Archive for the ‘Lyme Vaccine’ Category

Doctor’s Advocates Frustrated By Inaction on Tick-borne Diseases Report

https://poststar.com/news/local/doctors-advocates-frustrated-by-inaction-on-tick-borne-diseases-report/article

Doctors, advocates frustrated by inaction on tick-borne diseases report

5cc360779d9a8.image

Ticks spread the widest variety of diseases that are harmful to humans, including Lyme disease. This is an image of a blacklegged (deer) tick nymph. 

Congress has had over six months to review a federal report on tick-borne diseases, which includes action items for prevention, diagnosis and treatment, and both doctors and researchers are frustrated that nothing has been done so far.

The report was written by a working group under the U.S. Department of Health and Human Services to address the growing number of tick-borne diseases in the United States. It was delivered to Congress in December.

The diseases, especially Lyme disease, are wreaking havoc on the Northeast and New York. About 400,000 new cases of Lyme disease are reported nationwide annually.

About one-fourth of those cases are from New York alone.
Deadlier diseases are also spreading. Just last month, a Kingston resident died of Powassan virus.
Despite the trend in New York, lawmakers did not put funding in this year’s state budget for tick-borne illness research, either.
5c82ef099a60e.image
The $1 million the state Senate had put back into the budget for studying Lyme disease and other tick-borne illnesses is no longer there.

The seemingly lack of action by state and federal lawmakers has frustrated advocates like Holly Ahern, an associate professor of microbiology at SUNY Adirondack. Ahern was also on the testing and diagnostic subcommittee of the federal tick-borne disease working group.

She was approached by the New York State Academy of Family Physicians, and Ahern and the academy’s director, Barbara Keber, wrote an op-ed column for Newsday, calling for a multi-billion dollar “national public-private partnership — an initiative that must address more than just Lyme disease and must go beyond the current low-impact strategy of telling the public to beware of ticks, wear white socks or shower after being outdoors.”

“This wasn’t just a ‘sit around and do a report’ kind of body,” Ahern said about the working group, in a phone interview Thursday. “This was, ‘Do a report and make recommendations and do what you find.’ … With that in mind, there’s accountability there. We sent the report to Congress, and Congress should take that report and should be acting on that.”

5b117d388d743.image
The modern history of Lyme disease starts with an outbreak in the early 1970s in Lyme, Connecticut of a mysterious illness that afflicted chil…

It isn’t often that physicians and advocates work together when it comes to Lyme disease, Ahern said. She was a bit surprised when the New York State Academy of Family Physicians reached out to her with similar frustrations about the lack of action.

Keber, who is a physician at Glen Cove Hospital, said doctors face many challenges when it comes to diagnosing and treating tick-borne illnesses.

Lyme Disease Vaccines: Past & Future

https://thevaccinereaction.org/2019/07/lyme-disease-vaccines-past-and-future/

Lyme Disease Vaccines: Past and Future

Lyme Disease Vaccines: Past and Future

STORY HIGHLIGHTS

  • A new Lyme disease vaccine candidate approved by the FDA using the fast track process is currently in its second phase of clinical trials.
  • In 1998, the FDA granted licensure for a Lyme disease vaccine called LYMErix.
  • Following reports of severe adverse reactions to LYMErix, GlaxoSmithKline (formerly SmithKline Beecham) withdrew the vaccine from the market in 2002.

Lyme disease is an infection caused by a bacterium known as Borrelia burgdorferi and is transmitted to humans through infected ticks. Typical symptoms include fever, headaches, fatigue and a characteristic skin rash called erythema migrans. In 2017, there were a total of 42,743 confirmed and probable cases of Lyme disease reported to the Centers for Disease Control and Prevention (CDC)—an increase of more than 17 percent since 2016.1 2

There are currently no vaccines for Lyme disease available for humans in the United States. However, there is a new vaccine candidate in the pipeline now in clinical trials.

In 2017, the U.S. Food and Drug Administration (FDA) approved a Fast Track designation for a new Lyme disease vaccine. The goal of the Fast Track designation is to get the vaccine on the market as soon as possible by lowering the bar for proof of safety and efficacy in favor of speeding up the licensing process. When an experimental is designated by the FDA for Fast Track approval, the FDA will accept less data from the manufacturer pre-licensure and allow ongoing post-marketing clinical studies after licensure approval.3 4 5

French biotech company Valneva has announced  the initiation of the second study of Phase 2 clinical development for its Lyme disease vaccine candidate, VLA15. VLA15 is a multivalent, protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia.The goal of Phase 2 is to determine the optimal dosage level and vaccination schedule for its use in Phase 3 efficacy studies.5 6

