https://www.linkedin.com/pulse/action-request-lyme-community-fromgotcha-global-jenna-luche-thayer/

ACTION REQUEST for LYME COMMUNITY from GOTCHA! Global Oversight for Transparency against Corruption in Healthcare Alliance

Published on June 20, 2018
Jenna Luche-Thayer

ACTION REQUEST for LYME COMMUNITY from GOTCHA! Global Oversight for Transparency against Corruption in Healthcare Alliance

FRIENDS FROM ALL COUNTRIES!

I have ANOTHER URGENT ACTION REQUEST regarding Kristen Honey, the Vice Chair of the TICK-BORNE DISEASES WORKING GROUP.

This story gets more unbelievable!

Please read the complaint — and the information that follows it — and if you agree, AS SOON AS POSSIBLE, PLEASE:

(1) COPY the complaint located below and email it in (revisions are fine).

(2) Share this GLOBALLY on Facebook, websites, forums, etc., and word of mouth, and ask others to TAKE ACTION as well.

WE CAN DO THIS!

Thank you! from GOTCHA!

Cozette Moysa, USA contact <cocolake2015@gmail.com> Jenna Luché-Thayer, Global contact <jennaluche@gmail.com> Kristina Bauer, Communications Expert <mkbauer6@att.net>

********************COMPLAINT for IMMEDIATE ACTION************************

SAMPLE LETTER to COPY AND PASTE (revisions in your own words are fine) and send to the following addressees:

………………………………………………………………………………………………………………………………

To: james.Berger@hhs.gov, kaye.Hayes@hhs.gov, tynetta.Dreher@hhs.gov

cc: brett.giroir@hhs.gov

Dear Mr. Berger, Ms Hayes and Ms. Dreher,

According to statements on both the HHS website and on LinkedIn, Vice-Chair Kristen Honey of the Tick-Borne Diseases Working Group (Working Group) is not a federal officer, as required by the 21st Century Cures Act and the HHS legal Charter. This means the Working Group does not meet its basic legal membership mandate, as required by the 21st Century Cures Act.

Kristen Honey has potential conflicts of interests (COIs) and can be perceived as using her leadership position to incorporate the ‘Lyme Innovation’ brand into the activities and recommendations of the Working Group to Congress.

Past statements she has made concerning her plans to develop her patented Lyme disease treatment via the Lyme Innovation brand raise additional COIs.

Under the leadership of Kristen Honey for the past seven months, the lack of transparency of the Working Group has been evident and extremely problematic for the public.

In addition to the above stated concerns, an alarming lack of transparency has been a major issue for the Working Group since its inception last December.

Despite hundreds of public complaints to this issue and letters to HHS leadership, the Working Group has failed to comply with FACA transparency requirements.

Due to the above stated reasons, I am requesting that Vice-Chair Kristen Honey be removed immediately and permanently from all present and future member positions on the Tick-Borne Diseases Working Group.

Respectfully,

YOUR NAME

*************************************************************************************

BACKGROUND

ELIGIBILITY OF KRISTEN HONEY, COIS AND LACK OF TRANSPARENCY ON THE TICK-BORNE DISEASES WORKING GROUP

Numerous public complaints have been sent to HHS leadership regarding Kristen Honey, Vice-Chair of the Working Group. The receipt of these public complaints has not been acknowledged by HHS leadership and the issues surrounding the complaints have not been resolved by appropriate corrective action.

The eligibility of Vice-Chair Kristen Honey is under question, as she appears to be a ‘non federal employee’ and yet is occupying one of the seven required federal member positions on the Working Group.

There are potential conflicts of interest surrounding Vice-Chair Kristen Honey that have been identified by citizen stakeholders. There has been no response from HHS concerning the public comments regarding this issue.

The Working Group leadership has failed to meet the transparency requirements mandated by FACA. Numerous complaints have been sent to the Working Group and HHS leadership, with no response nor resolution.

Eligibility of Vice-Chair Kristen Honey

The 21st Century Cures Act requires the Working Group to contain seven federal employees/officers and seven non-federal members.[1] Kristen Honey was selected to occupy one of the federal employee/officer positions and is currently serving as Vice-Chair of the Working Group.

Honey’s eligibility to serve on the Working Group as a federal employee has been challenged by stakeholders because statements posted on the HHS website and on her LinkedIn page indicate her employment status does not meet the definition of ‘federal employee.’

Shortly after public complaints questioning Honey’s federal employment status were received by HHS, her bio on the HHS website was revised to state, “Dr. Honey is a Federal employee because she is ‘on assignment’ from Stanford University to the Federal government under the Intergovernmental Personnel Act.” [1]

This change appears to have been made in response to public complaints regarding her employment status and eligibility to serve on the Working Group.

A new link was also added to Honey’s revised HHS bio. The reference directs the reader to a page about the Intergovernmental Personnel Act Mobility Program (IPA), through which Honey has apparently secured a limited placement at her current worksite. [2] The inference of directing the viewer to the IPA link is that Honey is a ‘federal employee’ because she is working under an IPA assignment.

The site contains an extensive and detailed amount of information regarding the IPA program and can be confusing to anyone unfamiliar with federal personnel hiring practices. The link provides numerous details about the complicated IPA process of reassigning both federal and non-federal employees to both federal and non federal assignments.

Although Honey is working ‘on assignment’ via an IPA,, the statement inserted on her HHS bio and accompanying IPA link fail to support the claim that she is a ‘federal employee.’

The amended bio on the HHS website appears to intentionally misrepresent Honey as a ‘federal officer.’ It states that, “Dr. Honey is a Federal employee because she is on assignment from Stanford University to the Federal government and is working at the White House.”

The portion of the statement, “…she is on assignment from Stanford University to the Federal government…” not only fails to prove Honey is a ‘federal employee’ – it completely contradicts the preceding claim that she is a ‘federal employee.’

If the statement on her HHS bio is correct, Honey is an employee of Stanford University (not the federal government) and is working ‘on assignment’ from her employer to the federal government for a limited duration of time. Being an employee of Stanford does not prevent her from working for the federal government “on assignment” to the White House, but it prevents her from being classified as a ‘federal employee.’

