New Lyme Vaccine in Clinical Trials: Update!

syringeAn article on a new vaccine for Lyme disease, “New Effort for Lyme Disease Vaccine Draws Early Fire,” by Sumathi Reddy, appeared in the Wall Street Journal on July 9, 2018. The article, which includes a quote by LDA President, Pat Smith, reports that a European company, Valneva SE, is in clinical trials for a vaccine for Lyme disease, which has been fast tracked by the FDA. (see 4/28/19 update at end of article)

A company official estimates it will take at least five years before it becomes commercially available. The vaccine is similar to Lymerix, by Smith Klein Beecham (SKB), now GlaxoSmithKline, which was approved by the Food and Drug Administration (FDA) in December 1998 but was withdrawn from the market in 2002 due to low demand.

“We don’t feel that there has been enough research done to answer the questions as to what occurred with the prior vaccine,” says Patricia Smith, president of the Lyme Disease Association Inc., a New Jersey-based national nonprofit group, which raises money for Lyme research, education and patient support. “The vaccine that is now in development is something with the same base. There were a lot of patients that thought they were harmed from that vaccine. It’s very problematic.”

Check out the history of Lymerix and efforts by the LDA and others to get the facts behind the vaccine and its withdrawal– individuals who took the vaccine who spoke at the FDA on the problems they felt were related to the vaccine; class-action lawsuits that alleged it caused serious side effects; and a meeting requested by LDA at the FDA where LDA brought in a vaccine expert and physicians who were seeing patients with problems they felt were connected to receiving the vaccine.

Update on Lyme vaccine 4-28-19  On July 2017, Valneva received from the Food & Drug Administration (FDA) a Fast Track Designation for VLA15. On April 4, 2018, Valneva presented Phase 1 interim results of the vaccine at the World Vaccine Congress in DC. In December of 2018, Valneva announced the initiation of Phase 2 Clinical Trial Development to determine the optimal dosage level and schedule for use in Phase 3 field efficacy studies, based on immunogenicity & safety data.

Click here for a history of the LDA’s involvement with the FDA and the Lymerix vaccine

Click here to read full Wall Street Journal article

 

 




CFC 2018 Approves LDA as National Charity

CFC Logo LDAThe LDA has been designated as a national charity included in the 2018 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 13 years running. LDA’s administrative and fundraising costs were determined to be only 3.8% for 2017, meaning 96.2% went directly to programs.

The LDA’s CFC 2018 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.

 




Pat Smith on WNYJ-TV 2013

 

Lyme Disease Association from WNYJ-TV on Vimeo.




May 2018 Declared Lyme Disease Awareness Month

LDA Proclamation 2018States and counties throughout the US have proclaimed May Lyme Disease Awareness Month.

Many states and counties have taken steps to raise awareness regarding Lyme and tick-borne diseases.  Declaring “May Lyme Awareness Month” is one move to help remind people spring is here, ticks are out, prevention & proper education are your best tools to staying healthy.

Proclamations are issued by governors and resulutions are adopted by the legislature.  The LDA salutes and thanks all the governors, legislators, Lyme groups, and advocates who have helped raise awareness throughout the year.  Your efforts make a difference!

See if your state has joined in May Lyme Awareness & Read the state proclamations.

States and counties throughout the US have proclaimed May Lyme Disease Awareness Month.

Many states and counties have taken steps to raise awareness regarding Lyme and tick-borne diseases.  Declaring “May Lyme Awareness Month” is one move to help remind people spring is here, ticks are out, prevention & proper education are your best tools to staying healthy.

Proclamations are issued by governors and resulutions are adopted by the legislature.  The LDA salutes and thanks all the governors, legislators, Lyme groups, and advocates who have helped raise awareness throughout the year.  Your efforts make a difference!

We thank our neighbors to the North for joining in the efforts to prevent the spread of Lyme.

Please click on your state to see what has been done.

