Torrey vs. IDSA/Insurers Lawsuit Update: Cigna Third Insurance Defendant to Settle

The Lyme Disease Association is providing the most recent update regarding Torrey vs. IDSA/Insurers, the federal lawsuit filed by 24 Lyme patients against six members of the Infectious Disease Society of America (IDSA) and eight insurance companies in the U.S. District Court for the Eastern District of Texas, Texarkana Division.

According to investigative journalist Mary Beth Pfeiffer, Cigna has now become the third insurance company defendant in the case to settle following Kaiser Permanente in November 2019 and Blue Cross Blue Shield of Texas (BCBST) in January 2020. Pfeiffer reports that, as was the case with the first two, the Cigna settlement is being handled in secret with sealed documents. The public may never know what the plaintiffs received, or what was accomplished during the hearings. The remaining defendants include the IDSA, five other insurance companies, and six Medical Doctors. 

At this stage, this is all the information that has been made available. Details regarding the terms or amount of the settlements are unknown. The lawsuit was initially filed in 2017 on behalf of the group of Lyme disease patients who claim they have been denied care, as well as harmed, under existing insurance and medical protocols. The litigation proceedings will continue in the U.S. District Court in Texarkana, Texas.

LDA will provide updates when we have them. You can also continue to watch for updates on Mary Beth Pfeiffer’s website and Twitter feed

Click here to view the Notice of proposed settlement of Cigna Health and Life Insurance Company.

Click here to view the Notice of settlement of BCBS of Texas.

Click here to view the Settlement reached with Kaiser Permenente.

Referenced articles and websites:

  1. Thefirstepidemic.com. Patient lawsuit against IDSA and insurers moves forward in Texas. [Web Article]. Copyright 2019 thefirstepidemic.com. https://www.thefirstepidemic.com/lyme-lawsuit.
  2. Thefirstepidemic.com. Amended complaint in Lyme lawsuit; battle lines are drawn. [Web Article]. Copyright 2019 thefirstepidemic.com. https://www.thefirstepidemic.com/lyme-lawsuit.
  3. LymeDisease.org. TOUCHED BY LYME: Latest in anti-IDSA/insurers lawsuit: Kaiser settles. [Web Article]. Copyright 2019 LymeDisease.org. https://www.lymedisease.org/torrey-v-idsa-kaiser-settles/



Rodent-Targeted Bait Vaccine Shows Decrease in Lyme Disease Transmission

Photo credit James L. Occi (PhD candidate) LDA Scientific & Professional Advisory Board

The Connecticut Agricultural Experiment Station (CAES) and US Biologic, Inc. released the publication of a field trial study showing the effectiveness of an orally-delivered anti-Lyme vaccine that targets the white-footed mouse, the major wildlife source of Lyme disease.

The study took place in the residential area of Redding, CT, over a three-year time period and showed substantial decreases in the number of infected mice. One year into the study, test sites that had been treated with the vaccine showed a 13X greater decrease in blacklegged ticks (Ixodes scapularis, the primary vector associated with the spread of disease) infected with Borrelia burgdorferi (the bacterium that causes Lyme disease) compared to control sites (i.e., 26% drop versus 2% drop).

“Fewer infected ticks mean less infection in the field overall,” says Dr. Kirby C. Stafford, Chief Scientist and State Entomologist, “So the decrease would be greater year-over-year that the vaccine is applied.”

A second effect, which has been observed in previous laboratory-based studies showed that the vaccine causes the mice to generate antibodies and therefore previously infected ticks act as a ‘xenodiagnostic marker’ of vaccine impact, meaning once they ingest the antibodies, while feeding on vaccinated mice, the ticks then become ‘cleared’ of infection.

Dr. Scott C. Williams, Agricultural Scientist and co-author of the study verified that when non-infected mice feed on vaccine-coated pellets, they are then protected from the Borrelia burgdorferi infection. “Non-infected ticks, therefore, cannot pass the disease to other animals, including humans” he says.