In addition to the statement posted on the HHS website, Honey’s LinkedIn page corroborates the statement contained on her HHS bio. [3] Honey’s LinkedIn account clearly states that she is a Senior Policy Analyst at the White House “on assignment as a Senior Research Scholar from Stanford University, from Jan 2017 – Present.” She is also identified on the same page as being a Stanford University Affiliated Researcher from Sep 2012 – Present.

Based on the information provided and by federal definition of the term, Honey cannot be a ‘federal employee.’ Honey therefore fails to meet the basic requirement to be one of the seven federal employee members serving on the Tick-Borne Diseases Working Group, as mandated by the Cures Act and the HHS legal Charter.

For this reason, Honey must be removed immediately as Vice-Chair of the Working Group.

Any failure on the part of HHS leadership to take the immediate and appropriate action on this matter will jeopardize the entire process of the Working Group and all future Congressional recommendations made by this critically important advisory Committee.

NOTE: The content of the HHS TIck-Borne Diseases Working Group website is created and maintained by the HHS Office of HIV/AIDS and Infectious Disease Policy.

COIs – A Private Brand and Future Treatment Products

Concerns over potential COIs surrounding Vice-Chair Honey and others have been expressed, both in social media, and in public comments. The Working Group leadership has demonstrated a lack of dedication to two-way communication with interested stakeholders and with FACA-mandated transparency. For these reasons, HHS leadership must be made aware of the all potential COIs of the Working Group and take any and all appropriate corrective actions.

There are strict provisions in federal Criminal Conflict of Interest Laws (18 U.S.C., Sections 201-209) that prohibit a federal employee/officer from working on government matters in which the federal official may be holding a special interest. [4] Non-federal employees are held to the same ethics standards as federal employees.

Section 208 – Specifically prohibits the employee from working on government matters that will affect their own personal financial interest, or the financial interests of others, including an organization in which the federal employee is serving as an officer, director, trustee, general partner or employee.

Section 209 – Prohibits a federal employee from receiving their federal salary from anyone but the government, as compensation for their services as a government employee. The acceptance of payment from a private organization to a government employee for any service (such as a speaking engagement) to the organization is prohibited. This section of the law is written to prevent any divided loyalty and equally as important, even the appearance of wrongdoing.

Section 201 prohibits the federal officer from receiving any gifts or gratuities from a private entity, such as an organization, for an official act that has already taken place or may take place in the future.

A few members of the Working Group have been involved in branding endeavor that appears to be linked with potential future COIs. The brand Lyme Innovation was co-founded by Kristen Honey and launched with the 2016 and 2017 Lyme Hackathons prior to her becoming Vice-Chair. [5] [6]

To NOTE: John Aucott was also actively involved with Lyme Innovation before accepting his leadership role as Chair of the Working Group. Some individual members of the Working Group and other entities, including prominent Lyme advocacy organizations, have also been involved with the brand. [7]

Lyme Innovation co-founder Honey is apparently using the Lyme Innovation brand for fund-raising and also, to promote her personal patented “novel IV nano-mineral solution” which she refers to as her “lynchpin for Lyme recovery.” [8]

The Lyme Innovation brand is being used by Vice-Chair Honey to give public presentations concerning the Working Group and its activities. [6] One such presentation was recently conducted at the Midcoast Maine Lyme Disease Support and Education Conference this past April. [7] [8]

Honey has written that Lyme Innovation was developed “to catalyze next-gen solutions for Lyme disease.” [9]

This raises concerns about potential COIs between Lyme Innovation and the activities and future recommendations of the Working Group. It is particularly concerning since Honey, a cofounder of Lyme Innovation, occupies the second most influential position on the Working Group and takes an active role in conducting the meetings.

The process of associating Honey’s private-label Lyme Innovation brand with the activities and goals of the federal Working Group may serve to create an indiscernible merger between a private-brand and the federal advisory group.[10]

This obvious COI must be addressed and corrected by HHS leadership because it has potential to build a public perception that the federal government condones and endorses all items and actions associated with Lyme Innovation.

In fact, the brand is already being promoted by Vice Chair Kristen Honey and embraced by Lyme Disease Association (LDA) and Lyme Disease Organization (LDO), the two largest national Lyme advocacy groups, whose leaders and members also constitute the largest block of ‘patient advocates’ serving on the Tick-Borne Diseases Working Group and its Subcommittees.

There exists a potential that Honey’s leadership position, along with other Working Group members who are, or have been, involved with Lyme Innovation, could be used advantageously to create opportunities for individual and/or organizational wealth enhancement in the future.

Statements were made in Kristen’s honey2healing.org website (under ‘Book”) containing the following direct quote:

“…the novel IV nano-mineral solution, which Dr. Honey pioneered and calls her ‘lynchpin’ for Lyme recovery and thriving wellness—has been patented using open-source intellectual property (IP)…If you or your organization wish to support Dr. Honey’s vision to bring this IV nano-mineral solution to market through open-source medicine, we welcome contributions and collaborations.” [11]

To NOTE: A screenshot of the above statement was taken prior to a publication of article.

Interestingly, the above statement was removed from public view on the honey2healing.org website, possibly in response to a May 22, 2018 LinkedIn article (published and referenced to this website.)

The Working Group is a federal advisory committee whose sole purpose is to assess and make recommendations to Congress concerning federal agency health policies on tick-borne diseases.

The Lyme Innovation brand and any related associations cultivated before or during the Working Group between Vice-Chair Honey, the Voting Group and Subcommittee members, investors (individuals and/or advocacy organizations), proposed/developing/currently available products involved with tick-borne diseases —must not be used for marketing opportunities that are linked to the Working Group.

The Working Group must not be misused —by its leaders or members— as a taxpayer-funded public advertising platform to enhance future sales or monetary gain.
Transparency and Non-Compliance with Federal Advisory Committee Act (FACA)

The first meetings of the Working Group were held on December 11-12, 2017. Although the Working Group is governed by FACA, a profound lack of transparency on the part of its leadership has been a serious and continuing problem.