Arkansas New York
Colorado Oregon
Maine Virginia
North Carolina Vermont
New Hampshire Nova Scotia – Halifax
New Jersey Nova Scotia – Pictou

Lyme Disease Association, Inc. Proclamation

LDA Proclamation 2018(Click picture for pdf)

 

 

 

 

 

 

 


House Resolution Introduced by US Rep. Faso

House Faso Lyme Resolution(Click picture for pdf)

 

 

 

 

 

 

 

 


Arkansas Proclamation

AR Lyme Proclamation 2018(Click picture for pdf)

 

 

 

 

 

 

 

 

 

 


Colorado

CO Lyme Proclamation 2018(Click picture for pdf)

 

 

 

 

 

 


Maine Proclamation

ME Lyme Proclamation 2018(Click picture for pdf)

 

 

 

 

 

 

 

 

 

 


North Carolina Proclamation

NC Lyme Proclamation 2018(Click picture for pdf)

 

 

 

 

 

 

 

 

 

 


New Hampshire Proclamation

NH Lyme Proclamation 2018(Click picture for pdf)

 

 

 

 

 

 

 

 

 

 


New Jersey

State of NJ Joint Resolution Occurring Each Year

NJ Joint Resolution Each Year(Click picture for pdf)

 

Manchester County Proclamation

NJ Manchester Cnty Lyme Proclamation 2018b(Click picture for pdf)

 

 

 

 

 

 

 

 


New York

NY State Legislative Resolution

NY Lyme Resolution 2018(Click picture for pdf)

 

NY Erie County Resolution

NY Erie Cnty Lyme Resolution 2018(Click picture for pdf)


 

Oregon Proclamation

OR Lyme Proclamation 2018(Click picture for pdf)

 

 

 

 

 

 

 

 

 


Virginia Loudoun County Resolution

NH Lyme Proclamation 2018(Click picture for pdf)

 

 

 

 

 

 

 

 

 


Vermont Proclamation

VT Lyme Proclamation 2018(Click picture for pdf)

 

 

 

 

 

 

 

 


Nova Scotia – Canada

Halifax Proclamation

NovaScotia Halifax Proclamation 2018(Click picture for PDF)

 

 

 

 

 

 

 

 

 

Pictou Proclamation

NovaScotia Pictou Lyme Proclamation 2018(Click picture for PDF)




Congressman Smith Introduces: National Lyme & Tick-Borne Diseases Control & Accountability Act of 2018

Smith HeadMay 21, 2018 –The Lyme Disease Association, Inc. announces the introduction of HR 5900,* “National Lyme and Tick-Borne Diseases Control and Accountability Act of 2018’’ into the US House of Representatives by Congressman Christopher H. Smith (NJ-4). The Act will establish the Office of Oversight and Coordination for Tick-Borne Diseases in the Office of the Secretary of Health & Human Services (HHS) to be headed by a director appointed by the Secretary.  Representatives Peterson (D-MN7), Faso (R-NY19), Comstock (R-VA10) and Posey (R-FL8) have joined Mr. Smith in co-sponsoring the bill.

Smith HeadCongressman Christopher H. SmithMay 21, 2018–The Lyme Disease Association, Inc. announces the introduction of HR 5900,* “National Lyme and Tick-Borne Diseases Control and Accountability Act of 2018’’ into the US House of Representatives by Congressman Christopher H. Smith (NJ-4). The Act will establish the Office of Oversight and Coordination for Tick-Borne Diseases in the Office of the Secretary of Health & Human Services (HHS) to be headed by a director appointed by the Secretary.  Representatives Peterson (D-MN7), Faso (R-NY19), Comstock (R-VA10) and Posey (R-FL8) have joined Mr. Smith in co-sponsoring the bill.

Its purposes are to oversee the creation and establishment of an integrated national strategy to overcome Lyme disease and other tick-borne diseases (TBD) and to oversee and coordinate Lyme and TBD programs and activities across agencies and offices of HHS.

Reps. Chris Smith (R-NJ) and Collin Peterson (D-MN), the co-chairs of the Congressional Lyme Disease Caucus, and the other co-sponsors are pushing the bipartisan legislation to create a new national strategy for Lyme disease and strengthen treatment and prevention of Lyme and other tick-borne diseases.

According to LDA President Pat Smith, “There is an urgent need for the House to pass this bill so that Lyme and other tick-borne diseases (TBD) are addressed in a coordinated fashion. The US needs to play a leadership role in this effort, since Lyme is spreading around the globe as are many other TBD, ~20 in the US alone. The public is at risk, as are our children, since tick-borne disease cases have doubled over the past 13 years. I applaud Congressman Smith’s continued focus on the impact upon individuals and families who have TBD and upon the public at large who may contract these diseases from ever increasing existing tick populations, and perhaps in the future, from a new tick such as the invasive longicornis tick now found in NJ—the impact of which tick is yet little understood.”