The Phase 2 study is a randomized, observer-blind, placebo controlled trial conducted at sites in the U.S. where Lyme disease is endemic. Plans call for 250 people to receive one of two doses of VLA15 (100 people each) or placebo (50 people). The vaccine candidate contains aluminum adjuvants and will be injected intramuscularly at day 1, day 57 and day 180. The participants in the study will be monitored for 18 months immunogenicity will be measured at day 208. The clinical trial participants will include healthy adults between the ages of 18 and 65.5

The LYMErix Debacle

VLA15 is not the first Lyme disease vaccine to be developed. In December 1998, the FDA approved a recombinant Lyme disease vaccine known as LYMErix that was manufactured by SmithKline Beecham (now GlaxoSmithKline). LYMErix was a three-dose vaccine that was believed to be 49 to 68 percent effective at preventing Lyme disease with two doses and 76 to 92 percent effective after the third dose.6 7

As a result of concerns regarding the potential safety of the vaccine prior to its licensure, an FDA panel met in May 1998 to review the proposed LYMErix vaccine. The panel acknowledged that there were several safety concerns regarding the vaccine, one of which was its possible relationship to autoimmune arthritis. The panel was concerned that the vaccine could result in inflammatory arthritis in genetically susceptible patients. This concern was raised during a clinical study in which vaccine subjects reported a greater number of transient arthralgias than the placebo subjects. Despite the glaring concerns, the FDA panel gave its unanimous support for the vaccine’s licensure.7 8

Soon after the vaccine was licensed in the U.S, there was a burst of media coverage around Lyme disease and LYMErix. The vaccine received prime time media coverage, with news reports highlighting the benefits of the vaccine but with almost no mention of the potential risks associated with the vaccine. The media encouraged those living in endemic areas to consult their health professionals about getting the vaccine.8 9

By 1999, LYMErix was receiving more negative than positive publicity. There were reports of serious adverse reactions occurring after vaccination. Although there was a wide range of adverse reactions reported, musculoskeletal complaints such as arthritis were the most common in these reports. The media began reporting experiences of vaccine injured victims and the Lyme Disease Network, a non-profit citizen action group, had extensive website coverage about serious reactions to LYMErix.8

In December 1999, the Philadelphia law firm of Sheller, Ludwig & Bailey filed a class action lawsuit against the LYMErix™ manufacturer, SmithKline Beecham. The law firm represented 121 individuals who claimed that they experienced severe adverse reactions to LYMErix. The suit claimed that the vaccine caused harm and that the manufacturer deliberately concealed evidence about its risks and failures.8

As a result of lawsuits and public outcry at a Jan. 31, 2001 meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC), the committee discussed evidence for safety concerns about LYMErix and held a two-hour public comment session. Participants at the meeting included FDA scientific advisors, representatives from SmithKline Beecham, physicians, consumer advocacy organizations, vaccine injured victims and their lawyers.8 10

The FDA advisory committee reviewed a summary of the Vaccine Adverse Event Reporting System (VAERS) data and concluded that there was no causal relationship between LYMErix and inflammatory arthritis. SmithKline Beecham assured the panel that LYMErix was safe and provided a status review of their Phase 4 post-marketing surveillance. Physicians spoke about the effectiveness of the vaccine, noting a dramatic decline of Lyme disease in their clinical practices.8

There were other scientists at the meeting, however, who argued that the vaccine could indeed trigger OspA-autoimmunity in those patients who had a genetic susceptibility. Vaccine injured victims described their suffering and their lawyers said that the manufacturer deliberately failed to provide warnings about increased reaction risks for genetically susceptible patients.8

The FDA Committee, however, decided that the benefits of LYMErix outweighed its risks. No changes were made to the product’s labeling or indications. The FDA requested that the manufacturer provide more vaccine and efficacy data by increasing the number of subjects in the Phase 4 post-marketing trial. The vaccine remained on the market for public use.8

Due to the negative press coverage and publicity about the vaccine risks and lawsuits, the sales for LYMErix dropped significantly. In 2001, the manufacturer  reported $5 million in sales with the purchase of only 93,000 doses of the vaccine. In February 2002, GlaxoSmithKline (GSK) decided to withdraw the vaccine from the market citing poor market performance.7 8

In July 2003, GSK settled the class action lawsuit with Sheller, Ludwig & Bailey and other smaller law firms. The agreement included $1 million for legal fees for the prosecuting attorneys but no compensation for the vaccine injured victims. The prosecuting attorneys expressed that the voluntary withdrawal of the vaccine from the market was the main intention of the lawsuit.8

According to a report published in Epidemiology & Infection:

“Despite the settlement, the manufacturer continued to deny that LYMErix™ caused harm and indicated that the decision to settle represented a choice based on economic concerns (i.e. the desire to avoid the costs of lengthy litigation) for a product showing relatively poor performance in the market.”8