The Working Group has been extremely slow and in some cases, has failed entirely, to publish the required recordings/minutes/notes of the Working Group and Subcommittee meetings in a timely manner. Despite many public requests and complaints, citizen stakeholders were forced to wait months before the Working Group released the recordings of its December 2017 meetings.

Since Feb 2018, individual Subcommittee meetings were held unannounced and unreported to the public. Notes from the many Subcommittee meetings were not made available to the public for up to four months, until they were finally released, only 6 days before the Working Group’s Public Meeting scheduled for May 15-16. The electronic recordings and transcripts of the Working Group meetings held in May (over 5 weeks ago) have still not been released for public viewing.

FACA requires federal advisory groups to provide transparency of their activities to allow for public comment and discourse. The failure to provide videos and meeting minutes of the Working Group and meeting notes of the Subcommittees in a timely manner served to prohibit meaningful public comment. The failure to provide content in a transparent and timely manner has interfered with the public’s legal rights to have access to the same material as the federal stakeholders; and this violates the intent and practices of FACA.

As previously discussed, citizens were not allowed to know what was being researched, discussed and accomplished in the closed-door meetings of the Working Group and its Subcommittees. The lack of transparency prompted hundreds of public comments to the Working Group.

No response, nor release of information was forthcoming from the Working Group for many months, so stakeholder complaints were eventually directed to HHS upper-level leadership and the federal officer in charge of FACA complaints. No response, nor acknowledgement of receipt of these communications, were received in answer to the complaints.

More than 1000 public comments with requests to be placed into the public record (the actual number is unknown) have been sent to the Working Group. These stakeholder comments have not been made accessible for public review, despite hundreds of follow-up requests asking for the public comments to be released. In addition, only a small number of the 1000+ public comments have been made accessible to the members of the Working Group.

Despite promises of providing transparency, the line of communication between the Working Group members and private citizen stakeholders was deliberately severed by the Working Group leadership from the very beginning.

Reports have been received that communication within the membership of the Working Group and the Subcommittees has also been forbidden and monitored by the Committee’s leadership.

The enforced secrecy and withholding of information to the public about the activities of the Working Group is antithetical to the FACA requirements designed to ensure transparency of advisory Committees.

The subject of the transparency issue brought forth by the public was raised and discussed within the Working Group and at least, in the Access to Care Subcommittee. One member who expressed concern about the Working Group’s lack of transparency with Chair John Aucott and Vice-Chair Kristen Honey – was soon thereafter, verbally informed she was terminated. She has never received the required written statement of her termination. The proper procedure to terminate her was not followed by Chair John Aucott and therefore, she has been illegally blocked from rightful participation in her subcommittee activities.

Conclusion

Several letters from Lyme advocacy leaders and private citizens have been sent to the Working Group membership, HHS leadership and the FACA officer regarding the issues previously discussed. Little to no response, nor even acknowledgement of receipt of the letters has been received.

For the most part, HHS leadership has turned a deaf ear and a blind eye to the complaints from concerned citizens regarding the continuing mismanagement of the Working Group and the apparent disregard for the concerned public.

The lack of action on the issues raised to HHS leadership through vigorous public comment directed to the Working Group, and letters directed to HHS leadership, has the potential to result in a complete invalidation and repudiation of the Congressional recommendations of the Working Group in the future.

The failure by HHS leadership to take immediate and decisive action to correct these very serious issues will be recognized now, and in the future, as being a great disservice to the honorable and ethical members of the Tick-Borne Diseases Working Group, the Lyme community and the general public.

The importance of the Tick-Borne Diseases Working Group and its impact on the health and the economy of our nation cannot be understated. Nearly every person in the US is ‘at risk’ from tick-borne diseases. Countless thousands have been severely harmed and are still suffering from these diseases, while the tick population and spread of infections continue to expand at an exponential rate.

 

………………………………………………………####……………………………………………………………….

1. https://www.hhs.gov/…/tickbornedis…/about/charter/index.html

2. https://www.opm.gov/…/hirin…/intergovernment-personnel-act/…

3. https://www.linkedin.com/in/kristenhoney

4. https://oge.gov/…/$FI…/8f14c1b877a3426e9be1bca3e42d7d921.pdf

5. http://lymeinnovation.org/mentors/kristen-honey/

6. http://lymeinnovation.org

7. http://lymeinnovation.org/lyme-innovation/

8. http://honey2healing.org/news-events/

http://honey2healing.org/…/2…/05/Honey-LymeAid2017-FINAL.pdf

9. https://www.linkedin.com/in/kristenhoney (see under Policy Advisor)

10. https://twitter.com/MLDSEmaine/status/992895501560360960

11. http://honey2healing.org/book/

Note: The written text from which this quote is derived appears to have been removed from this website after portions were quoted and referenced in a May 22, 2018 LinkedIn article was written and posted by Jenna Luché-Thayer and was subsequently circulated on social media. (A screenshot was taken of the statement, prior to its subsequent removal.)

 

 

https://www.ncbi.nlm.nih.gov/m/pubmed/29893631/

Assessing Cat Flea Microbiomes in Northern and Southern California by 16S rRNA Next-Generation Sequencing.

Vasconcelos EJR, et al. Vector Borne Zoonotic Dis. 2018.

Abstract
Flea-borne diseases (FBDs) impact both human and animal health worldwide. Because adult fleas are obligately hematophagous and can harbor potential pathogens, fleas act as ectoparasites of vertebrates, as well as zoonotic disease vectors. Cat fleas (Ctenocephalides felis) are important vectors of two zoonotic bacterial genera listed as priority pathogens by the National Institute of Allergy and Infectious Diseases (NIAID-USA): Bartonella spp. and Rickettsia spp., causative agents of bartonelloses and rickettsioses, respectively.

In this study, we introduce the first microbiome analysis of C. felis samples from California, determining the presence and abundance of relevant pathogenic genera by characterizing the cat flea microbiome through 16S rRNA next-generation sequencing (16S-NGS). Samples from both northern (NoCal) and southern (SoCal) California were assessed to expand current knowledge regarding FBDs in the state. We identified Rickettsia and Bartonella, as well as the endosymbiont Wolbachia, as the most abundant genera, followed by less abundant taxa. In comparison to our previous study screening Californian cat fleas for rickettsiae using PCR/digestion/sequencing of the ompB gene, the 16S-NGS approach applied herein showed a 95% level of agreement in detecting Rickettsia spp. There was no overall difference in microbiome diversity between NoCal and SoCal samples. Bacterial taxa identified by 16S-NGS in this study may help to improve epidemiological investigations, pathogen surveillance efforts, and clinical diagnostics of FBDs in California and elsewhere.

