IDSA 2019 Lyme Guideline Draft
Comments Submitted
#1
2019 IDSA/ACR/AAN Draft Review Document
Lyme ACA & Skin Manifestations
After much trial and tribulation, the IDSA's website will not "accept" the prepared document, so please click on the link below to review it. Please note the formatting is slightly "off" using this method.
Link To Document
https://drive.google.com/file/d/1fM3u6tu_nf4cWigrFisCD1_55oJzB3l_/view?usp=sharing
Submitted this link- MarylandLyme webpage- to the IDSA on Monday August 5, 2019 (approx. 11:30 PM) thru their "system".
#2
2019 IDSA/ACR/AAN Draft Review Document
Bartonella IS A Tick Borne Disease
AGAIN, after much trial and tribulation, the IDSA's website will not "accept" the prepared Bartonella document, so please click on the link below to review the submission. Please note the formatting is slightly "off" using this method.
Link To Document
https://drive.google.com/file/d/1KzT6p7PaFs-cgsBMECM-xucA1XUK-99s/view?usp=sharing
Attempted to submit this document on Monday August 6, 2019 (approx. 1:50 AM) thru their "system" and was unsuccessful. Once it can be uploaded to a different document the link will be posted here.
Attempted again to share this on the IDSA form 8/7/19. Unsuccessful.
Sent this webpage link using the form, and an email to PracticeGuidelines@idsociety.org for guideline draft on Wednesday, August 7, 2019 (approximately 1:30 AM). Asked for a response from them to let me know they got it and/or if I should do it some other way.
Additional Comments Posted to the IDSA Website
The comments below were sent to IDSA through their
Monkey survey form on August 7, 2019.
#3
Lyme Guidelines Draft Page 19- Lines 434-435
The guidelines recommend- "If the mouthparts can not easily be removed from the skin, they should be left alone and allowed to fall out."
This comment has no scientific support at all. The only reason you would recommend tick parts are to be left alone and allowed to "fall out" is to save the insurer reimbursement costs for removing the "parts".
A trip to the ER, a walk-in medical clinic or doctors office can generate costs anywhere from $100 to $1,000 or more.
Additionally, if someone has professional help to remove the tick or its parts they will most likely receive a prescription for anitbiotics in the process, which we know you don't like to see happen.
Have you considered tissue necrosis, alpha-gal syndrome or a secondary infection? Obviously not.
"Histone H4 isolated from Ixodes ricinus salivary gland extract was identified as a molecule with a dissociating effect on human primary fibroblasts. This histone might be involved in the formation of the feeding pool formed around the tick mouthparts and responsible of tissue necrosis in the vertebrate host. Thanks to its selective antimicrobial activity, it may also sterilize the feeding pool and facilitate transmission of pathogens such as Borrelia burgdorferi sensu lato."
https://www.ncbi.nlm.nih.gov/pubmed/30595500
You need to remove statements that only serve to benefit the insurers and/or yourselves.
#4
Lyme Guidelines Draft Page 21- Lines 498-499
The guidelines recommend- "If the tick bite can not be classified with a high level of certainty as a high-risk bite, a wait-and-watch approach is recommended."
When your statements on what tick carries certain diseases is totally wrong, your percentage of those who develop an EM rash are way off, your recommended tests miss 74.9% of those infected and only work if you are tested on a Thursday while wearing one blue sock and a green one and your treatment protocol is known to have failed millions of people- how can this recommendation even be considered- AGAIN?
When the antibiotics you recommend have been found to be totally ineffective in the majority of cases, and left untreated Lyme and coinfections can become chronic diseases that have disabled and killed people, we must ask...
WHAT ARE YOU DOING?
This wait and watch approach you've recommended over the past two decades has been a miserable and complete failure and has caused irrefutable harm.
Multiple surveys starting back in the early 1990's have shown general practitioners are not listening to your recommendations, especially to your wait and watch theories. They've learned the risk to their patients is too high to hold off treating.
https://www.ncbi.nlm.nih.gov/pubmed/8052097
Common sense, even "peer-reviewed common sense", paints an entirely different picture. With dozens of infectious agents harbored in a variety of ticks, why wait and watch when the only known prevention method that actually works is to treat patients as soon as possible, before the infections can disseminate and become entrenched.
If your treatment protocols were successful this approach wouldn't be as terrible. But, they don't work and certainly not for everyone.
Johns Hopkins researchers have shown there are many drugs that put your doxy and amoxy treatment protocols to shame. Check out their multiple studies.
Your own ID doctors are saying TREAT THE BITE- DON'T WAIT!
Dedicated physicians working to help chronically ill patients are finding more effective treatments. For example, Dr. Kenneth Liegner is using disulfiram to help some of his patients while giving people their lives back and cleaning up your failures for you.
https://www.ncbi.nlm.nih.gov/pubmed/31151194
Waiting and watching is about the worst recommendation in your guidelines. That statement should be excluded from any and all literature- FOREVER.
I do believe you need to review your record below before thinking about publishing any guidelines.
