10th Meeting of TBDWG – Sept 12, 2019 Summary

The tenth meeting of the Tick-Borne Disease Working Group (TBDWG) was held via webcast on Sept 12, 2019 from 9:00 a.m. to 3:00 p.m. ET. 

 

 

  • Subcommittee members were announced, and the Working Group received reports from the eight subcommittees that were formed during the June 4, 2019 meeting. 
  • Two subcommittee name changes were approved to broaden the focus of the subcommittees. The two modified subcommittees are now 1.) Babesiosis & Tick-Borne Pathogens and 2.) Training, Education, Access to Care & Reimbursement.
  • Public comments were presented by eight patients and avocates over a 30 minute time period. Issues shared included alpha-gal, 2019 TBDWG membership as it relates to patient/advocate representation, and transparency of the TBDWG process.
  • Three topic development briefs were shared with the Working Group. A common theme throughout the briefs was that the most existing research that had been collected in this process is either inconclusive or indicates that further research is needed in each of the three topic areas presented. The three topic development briefs were: 1.) Cause of increase for tick-borne diseases, 2.) Cause of persistent Lyme disease, and 3.) State of current testing for tick-borne diseases.
  • The Working Group created a new subcommittee, Federal Inventory, to analyze the new Federal inventory content for use in the 2020 report to congress. LDA President and TBDWG member, Pat Smith, volunteered to be a part of this new subcommittee. 
  • Pat Smith also requested the list of NIH grants be released to the public.
  • Timeline for subcommittee work and dates for the next two (in-person) TBDWG meetings were announced.

The next (in-person) public meetings will be held January 28 & 29, 2020 in Washington, DC and March 3 & 4, 2020 in Philadelphia, PA

For details visit HHS-TBDWG webpage

Comments to the TBDWG may be emailed directly to tickbornedisease@hhs.gov




CDC Recommends New Lyme Disease Tests Cleared by FDA

The CDC formally recommends several new serologic assay testing methods recently cleared by the FDA. The Lyme disease serologic assays, which utilize a sensitive enzyme immunoassay (EIA) for detecting pathogens, were cleared by the FDA on July 29th, 2019 and have since been determined to be acceptable alternatives for the serologic diagnosis of Lyme disease by the CDC. Serologic assays that utilize EIA rather than western immunoblot assay in a two-test format can be used in place of the western immunoblot assay as the second tier of testing.

In 1994 the CDC and FDA met with several other government health organizations for the Second National Conference on Serologic Diagnosis of Lyme Disease. The consensus reached was a recommendation for a two-test methodology which uses an EIA or immunofluorescence assay as a first test, followed by a western immunoblot assay for specimens yielding positive or equivocal results (cdc.gov). At the time, it was determined that evaluation of any new serologic assays would include blind testing against a comprehensive challenge panel, and that new assays should only be recommended if their specificity, sensitivity, and precision equaled or surpassed the performance of tests used in the recommended two-test procedure (cdc.gov).

Clearance by FDA of the new Lyme disease assays indicates that test performance has been evaluated and is “substantially equivalent to or better than” a legally marketed predicate test (cdc.gov).

According to LDA President Pat Smith, “Although it has been the hope of the Lyme community to have a new Lyme test cleared, it was always with the proviso that new technology needed to be used in test development. With the current two-tier system, which was first implemented in 1994, a positive or equivocal ELISA test is followed by the Western blot. This method is considered to be about 50% accurate by many, although treating physicians feel the Western blot is perhaps the most significant element of the current Lyme testing protocol.”

“The new two-tier testing system for Lyme disease, the ZEUS ELISA, is now being offered as an alternative to the existing testing protocol. Because ZEUS lacks a Western blot and is not a new technology, it is difficult for many to fathom how this new paradigm, that has been cleared by the FDA as ‘substantially equivalent’ to the existing testing with 50% accuracy, will improve the diagnosis of Lyme disease.”

Click here to see the CDC’s recommendation of the new serologic assay testing.




Military Developing Uniform Repellent to Replace Permethrin

As part of the Pentagon’s second annual “Bug Week,” an event organized to raise awareness of insects and the diseases they carry, the Defense Department announced its plans to develop a new and improved product that will eventually replace permethrin, the repellent and insecticide currently used to soak most military combat uniforms to protect against insect bites and stings.

Officials were unable to disclose many details about the new product, which is undergoing testing and evaluation, but did comment that the new treatment could potentially be used at a lower level of toxicity, and can possibly last the entire length of a uniform’s lifetime, an improvement from permethrin’s coverage which lasts only up to 50 washes.