References:

_________________

**Comment**

Deny, deny, deny…..that’s what authorities have been doing for decades on pretty much everything regarding Lyme/MSIDS.

https://madisonarealymesupportgroup.com/2018/07/01/lyme-vaccine-fail-safety-ignored/

https://madisonarealymesupportgroup.com/2018/06/07/the-lyme-vaccine-russian-roulette/

https://madisonarealymesupportgroup.com/2018/06/06/valneva-seeking-partner-for-350m-lyme-disease-vaccine-effort-prepping-for-phase-2/  (Please read my comment after the article.  This is far from a benign vaccine.  It has caused outright harm – even death)

https://madisonarealymesupportgroup.com/2017/07/01/pbs-lyme-vaccine/  Did you know that the LYMERIX vaccine caused 640 emergency room visits, 34 life threatening reactions, 77 hospitalizations, 198 disabilities, and 6 deaths? In a vile cesspool of conflicts of interest are university patent holders, drug companies, and the FDA itself as another patent holder. It generated 40 million dollars before it was yanked. (2008, Drymon)
As you can see in Dr. Lapenta’s article, the death toll raised to 229.  https://madisonarealymesupportgroup.com/2018/01/28/the-secret-x-files-the-untold-history-of-the-lymerix-vaccine/

Besides, death and suicide, please see:
http://www.yourlawyer.com/topics/overview/lymerix One doctor stated that 21 patients developed severe arthritis after receiving the LYMERIX vaccine.

http://www.lymediseaseassociation.org/index.php/about-lyme/controversy/vaccine/261-lymerix-meeting

“Given that Dr. Marks lead the clinical trials for Lymerix’s competitor, the OspA vaccine produced and then abandoned by Aventis Pasteur, his conclusions mean a lot. “In my opinion,” he told FDA officials, “there is sufficient evidence that Lymerix is causally related to severe rheumatologic, neurologic, autoimmune, and other adverse events in some individuals. This evidence is such as to warrant a significantly heightened degree of warnings and possible limitations or removal from marketing of Lymerix.”

Another glaring issue about the Lyme vaccine is it only covers borrelia, the causative agent of Lyme when often there are many other pathogens involved. These pathogens work synergistically together to depress the immune system. Vaccines also depress the immune system purposely to initiate an immune response. Nobody is discussing what the two together do inside the human body, but logic would state it can’t be good:  https://madisonarealymesupportgroup.com/2018/10/30/study-shows-lyme-msids-patients-infected-with-many-pathogens-and-explains-why-we-are-so-sick/

Every single Lyme/MSIDS patient I work with that gets vaccinated suffers a relapse.

This doctor shows vaccines reactive latent infections:  https://madisonarealymesupportgroup.com/2017/12/02/scottish-doctor-on-lyme-msids-part-2/

https://madisonarealymesupportgroup.com/2016/04/24/gardasil-and-bartonella/

Then there’s the little known fact that there has been a history of retroviral contamination of vaccines:  https://madisonarealymesupportgroup.com/2017/10/15/vaccines-and-retroviruses-a-whistleblower-reveals-what-the-government-is-hiding/

These retroviruses are connected to chronic diseases according to a well known Lyme literate doctor:  https://madisonarealymesupportgroup.com/2018/06/23/the-role-of-retroviruses-in-chronic-illness-a-clinicians-perspective/

Study on An Anti-tick Vaccine

https://parasitesandvectors.biomedcentral.com/articles/10.1186/s13071-019-3468-x

Counterattacking the tick bite: towards a rational design of anti-tick vaccines targeting pathogen transmission

  • Ryan O. M. RegoEmail authorView ORCID ID profileJos J. A. TrentelmanJuan AnguitaArd M. NijhofHein SprongBoris KlempaOndrej HajdusekJulen Tomás-CortázarTal AzagiMartin StrnadSarah KnorrRadek SimaMarie JaloveckaSabína Fumačová HavlíkováMartina LičkováMonika SlávikováPetr KopacekLibor Grubhoffer and Joppe W. Hovius
    Parasites & Vectors201912:229