HOW WRONG CAN THEY BE?
https://sites.google.com/view/marylandlyme/chronic-lyme/how-wrong-can-they-be
#5
August 18, 2019
Response to IDSA Lyme Disease Guideline Draft
Due to the reprehensible practices, inaccuracies and irregularities surrounding the previous 2006 IDSA Lyme disease guidelines and its panel members, I feel it would certainly behoove all individuals and organizations involved in this new guideline development process to get it right the first time around. Now is your chance to help rather than harm people with Lyme and tick borne diseases and to minimize the legal actions anything less than what accurate and sound recommendations will bring upon the IDSA/ACR/AAN and other panel members and institutions.
Doing the right thing will prevent additional harm coming to patients, and should avoid generating more legal actions against the IDSA, and the chance of similar charges being brought against the ACR and AAN for their participation in this latest guideline development process.
The investigation into IDSA’s history of bias, fraudulent and exclusionary practices, conflicts of interest and its non-transparent nonsense has already cost guideline authors a reported $1,000,000 just to defend themselves against this one guideline related legal action that was filed by the government. That alone should be an incentive for this new panel to get it right.
Some of the 2006 IDSA guideline development process offenses were brought to light by one of the highest law enforcement agencies in the country. This action was not only necessary and long overdue, it was an embarrassment and disgrace to all involved that required a lot of web weaving by the IDSA to try to correct.
With the investigation and final report came years of professional shaming, bad publicity and a long list of additional legal actions against the IDSA, its panel members, and others, some of which actions are still ongoing.
As a reminder of some of the underhanded tactics that are not to be repeated, I am sharing the following quotes directly from the Attorney General’s May 1, 2008 report after his lengthy investigation into the 2006 guideline development process concluded. It is a “Do NOT Do This” check list for your use. [Bold added.]
“Attorney General Richard Blumenthal today announced that his antitrust investigation has uncovered serious flaws in the Infectious Diseases Society of America's (IDSA) process for writing its 2006 Lyme disease guidelines.”
“The IDSA failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a likeminded panel without scrutiny by or formal approval of the IDSA's oversight committee…”
“The IDSA's 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease, once removing a panelist from the 2000 panel who dissented from the group's position on chronic Lyme disease to achieve "consensus";
“The IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded…”
“The IDSA portrayed another medical association's Lyme disease guidelines as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time. In allowing its panelists to serve on both groups at the same time, IDSA violated its own conflicts of interest policy.”
My personal favorite describing the most obvious reasons [financial] for all of the damage to patients that has been occurring- "The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies -- to exclude divergent medical evidence and opinion.”
“In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards."
“Blumenthal's office found that the IDSA disregarded a 2000 panel member who argued that chronic and persistent Lyme disease exists. The 2000 panel pressured the panelist to conform to the group consensus and removed him as an author when he refused.”
“IDSA sought to portray a second set of Lyme disease guidelines issued by the American Academy of Neurology (AAN) as independently corroborating its findings. In fact, IDSA knew that the two panels shared key members, including the respective panel chairmen and were working on both sets of guidelines at the same time -- a violation of IDSA's conflicts of interest policy.”
“When IDSA learned of the improper links between its panel and the AAN's panel, instead of enforcing its conflict of interest policy, it aggressively sought the AAN's endorsement to "strengthen" its guidelines' impact. The AAN panel -- particularly members who also served on the IDSA panel -- worked equally hard to win AAN's backing of IDSA's conclusions.”
Source- https://web.archive.org/web/20170319133146/http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284
In spite of all of the new science and incredible amounts of clinical experience gathered over the past two decades, the 2019 Lyme disease guideline draft by the IDSA and its new partners, the ACR and AAN, has not changed its diagnostic and treatment recommendations from the original 2000 IDSA Lyme guidelines, or its published set of 2006 guidelines.
In Need of Attention: We are unable to verify if there are any Lyme patient representatives on the current panel as required, or if they were vetted for conflicts of interest. The IDSA claims to have three Lyme patients and a parent of a child with Lyme disease on the panel, but has not listed them as being part of the panel and states they will not release information about them (email communication 8/15/19):
“We greatly value their participation but have withheld their identities out of respect for their privacy, because listing their names would disclose protected health information about the patient representatives. We will make their identities public only at their request.”
If someone accepts a place on a panel the very least that should be known to them is that they will have to identify themselves. Otherwise, how will anyone know they exist? The public should know the basics, such as their names, who/what they represent, their experiences with Lyme disease if any, their knowledge of Lyme and tick borne diseases, any conflicts of interest, etc.
Please provide the above information on all of the patient representatives in a public and transparent manner.
Lucy Barnes
Sent by email to IDSA on Wednesday, August 21 at 8:52 PM.
#6
Response IDSA/ACR/AAN Lyme Disease Guideline Draft
Guidelines From Very Confused Authors
Oh What A Tangled Web We Weave
When First We Practice To Deceive
August 24, 2019
Accepting and trusting Lyme disease guidelines written by those who have a long history of being “confused” about multiple aspects of Lyme disease is troublesome. In fact, with the amount of confusion oozing from the authors throughout their 2019 guidelines and their previous Lyme publications it would be detrimental or even dangerous to unleash them on the public.
The common theme throughout Gary Wormser's Lyme disease related publications is CONFUSION. He uses the words confuse, confusion, and confusing almost as many times as he uses the word ‘Lyme’. Not only is Wormser confused, it is evident his handful of coauthors and CDC partners are also confused.
