On July 20, 2020, the Environmental Protection Agency (EPA) registered a new active ingredient called nootkatone, which repels and kill ticks, mosquitoes, and other pests including bed bugs, and fleas. The Center for Disease Control (CDC) discovered and developed the new ingredient, a non-toxic chemical found in Alaska yellow cedar trees and grapefruit skin in minute amounts. Nootkatone smells and tastes like grapefruit, and is used in the fragrance industry for perfumes and food industry for flavoring. It can be used on humans and pets.
Nootkatone apparently kills bugs differently than previous classes of insecticides, including pyrethroids, organophosphates, carbamates, and cyclodienes. Since it is a new chemical — the first insecticide approved in 11 years — it can kill bugs that are resistant to currently available pesticides. It lasts on skin and clothing for several hours.
CDC’s exclusively licensed partner, Evolva, and HHS Biomedical Advanced Research Development Authority were crucial to nootkatone development. Evolva can produce large amounts of nootkatone for low-cost, as it takes several tons of grapefruit to produce 2.2 lbs of nootkatone.
Dr. Brian Fallon, director of the Lyme and Tick-Borne Diseases Research Center at Columbia University in New York City, said of nootkatone, “I think it’s a major contribution to our arsenal of repellents.”(nbcnews.com)
Tick-borne diseases represent almost 80 percent of reported vector-borne disease cases in the U.S. Reported cases of vector-borne diseases doubled from 2004 to 2018. Companies interested to develop brand name products will be required to submit a registration package to EPA for review, and products could be available in stores as early as 2022.
Current ingredients registered by the EPA as skin-applied insect repellents include Catnip oil, Oil of citronella, DEET, IR 3535, p-Methane-3,8-diol (pmd), Oil of lemon eucalyptus, Picardin, 2-undecanone, and now nootkatone.
Severe Fever with Thrombocytopenia Syndrome (SFTS) cases first appeared in April 2020 in China and since then, 37 more cases have occurred in Jiangsu and 23 in Anhui Provinces in China. SFTS is a haemorrhagic fever transmitted by the Haemaphysalis longicornis tick (Asian longhorned tick). The disease spreads rapidly and has a high fatality rate so is of high concern to the World Health Organization (WHO). SFTS is a Phlebovirus.
Experts are now indicating possible transmission from humans via blood, the respiratory tract, and wounds and from infected animals to humans.
Another Phlebovirus, Heartland virus, is found in the US. It is apparently transmitted by the lone star tick and is most similar to the SFTS virus. The Asian longhorned tick, which is transmitting SFTS virus in Asia, is found in the US in 12 states.
House Approves Chris Smith Amendment Increasing Lyme Research by $4M
News from Congressman Chris Smith website:
The House of Representatives passed an amendment authored by Rep. Chris Smith (R-NJ) which increases Lyme disease research funding by $4 million, for a total of $20 million, at the Centers for Disease Control and Prevention (CDC) for fiscal year 2021. The amendment, which passed July 30th, has been co-sponsored by lead Democrat, Rep. Collin Peterson (MN), and Reps. Elise Stefanik (R-NY), Antonio Delgado (D-NY), Max Rose (D-NY), and Raul Grijalva (D-AZ).
Rep. Smith said, “Just three years ago CDC’s Lyme budget was only $11.7 million. The increase in funding achieved through my amendment will help CDC develop better diagnostic tests for Lyme, expand tick surveillance activities across the US and strengthen the federal government’s overall strategy to combat Lyme.”
In the news release, Pat Smith, LDA President was quoted: “Rep. Smith’s funding amendment is an important step in the fight to reign in Lyme disease. The rising case numbers and increasing spread of tick-borne diseases are alarming and require a sustained focus from Congress to try to control this epidemic. We are grateful to Congressman Smith for his continued dedication to this effort and his success along with his colleagues to acquire an additional $4M in funding for Lyme disease and other tick-borne diseases. In these difficult times for our country, that is an outstanding accomplishment.”