    https://doi.org/10.1186/s13071-019-3468-x

    Published: 14 May 2019

Abstract

Hematophagous arthropods are responsible for the transmission of a variety of pathogens that cause disease in humans and animals. Ticks of the Ixodes ricinus complex are vectors for some of the most frequently occurring human tick-borne diseases, particularly Lyme borreliosis and tick-borne encephalitis virus (TBEV). The search for vaccines against these diseases is ongoing. Efforts during the last few decades have primarily focused on understanding the biology of the transmitted viruses, bacteria and protozoans, with the goal of identifying targets for intervention. Successful vaccines have been developed against TBEV and Lyme borreliosis, although the latter is no longer available for humans. More recently, the focus of intervention has shifted back to where it was initially being studied which is the vector. State of the art technologies are being used for the identification of potential vaccine candidates for anti-tick vaccines that could be used either in humans or animals. The study of the interrelationship between ticks and the pathogens they transmit, including mechanisms of acquisition, persistence and transmission have come to the fore, as this knowledge may lead to the identification of critical elements of the pathogens’ life-cycle that could be targeted by vaccines. Here, we review the status of our current knowledge on the triangular relationships between ticks, the pathogens they carry and the mammalian hosts, as well as methods that are being used to identify anti-tick vaccine candidates that can prevent the transmission of tick-borne pathogens.

___________________

**Comment**

In the paragraph before the conclusion (in the full-length document) the following is stated:

Given the current health concerns related to LB, a novel vaccine would most likely be highly welcomed by society. On the other hand, the previously commercially available vaccine against LB was taken off the market for various and questionable reasons [232]. Therefore, efforts are needed to address societal prejudices associated with vaccination, including health benefits, risks, and necessity, especially from a public health perspective.

Well if that isn’t the understatement of the year, I don’t know what is.  The LB (Lyme borreliosis) vaccine was yanked off the market because it CAUSED Lyme symptoms in many people, as well as dogs:  https://madisonarealymesupportgroup.com/2018/07/22/why-we-care-so-strongly-about-a-potential-lyme-vaccine/

https://madisonarealymesupportgroup.com/2018/07/01/lyme-vaccine-fail-safety-ignored/  Excerpt:  

In reality, the vaccine was pulled off the market to avoid disclosure of Phase IV data that probably would have shown limited efficacy and significant safety concerns related to LYMErix (11-13). That data has never been publicly released.

Regarding dogs:  https://www.vetinfo.com/canine-lyme-disease-vaccine-side-effects.html  Excerpt:

Cornell University found long-term side effects that paint a different picture of the safety of the canine Lyme disease vaccination.

In some cases, dogs develop Lyme disease anyway. It’s believed that the antibodies in the vaccine can develop into Lyme disease. Research finds dogs develop all the symptoms of Lyme disease up to six weeks after receiving the shot. While tests for the Lyme disease bacteria show up as negative, there are many dogs developing all the symptoms. Left untreated more concerning issues develop.

A number of dogs develop rheumatoid arthritis months or years later. However, the development of acute kidney failure is more alarming. Remember that 90 percent of dogs never become sick and that pulling off ticks before 48 hours eliminates any risk. Many vets feel the benefit of the vaccination is often outweighed by the potential risks.

Seems veterinarians are often wiser than general practitioners.

For a history of the entire Lyme vaccine saga:  https://madisonarealymesupportgroup.com/2018/06/07/the-lyme-vaccine-russian-roulette/  Excerpt:  

It is believed that a rush to create a Lyme disease vaccine led to the mishandling of the disease. Current antibody tests for Lyme disease were manipulated in 1994 at the Dearborn Conference so as to facilitate vaccine development. The two most important indicators of infection were stripped out of serology tests so that the vaccinated would test seronegative. The vast majority of truly infected patients cannot obtain a timely diagnosis leading to a missed opportunity for successful short term treatment.

The vaccine known as LYMErix was supposed to expose the immune system to the outer surface protein A (OspA) of the spirochete responsible for causing Lyme disease but for some patients, it caused the same crippling effects of the disease itself as reported in the class action lawsuit:

https://www.dropbox.com/s/sodqs3pdeeesktf/Sheller%20Lymerix.pdf?dl=0

EXCERPT FROM THE LAWSUIT:

“The people who have contacted us were, prior to vaccination with LYMErix, healthy, active and energetic. Indeed, the very reason they sought the LYMErix vaccine was their desire to preserve their healthy, active lifestyle. However, what they experienced was a dramatic degradation of their health and quality of life. As will be described below, these previously healthy individuals are now afflicted with painful, at times debilitating arthritic symptoms, including joint pain and swelling, as well as extremely severe Lyme-disease-like symptoms which have persisted to this day.”

I counted at least 20 people who authored this study.  Where are the researchers who are studying better testing, effective treatments, transmission studies on all the ways Lyme/MSIDS can be transmitted, post mortem studies to end the Lyme wars, and answers to how patients can pay for this plague?

Researchers for those issues are no where to be found.  If there are any, they are in their own basements using their own microscopes with limited funding.

 

 

Valneva’s Lyme Disease Vaccine on FDA Fast Track Designation

https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/24581258?