Wormser, et. al. finds Lyme disease itself confusing and the Lyme tests used to diagnose it are confusing. Additionally, Wormser feels changes, even those that are for the better, but, that are not in line with his way of thinking, will cause confusion for others. Ye of little faith.
He admits his fabricated term from the last decade, "Post Treatment Lyme Disease Syndrome" (PTLDS)- is confusing and states the signs and symptoms of persistent or chronic Lyme also confuse him. Wormser goes so far as to warn others that “chronic Lyme disease”, that has stood the test of time in the scientific literature and most accurately describes the disease, should not be confused with his newly dubbed PTLDS.
It appears the confusion has gotten so overwhelming for Wormser (the tangled web we weave) he never even mentioned PTLDS in his latest guideline draft after having pushed this newly coined term on others for over a decade.
Confusion must have also caused Wormser to forget to mention his latest name change to be used in place of Lyme disease- B. burgdorferi sensu lato infection, or Bbsl infection for short. He stated…
QUOTE- “As scientific evidence is not persuasive in this matter, perhaps an approach that would enable clinicians and patients to better understand what was originally intended with the term Lyme disease, is to change the name of the illness using a name that conveys that the condition is not solely a clinical diagnosis, but instead a clinical and a microbiologic/laboratory diagnosis.
To this end, we propose the name B. burgdorferi sensu lato infection, or Bbsl infection for short, instead of Lyme disease. Since most patients with erythema migrans cannot be readily proven to have laboratory evidence of B. burgdorferi infection, such cases would be counted as possible Bbsl infection.” Source
Even though Wormser claims Lyme tests are accurate, he continues to say Lyme disease can be confused with other illnesses. If his tests are really accurate, how could this be?
Wormser appears to be confused about Western Blot bands on the Lyme tests- what the numbers actually mean. For some reason, he is also confused about fungal infections being mistaken for Lyme. ???
He states the Lyme rash (EM) is distinctive and if you have one you have Lyme disease and should be treated. But, he also says the Lyme rash can be confused with other rashes. Huh?
Wormser is confused about symptoms caused by multiple strains of Lyme disease and doesn't seem to know if STARI is one of them?
Wormser has been SO confused that his latest "gem" actually has the word "confusing" in its title!
J Clin Microbiol. 2018 Sep 26. pii: JCM.01406-18. doi: 10.1128/JCM.01406-18. [Epub ahead of print]
Limitations and Confusing Aspects of Diagnostic Testing for Neurologic Lyme Disease in the United States.
Theel ES1, Aguero-Rosenfeld ME2, Pritt B1, Adem PV3, Wormser GP4. Source
Wormser has published his opinions on Lyme disease over the years. Then he uses those same publications to support his opinions in his guidelines. It's clear looking back that there is a lot of confusion in Wormser's World.
For example, Wormser's discredited 2006 IDSA Lyme disease guidelines uses the word "confused" and similar wording EIGHT TIMES! That's not real reassuring when people’s lives are at stake! When an author takes it upon himself to write medical guidelines for patients there should be no room for his confusion!
But, then again, patients and knowledgeable, experienced doctors aren't really following his IDSA guidelines since they have a history of not helping patients in many cases. But, insurers are using them with no hesitation or confusion because they save them money.
In contrast, the most recent 2014 Lyme disease guidelines (Cameron, Johnson, Maloney) are based on facts, not Wormser's confused state of mind and his rocky opinions. Not once is the word "confused" found in Cameron, et. al. 2014 guidelines. And they are by far the most coveted guidelines on the market for those whose get Lyme disease and whose lives are at risk.
The following partial list, consisting of 52 "confused" related quotes, are from Wormser and his friends- Auwaerter, Dattwyler, Lantos, Nadleman, Halperin, Sigal, Steere, Dumler, Krause, Sigal, Nowakowski, Pachner, CDC publications and more.
The "confused" references are highlighted so you can skim through without having to read the "confusing" quotes in their entirety!
Gary Wormser Quotes
WORMSER- "Consequently, there is increasing confusion about what Lyme disease is, or is not, for both patients and healthcare practitioners."
WORMSER- "This change would be expected to cause even more confusion in the Lyme disease field and not benefit in any way clinicians, clinical microbiology laboratories, or patients."
More Quotes By Wormser & Friends
WORMSER- "This area is further confused as PTLDS, or what has been referred to as ‘chronic Lyme disease’, has become a diagnosis for medically unexplained symptoms, even when patients have no evidence of past or present Lyme borreliosis182,183." Source
WORMSER- "Importantly, the various post-infectious complications of Lyme borreliosis should not be confused with signs of persistent infection with B. burgdorferi, and prolonged antibiotic therapy has not been shown to be beneficial." Source
WORMSER- "PTLDS should not be confused with “chronic Lyme disease”." Source
WORMSER- "This, however, can be confused with other illnesses including southern tick−associated rash illness (STARI), an illness that lacks a defined etiological agent or laboratory diagnostic test, and is coprevalent with Lyme disease in portions of the eastern United States." Source
WORMSER- "Although an EM lesion is a hallmark for Lyme disease, other types of skin lesions can be confused with EM" Source
WORMSER- "Nevertheless, an overlap in clinical symptoms, including the development of an EM-like skin lesion, creates confusion and controversy for the clinical differentiation of STARI and Lyme disease" Source
WORMSER- "These latter bands might be confused with the 18-kDa antigen included in the IgG criteria for IB interpretation." Source
WORMSER- "Other skin lesions, however, such as tick-bite hypersensitivity reactions, STARI (southern tick associated rash illness), and certain cutaneous fungal infections, can be confused with EM." Source
WORMSER- "Lyme disease typically presents with a skin lesion called erythema migrans (EM), which though often distinctive in appearance may be confused with cellulitis." Source
WORMSER- "Other skin disorders, however, may be confused with EM." Source
The CDC and Others Are "Confused" Too
QUOTE- "When evaluating testing options, providers and their patients might be confused by the distinction between Clinical Laboratory Improvement Amendments (CLIA) certification of laboratories and FDA clearance or approval of specific tests." Source
John Halperin
Admits yes, he is "confused"!