Earlier in July, the House agreed to another Smith Lyme Disease amendment to mandate a GAO investigation into possible use of ticks in a Department of Defense bioweapons program. Read more on LDA website
Rep. Smith introduced the House version of the recently enacted law, the TICK Act (Ticks: Identify, Control, Knockout Act—HR 3073), which implements a national strategy to fight Lyme disease and authorizes an additional $150 million to increase funding for Lyme research, prevention and treatment programs. Read more on LDA website
Asian Longhorned Tick Continues to Multiply, Can transmit to Animals in the Lab
These pictures of the Haemaphysalis longicornis (Asian longhorned) were taken recently by LDA’s Scientific & Professional Advisory Board member James L. Occi, Rutgers, in Bergen County NJ. The invasive tick was first discovered on a NJ farm on a sheep in 2017. The tick probably came from Asia, where it is able to transmit diseases to cattle, other animals, and to humans and is now found in 12 states. One of the greatest concerns is about its parthenogenetic ability, the female reproduces without the male. This enables the tick to quickly become an established species in an area. It has already killed cattle in a couple states where more than a thousand ticks were found on each of the deceased animals.
To date, the Asian longhorned tick has been found in the laboratory to be able to acquire and transmit Rickettsia rickettsii, the agent of Rocky Mountain spotted fever (RMSF) and was also found to be able to transmit R. rickettsii through the ova (Stanley et al, 2020).* The Asian longhorned tick has not been found to transmit to humans outside the lab at this time in North America.
However, we need to be cautious, since until several years ago, the government indicated that brown dog ticks only fed upon dogs, not people. Therefore humans did not have to worry about getting RMSF from a brown dog tick. Now we know that human transmission is happening from the brown dog tick, since we know they are biting humans, especially in the Southwest.
Series of Amendments Go Through Process to Increase Lyme/TBD CDC $$$
In a complex government process, the Tick Act–a bill that provides funding for Vector-Borne Diseases including Lyme– was not fully funded according to the Committee report on HHS. The Committee report has 16M for Lyme and 38M for vector-borne diseases.
(NOTE: as LDA has mentioned in prior information on the Tick Act, it is for Vector-Borne Diseases of which TBD are only a part).
To address the issue, Congressman Chris Smith (NJ-4) developed an amendment to raise that funding for TBD, which was co-sponsored by Congressman Collin Peterson (MN). During amendment development, the President’s budget request for 2021 was examined, which asked for $14 million increase over 2020 for vector-borne diseases. Suggested funding levels in the Tick Act for vector-borne diseases were also examined. The LDA provided input into that amendment process and concurred with an additional $11.4M to be asked for on top of the $2M increase in appropriations asked for in the report. Congressmen Smith and Peterson submitted the amendment for $11.4M, but Congressman Delgado (NY) also submitted an amendment, asking for $4M. The Congressmen agreed on $4M in an amendment Smith et al # 289.
Amendment # 289. Smith, Christopher (NJ), Peterson (MN), Stefanik (NY), Delgado (NY), Rose, Max (NY) does the following: Redirects $4 million from General Departmental Management at the Department of Health and Human Services to Emerging Zoonotic and Infectious Diseases at the Centers for Disease Control, for Lyme Disease and other Vector-Borne Diseases.
Listen to the video below of Congressman Smith pitching the amendment to the committee.
GAO Investigation of Ticks/Vector-Borne Agents’ Biowarfare Experiments Passes House
Update July 29, 2020: The Bill and passed amendments such as this one (below) has now moved to the conference committee where the House and Senate will work to decide what language goes into the final product. The LDA provided input into the amendment language and has been working to get Senators to champion the inclusion of this GAO Investigation Amendment into the final bill.
Said LDA president Pat Smith: “We thank Congressmen Smith & Peterson for championing this investigation. Lyme and tick-borne diseases (TBD) patients and the public are entitled to know the truth about what past government research may reveal not only about the documented tick releases along the Atlantic bird flyway but also about research on the mysterious ‘Swiss agent’ which Dr. Willy Burgdorfer identified as a new Rickettsia strain in his work for the US Government– at Rocky Mountain Labs and in Switzerland. Perhaps it may uncover clues to help stop this epidemic of tick-borne diseases.”
July 23, 2020: The House voted this week to pass a number of amendments to the NDAA, National Defense Authorization Act, including a Chris Smith/Collin Peterson amendment, # 587 —The Comptroller General of the United States shall conduct a review of whether the Department of Defense experimented with ticks, other insects, airborne releases of tick-borne bacteria, viruses, pathogens, or any other tick-borne agents regarding use as a biological weapon between the years of 1950 and 1977. (https://rules.house.gov/bill/116/hr-6395).