Objectives of Office of Oversight and Coordination for Tick-Borne Diseases include expansion and enhancement of epidemiological research & basic translational, clinical and biomedical research; expansion and improvement of surveillance and reporting of Lyme and TBD including coinfections; development of effective diagnostic tests to accurately and timely diagnose Lyme & TBD, including direct detection tests; development of treatments to cure or improve the lives of those affected with Lyme & TBD or who suffer from tick-induced disorder; design and conduct clinical trials of sufficient size and duration to support clinical recommendations; development of patient registries; documentation of experiences of health care professionals in diagnosing TBD; inclusion individuals with chronic Lyme disease in clinical, research, and service efforts; and coordination with international bodies to integrate and inform the fight against Lyme and TBD globally.

The Lyme Disease Association provided input into the development of the bill with the Office of Congressman Christopher Smith.

*LDA Note:  HR 5900 introduced on 5/21 is the same as HR 5878 introduced on 5/18 — due to a technical glitch

Click here for full bill text HR 5878 (the same as HR 5900)

Click here for Congressman Smith’s press release

Click here for LDA’s Newsletter on Lyme bill




US Rep. Faso Intros House Resolution: May “National Lyme Disease Awareness Month”

rep john fasoRep. John FasoRep. Faso is a member of the House Lyme Caucus, a bi-partisan group working together in Congress to take action on Lyme & tick-borne diseases. The Caucus is co-chaired by Congressmen Chris Smith (NJ) and Collin Peterson (MN). The Caucus has initiated letters, and actions to benefit patients with Lyme & tick-borne diseases and the general public exposed to such diseases.

Click here for info on H.RES 887

 




Longhorned Tick Now Confirmed: NJ, VA, WV, AR, NC, NY, PA, CT, NH, KY, MD, & TN

2018 occi HLongicornis scapularis poppy3083 lr loI. scapularis on top (nymph, male, female), poppy seeds in middle and Haemaphysalis longicornis (nymph, female) on bottom. Thanks to J. Occi, Rutger The Lyme Disease Association reports that according to the National Veterinary Services Laboratory in Ames, Iowa, the Haemaphysalis longicornis tick (otherwise known as the East Asian or Longhorned tick) was found in Virginia, appearing on an orphaned calf on a beef farm in Albemarle County. The longhorned tick has since been identified in Warren County. As of 5/21/18, the tick has been confirmed in West Virginia, and 6/12/18, the tick has also been found in Arkansas, and in July 2018 in Westchester County, New York, North Carolina, Pennsylvania, Maryland and Kentucky.  Connecticut and New Hampshire have also confirmed the tick in 2018. And most recently, in Tennessee in May 2019.

H. longicornis was initially confirmed in Hunterdon County, NJ, on November 9, 2017 on a sheep farm, and a mystery still surrounds its appearance. The species survived the winter and was confirmed again in NJ in April 2018. There is no known direct link from the Virginia farm to the New Jersey farm. (In addition to the Hunterdon County farm, the Longhorned tick has been confirmed in other parts of NJ: the Rutgers University–New Brunswick’s Cook Campus farm in Middlesex County, and the National Veterinary Services Laboratory recently confirmed a tick taken from a dog in Union County in 2013 was also a Longhorned tick. June 5, 2018, National Veterinary Services Laboratory confirmed the Longhorned tick was found at a location in northern Mercer County. July 21, Longhorned tick found in Bergen County.)

The longhorned tick is self-cloning, and is already known to transmit several human diseases, including spotted fever rickettsiosis, in its native East Asian countries – China, Japan and Australia. It may be only a matter of time before they become carriers of tick-borne diseases that affect humans.

Longhorn.Tick.Spreading loUPDATE: Longhorned tick spreading – NOW CONFIRMED IN 12 STATES


5/24/2019 ag.tennessee.edu Invasive Tick Detected in Tennessee

5/16/19 wlwt.com  Notorious Asian longhorned tick now reported in Kentucky (confirmed in 2018)

11/6/18 vnews.com New Species of Tick Found in New Hampshire

10/1/18 ctpost.com First person bitten by east Asian longhorned tick (in CT)

8/7/18 maryland.gov First Confirmed Longhorned Tick Found in Maryland

7/31/18 phillyvoice.com Invasive longhorned tick species confirmed in Pennsylvania

7/17/18 wgrz.com A new, dangerous tick found in New York

7/12/18 Charlotte Observer New ‘exotic’ tick invades NC, and it’s an ‘aggressive biter.’ How far has it spread?