_____________

**Comment**

Bartonella and Rickettsia spp. are also diseases Lyme/MSIDS patients have to contend with.  There is no good, solid research studying the ability of ticks to transmit Bartonella, yet most of us out here in Lyme land have it.  Rickettsia’s out here too in plenty.  I would think this important issue would be dealt with.  Somehow patients are getting these diseases and its either happening by direct transmission or by being activated once they get Lyme and their immune systems become compromised.

Either way, this issue MUST be studied, resolved, and appropriately death with.

Mainstream medicine is completely lost when it comes to tick borne illnesses such as these.  Lyme is finally getting acknowledged due to shear numbers, but don’t kid yourself, thousands upon thousands have Bartonella and Rickettsia as well.  The one drug, one pathogen paradigm needs to be forgotten like a bad dream and researchers and doctors need to become educated on this complex 21st Century plague.

BTW:  Wolbachia is being widely used as a biocontrol.  Here’s why that may not be such a great idea:  https://madisonarealymesupportgroup.com/2017/07/10/wolbachia-the-next-frankenstein/

https://madisonarealymesupportgroup.com/2018/02/12/wolbachia-laced-mosquitoes-being-released-why-lyme-msids-patients-might-be-negatively-affected/

https://madisonarealymesupportgroup.com/2018/05/22/mosquito-spit-alone-may-significantly-alter-your-immune-system-for-days-after-a-bite/

https://madisonarealymesupportgroup.com/2018/05/02/tick-mosquito-and-flea-diseases-more-than-tripled-since-2004/

It is my strong opinion that ALL of these factors are a perfect storm of events causing human suffering and disease.  Researchers need to zoom out and look at the big picture and the interconnection of things or we are doomed.

http://outbreaknewstoday.com/brazil-santa-maria-reports-569-confirmed-cases-toxoplasmosis-50-pregnant-women-97689/

Brazil: Santa Maria reports 569 confirmed cases of toxoplasmosis, of which 50 are pregnant women

June 19, 2018
By Marcos Vinicius Malveira de Lima

The number of confirmed cases of toxoplasmosis in Santa Maria, in the Central Region of Rio Grande do Sul, rose to 569, according to a report released Monday (June / 2018) by the municipal and state health departments. According to the document, of the confirmed cases, 50 are pregnant women. The previous bulletin, released on June 8 [2018], reported 510 cases.

According to the new report, 312 suspected cases of the disease are under investigation. A press conference was held this afternoon to discuss the issue. At the time, the Ministry of Health announced that analyzes and cross-checks of data collected during the first stage of field research are done.

For one month, health workers applied more than 230 questionnaires to people with toxoplasmosis and other residents without the disease. The main objectives are to identify the probable source that gave rise to the outbreak and to ensure that the persons who have been diagnosed have adequate care and treatment. There is no prediction as to when the results of this work will be released.

While the cause of the outbreak is not discovered, the orientation continues to be boiling the water before drinking, avoiding raw or undercooked meat and having enough hygiene in the preparation of food.

The Federal Public Prosecutor filed a lawsuit to ensure the transfer of the drugs for treatment. During the press conference, the agency and the state assured that there are medicines for another three months, considering loans of medicines that came from other cities, such as São Paulo. In addition, a new tender for drug purchases is also planned.

Data from last report
– 1,430 reported cases
– 1,103 suspects, of which 569 confirmed, 222 discarded and 312 under investigation

________________

**Comment**

https://madisonarealymesupportgroup.com/2016/05/21/toxoplasmosis/  Please know there is evidence of coinfection of Toxoplasmosis with Lyme Disease.  As Toxoplasmosis is significant in people who are immuno-suppressed, Lyme Disease will trigger a previous asymptomatic case.  While undercooked food, unsanitary conditions, and cats are normally blamed, sexual transmission has been theorized.

Czech scientist believes that 75% of schizophrenia is associated with infections, with Toxo a significant portion.

http://www.medicalnewstoday.com/articles/295012.php?trendmd-shared=0 Medical News Today reported on a study claiming the parasite is responsible for around a fifth of schizophrenia cases. Now, new research by Johns Hopkins provides further evidence of this association after reviewing two previous studies which identified a link between cat ownership in childhood and development of schizophrenia and other mental disorders later in life and then comparing them with the results of a 1982 National Alliance for the Mentally Ill (NAMI) questionnaire. The questionnaire revealed that around 50% of individuals who had a cat as a family pet during childhood were diagnosed with schizophrenia or other mental illnesses later in life, compared with 42% who did not have a cat during childhood.

T. gondii may be the culprit.

Researchers at the Academic Medical Centre in Amsterdam, the Netherlands conducted a meta-analysis of more than 50 studies that established a link between T. gondii and increased risk of schizophrenia.
http://www.medicalnewstoday.com/articles/247346.php Women carrying IgG antibodies to Toxo when giving birth have a higher risk of self-harm or suicide later on, especially if antibody levels are high.

See first link for treatments.  If you are a Lyme/MSIDS patient and have been diagnosed with schizophrenia and have similar symptoms, please discuss the possibility of Toxoplasmosis with your practitioner.

https://www.governor.ny.gov/news/governor-cuomo-announces-new-public-private-research-collaboration-advance-diagnosis-and

For Immediate Release: 6/19/2018

GOVERNOR ANDREW M. CUOMO

Wadsworth Center Laboratory and Regeneron Pharmaceuticals, Inc. Aim to Improve Diagnosis of Lyme Disease and Develop New Treatments

Governor Andrew M. Cuomo today announced a new, groundbreaking public-private research collaboration to advance the diagnosis and treatment of tick-borne diseases. The New York State Department of Health Wadsworth Center Laboratory and Regeneron Pharmaceuticals, Inc. – a leading biotechnology company that invents life-transforming medicines for people with serious diseases, will collaborate to potentially develop improved diagnostics, prophylactics, and therapeutics for the diagnosis and treatment of tick-borne diseases, starting with Lyme disease.

