include critiques of these studies as inadequate and/or rebuttal references of low quality (32). Many also either offer untested theories or rely on anecdotal experience to guide their practice.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540629/
QUOTE- “The argument of whether current scientific and clinical data support or refute chronic Lyme disease has itself consumed considerable energies. The debate may be side-tracking efforts to research the causes and treatment of these poorly understood problems. Critics claim that an open mind should be maintained about chronic Lyme disease. Allowing this entity to secure any significant footing, however, will only add fuel to the forces that have corrupted public opinion in similar veins…”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540629/
Here is a list by Auwaerter in his CV that states what journals he reviews.
Editorial Activities (ad hoc reviewer)
American Family Physician
American Journal of Managed Care
American Journal of Medical Sciences
American Journal of Tropical Medicine and Hygiene
British Medical Journal
Clinical Infectious Diseases
Emerging Infectious Diseases
European Journal of Internal Medicine IDSA Guideline Reviews
International Journal of STD & AIDS
Journal of the American Family Physician
Journal of the American Medical Association (JAMA)
Journal of General Internal Medicine
Journal of Infectious Diseases
Journal of the Physician and Sports Medicine
Lancet
Medicine
Medical Principles and Practice
New England Journal of Medicine
Science Translational Medicine
World Journal of Pediatrics
See page 22 at this link…
https://badlymeattitude.files.wordpress.com/2016/02/auwaerter-paul-cv_2012_rh_redacted.pdf
Auwaerter Quotes
QUOTE- “Curiously, Paul Auwaerter… states that “there is a scarcity of data” that Lyme disease infections may persist—even though he co-authored a 2016 Frontiers of Microbiology article that describes how Lyme-causing Borrelia burgdorferi bacteria can morph into forms that survive typical antibiotic treatment, and which [he] seeks to find new combinations of antibiotics that may kill these “persisters.” https://www.huffingtonpost.com/entry/the-lyme-wars-meet-the-players_us_58de57b2e4b04ba4a5e252db
QUOTE- “The problem, Auwaerter said, is that Lyme has taken on a certain "disease du jour" quality. And believers in the chronic form ascribe such a broad range of symptoms to it that they can chalk up virtually any physical or psychological problem to Lyme disease. … Regarding patients who claim they've recovered after extended treatment with antibiotics, Auwaerter said he suspects that they're simply getting over the after-effects and would have recovered anyway.”
QUOTE- “Because there is no FDA-approved treatment for persistent Lyme disease, it falls to doctors to treat the symptoms affecting patients, using anything from cognitive-behavioral therapy to pain medication." Tick Wars
NOTE- Auwaerter has served on the Food and Drug Administration’s Anti-Infective Drugs Advisory Committee. He is also an ad-hoc editor for over 20 journals which explains in part why many chronic Lyme disease articles are not published.