President's BlogSlam Dunk for WNBA−Slam for Delle Donne & Lyme Patients
From LDA President Pat Smith’s Blog:
What has happened to one of the best Women’s National Basketball Association (WNBA) players is no surprise to the Lyme Disease Association or hundreds of thousands of chronic Lyme patients. Elena Delle Donne, of the Mystics, has been denied by the WNBA league’s panel of physicians as having a health exemption due to being at high risk for COVID 19, thus unable to be paid for exemption status if she does not play the upcoming season. She had a letter from her personal physician who confirmed her high risk status as she has suffered from Lyme for many years, and the team doctor deferred to that physician’s appraisal.
Apparently, the league’s physician panel decision was based on the CDC’s list of people of any age with certain underlying medical conditions are at increased risk for severe illness from COVID-19. The CDC medical conditions list does not include Lyme. The omission is not surprising when you consider that our government has denied treatment to 20%+ of Lyme patients because it does not acknowledge their condition. This position of the government on chronic Lyme has persisted for decades–Lyme disease as we know it has been around 46 years.
Chronic Lyme can lead in many cases to complete debilitation and even death, so why wouldn’t the government classify someone with chronic Lyme as high risk? A high risk admission would provide validity to the claims backed by hundreds of peer reviewed articles published on research in credible institutions that indicate chronic, persistent, Lyme might be real.
The recent discovery of “persisters” and biofilms associated with Lyme disease threaten the house of cards built by the deniers. The patients they have denigrated, mocked, and dismissed over decades might really be sick? These chronic patients might actually need more antibiotics than the ~3 weeks now provided under the IDSA guidelines—guidelines clandestinely, or not so, supported by federal health officials? Guidelines that these officials have tried to remove references to on their websites by removing the name and keeping the contents? As the saying goes, “If it looks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck.” From what I hear, the Lyme community votes for the duck. The government continues to endorse IDSA guidelines for diagnosis and treatment.
The government will not however, reference the International Lyme & Associated Diseases Society (ILADS) Lyme Treatment Guidelines, those used by Lyme literate physicians, who use clinical judgment to treat longer-term for Lyme disease if they feel it is necessary.
In fact, a recent NIH FOIA came to my attention which documents a discussion in 2008 between a then NIH official and an HHS employee as to possible removal of the ILADS guidelines from the government’s then active National Guidelines Clearing House under HHS’s Agency for Healthcare Research and Quality (AHRQ).
The chronic Lyme deniers carefully choose their handpicked biased science often published in their own journals and loudly tout the over generalized Lyme treatment trial conclusions–all are sacrosanct. Their message is clear: No more research is necessary, and no one should question that, especially patients, advocates, and Lyme literate physicians.
Meanwhile, patients cannot get a timely diagnosis, an appropriate treatment, and as Delle Donne found out, a high risk designation. All this denial, yet CDC estimates from studies that there are 300,000+ Lyme disease cases annually in the US alone, and government admits some 15-20% continue to have symptoms. But is it Chronic Lyme? NO. Persistent Lyme? NO. What is it then we ask, 46 years later. Listen to the sounds… of silence.
NOTE: Although LDA President Pat Smith is an HHS TBD Working Group Member, this Blog does not express the opinions of HHS or the HHS Tick-Borne Disease Working Group.
For more information:
Contentious 9 Hour WG Meeting: Persistent Infection a Religious Belief? WG Co-Chair Says Yes
Pat Smith Describes Pre-Meeting Effort to Minimize Lyme.
Below in For the Record are the written comments LDA President Pat Smith, a public member of HHS TBD Working Group read (slightly compressed) into the record at the Working Group (WG) meeting on July 8 about the potential WG Chapter report for which she was responsible, the only one addressing patient issues. 89 written comments/deletions to the report had been suggested before the meeting by Working Group members. Working Group Co-Chair Dr. David Walker and Member Eugene Shapiro were responsible for moving to delete entire sections of Lyme material from the report, many of which called for the removal of much of the Lyme material and the de-emphasis of Patient Access to Care in the Chapter.
Co-Chair Says “almost religious belief that it’s a persistent infection”
At the meeting itself, Working Group Co-Chair, Dr. David Walker, and Member Eugene Shapiro made and seconded many motions to remove material from the proposed draft report including the two sets of guidelines, shared decision making, access to care, Lyme treatment trials, and cost of Lyme disease. There was also a discussion in which Shapiro and Walker wanted to remove Lyme mouse model studies and other animal studies that showed persistence that were included in the draft report, saying animal models were really not a good use for this infection.
Dr. Walker said there is “emphasis on belief…almost religious belief that it’s a persistent infection” and at various times said they probably didn’t have Lyme to start with. After many hours of this discussion, no other WG members would second the motions for removal.