The study’s findings were published in the peer-reviewed publication, Experimental and Applied Acarology. Click here to view the press release from The Connecticut Agricultural Experiment Station.




Neurological Complications of Vaccination with Outer Surface Protein A (OspA). Marks DH1

Int J Risk Saf Med. 2011;23(2):89-96. doi: 10.3233/JRS-2011-0527.

https://www.ncbi.nlm.nih.gov/pubmed/21673416

Abstract

A wide range of neurological complications have been reported via the medical literature and the VAERS system after vaccination with recombinant outer surface protein A (OspA) of Borrelia. To explore this issue, 24 patients reporting neurological adverse events (AE) after vaccination with Lymerix, out of a group of 94 patients reporting adverse events after Lymerix vaccination, were examined for causation. Five reports of cerebral ischemia, two transient Ischemic attacks, five demyelinating events, two optic neuritis, two reports of transverse myelitis, and one non-specific demyelinating condition are evaluated in this paper. Caution is raised on not actively looking for neurologic AE, and for not considering causation when the incidence rate is too low to raise a calculable difference to natural occurence.

PMID:
21673416
DOI:
10.3233/JRS-2011-0527

[Indexed for MEDLINE]




Torrey vs. IDSA/Insurers Lawsuit Update: Proceedings Delayed ‘Till Feb.

The Lyme Disease Association is providing an update regarding Torrey vs. IDSA/Insurers, the federal lawsuit filed by 24 Lyme patients against six members of the Infectious Disease Society of America (IDSA) and eight insurance companies in the U.S. District Court for the Eastern District of Texas, Texarkana Division.

Recently, two documents were filed electronically by the suit’s mediator. The first announces that Kaiser Permanente, one of the eight insurance company Defendants, has settled with the Plaintiffs. The second stated that the mediation session, which commenced in February of this year, has been suspended, and that “the undersigned mediator will continue to work with the parties in an effort to settle”.

More recently, according to Investigative journalist and author, Mary Beth Pfeiffer, “Proceedings have again been delayed, to 2/14/20. Parties will report by 1/31/20 on ‘agreements and/or differences concerning the case schedule, the amount of time necessary to finish discovery and trial timing.'”

At this stage, this is all the information that has been released to the public. Details regarding the terms or amount of the settlement are currently unknown. The lawsuit was initially filed in 2017 on behalf of the group of Lyme disease patients who claim they have been denied care, as well as harmed, under existing insurance and medical protocols. The litigation proceedings will continue in the U.S. District Court in Texarkana, Texas.

LDA will provide updates when we have them. You can also continue to watch for updates on Mary Beth Pfeiffer’s website and Twitter feed

Referenced article:

  1. Thefirstepidemic.com. Patient lawsuit against IDSA and insurers moves forward in Texas. [Web Article]. Copyright 2019 thefirstepidemic.com. https://www.thefirstepidemic.com/lyme-lawsuit.
  2. Thefirstepidemic.com. Amended complaint in Lyme lawsuit; battle lines are drawn. [Web Article]. Copyright 2019 thefirstepidemic.com. https://www.thefirstepidemic.com/lyme-lawsuit.
  3. LymeDisease.org. TOUCHED BY LYME: Latest in anti-IDSA/insurers lawsuit: Kaiser settles. [Web Article]. Copyright 2019 LymeDisease.org. https://www.lymedisease.org/torrey-v-idsa-kaiser-settles/



Research Review Finds IDSA Guidelines Contribute to Mental Health Epidemic

Researchers, including Robert C. Bransfield, MD, Lyme Disease Association Professional & Medical Advisory Board Member, recently reviewed the proposed new Lyme Disease Guidelines, a 100 page document on the prevention, diagnosis, and treatment of Lyme disease drafted by the Infectious Disease Society of America (IDSA) in collaboration with the American Academy of Neurology and American Academy of Rheumatology.  The draft of the IDSA Guidelines  was released for public comment in August of 2019 and received a considerable number of responses from the Lyme community, many critical of the proposed Guidelines.