Valneva’s Lyme disease vaccine on FDA Fast Track Designation

MAY 19, 2019 — 

The letter below was sent to The New Hampshire Medical Society which is the committee given responsibly for further study of New Hampshire House Bill 490.

House Bill 490
https://legiscan.com/NH/text/HB490/id/1962817

Please forward this email to as many contacts that you may have in order to inform the public of the truth behind the mishandling of Lyme disease here in the United States. Lyme patients worldwide have been affected as foreign public health agencies are blindly following what has been deceitfully established here in the US.

Lyme Bumper Stickers (Public Service Announcement)
https://www.ebay.com/itm/123659578861

WAKE UP AMERICA!

——— Original Message ———-
From: CARL TUTTLE <runagain@comcast.net>
To: james.potter@nhms.org, michael.padmore@nhms.org
Cc: Howard.Moffett@leg.state.nh.us, amknh78@gmail.com, Tom.Sherman@leg.state.nh.us, Martha.FullerClark@leg.state.nh.us, Jeb.Bradley@leg.state.nh.us, James.Gray@leg.state.nh.us, Shannon.Chandley@leg.state.nh.us, Doug.Marino@leg.state.nh.us, kathie@kathiefife.com, Polly.Campion@leg.state.nh.us, jc.salloway@unh.edu, wmarshmd@gmail.com, nhbidc@dhhs.nh.gov, saunderson.george@gmail.com, electdavidkarrick@gmail.com, cmcmahon55@gmail.com, jeffrey.meyers@dhhs.nh.gov, cutler_library@comcast.net, brett.giroir@hhs.gov, tickbornedisease@hhs.gov, abigail.mathewson@dhhs.nh.gov
Date: May 18, 2019 at 8:41 AM
Subject: Valneva’s Lyme disease vaccine on FDA Fast Track Designation

To: The New Hampshire Medical Society Advisory Council on Tick and Other Insect Borne Diseases,

Please take a moment to read the following Facebook message I received yesterday regarding a personal experience after receiving the LYMErix vaccine previously FDA approved in 1998.

Contrary to public belief, LYMErix was not pulled from the market in 2002 solely due to low demand. More on that in a moment…….

Beth Leahy
https://www.facebook.com/beth.leahy.77

Hi Carl i have a question. Ty for all your hard work btw. i had the 3 lymerix vaccines in 2000-2001. i am 43 years old and was forced to retire 3 years ago. i have neuro chronic lyme. I have reached out to several forums and organizations asking if anyone would be willing to do any testing on me for free. the benefit to this is i have a twin sister who did not receive the vaccines and has never been bitten. she has agreed to undergo comparative testing with me whether its gene testing or any other testing. we are willing to do anything. Thankfully she is willing to do whatever it is to help me and others. Maybe bc of our unique situation we could help in doing something positive. I have received no response from anyone. i am disappointed because i think its a unique opportunity at least no harm in trying. Can u please ask some of your resources if they are interested? I live near Albany NY but we will travel anywhere. Thank you. my phone # is 518-XXX-XXXX and my name is Beth Leahy. Thank you in advance!! I hope with all your contacts maybe you will have better luck in finding a researcher or dr. who will be interested.

____________________________________

In reference to Beth Leahy’s experience above, please see the following excerpt from the attached REPORT ON LYMErix prepared for the 2001 Advisary Committee Meeting:

Sheller Lymerix
https://www.dropbox.com/s/sodqs3pdeeesktf/Sheller%20Lymerix.pdf?dl=0

“The people who have contacted us were, prior to vaccination with LYMErix, healthy, active and energetic. Indeed, the very reason they sought the LYMErix vaccine was their desire to preserve their healthy, active lifestyle. However, what they experienced was a dramatic degradation of their health and quality of life. As will be described below, these previously healthy individuals are now afflicted with painful, at times debilitating arthritic symptoms, including joint pain and swelling, as well as extremely severe Lyme-disease-like symptoms which have persisted to this day.”

Below is the link to the Final Judgement and Approval of the class action against SmithKline Beecham as a settlement was awarded to these individuals.

JUDGEMENT, FINAL ORDER AND DECREE GRANTING FINAL APPROVAL OF THE CLASS ACTION SETTLEMENT:

https://www.dropbox.com/s/v3gyw4fv8nst9bz/2003_Vaccine_Judgement_Final_Sttle_Apprvl..pdf?dl=0

In addition please see the following study reporting adverse neurological complications:

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

Neurological complications of vaccination with outer surface protein A (OspA).

Marks DH1. http://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.

_________________________________

To: The New Hampshire Medical Society Advisory Council on Tick and Other Insect Borne Diseases,

To my knowledge there was no follow-up research to determine why this class of patient suffered the reaction they experienced. Is there a genetic predisposition that could give a similar reaction to the next OspA vaccine?