Dr. James English, a global health specialist with the Uniformed Services University pointed out the many shortcomings of permethrin and stated, “We are working on a new chemical … that would also include environmental factors like sweat, ultraviolet light and abrasion, so we are trying to make it last longer.”

When it comes to vector-borne diseases, the Defense Department asserts that Lyme disease continues to be the top domestic threat to U.S. troops while mosquitoes and the diseases they carry are a major challenge overseas.

References
1. Military.com. Military Eyes Bug-Repellent Coating to Replace Permethrin in Uniforms. [News Article]. Copyright 2019 Military Advantage. https://www.military.com/daily-news/2019/08/02/military-eyes-bug-repellent-coating-replace-permethrin-uniforms.html




Educate Your Doctors! Publicize the 20th Annual Lyme Conference

Help ensure that our doctors and others are educated about Lyme and tick-borne diseases.
 
The Lyme Disease Association & Columbia University will be holding their 20th CME scientific conference, Lyme & Other Tick-Borne Diseases: 20th Annual Scientific Update for Clinicians & Researchers, on September 21 & 22, 2019 in Philadelphia, PA at the Hilton Penn’s Landing on the banks of the Delaware. 
 
Please print CONFERENCE FLYER and distribute to places in your community such as:
  • Doctor’s office2019 Conference Flyer
  • Local hospital
  • Urgent Care Centers
  • School Nurse
  • Support group meetings
  • Library
Note: adjust printer for legal-sized paper
 
Click here to Register
Click here for General Info
Pre-Conference Video



HHS Announces Sep 12 Tick-Borne Disease Working Group Meeting

State CapitalThe Department of Health and Human Services (HHS) gave notice that the Tick-Borne Disease Working Group (TBDWG) will hold a public meeting via webcast on September 12, 2019, from 8:30 a.m. to 5 p.m. ET (times are tentative and subject to change).

At the upcoming meeting, the TBDWG will receive updates from eight subcommittees that were formed and tasked with drafting a 2019 report for the HHS Secretary and Congress regarding activities and research related to tick-borne diseases, such as surveillance, prevention, diagnosis, diagnostics, and treatment (source, hhs.gov). The subcommittees will take into consideration the 2018 report and are expected to identify gaps in tick-borne disease research as well as offer suggestions (source, federalregister.gov).

The confirmed times and agenda items for the online meeting will be posted on the TBDWG page of the HHS website.  Members of the public who wish to view this meeting online are encouraged to register. Click here to register for the September 12th TBDWG Meeting.

Article References: FederalRegister.Gov and HHS.Gov

View the announcement for the 10th meeting of the TBDWG on FederalRegister.Gov




Illinois Governor Signs Law Expanding Insurance Coverage for Lyme Disease Treatment

On August 12, 2019, Illinois Governor, JB Pritzker, signed House Bill 889 into law which will expand insurance coverage for Lyme Disease testing and treatment. According to the Governor, this new legislation has been greatly needed and is a big step forward in protecting children and families throughout the state.

Tick-borne illnesses have been on the rise throughout Illinois since 2004, and have had an especially devastating effect on working-class farming communities.

“Many are losing their homes, their businesses and their pensions to try and pay for continued treatment,” said Illinois Lyme Association Director Jennifer Russell. “This legislation provides them with desperately needed options.”

The new law will be a great source of support for families who have struggled to pay for the high costs of continuous treatments often associated with long-term recovery. “State government ought to be standing up for working families … Expanding health care coverage is one important way to help lower costs and build a higher standard of living for all Illinoisans,” said Governor Prizker.

Sources:
week.com
http://ilga.gov
www2.illinois.gov

Lyme Disease Association, Inc. has not yet reviewed this legislation.

 



URGENT: Your Help Needed for Inspector General Investigation

TO: Lyme Disease Advocates & Patients ActNow
FROM:
Lyme Disease Association, Inc. Pat Smith, President, 8-15-19
RE: Urgent & Immediate Help Needed to Investigate Information Which Could Lead to Helping to Solve Tick-Borne Diseases Problem

ISSUE: The debate over the prevalence of Lyme disease and whether it exists in a chronic form has raged for decades. Kris Newby’s well-researched book, “Bitten,” provides documented evidence that the properties of the Lyme pathogen itself and its ally, the tick, appear to be part of our nation’s biowarfare studies. The suspicions of disease sufferers, their advocates, and treating physicians deserve investigation.