The review was published in Healthcare Scientific Journal and scrutinizes specific sections of the guidelines that are most relevant to psychiatry including the disclaimer, laboratory testing, and adult and pediatric psychiatric sections. The researchers have outlined many issues with the IDSA Guideline draft, most notably, the failure to outline the causal association between Lyme disease and psychiatric illnesses throughout, despite the vast amount of well-founded supporting evidence.

The Disclaimer

According to the researchers, the proposed disclaimer, which was more extensive than the one on past IDSA  guidelines, contained many issues, including failure to state that the guidelines cannot be used to establish a standard of care. The analysis found that the disclaimer offered no type of warranty of accuracy or reliability with the methods outlined and that the institutions responsible for creating the guidelines held themselves harmless from any potential losses that may occur when practicing physicians use the guidelines to treat patients. The seriousness of the guidelines issue came to the attention of the US Health and Human Services Tick-Borne Disease Working Group (TBDWG), of which LDA President Pat Smith is a member, and discussion was included in the group’s 2018 Report to Congress.

Diagnostic Testing

According to the researchers, one of the most central flaws contained within the guidelines was the recommended use of the scientifically unfounded surveillance case definition as diagnostic criteria. The IDSA Guidelines make the incorrect assessment that patients who do not meet the surveillance case definition for Lyme disease do not meet clinical diagnostic criteria either, and therefore, do not have Lyme disease. Additionally, the review calls attention to issues with the IDSA’s arbitrary focus on 2-tiered testing as a reliable method of diagnosis.

Testing Adults with Psychiatric Illness for Lyme Disease

The IDSA Guidelines advise against testing for Lyme disease in adults with diagnosed psychiatric illness, yet a number of studies show a causal relationship between Lyme disease and certain kinds of psychiatric illnesses. Prior research has shown that a low prevalence of mental illness may exist prior to infection while the presence of psychiatric illnesses and comorbidities is more significant post-infection.

The researchers were able to identify 377 unique citations on the ILADS website, supporting an association between Lyme disease and psychiatric illness. However, the IDSA Guidelines include only a small number of articles limited to epidemiologic studies that selectively reported outcomes

Testing Children with Developmental, Behavioral, or Psychiatric Disorders for Lyme Disease

The IDSA Guidelines also recommend against standard testing for Lyme disease in children with developmental, behavioral, or psychiatric disorders, referencing that there is no data to support a causal association between tick-borne infections and behavioral disorders or developmental delays in children. However, as the researchers who analyzed the IDSA Guidelines state, the IDSA included no references to support these claims and in fact, numerous articles demonstrating the causal relationship between Lyme disease and developmental, behavioral, and psychiatric disorders in childhood do exist.

References:
1. Bransfield RC, Cook MJ, Bransfield DR. Proposed Lyme disease guidelines and psychiatric illnesses. Healthcare. 2019;7(3):105.

2. Rheumatologyadvisor.com. Review Indicates Inclusion of Psychiatric Illness Association in Proposed Lyme Disease Guidelines. [Web Article]. Copyright 2019 Rheumatology Advisor. https://www.rheumatologyadvisor.com/home/topics/lyme-disease/review-indicates-inclusion-of-psychiatric-illness-association-in-proposed-lyme-disease-guidelines/




“Bitten” Book Review

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 provides documented evidence that the suspicions of disease sufferers, their advocates, and treating physicians deserve investigation. The properties of the pathogen itself and its ally, the tick, appear to be part of our nation’s biowarfare studies.

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 Ricketttsia, 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 now revealed government studies.

Ultimately, whatever mix of causes is responsible for the Lyme and other tick-borne diseases epidemic in the US, the solutions, as strongly stated by Kris Newby, lie with better science, advanced research and proper funding.  

Click here for YouTube video of Under Our Skin, Director, Andy Abrams and Kris Newby discussing her new book.