Valneva’s Lyme disease vaccine now on FDA Fast Track Designation is yet another OspA vaccine.

TOUCHED BY LYME: Why we care so strongly about a potential vaccine
https://www.lymedisease.org/touchedbylyme-why-we-care-lyme-vaccine/

_________________________________

It is believed that Lyme disease was pigeonholed into its current status by the two principal investigators of the previous Lyme disease vaccines as these investigators conceptualized a disease that would enable vaccine development.

A preventive vaccine for Lyme disease would not satisfy the FDA if a chronic persistent infection and seronegative disease exist. The lead author of the one-size-fits-all IDSA Lyme treatment guideline (which matches the conceptualized disease) was the principal investigator of Connaught’s Lyme vaccine, Dr. Gary Wormser. This is a flagrant conflict of interest. Have we been dealing with an antibiotic resistant/tolerant superbug purposely concealed to promote vaccine development?

When the LYMErix vaccine was pulled from the market the deception had to continue and this is why all the science identifying persistent infection must be ignored.

There are published studies early on describing the destructive nature of borrelia (1988 Paul Duray paper coauthored by Allen Steere, See attached PDF) so Steere and Wormser (Principal investigators of the previous Lyme vaccines) know everything the disabled Lyme community is experiencing. The rush to create a vaccine should have been the tip-off as it was going to be the “cure-all” for an incurable/disabling disease.

Paul Duray paper:

https://www.dropbox.com/s/gjl0cym2mr2phij/1988-clinical-pathologic-correlations-of-lyme-disease-by-stage-Duray.pdf?dl=0

Leaving the CDC in control of Lyme disease under the watch of Health and Human Services will allow this public health crisis to continue.

Anyone who does not see this is turning a blind eye to an immoral act.

Respectfully submitted,

Carl Tuttle

Lyme Endemic Hudson, NH

“Justice will not be served until those who are unaffected are as outraged as those who are.” ― Benjamin Franklin

____________________

For more:  https://madisonarealymesupportgroup.com/2018/01/28/the-secret-x-files-the-untold-history-of-the-lymerix-vaccine/

https://madisonarealymesupportgroup.com/2018/07/22/why-we-care-so-strongly-about-a-potential-lyme-vaccine/

https://madisonarealymesupportgroup.com/2018/07/01/lyme-vaccine-fail-safety-ignored/

https://madisonarealymesupportgroup.com/2018/06/07/the-lyme-vaccine-russian-roulette/%20https://

https://madisonarealymesupportgroup.com/2017/07/01/pbs-lyme-vaccine/

When Lyme Disease Doesn’t Go Away

https://news.columbia.edu/news/when-lyme-disease-doesnt-go-away

When Lyme Disease Doesn’t Go Away

It’s tick season. Here’s what Brian Fallon, the director of Columbia’s Lyme & Tick-borne Diseases Research Center, has to say about combating chronic Lyme disease.
By

Carla Cantor
April 29, 2019

Brian A. Fallon, (VP&S ’85, MPH ’85) spent his early career working with patients whose medical symptoms were a mystery. The Columbia University Irving Medical Center psychiatrist became one of the foremost researchers of hypochondria and somatic disorders, or psychological illness that manifests as physical symptoms.

He might have stayed with that specialty had he not begun in the early 1990s to see a surge in referrals of patients with chronic, unexplained symptoms who had all been healthy—until they got Lyme disease. These patients suffered from chronic pain, fatigue and cognitive problems that had a debilitating effect on their lives. They all had been treated with antibiotics with partial response but then relapsed.

Since such persistent infection was considered impossible, they were told they were hypochondriacs.

“At the time, the medical community was saying that initial antibiotic therapy led to a cure,” Fallon said. “I found this hard to believe given the suffering among these patients. We needed to look further.”

Since 2007 Fallon has headed Columbia’s Lyme & Tick-borne Diseases Research Center, a joint effort by the Global Lyme Alliance, the Lyme Disease Association and the Columbia University Medical Center Board of Trustees. It is the first such academic research center in the country, and its mission is to tackle the core clinical questions of the disease and identify better diagnostics, biomarkers and treatments.

Fallon discusses why this is a pivotal time in the world of Lyme disease.

Book cover of Conquering Lyme Disease

Q. Lyme disease was first reported in the United States in 1977 in the town of Old Lyme, Connecticut.  How far have we come?