WHAT GOOD WOULD AN INVESTIGATION DO? Results of an investigation could possibly:
  • Change how tick-borne diseases are viewed.
  • Change attitudes about patients.
  • Have an impact on treatments.
  • Have an impact on tick control.
  • Lead to increased federal funding.

WHAT CAN YOU DO TO HELP?


BACKGROUND: Swiss-American scientist Willy Burgdorfer is acclaimed for identifying the spirochetal bacteria which causes Lyme disease. Indeed, the pathogen bears his name, Borrelia burgdorferi. Yet, as the author discloses through filmed interviews and archival reviews, there were other aspects to Willy’s research. Employed by the US government and headquartered at Rocky Mountain Laboratories, Burgdorfer was enmeshed in biological warfare projects.  Ms. Newby discusses his work in Switzerland for the American government which led to the identification of a new strain of Rickettsia, a pathogen, if crossed with Borrelia, might well complicate treatment and thus be a candidate for biowarfare.  Interviews by Ms. Newby with American researchers on the topic of the Rickettsia, dubbed “the Swiss agent” by Dr. Burgdorfer, did not shed any light on the mystery pathogen whose existence seems to be buried in the past.

Ms. Newby’s discovery of tick drops and the experimental release of ticks document ongoing biowarfare research and questions the consequences if studies go awry. The prevalence of new diseases and the expansion of tick territories are examined in the context of newly revealed government studies.

CONGRESSIONAL ACTION TAKEN TO DATE: The Lyme Disease Association has kept Congressman Christopher H. Smith (NJ) apprised of Lyme disease developments over the decades including the release of the book, “Bitten,” and provided him with a pre-released copy along with our grave concerns that the quality of material and level of research merited immediate action. He read the book and took action that included educating as many in Congress as possible, which culminated with the US House of Representatives voting July 11, 2019, to pass Smith’s Amendment #355 to the National Defense Authorizations Act (NDAA) for Fiscal Year 2020 (HR 2500), directing the Inspector General of the Department of Defense to “conduct a review of whether the Department of Defense experimented with ticks and other insects regarding use as a biological weapon between the years of 1950 and 1975. HR2500, as amended, passed the House on July 12, 2019. View Amendment #355

WHO OPPOSES AN INVESTIGATION TO UNCOVER THE TRUTH?: The same entities who claim there is no scientific evidence to support chronic Lyme claim— with little or no evidence— that this is a conspiracy theory perpetuated by advocates and patients. Most of them are the same individuals who have distorted information about the diagnosis and treatment of Lyme disease. They have debunked chronic Lyme disease for decades, despite a vast amount of new research evidence from prestigious institutions on the topic of persistent infection with the Borrelia bacteria after treatment. Like their specious arguments against chronic disease, these critics do not acknowledge nor present any verified opposition to the documents chronicled meticulously by Ms. Newby over five years of visits to the government archives, the Burgdorfer home−including interviews with Dr. Burgdorfer himself, and other places where Dr. Burgdorfer gave some records he did not want the government to have.


HOW CAN YOU HELP?

Here’s What To Do & Say: Contact the Senators offices as explained in STEPS listed below

*Let them know you want him/her to support the Smith Amendment #355 to the National Defense Authorizations Act (NDAA) which requires the Inspector General of the Department of Defense to investigate a possible US biowarfare program involving ticks and other insects that may have contributed to the spread of tick-borne diseases.

*Tell them that the public has a right to know if there was such a bioweapons program and a right to be provided with the details on what, where, and when these weaponized organisms may have been released on an unsuspecting public.

*Explain that there may be information which could help in the fight of tick-borne diseases today, when about 427,000 cases of Lyme disease occurred in 2017 in the US according to the CDC, and about 20 tick-borne diseases and conditions are now found in the US.

Thank him/her.

Please contact Milena@LymeDiseaseAssociation.org with any questions. 

 

URGENT! ACTIONS FOR YOU TO TAKE NOW:
Congress is on recess and many Members are back in their home districts.

STEPS:

Look at the US Senate Armed Services Committee Table Below

1. If there is a Member who is a US Senator from your state

  • Call his/her state office (number in table below) to get a personal meeting with him/her while they are home in-state.

OR

  • If you cannot get a personal in-state meeting with your Senator
      • Set up a meeting with a local office staff member and ask them to teleconference in the appropriate staff member from the Washington, DC office to your meeting.

    OR

  • If you cannot meet with your Senator’s office in-state, call them at the DC office number (in the table below)

After completing the above, please call as many of the remaining offices as possible at the DC number (in the table below).

Skip #2.