“This public-private collaboration harnesses the expertise of a world-leading biotech company to tackle one of the most pressing public health issues of our time,” Governor Cuomo said. “Together, Regeneron and the Wadsworth Center Laboratory have the potential to advance health research, develop life-saving treatments for Lyme disease, and address major gaps in our knowledge of tick-borne illnesses. New York is proud to help bolster our world-class, life sciences industry while investing in a safer, healthier Empire State for all.”

Tick-borne diseases, particularly Lyme disease, are among the fastest growing infectious diseases in the United States. When diagnosed correctly and treated, most Lyme disease patients recover within two weeks. However, proven diagnostic tests for Lyme disease have been mostly unchanged for the past 40 years and can have limitations when used at certain times during the course of illness, leaving patients and their providers frustrated, which may lead to missed opportunities for treatment.

Regeneron and the Wadsworth Center Laboratory will jointly research how the causative agent of Lyme disease, the bacterium Borrelia burgdorferi, replicates when a human is bitten by a tick carrying the bacterium, and how the host’s immune response is activated. This information will potentially advance the development of improved diagnostics, prophylactics, and new therapeutics. Over the course of five years, Regeneron will invest up to $48 million in this research and the state will reimburse 50 percent of Regeneron’s research costs up to a total reimbursement of $24 million through the New York State Life Sciences Initiative. Additionally, up to $6 million will be provided to Wadsworth Center Laboratory through the Life Sciences Initiative.

The groundbreaking collaboration between Regeneron and the Department of Health’s Wadsworth Center Laboratory builds on Governor Cuomo’s $750 million commitment to support construction of a new worldclass, stateoftheart Wadsworth Center Laboratory public health laboratory in the Capital Region that will promote collaborative public-private research. Redesigned as “A Lab for The 21st century,” Wadsworth will function as a magnet for future private sector investments where employees, visiting researchers, company executives, and academic partners cross paths to accelerate innovation and value creation. As one of the world’s largest public health research laboratories, this modern facility and committed co-investment will serve as a flagship project for the state, signaling a strong and long-term commitment to the Capital Region’s life sciences industry.

The Wadsworth Center Laboratory serves a vital role in the Department of Health’s efforts to protect and promote the health of New York residents. Building on more than a century of excellence as the state’s public health laboratory, the Wadsworth Center Laboratory continues as a premier biomedical institute that merges clinical and environmental testing with fundamental, applied and translational research. Today, laboratory scientists use both classical and contemporary approaches to study environmental and biological questions related to human health and disease, which will support the collaboration with Regeneron.

Regeneron is a science-driven, world-leading biopharmaceutical company headquartered in Tarrytown, New York that discovers, develops and manufactures innovative medicines. Regeneron was established as a biotech start-up in 1988 in New York City, and the following year, under the leadership of then-Governor Mario Cuomo, Empire State Development invested $250,000 to support the company’s growth. Within years, the state realized a 300-percent return on that investment. Regeneron is now the largest biotech company in New York State and one of the largest in the world, with several approved treatments and a robust pipeline of compounds all developed in New York laboratories.

Regeneron is progressing several important potential infectious disease treatments, all of which were built and tested using the company’s proprietary VelociSuite platforms. Regeneron’s Rapid Response capability speeds development of potential treatments by using their VelociGene and VelocImmune technologies to quickly develop fully human antibodies specific to a particular pathogen and create a genetically humanized model to test and validate these antibodies. The company recently delivered its investigational Ebola treatment, REGN-EB3, to the Democratic Republic of the Congo for potential use in the ongoing outbreak.

ESD President, CEO & Commissioner Howard Zemsky said, “Empire State Development is proud to incentivize this innovative partnership between Regeneron and the Wadsworth Center Laboratory that both advances human health and spurs the growth of a world-class life science research cluster in New York.”

Department of Health Commissioner Dr. Howard Zucker said, “The Department’s Wadsworth Center Laboratory is home to some of the nation’s premier research scientists, and by partnering with a first-class organization like Regeneron, we are taking a significant step forward in developing a more accurate and efficient test to diagnose and ultimately treat these devastating diseases. Governor Cuomo understands the important role research plays in improving the health and well-being of New Yorkers.”

“As a proud New York biotech company, we appreciate the continued commitment of Governor Cuomo’s administration to make New York the ideal location to progress innovative life science research,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “We are looking forward to expanding the potential impact of our infectious disease program and collaborating with the Wadsworth Center Laboratory on potential solutions for tick-borne diseases, which are increasing in incidence and can be extremely difficult to diagnose and treat.”

Senator Sue Serino, Chair of the Task Force on Lyme and Tick-Borne Diseases said, “Since taking office, I have heard from countless New Yorkers who have suffered gravely as a result of an inaccurate Lyme Disease diagnosis and lack of advancement in this field. Last year, Senator Kemp Hannon and I held a joint hearing to help the state improve its response to the Lyme and tick-borne disease epidemic. At that time, we urged the state to lead the way and make a significant investment in this critical area. As Chair of the Senate’s Task Force on Lyme and Tick-Borne Diseases, I am proud that the voices of so many who have been suffering in silence for far too long are finally being heard. I thank the Governor for giving this issue the attention it deserves and I look forward to the day when false negatives and inaccurate results are a thing of the past and patients in New York can receive the effective, quality care they deserve.”

Senator Neil D. Breslin said, “The growth of health care treatments and services have become key economic drivers for New York’s economy. The Governor’s focus on expanding these industries provides a major boost to the Capital Region by supporting our academic institutions, attracting top scientists, and advancing treatments for diseases like Lyme that impact so many of our residents. I look forward to the continued development of treatments through this new collaboration, and thank Regeneron for working with the state of New York to provide stronger communities for the next generation.”