Click here to purchase Bitten on amazon.com

Click here for other purchasing options of Bitten on HarperCollins.com

 




L. Johnson on Meaningful Patient Representation on the next TBDWG

Lorraine Johnson, JD, MBA, Chief Executive Officer of LymeDisease.org delves into the importance of meaningful patient representation on the Federal HHS Tick-Borne Disease Working Group (TBDWG) in her latest blog.  This is especially important as we await the announcement of panelists to the new TBDWG charged with the next report to Congress due in 2020. A recent patient survey conducted by lymedisease.org  found “To be a meaningful representative, patients chosen for a panel should: a) have or be a caregiver to a patient with chronic Lyme disease and b) should be an officer or director or someone vetted and approved by a recognized and trusted patient advocacy group (PAG) or someone approved by a PAG.” Read the entire blog by Lorraine Johnson here:

LYMEPOLICYWONK: Who represents Lyme disease patients? Why it matters.




New Book Exposes Secret Lyme Disease & Bioweapons Link

UNDER OUR SKIN Director Andy Abrahams Wilson interviews Kris Newby, author of “Bitten: The Secret History of Lyme Disease and Biological Weapons.” May 1, 2019
– UnderOurSkin.com




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

 

 




Lyme Vaccine Meeting: FDA Vaccines & Related Biologics Products Advisory Committee

Food And Drug Administration Center For Biologics Evaluation And Research. Open meeting of: The Vaccines & Related Biologics Products Advisory Committee, June 7, 1994, Silver Spring, MD. Click Here for Lyme Vaccine Meeting

PARTICIPANTS

EXECUTIVE SECRETARY   NANCY CHERRY, Scientific Advisors &
Consultants Staff, CBER, FDA(HFM-21) Rockville MD 20852-1448

COMMITTEE MANAGEMENT ASSISTANT  STEPHANIE MILWIT, Scientific
Advisors & Consultants Staff, CBER FDA(HFM-21) Rockville, MD

COMMITTEE MEMBERS
STANLEY LEMON, MD CHAIRMAN, Prof. Of Medicine, Microbiology
& Immunology, University Of North Carolina, Chapel Hill
MARY GLODE, MD, Prof, Pediatrics, Children’s Hospital Of
Denver, U. Colorado School Of Medicine, Denver, CO 80218
ALISON O’BRIEN, PhD, Professor Of Microbiology, Uniformed
Services Univ. Of Health Sciences, Bethesda, MD 20814-4799
RAYMOND ROOS, MD, Professor Of Neurology, Dept Of Neurology
/MC 2030, Univ. Of Chicago, Chicago, IL 60637

TEMPORARY VOTING MEMBERS
CLAIRE BROOME, MD, Acting Deputy Director, CDC, 16013 Clifton
Road, N.E., Building 1, Room 2000, D-14, Atlanta, GA 30333
THEODORE EICKHOFF, MD, Professor Of Medicine, Division Of
Infectious Diseases, Univ. Of Colorado Health Sciences Ctr,
Mall Container B-168, 4200 E. Ninth St, Denver, CO 80262
PATRICIA FERRIERI, MD, Professor Of Pediatrics, Laboratory
of Medicine And Pathology, University Of Minnesota, Box 296,
Delaware Street, S.E., Minneapolis, Minnesota 55455
RICHARD JOHNSTON, MD, Med. Dir, March Of Dimes Birth Defects
Foundation, 275 Mamaroneck Ave, White Plains, NY 10605

CBER CONSULTANT
DR. DAVID CARZON, Department Of Pediatrics, Division Of
Infectious Diseases, Vanderbilt University Medical School,
1161 21st Avenue, South, Nashville, Tennessee 37232-e-2581

GUESTS AND SPEAKERS
DR RAYMOND DATTWYLER, Div Of Allergy, Rhumatology & Clinical
Immunology, SUNY School Of Med., Stonybrook, NY 121794-8161
DR DAVID DENNIS, Bacterial Zoonoses Br, Div. Of Vector-Borne
Infectious Diseases, CDC, Box 2087, Fort Collins, CO 80522
DR. ALLEN STEERE, New England Medical Center, Box 401, 750
Washington Street, Boston, Massachusetts 02111