7/1/18 nj.com This invasive tick is cloning itself. Rutgers DNA researchers are racing to contain it.

6/12/18 4029tv.com First Longhorned Tick confirmed in Arkansas

6/1/18 The Winchester Star Exotic invasive tick found on Warren County horses (Virginia)

5/23/18 Click here for info on Longhorned tick in West Virginia

5/16/18 Click Here for Press Release on Longhorned Tick in Virginia


Related Articles – Longhorned Tick in NJ:

7/21/18 northjersey.com Exotic Longhorned tick found in Bergen County

6/5/18 mycentraljersey.com  Longhorned tick spreads to Mercer County

5/10/18 NBC, NY Longhorned Tick Mysteriously Invades New Jersey, Has Already Spread

5/7/18 mnn.com This Self-cloning Tick Now Calls N.J. Home: Longhorned Tick Survived the Winter and is Poised to Spread

4/21/18  LDA website  Longhorned Ticks Survived the NJ Winter: Invasive Species May Be Established

 




Lyme Patients File Civil Suit Against Insurers/IDSA/IDSA Panelists

The Lyme Disease Association (LDA) has announced that on November 10, 2017, twenty-three Lyme patients/estates of patients filed Civil Action No. 17-cv-190 in the US District Court for the Eastern District of Texas, Texarkana Division─4 counts under Racketeer Influenced and Corrupt Organizations Act (RICO) and one count of antitrust violations of the Sherman Act. The plaintiffs are asking for actual damages, treble damages, reasonable attorney’s fees, and court costs and have demanded a jury trial. The defendants are:

• Infectious Diseases Society of America (IDSA)
• Blue Cross and Blue Shield Association
• Blue Cross and Blue Shield of Texas
• Anthem Inc.
• Aetna Inc.
• Cigna Corp.
• Kaiser Permanente Inc.
• United HealthCare Services Inc.
• UnitedHealth Group Inc.
• IDSA Panelists: doctors Gary P. Wormser, Raymond J. Dattwyler, Eugene Shapiro, John J. Halperin, Robert B. Nadelman, Leonard Sigal, & Allen Steere.

Discussion of the investigation of the IDSA by then Attorney General Richard Blumenthal (now Senator) is presented, testimonies before governing bodies of an advocate and a doctor are included, and cases of defendant patients are presented as well as cases of some physicians who were charged by state medical boards.

One excerpt from the Factual Allegations Common to All Counts & Claims is below: (p.23-4)

The acts of the defendants form a ‘pattern of racketeering’

99. The IDSA, Insurance Defendants, and the IDSA Panelists, acting through their officers, agents, employees and affiliates, committed numerous predicate acts of “racketeering activity,” as defined in 18 U.S.C. §1961(5), prior to and during the period made the basis of this suit, and continues to commit such predicate acts, in furtherance of their scheme to prevent treatment of chronic Lyme disease and to prevent the proper testing of potential Lyme disease patients, including including (a) mail fraud, in violation of 18 U.S.C. §1341, and (b) wire fraud, in violation of 18 U.S.C. §1343. Such predicate acts include the following: mailing, causing to be mailed, knowingly agreeing to the mailing of various materials and information, and/or wiring information including, but not limited to, correspondence regarding the following: fraudulently and wrongfully claiming lack of insurance coverage for chronic Lyme disease; fraudulently and wrongfully denying insurance coverage to people with chronic Lyme disease; issuing false and misleading EOB’s to patients with Lyme disease; fraudulently and wrongfully claiming all Lyme disease patients can be easily treated and cured with short-term antibiotics; fraudulently and wrongfully claiming Lyme disease patients only have Lyme disease if they exhibit an EM rash or test positive with a two-tier serology test; wrongfully and illegally reporting doctors to their medical boards for treating chronic Lyme disease; fraudulently and wrongfully misleading people with Lyme disease, and their doctors, by classifying their chronic Lyme disease as a mental disorder; fraudulently and wrongfully misleading people with Lyme disease, and their doctors, by classifying their chronic Lyme disease as a different physical condition such as chronic fatigue syndrome or fibromyalgia; and fraudulently and wrongfully enforcing the IDSA guidelines even when doctors determine a patient requires long-term antibiotic treatment.

Click here for a news release on suit

Click here for complete lawsuit