A. We still have many unanswered questions, but there has been tremendous progress. We now know the cause of the disease, a bacterium called Borrelia burgdorferi, and its multi-system manifestations. We know many of the biologic tricks the organism uses to evade the human immune response and we know its genetic makeup, as it has been fully sequenced. We know that while most Borrelia are easily eradicated with a standard course of antibiotics, some persist despite treatment. We briefly had a vaccine on the market, which is no longer available, but a new vaccine is now in clinical trials. Despite advances in some areas, there remain serious problems, most prominently that the epidemic of Lyme disease continues to expand both geographically and in the number of new cases—an estimated 400,000 in the United States each year.

Q. What are the symptoms of chronic Lyme disease and how is it diagnosed? What percentage of Lyme sufferers go on to have chronic problems?

A. Most patients do well if the infection is recognized and treated early. In about 10 to 20 percent of cases, patients develop a more severe disease whose symptoms can include debilitating pain, fatigue, headaches, mental fog causing difficulty with memory or finding words, irritability and  sleep disorders. Unfortunately, because our blood tests are antibody-based and can remain positive for years even when infection is no longer present, it is hard to determine whether a patient’s recurrent symptoms are due to persistent infection, a new infection or a post-infectious disorder.

Q. Why does post-treatment Lyme disease affect some people and not others?

A. This is an important question for which we have only preliminary answers. Infection by a more invasive strain of the Borrelia microbe, rather than one that only causes skin manifestations, increases the risk of more severe disease. Certain genetic markers increase the risk of chronic Lyme arthritis. Patients with a history of multiple physical illnesses and other life stressors may have less resilience to infection. And because the tick may transmit other microbes, some patients may have two or more infections.

Q. What are the current treatments for persistent Lyme disease?

A. There are multiple approaches to the treatment of lingering symptoms, but there haven’t been any new, large clinical trials in the U.S. on chronic Lyme-related symptoms in over 10 years. Studies in Europe of early Lyme disease indicate that some of these patients improve without further treatment over the course of one year after initial antibiotic therapy. Patients with chronic symptoms need a personalized approach based on the cause of their symptoms.

Q. Is there hope of finding a cure?

A. Absolutely. With precision medicine approaches, biomarkers are now emerging that appear able to predict who might respond to standard antibiotic therapy and those who might not. This provides an opening for testing new treatment approaches for the latter group, leading to improved long-term outcome.


Dr. Fallon is co-author of Conquering Lyme Disease: Science Bridges the Great Dividewith Dr. Jennifer Sotksy ( VP&S’16,) a fourth-year psychiatry resident at Columbia University Irving Medical Center. (Columbia University Press, 2017 hardcover,  2019 paperback)

For media inquiries or more information, contact Carla Cantor at 212-854-5276 or carla.cantor@columbia.edu.

__________________

**Comment**

  • Again, the erroneous percentages of 10-20% of patients going on to develop persistent symptoms is inaccurate.  There’s a whole lot more of us out here in Lyme-land than that.  Please read:  https://madisonarealymesupportgroup.com/2019/02/25/medical-stalemate-what-causes-continuing-symptoms-after-lyme-treatment/  In a nutshell, microbiologist Holly Ahern points out that the 10-20% the CDC calls PTLDS only includes those patients diagnosed and treated early.  It does not and should not include a large subset of patients (30-40%) diagnosed and treated late.  When you add the two groups together, you get 60% of patients going on to struggle with persisting symptoms.  This is an important detail as it shows the vast numbers struggling as well as the need for high priority research studying this issue.  

 

  • He discusses strains of borrelia.  I learned something the other day – that borrelia (Lyme) is unique in that bacteria are typically only allowed 1 species name, but due to honoring Willy Burgdorfer, all borrelia are “Lyme.” This little fly in the ointment is a huge reason many are not getting diagnosed.  Current 2-tiered testing only tests for 1 strain. I was told by a researcher to think of the Borrelia burgdorferi sensu lato complex as an umbrella, and the 23 genospecies are dangling from it (soon to be 24, BTW!) This may be why Southerners struggle with getting a diagnosis. STARI may be one of these borrelia that doesn’t fit into the box researchers have created for this night-mare.

 

 

  • He also found IV’s give much higher blood levels of drugs than orals, and that the following variables necessitated IV treatment:
    1. Spinal tap shows high inflammation (high protein)
    2. High Sed rate and synovitis (inflammation of synovial membrane)
    3. People sick for more than 1 year
    4. Age over 60
    5. Acute carditis
    6. Immune deficiency
    7. Those who used immunosuppressants
    8. Failed oral treatment

 

  • If you study this for 1 second you begin to appreciate the complexity of treating this which mainstream doctors still haven’t even accepted.

 

  • The fact that there haven’t been any new, large clinical trials in the U.S. on chronic Lyme-related symptoms in over 10 years is unacceptable when you consider that this is two times more prevalent than breast cancer.  HELLO?  Where’s the green ribbons and huge institutions raising funds for Lyme research?  Oh, yeah, I remember, our researchers are using their own microscopes in their basements!  https://lymelifescapeswithcaroline.com/2014/03/25/dr-alan-b-macdonald/  MacDonald is shown in the documentary, “Under Our Skin.”  