There is information in various publications that such activities did occur, especially in the book “Bitten” by Kris Newby– a science writer at Stanford University—a book, which explores the evidence through actual government documents and interviews with some researchers who were involved that document such experiments.
Said LDA president Pat Smith: “Lyme and tick-borne diseases (TBD) patients and the public are entitled to know the truth about what past government research may reveal not only about the documented tick releases along the Atlantic bird flyway but also about research on the mysterious ‘Swiss agent’ which Dr. Willy Burgdorfer identified as a new Rickettsia strain in his work for the US Government– at Rocky Mountain Labs and in Switzerland. The book indicates there is speculation that this pathogen, if crossed with Borrelia, might well complicate treatment and thus be a candidate for biowarfare.” She added, “There is the possibility that any uncovered information could lead to facts which could shed light on the current epidemic of Lyme and other TBD and help develop solutions. We thank Congressmen Smith and Peterson for their continued push to make the truth known and the US House of Representatives for their vote to approve the amendment. ”
Some things author Newby revealed for the first time were: that ticks were developed and deployed as stealth biological weapons during the Cold War, and that Willy Burgdorfer, the scientist the Lyme bacteria, Borrelia burgdorferi, was named after, was at the center of this program. According to Newby, specific revelations she makes in book include:
A 1962 pilot study where infected ticks were dropped on Cuba sugar workers.
Releases of hundreds of thousands of radioactive, aggressive Lone Star ticks on the Atlantic coastal bird flyway.
Omissions of other microbes transmitted with Lyme-carrying ticks during the original outbreak (“Swiss Agent´).
Documentation of military studies where live disease-causing bacteria, some which can be spread by ticks, were sprayed from planes, boats and vehicles on the unsuspecting American public.
In 2019, a similar amendment was introduced and passed the House unanimously but there was no senate support for it.
The Lyme Disease Association (LDA) has been encouraging Lyme advocates across the country to contact both of their US Senators to champion and support this amendment. It is being heard in the Senate this week. LDA thanks those leaders who have made calls and sent emails to garner support.
Lyme Vaccine Candidate: Valneva Announces Phase 2 Study Results
Valneva announced that the vaccine candidate against Lyme disease, VLA15-201, showed positive initial results meeting its endpoints in the Phase 2 study. They stated in the July 22, 2020 press release that “compared to Phase 1, the higher doses used in this trial elicited higher antibody responses across all serotypes.” Of particular note was the the immunological response found in older adults (50-65 years), one of the main target groups for a Lyme vaccine. The vaccine candidate is described as “generally safe across all dose and age groups tested”, finding no Serious Adverse Events (SAEs) associated with VLA15. This is an important finding given the history of vaccines and serious concerns that have been generated regarding patient safety and vaccines in the Lyme community.
VLA15 is the only active Lyme disease vaccine candidate in clinical development today, covering six serotypes of Lyme disease prevalent in North America and Europe. It was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017. In a few months, Valneva expects to report top-line results for the second Phase 2 study, VLA15-202. Valneva and Pfizer are collaborating for development and commercialization of VLA15.
Slam Dunk for WNBA−Slam for Delle Donne & Lyme Patients
From LDA President Pat Smith’s Blog:
What has happened to one of the best Women’s National Basketball Association (WNBA) players is no surprise to the Lyme Disease Association or hundreds of thousands of chronic Lyme patients. Elena Delle Donne, of the Mystics, has been denied by the WNBA league’s panel of physicians as having a health exemption due to being at high risk for COVID 19, thus unable to be paid for exemption status if she does not play the upcoming season. She had a letter from her personal physician who confirmed her high risk status as she has suffered from Lyme for many years, and the team doctor deferred to that physician’s appraisal.
Apparently, the league’s physician panel decision was based on the CDC’s list of people of any age with certain underlying medical conditions are at increased risk for severe illness from COVID-19. The CDC medical conditions list does not include Lyme. The omission is not surprising when you consider that our government has denied treatment to 20%+ of Lyme patients because it does not acknowledge their condition. This position of the government on chronic Lyme has persisted for decades–Lyme disease as we know it has been around 46 years.
Chronic Lyme can lead in many cases to complete debilitation and even death, so why wouldn’t the government classify someone with chronic Lyme as high risk? A high risk admission would provide validity to the claims backed by hundreds of peer reviewed articles published on research in credible institutions that indicate chronic, persistent, Lyme might be real.