For the record: The importance of today’s meeting and our Chapter review can’t be overstated. My Access to Care, Education & Training subcommittee including healthcare providers and patients, with expertise in the problems associated with patients’ access to care including physician education, submitted a 75-page subcommittee report and additional 45 citation pages documenting these problems to get help for a body of patients neglected especially those who develop the most serious stage of Lyme and to prevent acute patients from reaching that stage. Patients looked to this WG created through legislation initiated by, written by, and pushed through Congress by Lyme patients/advocates. In 2019 through now, 78% of comments to the online WG mailbox were about TBD/Ticks, 70% of those TBD comments were on Lyme disease and 81% of those were on chronic/persistent/PTL, not acute.
Before the January 2020 Working Group meeting, WG members were instructed to read each subcommittee report. Subcommittee co-chairs presented reports at that meeting. In my subcommittee case, since I had not had an active co-chair for a while, a subcommittee member stand-in, not permitted to vote or ask questions, was allowed to present with me a PowerPoint, including Subcommittee rationale and recommendations later discussed, modified, and voted upon.
Then, writing groups of 2 WG members each were solicited for each Chapter to be written for the WG report to Congress. The WG was definitively told that all information for the WG report had to be taken from the Subcommittee reports. I asked if newly published information, for example, could be used, was told, yes, but then the WG would have to approve that new material. Recently activated WG alternate member Captain Scott Cooper and I volunteered to write the Chapter we’re presenting today.
As directed, we pulled language from the subcommittee reports, submitted our Chapter for review and was told “well organized, appropriate to audience level, and it flowed logically,” but we needed to “rebalance” the chapter as there was too much information on Lyme disease and access to care than other tick-borne diseases and education. Suggested rebalancing included removing a factual table from CDC which listed TBDs for 3 years, in descending order of reported case numbers, as the table could “inadvertently diminish the importance of other tick-borne diseases because their numbers are much lower.” It was OK that we led with burden of disease (cost, quality of life, & productivity), compelling reasons for Congress to act. However, we should remove those items from our Chapter report background and put them into the background for the entire WG report, despite the fact they were developed specifically for our patient issues. Bottom line: minimize Lyme, reduce access to care.
We incorporated additional other TBD material from subcommittee reports into the Chapter and shortened the Lyme portion. We didn’t remove the table, since it factually portrayed reported case numbers, nor did we remove our background material germane for our specific patient issues. After another review submission, we were told the Chapter was “starting to become balanced” but now it was too long. We needed to shorten it. We again shortened to include removing the redundant list of recommendations upfront, already elsewhere in the Chapter.
All WG Chapter Writers had a deadline to post draft Chapters to a WG private Share Point site. WG members had a May 22 deadline to submit comments there on all chapters. All Chapter language was now up for grabs, we were told, even the language we took from the already discussed Subcommittee reports, not just new language. I objected, since that seemed to contradict process discussion at the prior meeting. Significantly, I objected to the lack of process transparency, which was directing these online SharePoint discussions to be behind the scenes–not WG members in public holding transparent discussion with all WG members, embodying the intent of a FACA Working Group. Time went by with no response to my objection, so I reluctantly decided to proceed with filing for resolution through a FACA complaint, but I was subsequently informed my concerns were heard, and all discussion would now be in public, as we are doing today so I did not proceed with the complaint.
While working in the private SharePoint site, I stumbled across an unknown person who had direct access to all Chapters and material in the site. Research showed me this individual was from NIH, not either the NIH Working Group member or alternate—another NIH employee, an attorney. Upon questioning the individual’s identity and purpose, I was informed NIH requested that that individual be allowed access to our SharePoint documents and was given access. It appears that government employee WG members have rights public members do not have, are not aware of, and do not have to be informed of. Since public members are considered special government employees, I requested to federal officials that I be permitted to have a patient advocate attorney in SharePoint to review for patient perspective. I was informed my request was denied by WG legal counsel.
These items coupled with others such as a WG member who did not attend being allowed to vote by proxy through the co-chair, without knowledge of the WG, and the unexplained delay in releasing these draft Chapters to the public prior to this meeting for their review and comments before the WG vote are concerning, and refusal to provide the public with government inventories as agreed to at the April meeting. I questioned those practices, which in my opinion, exhibit a disregard for the public, in particular, the patient community. History coupled with these practices reinforce the sentiments of many in the public that they are again being deceived by their own government.