 

2. If there is NOT a member from your state

  • Please call as many Armed Services Committee members on the list below, as possible at their DC office number. Ask for whoever is responsible for the National Defense Authorizations Act (NDAA) in that office. The more Senators we contact, the better chance we have of getting an investigation.

 

Tips for How to Contact U.S. Senators

  • A telephone call usually has the most impact. When addressing your U.S. Senator, always refer to them as “Senator (Name)” or “The Honorable (Name)”.
  • When emailing, use the same formality as you would when writing a letter. 
  • When addressing an envelope or letter, always refer to your legislator as “The Honorable (Name)”. For the salutation, write: “Dear Senator (Name),” so your message doesn’t look like junk mail (referenced from sbsb.com).
    • Example:
        • The Honorable (Senator’s Name) 
          United States Senate 
          Washington, D.C. 20510 
  • If your senator is the chairman or ranking member of a committee, type the full title under the senator’s name in the address block. Committee position information is included in the table below. 
  • For more information on how to contact U.S. Senators, visit www.senate.gov OR www.sbsb.com
  • If you have any questions, please contact Milena@LymeDiseaseAssociation.org

 

 

MEMBERS of SENATE ARMED SERVICES COMMITTEE

See above TIPS on how to contact your Senator.

NamePRT-STCommittee PositionDC Office Ph # State Office Ph #Email/Form Contact LinkWebsite
James InhofeR-OKChair, Senate Armed Services(202) 224-4721(918) 748-5111https://www.inhofe.senate.gov/contactwww.inhofe.senate.gov
Jack ReedD-RIRanking Member, Senate Armed Services(202) 224-4642(401) 528-5200https://www.reed.senate.gov/contact/emailwww.reed.senate.gov
Roger F. WickerR-MSMember, Senate Armed Services(202) 224-6253(601) 965-4644https://www.wicker.senate.gov/public/index.cfm/contactwww.wicker.senate.gov
Deb FischerR-NEMember, Senate Armed Services(202) 224-6551(402) 441-4600https://www.fischer.senate.gov/public/?p=email-debwww.fischer.senate.gov
Tom Cotton R-ARMember, Senate Armed Services(202) 224-2353(479) 751-0879https://www.cotton.senate.gov/?p=contactwww.cotton.senate.gov
Mike RoundsR-SDMember, Senate Armed Services(202) 224-5842(605) 224-1450https://www.rounds.senate.gov/contact/email-mikewww.rounds.senate.gov
Joni ErnstR-IAMember, Senate Armed Services (202) 224-3254(515) 284-4574https://www.ernst.senate.gov/public/index.cfm/email-joniwww.ernst.senate.gov
Thom Tillis R-NCMember, Senate Armed Services(202) 224-6342(919) 856-4630https://www.tillis.senate.gov/www.tillis.senate.gov
Dan SullivanR-AKMember, Senate Armed Services(202) 224-3004(907) 271-5915https://www.sullivan.senate.gov/contact/emailwww.sullivan.senate.gov
David PerdueR-GAMember, Senate Armed Services(202) 224-3521(404) 865-0087https://www.perdue.senate.gov/connect/emailwww.perdue.senate.gov
Kevin CramerR-NDMember, Senate Armed Services202-224-2043701-232-5094https://www.cramer.senate.gov/contact_kevinwww.cramer.senate.gov
Martha McSallyR-AZMember, Senate Armed Services(202) 224-2235(602) 952-2410https://www.mcsally.senate.gov/contact_marthawww.mcsally.senate.gov
Rick ScottR-FLMember, Senate Armed Services(202) 224-5274(850) 942-8415https://www.rickscott.senate.gov/contact_rickwww.rickscott.senate.gov
Marsha BlackburnR-TNMember, Senate Armed Services202-224-3344865-540-3781https://www.blackburn.senate.gov/contact_marshawww.blackburn.senate.gov
Josh HawleyR-MOMember, Senate Armed Services(202) 224-6154(816) 960-4694https://www.hawley.senate.gov/contact-senator-hawleywww.hawley.senate.gov
Jeanne ShaheenD-NHMember, Senate Armed Services (202) 224-2841(603) 750-3004https://www.shaheen.senate.gov/contact/contact-jeannewww.shaheen.senate.gov
Kirsten E. GillibrandD-NYMember, Senate Armed Services(202) 224-4451(518) 431-0120https://www.gillibrand.senate.gov/contact/email-mewww.gillibrand.senate.gov
Richard BlumenthalD-CTMember, Senate Armed Services(202) 224-2823(860) 258-6940https://www.blumenthal.senate.gov/contact/www.blumenthal.senate.gov
Mazie K. HironoD-HIMember, Senate Armed Services(202) 224-6361(808) 522-8970https://www.hirono.senate.gov/contactwww.hirono.senate.gov
Tim KaineD-VAMember, Senate Armed Services(202) 224-4024(804) 771-2221https://www.kaine.senate.gov/contact/share-your-opinionwww.kaine.senate.gov
Angus King D-MEMember, Senate Armed Services(202) 224-5344(207) 622-8292https://www.king.senate.gov/contactwww.king.senate.gov
Martin HeinrichD-NMMember, Senate Armed Services(202) 224-5521(505) 346-6601https://www.heinrich.senate.gov/contact/write-martinwww.heinrich.senate.gov
Elizabeth WarrenD-MAMember, Senate Armed Services(202) 224-4543(617) 565-3170https://www.warren.senate.gov/contact/shareyouropinionwww.warren.senate.gov
Gary C. PetersD-MIMember, Senate Armed Services(202) 224-6221 (313) 226-6020https://www.peters.senate.gov/contact/email-garywww.peters.senate.gov
Joe Manchin D-WVMember, Senate Armed Services202-224-3954304-342-5855https://www.manchin.senate.gov/contact-joe/email-joewww.manchin.senate.gov
Tammy DuckworthD-ILMember, Senate Armed Services(202) 224-2854(312) 886-3506https://www.duckworth.senate.gov/connect/email-tammywww.duckworth.senate.gov
Doug Jones D-ALMember, Senate Armed Services(202) 224-4124(334) 230-0698https://www.jones.senate.gov/contact/email-dougwww.jones.senate.gov