The recent discovery of “persisters” and biofilms associated with Lyme disease threaten the house of cards built by the deniers. The patients they have denigrated, mocked, and dismissed over decades might really be sick? These chronic patients might actually need more antibiotics than the ~3 weeks now provided under the IDSA guidelines—guidelines clandestinely, or not so, supported by federal health officials? Guidelines that these officials have tried to remove references to on their websites by removing the name and keeping the contents? As the saying goes, “If it looks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck.” From what I hear, the Lyme community votes for the duck. The government continues to endorse IDSA guidelines for diagnosis and treatment.
The government will not however, reference the International Lyme & Associated Diseases Society (ILADS) Lyme Treatment Guidelines, those used by Lyme literate physicians, who use clinical judgment to treat longer-term for Lyme disease if they feel it is necessary.
In fact, a recent NIH FOIA came to my attention which documents a discussion in 2008 between a then NIH official and an HHS employee as to possible removal of the ILADS guidelines from the government’s then active National Guidelines Clearing House under HHS’s Agency for Healthcare Research and Quality (AHRQ).
The chronic Lyme deniers carefully choose their handpicked biased science often published in their own journals and loudly tout the over generalized Lyme treatment trial conclusions–all are sacrosanct. Their message is clear: No more research is necessary, and no one should question that, especially patients, advocates, and Lyme literate physicians.
Meanwhile, patients cannot get a timely diagnosis, an appropriate treatment, and as Delle Donne found out, a high risk designation. All this denial, yet CDC estimates from studies that there are 300,000+ Lyme disease cases annually in the US alone, and government admits some 15-20% continue to have symptoms. But is it Chronic Lyme? NO. Persistent Lyme? NO. What is it then we ask, 46 years later. Listen to the sounds… of silence.
NOTE: Although LDA President Pat Smith is an HHS TBD Working Group Member, this Blog does not express the opinions of HHS or the HHS Tick-Borne Disease Working Group.
Contentious 9 Hour WG Meeting: Persistent infection a Religious Belief? WG Co-Chair Says Yes
Pat Smith Describes Pre-Meeting Effort to Minimize Lyme.
Below in For the Record are the written comments LDA President Pat Smith, a public member of HHS TBD Working Group read (slightly compressed) into the record at the Working Group (WG) meeting on July 8 about the potential WG Chapter report for which she was responsible, the only one addressing patient issues. 89 written comments/deletions to the report had been suggested before the meeting by Working Group members. Working Group Co-Chair Dr. David Walker and Member Eugene Shapiro were responsible for moving to delete entire sections of Lyme material from the report, many of which called for the removal of much of the Lyme material and the de-emphasis of Patient Access to Care in the Chapter.
Co-Chair Says “almost religious belief that it’s a persistent infection”
At the meeting itself, Working Group Co-Chair, Dr. David Walker, and Member Eugene Shapiro made and seconded many motions to remove material from the proposed draft report including the two sets of guidelines, shared decision making, access to care, Lyme treatment trials, and cost of Lyme disease. There was also a discussion in which Shapiro and Walker wanted to remove Lyme mouse model studies and other animal studies that showed persistence that were included in the draft report, saying animal models were really not a good use for this infection.
Dr. Walker said there is “emphasis on belief…almost religious belief that it’s a persistent infection” and at various times said they probably didn’t have Lyme to start with. After many hours of this discussion, no other WG members would second the motions for removal. For the record: The importance of today’s meeting and our Chapter review can’t be overstated. My Access to Care, Education & Training subcommittee including healthcare providers and patients, with expertise in the problems associated with patients’ access to care including physician education, submitted a 75-page subcommittee report and additional 45 citation pages documenting these problems to get help for a body of patients neglected especially those who develop the most serious stage of Lyme and to prevent acute patients from reaching that stage. Patients looked to this WG created through legislation initiated by, written by, and pushed through Congress by Lyme patients/advocates. In 2019 through now, 78% of comments to the online WG mailbox were about TBD/Ticks, 70% of those TBD comments were on Lyme disease and 81% of those were on chronic/persistent/PTL, not acute.
Before the January 2020 Working Group meeting, WG members were instructed to read each subcommittee report. Subcommittee co-chairs presented reports at that meeting. In my subcommittee case, since I had not had an active co-chair for a while, a subcommittee member stand-in, not permitted to vote or ask questions, was allowed to present with me a PowerPoint, including Subcommittee rationale and recommendations later discussed, modified, and voted upon.