Halperin Quotes
QUOTE- "A great deal of confusion surrounds the diagnosis, clinical phenomenology, and treatment of Lyme borreliosis." Source
QUOTE- "Samples were obtained from 16 patients with CNS Borrelia burgdorferi infection, eight patients with Lyme encephalopathy (confusion without intra-CNS inflammation), and 45 controls." Source
Paul Auwaerter
A Big Ball of Confusion
Auwaerter's Quotes
QUOTE- "Those who have true Borrelia burgdorferi infection are relatively easily to determine; however, others may be well complicated by confusion regarding test result interpretation as well as competing ideas about Lyme disease from Internet sources or alternative practitioners who often use the term “chronic Lyme disease” or diagnose concomitant tick-borne coinfections. Source
QUOTE- "Much of this confusion arises from improper interpretation of serologic tests for Lyme disease, most notably, reliance on IgM immunoblots for symptoms of beyond 4 weeks’ duration despite admonition otherwise due to high rates of inaccuracy, or application of such testing in nonendemic regions where acquisition of true infection is improbable and therefore false positive findings are highly likely." Source
QUOTE- "Many patients are confused by the apparently polar sets of diagnostic and therapeutic advice voiced by most established professional societies as compared with those articulated by advocates of chronic Lyme disease." Source
QUOTE- "More commonly, it is associated with a febrile illness and can be confused with atypical Lyme disease (without a rash), ehrlichiosis, or anaplasmosis." Source
QUOTE- "Auwaerter said multiple sclerosis, Parkinson’s and fibromyalgia are just some of the conditions frequently confused with Lyme." Source
QUOTE- "It is not possible to draw firm conclusions on the relative efficacy of accepted antibiotic drug regimens for the treatment of LNB." Source
Raymond Dattwyler
A Never Ending Chain of Confusion
Dattwyler Quotes
QUOTE- "The question of how long to treat Borrelia burgdorferi infection is a topic that provokes confusion among a large number of physicians." Source
QUOTE- "One has to question why a reasonable physician would treat a patient this way and more importantly what has led to this confusion." Source
QUOTE- "The occurrence of positive serologies to B burgdorferi in the presence of other diseases can lead to diagnostic confusion." Source
QUOTE- "Despite these possible sources of confusion, the academic physicians believe that Lyme disease usually can be accurately diagnosed." Source
QUOTE- "And some diseases that might be confused for Lyme disease- such as early multiple sclerosis- have periods of remission." Source
Paul Lantos
Super Confusion
Lantos Quotes
QUOTE- "For a medical consumer and for the physician unfamiliar with this subject, this volume of information can be confusing and difficult to navigate." Source
QUOTE- "THE CONFUSING TERMINOLOGY OF CHRONIC LYME DISEASE" Source
QUOTE- "The mere name “chronic Lyme disease” is in itself a source of confusion." Source
Alan Steere
Leader of Mass Confusion
Steere Quotes
QUOTE (1993) "Lack of standardized serologic tests and varying clinical presentations do create confusion." Source
QUOTE (1984)- "Although incomplete presentations of neurologic involvement of Lyme disease may be confused with other entities, the typical constellation of neurologic symptoms represents a unique clinical picture." Source
Peter Krause
Coinfection Confusion!