Assembly Member Patricia A. Fahy said, “The Governor’s comprehensive Life Sciences initiative is drawing world-class researchers Upstate to be part of the transformative health advances that are being discovered right here in the Capital Region. I am proud of the life-changing R&D that Wadsworth and Regeneron have already accomplished, and by partnering on this latest endeavor, New Yorkers across the state will reap the benefits of newly developed diagnoses and treatments.”

Assembly Member John T. McDonald III said, “Lyme Disease and tick-borne diseases are ongoing healthcare concerns especially in New York State. I applaud this public-private partnership that advances the research surrounding these diseases and will hopefully provide innovative solutions to this issue. The Governor’s new investment to support the partnership between Regeneron and Wadsworth Center Laboratory will take these efforts even further by leveraging the assets found in the Capital Region to develop new, potentially life-saving treatments for tick-borne illnesses. I proudly support projects that aim to keep the health of all New Yorkers a top priority.”

Albany County Executive Daniel P. McCoy said, “I commend Governor Cuomo for investing in the development of new treatments for Lyme disease here in the Capital Region at the Wadsworth Center. By supporting New York State’s growing life science research cluster, this partnership will help create jobs, develop new life-saving health services and support an improved quality of life for our residents.”

Albany Mayor Kathy Sheehan said, “As summer approaches, New Yorkers are reminded of the dangers of tick-borne illnesses. This collaborative public-private partnership will bring together world-class scientists and health researchers to uncover new treatments and preventative measures at the Capital Region’s premiere public health laboratory. Thank you to Governor Cuomo for supporting this critical public health project and investing in Albany’s Wadsworth Center Laboratory.”

New York State’s $620 Million Life Science Initiative

In the FY 2018 state budget includes a $620 million initiative to spur the growth of a world-class life science research cluster in New York, as well as expand the state’s ability to commercialize this research and grow the economy. The Governor’s multi-faceted initiative includes, $100 million to expand the Excelsior Jobs Program Tax Credit to the life sciences industry, $100 million for a life sciences research and development refundable tax credit program, and $320 million in other forms of investment.

To support the development of wet-lab and innovation space, the initiative includes state capital grants for operating support and investment capital for early stage life science companies that leverage an additional match of at least $100 million from the private sector.

The Life Science sector encompasses the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, and includes organizations and institutions that devote the majority of their efforts to the various stages of research, development, technology transfer and commercialization. Every day, firms in this sector are developing new medical and pharmaceutical breakthroughs that have the potential to save lives, whether through new therapies or the early detection of diseases like autism and cancer. These firms are also making significant advancements in the realms of agriculture and environmental biotechnologies, helping create a cleaner and more sustainable future.

By strengthening incentives, investing in the facilities, and improving access to talent and expertise, New York will significantly increase its share of industry-funded research and development, support the commercialization of existing academic research, and usher in the next generation of advanced technologies. Beyond the advancements in science, this initiative will position New York as a magnet for emerging manufacturing- based enterprises to bolster regional economies and create thousands of jobs.

 

https://www.ncbi.nlm.nih.gov/m/pubmed/29805824/

Ischemic Stroke: Do Not Forget Lyme Neuroborreliosis.

Moreno Legast G, et al. Case Rep Neurol Med. 2018.

Abstract
Lyme neuroborreliosis is a rare cause of ischemic stroke; it has only been described in case reports and mostly in Europe. Diagnostic criteria have been proposed for Lyme neuroborreliosis but the association with a cerebral ischemic presentation is not always straightforward. We here describe the case of an 83-year-old man for whom we strongly suspect Lyme neuroborreliosis as the etiology of his stroke. This case reminds us of the importance of a thorough history taking (i.e., tick bite) and to perform the adequate ancillary tests accordingly (lumbar puncture) so as to propose validated treatment.

______________

**Comment**

This is rich.  They explain that cerebral ischemic presentation is not always straightforward yet announce with confidence that Lyme is a rare cause of it.  How do you know?  Just because it isn’t bountiful in the literature does not mean isn’t out here.  Remember, the testing only gets about 50% of those infected.  All those folks are misdiagnosed with something else.  Anything but Lyme/MSIDS!   Is anyone even looking for it?  Nope.

Don’t call anything about Lyme/MSIDS rare.  It’s just a matter of time before articles burgeon with all the ways it presents itself.  Until that time, just know, it’s out here – a lot.

Also, please know that one of the only ways Lyme/MSIDS has made the map is by case studies.  Research on all things in Lyme land is abysmal, so take the case studies seriously.

 

http://thechronicleherald.ca/opinion/1577953-counterpoint-we-don’t-take-lyme-seriously-enough#.WybeW46-8U4.linkedin

COUNTERPOINT: We don’t take Lyme seriously enough

by JIM WILSON

Published June 16, 2018

Diagnosis, treatment is still lacking in Nova Scotia
B97808243Z.120180615163154000GK8L2CS6.11The bullseye rash, like the one pictured on a woman’s arm above, is often associated with the early stages of Lyme disease. (JAMES GATHANY)

Re: your June 9 Letter of the Week: “Stop pushing the Lyme disease panic button.” I think it is time for a different take than what’s offered in this letter and the June 3 news article it stemmed from, “Public health failing to address Lyme disease crisis, says author.”

Born in Nova Scotia, I contracted Lyme disease in Dartmouth in 1991.

Little has improved since then, except for awareness.

Diagnosis and treatment are still very poor. Testing for Lyme disease is not even recommended until at least two to three weeks after infection because the current testing protocols used Canada-wide are indirect tests — checking to see if the patient has developed detectable levels of antibodies to the bacterium that causes Lyme disease (borreliosis), and it takes that long for us to develop the antibodies. By then, the disease has moved into deep tissue.

Lyme disease is not easily preventable; it requires daily due diligence and even then you can still become infected.

It may require landscaping redesign of your property, separating tick habitat from your living space.

Ticks, especially those that transmit Lyme disease, are tiny and not easily seen. Frequently, if you see one tick on you, you may miss other ticks that are in areas of the body not easily observed, including under the hair and in private parts.

Also, Canada says it is keen on prevention. Yet a majority of countries have approved products for sale designed to prevent ticks from attaching, such as permethrin-soaked clothing and eucalyptus oil with icaridin. Only after years of asking, Health Canada finally approved permethrin-soaked clothing to be sold here, but strangely only to prevent insect bites, not tick attachments (unlike 45 other countries).