Then, writing groups of 2 WG members each were solicited for each Chapter to be written for the WG report to Congress. The WG was definitively told that all information for the WG report had to be taken from the Subcommittee reports. I asked if newly published information, for example, could be used, was told, yes, but then the WG would have to approve that new material. Recently activated WG alternate member Captain Scott Cooper and I volunteered to write the Chapter we’re presenting today.
As directed, we pulled language from the subcommittee reports, submitted our Chapter for review and was told “well organized, appropriate to audience level, and it flowed logically,” but we needed to “rebalance” the chapter as there was too much information on Lyme disease and access to care than other tick-borne diseases and education. Suggested rebalancing included removing a factual table from CDC which listed TBDs for 3 years, in descending order of reported case numbers, as the table could “inadvertently diminish the importance of other tick-borne diseases because their numbers are much lower.” It was OK that we led with burden of disease (cost, quality of life, & productivity), compelling reasons for Congress to act. However, we should remove those items from our Chapter report background and put them into the background for the entire WG report, despite the fact they were developed specifically for our patient issues. Bottom line: minimize Lyme, reduce access to care.
We incorporated additional other TBD material from subcommittee reports into the Chapter and shortened the Lyme portion. We didn’t remove the table, since it factually portrayed reported case numbers, nor did we remove our background material germane for our specific patient issues. After another review submission, we were told the Chapter was “starting to become balanced” but now it was too long. We needed to shorten it. We again shortened to include removing the redundant list of recommendations upfront, already elsewhere in the Chapter.
All WG Chapter Writers had a deadline to post draft Chapters to a WG private Share Point site. WG members had a May 22 deadline to submit comments there on all chapters. All Chapter language was now up for grabs, we were told, even the language we took from the already discussed Subcommittee reports, not just new language. I objected, since that seemed to contradict process discussion at the prior meeting. Significantly, I objected to the lack of process transparency, which was directing these online SharePoint discussions to be behind the scenes–not WG members in public holding transparent discussion with all WG members, embodying the intent of a FACA Working Group. Time went by with no response to my objection, so I reluctantly decided to proceed with filing for resolution through a FACA complaint, but I was subsequently informed my concerns were heard, and all discussion would now be in public, as we are doing today so I did not proceed with the complaint.
While working in the private SharePoint site, I stumbled across an unknown person who had direct access to all Chapters and material in the site. Research showed me this individual was from NIH, not either the NIH Working Group member or alternate—another NIH employee, an attorney. Upon questioning the individual’s identity and purpose, I was informed NIH requested that that individual be allowed access to our SharePoint documents and was given access. It appears that government employee WG members have rights public members do not have, are not aware of, and do not have to be informed of. Since public members are considered special government employees, I requested to federal officials that I be permitted to have a patient advocate attorney in SharePoint to review for patient perspective. I was informed my request was denied by WG legal counsel.
These items coupled with others such as a WG member who did not attend being allowed to vote by proxy through the co-chair, without knowledge of the WG, and the unexplained delay in releasing these draft Chapters to the public prior to this meeting for their review and comments before the WG vote are concerning, and refusal to provide the public with government inventories as agreed to at the April meeting. I questioned those practices, which in my opinion, exhibit a disregard for the public, in particular, the patient community. History coupled with these practices reinforce the sentiments of many in the public that they are again being deceived by their own government.
As we move forward on our Chapter section now, note that our printed report has 12 pages with internal citations to address the decades-long problems of hundreds of thousands of Lyme patients plus other tick-borne diseases patients. Additionally, there are 7+ printed pages of comments from SharePoint made by WG members on our Chapter, a number of which call for removal of much of our documented material on Lyme disease─ a disease under-reported by a factor of 10 according to CDC studies and CDC testimony by Lyle Peterson to a Senate Committee, (1) meaning about 350,000 cases annually. According to NIH, Lyme is a disease that makes up 82% of tick-borne diseases, (2) and there were 74 Lyme deaths in 2017. (3) Thus, our Chapter focuses on the tick-borne disease whose patients comprise the largest burden of disease, Lyme disease. That is balance. Captain Cooper, I now turn further Chapter discussion to you.
(3) NIH says 74 deaths in 2017.NOTE: I had accessed this info prior and printed out the information. Link no longer goes to the page. NIH asked at the meeting where I got that death data as they could not find it anywhere. I have sent it to them.