As we move forward on our Chapter section now, note that our printed report has 12 pages with internal citations to address the decades-long problems of hundreds of thousands of Lyme patients plus other tick-borne diseases patients. Additionally, there are 7+ printed pages of comments from SharePoint made by WG members on our Chapter, a number of which call for removal of much of our documented material on Lyme disease─ a disease under-reported by a factor of 10 according to CDC studies and CDC testimony by Lyle Peterson to a Senate Committee, (1) meaning about 350,000 cases annually. According to NIH, Lyme is a disease that makes up 82% of tick-borne diseases, (2) and there were 74 Lyme deaths in 2017. (3) Thus, our Chapter focuses on the tick-borne disease whose patients comprise the largest burden of disease, Lyme disease. That is balance. Captain Cooper, I now turn further Chapter discussion to you.
(3) NIH says 74 deaths in 2017. NOTE: I had accessed this info prior and printed out the information. Link no longer goes to the page. NIH asked at the meeting where I got that death data as they could not find it anywhere. I have sent it to them.
One Health Lyme: ILADS Launches New Research Database
The International Lyme and Associated Diseases Society (ILADS) announced they are launching One Health Lyme, a new registry and crowd-solving platform for medical care providers treating Lyme and other Tick-borne diseases (TBD). This repository is exciting news for the Lyme community!
One Health Lyme is designed to provide valuable resources to clinicians who are treating this patient population. Due to the COVID-19 pandemic, this effort is being pushed forward quickly to provide clinicians the best available resources at this critical time. Clinicians will have a unique opportunity to both track and communicate the impact of COVID-19 on patients with Lyme, allowing important insight from unique immunological legions of these patients to be gathered in the fight against COVID-19.
Through this platform, data regarding patient experience and treatments will be collected from medical care providers to create a vast repository of information about Lyme that physicians and researchers can use to study and treat it and related diseases.
The platform will also be used to provide educational material and act as a support for crowd-sourcing solutions that face physicians treating this patient population.
ILADS plans to seek a partnership with other organizations such as Lymedisease.org, who have been collecting patient data for years, allowing medical professionals to benefit from both initiatives.
Collaboration with Groopit.co, a crowd solving organization, has provided software that allows for the collection of data in real–time from a vast team which allows for more efficiency.
The hope is that One Health Lyme will be able to both inform clinicians on how Lyme disease patients are cared for as well as provide potential insight into COVID-19 itself and the public at large.
*ILADS is a nonprofit, international, multi-disciplinary medical society, dedicated to the diagnosis and appropriate treatment of Lyme and its associated diseases. ILADS promotes understanding of Lyme through research and education and strongly supports physicians and other healthcare professionals dedicated to advancing the standard of care for Lyme and its associated diseases.
For more information, visit: www.ilads.org
12th meeting of the TBDWG-Summary
The 12th meeting of the Tick-Borne Disease Working Group (TBDWG) took place over two days, March 3rd-4th, 2020, at The College of Physicians of Philadelphia in Philadelphia, PA. A summary of this in-person public meeting is as follows:
- Opening statements were presented by Tammy R. Beckham, Director, Office of Infectious Disease and HIV/AIDS Policy (OIDP), US Health and Human Services (HSS).
- The TBDWG discussed and voted on recommendations for the format/template of the 2020 TBDWG Report to the HHS Secretary and Congress. There was full agreement by the TBDWG to use the same format/branding of the 2018 TBDWG Report for the 2020 TBDWG Report to HHS Secretary and Congress.
- Ben Beard, Deputy Director, Division of Vector-Borne Diseases, Centers for Disease Control and Prevention (CDC) provided an update to the CDC Tick Surveillance program. CDC has increased monies and guidance being provided to States to conduct active tick surveillance activities. In addition, the CDC will provide both tick identification and testing services for States that do not have the expertise needed to conduct these activities.
- Public comment was provided by eleven patients/advocates to the TBDWG. These patients/advocates provided heartfelt comments on both personal experience as well as recommended research needs. (click here for public comments)
- Each of the eight Subcommittee chairs brought forward their top three recommendations which were developed from the reports each of the TBDWG subcommittees. The TBDWG discussed and modified each of the three recommendations from each subcommittee and then voted to accept the recommendations to include in the report.
- Writing co-leads were determined for each section of the report. And next TBDWG meeting dates were discussed for May/April and July, 2020, though not yet set.
Though the TBDWG worked through many of the subcommittee recommendations with good consensus, discussions regarding the recommendations brought forth by LDA President, Pat Smith for the “Training, Education, Access to Care and Reimbursement” subcommittee became heated (click here for video) as Pat asked the Federal agency representatives for agreement on website disclosures to increase public awareness for the two divergent diagnostic and treatment and approaches reflected in guidelines for Lyme disease. (video clips: Training, Education, Access to Care and Reimbursement)
Ben Beard, CDC, commented after reading an excerpt from a 1990’s report, that the situation patients face today is very much unchanged from what they faced back then and that this is a “heartbreaking, tragic, failure of Public Health.” However, he also stated that “The vast majority of Lyme disease patients are served quite well by the guidance we have on our website. The diagnostic test is reliable in terms of it telling you what you expect to hear.”