Also, the eucalyptus-oil-based products containing icaridin (also called picaridin) that have been shown to be very effective have not been approved for sale in Canada either. So is Canada truly concerned about prevention? It appears not.

Rhode Island, a tiny U.S. state, has 9,000-plus cases per year, using the United States Center for Disease Control model of 10 times the confirmed cases (due in large part to poor tests, poor medical education and other reasons).

It is illogical to blame the individual for not taking precautions, which is the implication in the article and in this letter.

The fact is, even with the best of precautions and awareness, people are still becoming infected in record numbers, as there is a large amount of under-reporting.

The article and the letter also fail to point out that ticks do not only transmit Lyme disease.

Our motto at the Canadian Lyme Disease Foundation (CanLyme.org) is No Tick Is A Good Tick.

That’s because we must be concerned about all species of ticks that will attach to humans. They are all capable of transmitting various diseases (ehrlichiosis, babesiosis, rocky mountain spotted fever, etc.) — some requiring only a short period of attachment — and they can deliver serious neurotoxins such as tick paralysis (from the Dermacentor ticks commonly known in the west as the wood tick and in eastern and central Canada, the dog tick).

According to the original article, “Heather Fairbairn, a spokeswoman with the province’s public health department, states Lyme disease is easily curable both in the early and later states of the disease.”

That is simply an irresponsible statement that flies in the face of all credible evidence-based, grade-level science.

If caught very early, it can usually be cured with antibiotics. Sadly though, most cases are not diagnosed early — and typically it is only those who present with a nicely defined bull’s-eye rash who are.

But most people do not get that rash.

You can easily apply the “10 times of reported confirmed cases” estimate to Nova Scotia as well, putting the likely number of cases at around 4,000 per year — not around 400 — showing clearly that it is not easily prevented.

Later-stage Lyme disease is very difficult to treat in many cases — again a well-known fact supported by all studies done on animals and thousands of individuals’ testimony (similar to the 100 people who testified on camera at the 2016 Lyme disease conference sponsored by the Public Health Agency of Canada as required by federal legislation enacted with all-party, unanimous support).

The legislation came about due to misinformation by government and medical authorities over decades.

Physicians are improperly educated and not given the true picture of Lyme borreliosis and other tick-borne diseases. People do not have access to adequate diagnosis and treatment.

Jim Wilson is president of the Canadian Lyme Disease Foundation.

_____________

**Comment**

Bravo, Jim.  You are spot on.

https://www.lymehope.ca/news-and-updates/33-years-of-documentation-of-maternal-child-transmission-of-lyme-disease-and-congenital-lyme-borreliosis-a-review-by-sue-faber-rn-bscn

33 Years of Documentation of Maternal-Child Transmission of Lyme Disease and Congenital Lyme Borreliosis – A Review

by Sue Faber, RN, BScN

6/16/2018

‘Transplacental transmission, adverse outcomes and reports of congenital infection of Borrelia Burgdorferi have been clearly documented over the last 33 years (1985 to 2018) by multiple international physicians, researchers, scientists and other experts. As entire families worldwide are affected by Lyme borreliosis resulting in serious debilitating illness and complex multi-systemic chronic infection, we must take this alternate mode of transmission – from mother to child in pregnancy, seriously.

For Lyme disease to be passed from mother to child in pregnancy drastically changes the narrative, we know that, it opens up new issues and challenges – however, recognizing it for what it is, is the right thing to do. It means upheaval and reordering and re-prioritizing in what has been taught and rethinking many areas of concern which perhaps have been looked over – but we must remember – we have no choice but to act with the highest integrity and honesty.

We have no option but to constructively engage, discuss and determine solutions and a clear path forward which will be a light for those who suffer, a beacon of Hope and healing. We need to prevent more miscarriages, stillbirths and babies from being born with Lyme and tick-borne illnesses – potentially leading to chronic pervasive, persistent and often disabling illness’. Sue Faber, RN.

https://www.lymehope.ca/uploads/8/4/2/8/84284900/updated_june_16_2018_-_32_years_of_literature_review_march_18_2018.pdf  (Excerpt below.  Please see link for more studies)

“Now we have found a spirochete capable of spreading transplacentally to the organs of the fetus, causing congenital heart disease and possible death of the infant.”

Dr. Willy Burgdorfer – The Enlarging Spectrum of Tick-Borne Spirochetoses: R. R. Parker Memorial Address, Reviews of Infectious Diseases. Vol 8, No 6. November-December 1986.

“It is clear that B. Burgdorferi can be transmitted in the blood of infected pregnant women across the placenta into the fetus. This has now been documented with resultant congenital infections and fetal demise. Spirochetes can be recovered or seen in infant’s tissues including the brain, spleen and kidney. The chronic villi of the placenta show and increase in Hofbauer cells as in luetic placentitis. Inflammatory changes of fetal or neonatal changes are not as pronounced as in the adult, but cardiac abnormalities, including intracardiac septal defects, have been seen. It is not known why inflammatory cells are so sparse from maternal transmission, but it is possible that an immature immune system plays a role.”

Dr Paul Duray and Dr Allen Steere – Clinical Pathologic Correlations of Lyme Disease by Stage. 1988.

“It is anticipated that more infants and fetuses with complications related to gestational Lyme borreliosis will be diagnosed in the future as the diagnosis is more frequently considered; it eventually will be possible to better describe the various clinical manifestations of congenital Lyme borreliosis.

“..in order for infants with congenital Lyme borreliosis and therefore initiation of prompt antibiotic therapy of the congenitally infected infant usually depend on suspicion or confirmation of Lyme borreliosis in the mother. Therefore, in order for infants with congenital Lyme borreliosis to be recognized, it is essential for clinicians caring for newborns and infants to become familiar with the various manifestations of Lyme borreliosis in the adult, as well as in the congenitally infected infant.”

(serology) does not appear to be a sensitive method of diagnosis and reliance on sero-positivity leads to misdiagnosis of the majority of congenitally infected infants.”