Krause Quotes
QUOTE- "The diagnosis of babesiosis may be confused with malaria and should be included in the differential diagnosis of posttransplant hemolytic-uremic syndrome in organ transplant patients." Source
QUOTE- "Other skin disorders, however, may be confused with EM." Source
Previous IDSA Lyme Disease Guideline Authors & Supporters
Confused, Confused, Confused
Stephen Dumler Quotes
QUOTE- "Because of the shared tick vector and increased seroprevalence of HGE in patients with Lyme disease, there is some confusion about the identity of these infectious agents and the clinicopathologic spectrum of the disease." Source
Lenny Sigal Quotes
QUOTE- "Disagreement between the belief systems has led to confusion and anxiety, resulting in an alternative, but unproved, approach to management." Source
QUOTE- "Because of confusion over conflicting reports, anxiety related to vulnerability to disease, and sensationalized and inaccurate lay media coverage, a new syndrome, "chronic Lyme disease," has become established." Source
QUOTE- "We describe factors involved in the psychopathogenesis of chronic Lyme disease and focus on the confusion and insecurity these patients feel, which gives rise to an inability to adequately formulate and articulate their health concerns and to deal adequately with their medical needs, a state of disorganization termed aporia." Source
QUOTE- (Title)- "Misconceptions about Lyme disease: confusions hiding behind ill-chosen terminology." Source
QUOTE- "A quarter century after its initial description, a review of the terminology contributing to confusion about Lyme disease is needed." Source
John Nowakowski Quotes
QUOTE- "Lyme disease typically presents with a skin lesion called erythema migrans (EM), which though often distinctive in appearance may be confused with cellulitis." Source
QUOTE- “While this lesion may at times be almost unmistakable in appearance, diagnostic confusion can occur with insect bites, plant dermatitis, or other cutaneous erythemas.” Source
QUOTE- “The presence of these bands might lead to diagnostic confusion.” Source
Andrew Pachner Quotes
QUOTE- "Third-stage parenchymal involvement causes a multitude of nonspecific CNS manifestations that can be confused with conditions such as multiple sclerosis, brain tumor, and psychiatric derangements." Source
QUOTE- "Although incomplete presentations of neurologic involvement of Lyme disease may be confused with other entities, the typical constellation of neurologic symptoms represents a unique clinical picture." Source
Robert Nadelman Quotes
QUOTE- "Other skin disorders, however, may be confused with EM." Source
IDSA LYME GUIDELINES
CONFUSION RELATED QUOTES
QUOTE- "There is no well-accepted definition of post–Lyme disease syndrome. This has contributed to confusion and controversy and to a lack of firm data on its incidence, prevalence, and pathogenesis."
QUOTE- "Possible explanations for the higher proportion of arthritis cases in national reporting include reporting bias favoring the tabulation of seropositive Lyme disease cases, confusion between arthritis and arthralgia by the treating health care provider [203], and inaccuracy of Lyme disease diagnosis [203]."
QUOTE- "Lyme encephalomyelitis may be confused clinically with a first episode of relapsing-remitting multiple sclerosis or primary progressive multiple sclerosis, but appropriate CSF and serum studies for B. burgdorferi–specific antibody should differentiate between these entities in most instances [216–218]."
QUOTE- "Considerable confusion and controversy exist over the frequency and cause of this process and even over its existence."
QUOTE- "This was an important omission, because the appearance of cellular debris may be confused with spirochetes on microscopic examination of culture supernatants [304]."
QUOTE- "This has contributed to confusion and controversy and to a lack of firm data on its incidence, prevalence, and pathogenesis."
QUOTE- "Because Babesia species may be confused with malarial parasites on blood smear, confirmation of the diagnosis and identification of the specific babesial pathogen may require additional laboratory testing."
QUOTE- "Sigal, LH. Misconceptions about Lyme disease: confusions hiding behind ill-chosen terminology, Ann Intern Med , 2002 , vol. 136 (pg. 413- 9)"
We Need People Writing Guidelines
Who Are NOT Confused Or
Who Think Others Are Confused!
Lucy Barnes
Sent to IDSA Practice Guidelines Email Address- September 5, 2019- 2:22 AM
RESPONSE FROM IDSA, AAN & ACR ON
GRANTING EXTENSIONS &
ADDITIONAL ACCOMMODATIONS
Due to the inability of many with Lyme & Tick Borne Diseases to be able to use the IDSA/ACR/AAN & Tufts Guideline Draft Review and Submission process and forms, and prepare and submit a response within the 45 days allotted, I wrote the following letter to ask for disability accommodations.
Hopefully we will be provided the help needed to have our voices heard.
ATTENTION- TIME SENSITIVE
August 7, 2019
Dear IDSA, ACR and AAN Members & Staff, Tufts University Staff, 2019 Lyme Disease Guideline Panel Members & Staff, CDC and NIH,
As a volunteer involved in Lyme and tick borne disease education, prevention and support for more than two decades, I would appreciate being able to participate in the IDSA/AAN/ACR and Tufts Lyme Disease Guideline Draft Review and Comment period. Along with others, I am very interested in having medical guidelines that are used by the CDC, NIH, insurers and other agencies, that will help patients and their physicians in the coming years, while also having meaningful input along the way.
It has been thirteen years since the 2006 IDSA Lyme disease guidelines were published. Since that time the IDSA, AAN, ACR and Tufts have had the opportunity to review the new scientific literature as it is published, make notes and examine all of the details in preparation for the next set of guidelines.
As you know, there are a record number of IDSA/ACR/AAN panel members (33) who have been working on these new 2019 guidelines for several years, as well as three large medical organizations and their staff members to assist as needed in the process.
Your team has also had the benefit of additional staff at Tuft’s doing much of the detailed work over a period of several years.
In the guidelines you stated (page 2) the following.
xxxxx
As you will note, there are a number of different topics to be reviewed. The IDSA/ACR/AAN and Tufts members were fortunate, unlike members of the general public, to have specialists on hand to consult with if they had questions. Unlike the general public, they also have access to scientific articles that are often hidden behind pay walls from those who need more information.
The majority of patients I assist as a volunteer are already chronically ill and often totally disabled. Many have families to care for and/or part time jobs to focus on.
Given their experience with Lyme and tick borne diseases they certainly want to make comments and have their voices heard in this important process. Unfortunately, they aren’t being given the chance.