During discussions, Pat implored to the TBDWG, “You have left out a whole entire group of people…the chronic people. These are the people that need the help.” She further stated that “it’s the chronic population that’s being neglected and marginalized.”
LymeDisease.org provides a video clip of Pat Smith’s continued strong advocacy for patient needs in Dorothy Leland’s March 5th, Touched by Lyme blog here.
For upcoming meeting notifications please visit the HHS-TBDWG webpage here.
Public comments may be made in writing directly to the HHS-TBDWG at firstname.lastname@example.org
Two Columbia Studies Need Participants!
Researchers at Columbia University Lyme and Tick-Borne Diseases Research Center are seeking research study participants for two studies. Women to serve as healthy controls are critical to conducting this first study on metabolomics, and patients with confirmed Lyme disease are needed for the second study on Lyme disease and Disulfiram. Please support these clinical studies.
Metabolomics study of Lyme disease: Columbia (Brian Fallon, MD) in collaboration with UCSD:
- Women in Manhattan NY area over next four weeks
- 6-10 healthy women ages 40-60 for controls come to Columbia lab for blood & urine testing, questionnaire, clinical evaluation, sensory testing
- Participants receive $75 & free copies of their bloodwork
- Email Lily Murray for details email@example.com
Lyme patient Disulfiram study:
- 14 week disulfiram study (Brian Fallon, MD)
- Ages 18-65 with confirmed Lyme disease, persistent fatigue, don’t have other major medical comorbid problems, acquired Lyme within prior 16 years
- All research treatment is provided free of charge
- Inquiries on disulfiram study can be sent to: firstname.lastname@example.org or can be made by phone 646-774-7503
- Weblink for this study https://recruit.cumc.columbia.edu/clinical_trial/1661#
For details on these studies and other clinical research opportunities please visit Columbia University, Lyme and Tick-Borne Disease Research Center here.
Researchers! Fiscal Year 2020 Preannouncement for TBDRP is Posted
The FY20 Tick-Borne Disease Research Program (TBDRP) Program managed by the Department of Defense (DOD) office of Congressionally Directed Medical Research Programs (CDMRP) has issued a preannouncement for the FY20 funding opportunity.
The link to the preannouncement can be found here: https://cdmrp.army.mil/pubs/
FY20 funding opportunities available for the Tick-Borne Disease Research Program (TBDRP) include a Career Development Award and an Idea Development Award. Descriptions of each of the funding opportunities, eligibility, key mechanism elements, and funding can be found in the Program pre-announcement.
Submission deadlines will not be available until the Program Announcements are released.
Flyer on CDMRP TBD program highlights:
Point of Contact:
CDMRP Public Affairs
NOTE from Lyme Disease Association: Please do not contact us for information. Contact the CDMRP TBDRP directly. Thank you!
TBDWG Subcommittee Reports Now Accessible
New Study Finds Haemaphysalis longicornis Fails as Experimental Vector of Lyme Disease
The Asian longhorned tick, Haemaphysalis longicornis, first detected in New Jersey in 2017, has since been recorded from 88 counties across 12 eastern states. This highly invasive tick is able to reproduce asexually and is considered an important vector of human pathogens in it native range of Asia. Since it’s detection in the US, many questions have been raised about the potential of this tick to transmit pathogens, and to what extent it will feed on humans. In a new experimental study by Breuner et al., vector competence of a population of H. longicornis ticks originating from New York for a native isolate of the Lyme disease spirochete, Borrelia burgdorferi sensu stricto (s.s.) was performed. The study found that uninfected H. longicornis larvae could acquire B. burgdorferi s.s. while feeding on infected Mus musculus mice, but that the infection was lost during the molt to the nymphal stage. The study also found that attachment and feeding success was minimal when larvae were placed freely on the fur of mice. The study concluded that H. longicornis is unlikely to contribute more than minimally, if at all, to transmission of Lyme disease spirochetes in the United States.
Read full Article:
The Lyme Wars are Not Over for Patients & Treating Physicians
Almost a decade ago, Lyme advocates in Minnesota, pursuing Lyme doctor protection legislation, settled for a compromise from the State Medical Board which issued a Moratorium taking action against doctors who treat long term. The Moratorium was reviewed and extended in 2014, while awaiting more research on the topic.