“Large-scale, prospective studies of sufficient numbers of patients with Lyme borreliosis with follow-up to determine the pregnancy outcome of each enrolled patient; B burgdorferi-specific evaluation of any fetal or neonatal demise; and long-term follow-up of each infant born to determine the occurrence of possible early and late sequelae are needed.”

Dr. Tessa Gardner, Pediatric Infectious Disease MD, trained at Harvard University, 2001. Gardner, T. Lyme disease. In: Remington JK, J. editor. Infectious Diseases of the Fetus and Newborn. 5th ed: Saunders; 2001

“Transmission of Borrelia infection occurs via both zoonotic vectors and other humans. Congenital transfer is an established fact. Maternal to fetal transfer of Borrelia, can furthermore be clinically silent or unrecognized, and if not successfully treated, infection can be life long and latency, late activation and reactivation can occur.”

O’Brien J, Hamidi O. Lyme Disease (www.smgebooks.com). Infection with Borrelia: Implications for Pregnancy, Nov. 2017.

“Intra-human transfer of Borrelia can be initially silent or unrecognized’

‘The similarities of the clinical presentation of congenital syphilis to pregnancies with acute Lyme disease helps guide ante partum management. Due to the severity of previously documented cases, there should be a low threshold of suspicion to diagnose cases of Lyme disease in pregnancy.

O’Brien J, Hamidi O. ‘Borreliosis Infection during Pregnancy’. Ann Clin Cytol Pathol 3(8). Oct. 2017.

“Pregnant women who are acutely infected with Borrelia burgdorferi (the primary cause of Lyme disease) and do not receive treatment have experienced multiple adverse pregnancy outcomes including preterm delivery, infants born with rash and stillbirth.”

“In obstetric patients acutely infected during the first trimester, a fetal echocardiogram is reasonable, given the demonstrated high potential of fetal cardiac abnormalities.’

O’Brien J, Baum, J. Case Report. The Journal of Family Practice. Vol 66, No 8, Aug, 2017.

“It was stated and proved transplacental transfer of borrelia

“We need serious studies among pregnant women and newborn children in endemic regions…and in the future such patients should be monitored throughout pregnancy and after childbirth. Children born to these women should be examined for tick-borne infections at least during the first two years of life.”

Utenkova EO. Lyme disease and Pregnancy. Kirov State Medical Academy, Kirov Russia. Journal of Infectology, Volume 8, Number 2, 2016. *translated from Russian

“a new acronym is needed to include other, well-described cause of in utero infection: syphilis, enteroviruses, varicella zoster virus, HIV, Lyme disease (Borrelia burgdorferi) and parvovirus.”

In utero infection and intrapartum infections may lead to late-onset disease. Such infections may not be apparent at birth but may manifest with signs and symptoms weeks, months or years later.”

Maldonado Y, Nizet V, Klein J et al. Current Concepts of Infections of the Fetus and Newborn Infant (Chapter 1). Found in Remington and Klein’s Infectious Diseases of the Fetus and Newborn Infant, 8th ed., 2016.

“Histological observations have confirmed the presence of Bb in children with congenital Lyme disease. It is interesting that spirochetes may exist in the spleen, kidney, bone marrow and nervous system.”

“The ability of long term survival of Bb sl in tissues and spreading of spirochetes in the body despite antibiotic treatment can contribute to intergenerational infection with Lyme disease.”

Jasik K, Okla H, Slodki J et al. Congenital Tick-Borne Diseases, is this an alternative route of transmission of tick- borne pathogens in mammals? Vector- Borne and Zoonotic Diseases, Volume 15, Number 11, 2015.

“these documented cases strongly suggest that transplacental transfer occurred via identification of Borrelia Burgdorferi in fetal tissues by culture, immunohistochemistry or indirect immunofluorescence.”

“the outcome of a pregnancy affected by Lyme disease remains relatively unknown and unstudied. However, it is still important to equip obstetrical patients with information that will help protect them against Lyme disease and provide treatment options if a suspected case of Lyme disease occurs during pregnancy.”

O’Brien JM, Martens MG. Lyme disease in Pregnancy, a New Jersey Medical Advisory. MD Advisor, 2014;7:24- 27.

Borrelia Burgdorferi does appear to cross the placenta and infect the fetus. There are data to suggest an increased incidence of spontaneous abortion, stillbirth and congenital malformations associated with Lyme disease.”

“Adverse pregnancy outcomes are also more likely in women with untreated Lyme disease.”

Dotters-Katz S, Kuller J, Heine P. Arthropod-Borne Bacterial Diseases in Pregnancy. Obstetrical and Gynecological Survey, Vol 68(9). 2013.

“The parents of the five children in the study could not pinpoint an exact date of infection, but their treating physician suggested that the Bb bacteria could have been transmitted congenitally since all five of their mothers were diagnosed with Lyme disease and Bb has been shown to be transmitted congenitally in infected mothers. If the Bb bacteria were transmitted congenitally and this latency period presented itself in the infected children it could lead to an explanation of their late onset autistic symptomology.”

Kuhn M, Grave S, Bransfield R, Harris S. Long term antibiotics therapy may be an effective treatment for children co-morbid with Lyme Disease and Autism Spectrum Disorder. Medical Hypothesis (2012)

“The clinical picture of a fetus infected by B Burgdorferi is similar to that seen in the course of a syphilis infection. Most frequently they are: premature birth, intrauterine foetus death and malformation

“In the second stage of the illness, B. Burgdorferi traverses the placental barrier. Apart from foetal death, the following occur most frequently: syndactyly, sight loss, premature birth, neonatal rash, heart, liver, kidney damage or damage to the central nervous system.”

Relic, M, Relic, G. Lyme borreliosis and pregnancy. Vojnosanit Pregl 2012; 69(1):994-998. *translated from Polish

For more:  https://madisonarealymesupportgroup.com/2018/02/26/transplacental-transmission-fetal-damage-with-lyme-disease/

https://madisonarealymesupportgroup.com/2018/05/24/new-berlin-mom-given-life-altering-lyme-disease-diagnoses-after-pregnancy/

https://madisonarealymesupportgroup.com/2017/10/15/pregnancy-in-lyme-dr-ann-corson/