The problem is they are unable to read and thoroughly review the three hundred (300) plus guideline draft pages, supplements, charts, lists, sources, etc., and take notes, research detailed scientific literature, prepare a report and submit their completed project in less than 45 days.
With over 200 pages laid out in the format below, it would be difficult for even the most educated and healthiest of people, who have a lot of free time and no disabilities, to plow through to be able to comprehend the information provided on all of these pages.
xxxxx
Many disabled patients are unable to read the entire document online or even parts of it, especially in one sitting. Many need the document printed out (often in large print form) due to their compromised vision and cognitive damage.
Many are unable to think clearly on many days due to Lyme related “brain fog”, pain and other symptoms and complications, which also limits the amount of days/time they can devote to this project.
Many patients across the country simply can not participate in this process and complete the project on time due to the severity of their tick borne disease related illnesses, their resulting disabilities and/or the effort and energy involved.
As volunteers, some of us may be able to assist them, however, we’ve been trying to get our own papers completed within the 45 day deadline so we haven’t been able to reach out to help. Some will succeed and others will not.
The IDSA/ACR/AAN and Tufts policy does not allow people to print the documents to be able to read them and take notes.
That combined with the restrictions preventing people from copying and pasting sections into a word document so they can be addressed, and the short amount of time allotted to complete this daunting task is unfair to all interested parties, especially the disabled.
It places an undue burden on them, essentially silencing countless voices across the country and even world wide.
Personally, I have prepared two large documents complete with photos and links that will not copy and paste into the monkey survey form we are required to use when submitting comments.
The photos don’t show up at all, and the links are not working. Additionally, the formatting becomes so jumbled (paragraphs pushed together, no center for titles, spacing problems, etc.) that it would take hours to try to correct it once inserted into the form and even then I am still not sure it will be readable.
My vision is too poor to be able to do this additional work in the tiny space allotted on the form in the small font that automatically appears, and my energy levels are already strained attempting to complete my project on time; therefore, I am not able to use the only option you’ve provided to submit comments.
I’ve attempted to submit my larger papers several times over several days via the required form; however, it is not working and I’ve not been given another option by those running the site to assure my comments will be accepted and distributed to the panel members.
I basically got a “canned” response when I contacted practiceguidelines @idsociety.org that was not helpful (more confusion) and I have not heard back since my last email to this address.
I write to you today, shortly before the 45 day deadline is upon us, and at a time when we’ve realized too many people are being excluded from this review process due to their disabilities.
I (we) request that you act immediately to accommodate anyone who is unable to complete their submissions by the deadline so they may have a chance to participate in this process.
You can do this easily by allowing an additional 90 days for everyone to review the documents and submit comments; by releasing the lock preventing anyone from copying and/or copying and pasting sections of the guidelines into their documents before submitting them; and by providing a regular email address for submissions that can not be entered, as is, into the form provided.
Please immediately accommodate all of us so we are not excluded and we may have a voice in this very important matter. Thank you very much for your consideration. I will be awaiting your reply.
Sincerely,
Lucy Barnes
Friday, August 9, 2019
Received an email at 8:48 PM tonight.
Ms. Barnes:
Thank you for submitting your comments on the draft guidelines. IDSA, AAN and ACR have extended the public comment periodfor the draft of their joint guidelines for the prevention, diagnosis, and treatment of Lyme disease for an additional 30 days.
The deadline to submit comments is now Sept. 9, 2019.
In addition to the deadline extension, the format of the draft guidelines posted on the public comment website has been changed to allow readers to search, download and print the document, ensuring that anyone interested in submitting comments is able to access the draft guidelines and have appropriate time to review and comment.
We sincerely value the opinions of patients and the general public and are hopeful that the new format of the draft document on the website, as well as the 30-day extension, will provide more opportunity for valuable feedback.
Thank you.
~ ~ ~ ~
Verification for the new submission date (September 9, 2019) is posted on the IDSA website, located here.
For those who have already submitted their comments, please remember you are allowed up to 20 submissions, so there may be time to make some additional short comments.
For those who were unable to complete the task in the short time allotted please take this time to share your comments.
2nd Request For Accommodations
Monday, August 12, 2019
Good morning practiceguidelines@idsociety.org
Sorry! I asked, but you have not provided a name yet, so I am unsure how to address you?
Thank you for responding to some of our disability related concerns. Your effort is appreciated; however, you did not respond to several of our requests so I am contacting you once more on behalf of the disabled Lyme patients and general public.
1.) We previously requested a 90 day extension, but for some reason after the IDSA/ ACR/ AAN has worked on these guidelines for years, you’ve allowed us only 30 more days to respond.
That will not alleviate the problem for many patients who couldn’t complete the task in the original time limit of 45 days, since they will now need to start over with the process and there is even less time allotted to complete it.
If you could extend that arbitrary 30 days and allow us more time- the 90 days as originally requested- that would be accommodating.
2.) We need the ability to copy and paste specific sections of the draft into our documents so we can stay focused during our reply, and so the readers know exactly what we are referring to as they are looking over our comments.
Since the guideline questions were divided up between 33 members of the panel there are additional concerns.
(The draft said there were 36 panel members, however, the 3 patient representatives were not named, not given credit for their work and by the looks of the guidelines supposedly did not participate in the process?)
The IDSA/ACR/AAN guideline draft states panel members each got two clinical questions out of the thirty total questions (pg. 6, line 136).