Back to Steps




LDA/Columbia Pre-Conference Video – 2019

Dr. Brian Fallon, Columbia University; Dr. Joanna Lyon, University of Maryland School of Pharmacy; Dr. Adrian Baranchuk, Queen’s University; and Dr. George Chaconas, University of Calgary discuss topics of research to be presented at upcoming LDA/Columbia CME Conference September 21 & 22, 2019.




FDA Clears New Lyme Test

The Lyme Disease Association announces that the Food and Drug Administration (FDA) yesterday cleared for marketing four previously cleared tests for the diagnosis of Lyme disease. Called the modified two-tier, enzyme immune assay, (EIA), the new tests are able to be run at the same time or sequentially. The current two-tier testing has an EIA test (ELISA) run which is then followed by a Western Blot (WB).

The FDA reviewed data from clinical studies of the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System, ZEUS ELISA Borrelia burgdorferi IgM Test System, and the ZEUS ELISA Borrelia burgdorferi IgG Test System. The FDA claims this alternative approach is as accurate as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi, the bacteria causing Lyme disease.

The tests were reviewed through FDA’s premarket notification (510(k)) pathway– the device to be marketed is at least as safe and effective to a legally marketed device, i.e., substantially equivalent.

According to LDA President Pat Smith, “It appears the new two-tier system is being offered as an alternative to the existing two-tier. Whether it will prove out to be as accurate as the current system remains to be seen. Since the current two tier system is considered to be about 50% accurate by many, and many treating physicians feel the Western Blot is perhaps the most significant portion of that system, it is hard to say what impact this new system without the WB will have on diagnosis. The fact that the tests can be run concurrently could mean less delay in testing to diagnosis/treatment time for some individuals. However, at this point, we do not know enough about the tests to make any further assessments, although it is not the new technology many have hoped for in a new testing paradigm.”

Click here for PR NewswireFDA clears new indications for existing Lyme disease tests that may help streamline diagnoses




CFC 2019 Approves LDA as National Charity

CFC-Logo-LDAThe LDA has been designated as a national charity included in the 2019 Combined Federal Campaign (CFC) Charity List. CFC is part of the Office of Personnel Management (OPM). Each year, federal employees are provided with lists of approved charities for their workplace giving through the CFC. The LDA has met the requirements and been a part of CFC for 14 years running. LDA’s administrative and fundraising costs were determined to be only 2.5% for 2018, meaning 97.5% went directly to programs.

The LDA’s CFC 2019 identification for donors is #11424, and the Lyme Disease Association, Inc. will appear in the listing of National/International Independent Organizations, which is published in each local campaign charity list. See your federal employer for details. Check the CFC website at: http://www.opm.gov/cfc/ for details about the Combined Federal Campaign.

Thanks to all those volunteers who have helped with our programs nationwide, and a special thanks to those who have been contributing through their federal workplace CFC to the Lyme Disease Association, Inc.