I would like to know if the original members will be getting the comments relevant to their previously drawn conclusions, or a more independent review will be considered by sharing the comments with other panel members who will need to actually see the sections being addressed. Either way, the documents we submit to you need to be complete and can not be for many if we don’t have the ability to use the copy/paste function.
Since this request may not seem important to those with all of their faculties, I will explain further.
The inability to copy and paste requires those like myself with brain/eye/joint/muscle damage, memory problems and vertigo triggered by excessive eye movement (scrolling, sideway movements, etc.) to have to try to go back and forth between their own document and the guideline draft, if they can, to find where they left off and then read it word for word, then switch over, line up the cursor and try to remember what the guidelines said, and then type it out- small piece by small piece.
This creates a wickedly frustrating and often impossible situation for many.
For those only addressing one line from the 303 draft pages it is no doubt a chore, but for those who are addressing multiple sentences and paragraphs throughout the draft, or who are preparing multiple submissions- you allow 20 per person- it is not possible.
Personally, I can not do this “back and forth” task at all and depend on the ability to copy and paste so I will not become more ill by jumping around from page to page, and so I can also remember what I am addressing as I write.
This is a fairly common disability in those with neurological Lyme disease who have sustained cognitive damage.
3.) I also asked for an alternate way to submit our comments rather than using the monkey survey form. (Please refer to my original letter.)
As I have explained, one of my responses is 49 pages long and another is 40 pages.
They both include photos and many links with sources. We were able to email comments to the IDSA in the past, however, there is no option now other than using the monkey survey form that won’t allow us to submit our documents in tact.
It is not just those who are compromised who are having problems with the monkey survey form and the restrictions. I spoke with someone who is not disabled, is very bright, who is familiar with the system you are using and who is quite “techy”.
It took them over three hours to submit their document which was smaller than either of mine and included no photos. They, as well as others, are concerned many of us will not be able to comment at all due to this situation.
With that in mind, I would like to have an email address for the IDSA, ACR and/or AAN to mail our attached documents to that is not the following address.
practiceguidelines@idsociety.org
IF we get responses from that address, and I haven’t gotten responses on some emails I’ve sent, they are slow in coming and don’t fully address the situation, requiring a delay and multiple emails.
We also don’t know if the person responding is an IDSA representative or is part of the monkey survey outfit.
Again, I do appreciate the help you have provided to date. However, if I can sum it up…
If I was provided a wheel chair with only one wheel, I still wouldn’t be able to do what is necessary to get by.
Therefore, I would appreciate a longer time frame to submit the comments, the ability to copy and paste the sections referenced from the draft into our documents, and a good, working email address where we can send our comments to when they are not able to be submitted in tact through the survey monkey form.
A prompt reply would be appreciated and is actually necessary to allow those who are trying to comment on the guideline draft the ability to do so.
Thank you,
Lucy Barnes
(Sent by email to IDSA, ACR & AAN on Monday, August 12, 2019 at 4:21 AM)
2nd Response From IDSA/AAN/ACR
Thursday, August 15, 2019 (12:21 PM)
Ms. Barnes,
Thank you for your additional feedback. We have adjusted the draft guideline document so individuals may cut and paste from it in addition to downloading and printing and hope this will make it easier for you and others to review and provide feedback on the document.
Because the draft guidelines have been publicly available since June 26, 2019, we believe that the additional 30 days provides sufficient time for those who were unable to submit comments earlier to finish their submissions.
Since you have had difficulty using the survey, you are welcome to submit your comments to the practiceguidelines@idsociety.org email address.
We have also updated the language on the public comment webpage to indicate that others may also submit comments using the email address.
Please note that this email address provided (practiceguidelines@idsociety.org) is the optimal way for you to communicate to ensure that messages are received.
While the guideline questions were divided among the panel members for the purposes of developing the draft, every member of the panel will be provided all of the feedback from the public comment phase and will update the draft if needed.
Finally, you are correct that the panel includes three patient representatives.
We greatly value their participation but have withheld their identities out of respect for their privacy, because listing their names would disclose protected health information about the patient representatives.
We will make their identities public only at their request.
Thank you again for your feedback on the draft guidelines.
[Again, no name provided]
My Response to IDSA/ACR/AAN
August 16, 2019 (10:31 AM)
Good morning,
Thank you for responding, who ever you are. Problem-- you said the guideline draft was now able to be copied and pasted. It isn’t working for some reason. Please adjust it and let me know so I can notify others who are also waiting. Thank you.
I am sincerely disappointed about the lack of time granted for people to be able to review the 303 pages and respond. Many people couldn’t reply or quit trying early on when they saw how difficult it would be. They now must start over from scratch with less than half the time originally allotted, so I’d appreciate more consideration on this accommodation. Thank you.
Unfortunately, no one is buying the IDSA's explanation about the three patient representatives (and parent of a child with Lyme disease?) who are mysteriously missing in action, including myself. Due to the long history of Lyme patients, volunteer patient advocates, Lyme organizations, doctors, lab personnel and others with differing opinions being excluded from IDSA Lyme related projects that affect our lives dramatically, we’d like to explore this current lack of representation further. More to follow.
Thank you,
Lucy Barnes
My Response To IDSA/ACR/AAN
Addressing No Patient Representatives Listed
August 16, 2019 (12:22 PM)
August 15, 2019
Dear IDSA/ACR/AAN & Lyme Disease Guideline Panel Members,
Due to the reprehensible practices and irregularities discovered surrounding the previous 2006 IDSA Lyme disease guidelines and its panel members, I feel it would certainly behoove all individuals and organizations involved in this new guideline development process to get it right the first time around to prevent any additional harm coming to patients, and to avoid generating any more legal actions against the IDSA, and the chance of similar charges being brought against the ACR and AAN for their participation in this latest guideline development process.
The previous investigation into IDSA’s bias, fraudulent and exclusionary practices, conflicts of interest and its non-transparent nonsense cost guideline authors a reported $1,000,000 just to defend themselves against this one guideline related legal action filed by the government. That alone should be an incentive for you to get it right.
Some of the most blatant of the 2006 IDSA guideline development offenses were brought to light by one of the highest law enforcement agencies in the country.
This legal action was not only necessary, it was an embarrassment and disgrace to all involved. With it came years of shaming, bad publicity and a long list of additional legal actions against the IDSA, its panel members, and others; some of which are still in progress.
As a reminder of some of the actions not to be repeated, I am sharing the following quotes directly from the Attorney General’s May 1, 2008 report after his lengthy investigation into the 2006 guideline development process concluded. [Bold added.]
“Attorney General Richard Blumenthal today announced that his antitrust investigation has uncovered serious flaws in the Infectious Diseases Society of America's (IDSA) process for writing its 2006 Lyme disease guidelines.”
“The IDSA failed to follow its own procedures for appointing the 2006 panel chairman and members, enabling the chairman, who held a bias regarding the existence of chronic Lyme, to handpick a likeminded panel without scrutiny by or formal approval of the IDSA's oversight committee…”
“The IDSA's 2000 and 2006 Lyme disease panels refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease, once removing a panelist from the 2000 panel who dissented from the group's position on chronic Lyme disease to achieve "consensus";
“The IDSA blocked appointment of scientists and physicians with divergent views on chronic Lyme who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though it was later expanded…”
“The IDSA portrayed another medical association's Lyme disease guidelines as corroborating its own when it knew that the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time. In allowing its panelists to serve on both groups at the same time, IDSA violated its own conflicts of interest policy.”
[My personal favorite to describe the damage to sick patients that has been occurring]- "The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests -- in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies -- to exclude divergent medical evidence and opinion.
In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards."
“Blumenthal's office found that the IDSA disregarded a 2000 panel member who argued that chronic and persistent Lyme disease exists. The 2000 panel pressured the panelist to conform to the group consensus and removed him as an author when he refused.”
“IDSA sought to portray a second set of Lyme disease guidelines issued by the American Academy of Neurology (AAN) as independently corroborating its findings. In fact, IDSA knew that the two panels shared key members, including the respective panel chairmen and were working on both sets of guidelines at the same time -- a violation of IDSA's conflicts of interest policy.”
“When IDSA learned of the improper links between its panel and the AAN's panel, instead of enforcing its conflict of interest policy, it aggressively sought the AAN's endorsement to "strengthen" its guidelines' impact.
The AAN panel -- particularly members who also served on the IDSA panel -- worked equally hard to win AAN's backing of IDSA's conclusions.”
Source- https://web.archive.org/web/20170319133146/http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284
In spite of all of the new science and incredible amounts of clinical experience gathered over the past two decades, the 2019 Lyme disease guideline draft by the IDSA and its new partners, the ACR and AAN, have not changed their diagnostic or treatment recommendations from the original 2000 IDSA Lyme guidelines, or its next published set of 2006 guidelines.
1st Situation In Need of Attention: We are unable to verify if there are any Lyme patient representatives on the current panel as required, or if they were vetted for conflicts of interest.
The IDSA claims to have three Lyme patients and a parent of a child with Lyme disease on the panel, but has not listed them as being part of the panel and states they will not release information about them (email communication 8/15/19):
“We greatly value their participation but have withheld their identities out of respect for their privacy, because listing their names would disclose protected health information about the patient representatives. We will make their identities public only at their request.”
At this time I am formally requesting the IDSA/ ACR/ AAN patient representatives and the additional parent with a child with Lyme disease be identified for the public (ask them for the information), along with their experiences in dealing with Lyme and tick borne diseases, and the level of their education regarding Lyme and tick borne diseases.
We also want to know if they have been through any process to check for conflicts of interest, if they have published or worked with, or are related to any of the panel members and if they will be morally and legally responsible for the recommendations they helped to develop.
We would like, and it is long overdue, a finished usable product that will help and not hurt any more people. You still have a long way to go to get there.
Sincerely,
Lucy Barnes
SEVEN DAYS WITH NO RESPONSE FROM IDSA, ACR or AAN
Resent previous email and attached letter on Friday, August 23, 2019 at 6:35 PM, with a note stating...
Practice Guidelines- IDSA Society,
It’s been 7 days and there has been no response to this letter. We also, still, can not copy and paste sections as you said we could do. That is holding up responses. Please fix the copy/paste function and respond to the letter.
Thank you,
Lucy Barnes
Last Updated- August 2019
Lucy Barnes
scc