 

  • BTW: when MacDonald presented his culture findings (direct testing) at a meeting of the NY State medical society where there were many detractors from Yale & Stoneybrook who didn’t want their patented serological tests to be usurped. They accused him of falsifying his results.  Dr. McDonald then went on to prove conclusively it was Lyme by morphology, silver staining, monoclonal antibodies staining, DNA PCR and finally electron microscopy.  Frustrated, he quit the field and moved to Texas leaving all his old files in Burrascano’s basement until twenty years went by and he became interested again due to Alzheimer’s research & picked up his old files. https://madisonarealymesupportgroup.com/2019/02/22/why-mainstream-lyme-msids-research-remains-in-the-dark-ages/

 

 

 

 

 

Lyme & Reason: Interviews with Advocates & Researchers

 Approx. 20 Min

Lyme & Reason: Battles & Breakthroughs Against Lyme Disease

Published on Sep 5, 2018

It’s a battle that has been raging for decades – the battle against Lyme Disease. Over the years, progress has been made against this dreaded tick-borne illness. But with breakthroughs come even more barriers. Watch this early peek at a new Fox 5 News special on the fight that could be signaling a new chapter in the ongoing bout against Lyme.
  • Interview with President and CEO of Valneva, Thomas Lingelbach on the Lyme Vaccine
  • Interview with Dr. Sung Lee on Lyme testing and his lawsuit against the CDC
  • Interview with Olivia Goodreau of LivLyme – an organization that raises money for research

Lemons & Lyme Part 2

https://www.change.org/p/1120418/u/23307673?

Lemons and Lyme by Stanley Plotkin (Part 2)

Carl Tuttle
Hudson, NH

SEP 22, 2018 —
Please see the letter below addressed to Theoklis Zaoutis, MD, EDITOR-IN-CHIEF of the Journal of the Pediatric Infectious Diseases Society regarding Plotkin’s commentary on the Lyme vaccine. A copy of this letter was forwarded to the Tick Borne Disease Working Group.

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Wikipedia Plotkin page: https://en.wikipedia.org/wiki/Stanley_Plotkin

——— Original Message ———-
From: Carl Tuttle <runagain@comcast.net>
To: zaoutis@email.chop.edu
Cc: stanley.plotkin@vaxconsult.com, chris.smith@mail.house.gov, collin.peterson@mail.house.gov, ddutko@hanszenlaporte.com, evpdean@upenn.edu, JPIDS.EditorialOffice@oup.com, paul.spearman@cchmc.org
Date: September 22, 2018 at 8:32 AM
Subject: Fwd: Lemons and Lyme by Stanley A. Plotkin
Journal of the Pediatric Infectious Diseases Society

13 September 2018 P L O T K I N C O L U M N
Lemons and Lyme
https://academic.oup.com/jpids/advance-article-abstract/doi/10.1093/jpids/piy083/5094865?redirectedFrom=fulltext
Stanley A. Plotkin
Emeritus Professor of Pediatrics, University of Pennsylvania, Doylestown

Excerpt:

“It is odd that there is a lobby against the development and deployment of a vaccine against the disease by people who think they are suffering from Lyme infection in a chronic form, the existence of which remains doubtful. They believe that the first vaccine against Lyme disease caused chronic arthritis.”

Sept 22, 2018
The Journal of the Pediatric Infectious Diseases Society
Oxford University Press
2001 Evans Road
Cary, NC 27513
ATTN: Theoklis Zaoutis, MD, MSCE, EDITOR-IN-CHIEF

Dear Dr. Zaoutis,
In reference to Dr. Plotkin’s statement above, please see the following excerpt from the attached REPORT ON LYMErix prepared for the 2001Advisary Committee Meeting:
https://www.dropbox.com/s/sodqs3pdeeesktf/Sheller%20Lymerix.pdf?dl=0

“The people who have contacted us were, prior to vaccination with LYMErix, healthy, active and energetic. Indeed, the very reason they sought the LYMErix vaccine was their desire to preserve their healthy, active lifestyle. However, what they experienced was a dramatic degradation of their health and quality of life. As will be described below, these previously healthy individuals are now afflicted with painful, at times debilitating arthritic symptoms, including joint pain and swelling, as well as extremely severe Lyme-disease-like symptoms which have persisted to this day.”

Below is the link to the Final Judgement and Approval of the class action against SmithKline Beecham as a settlement was awarded to these individuals.

JUDGEMENT, FINAL ORDER AND DECREE GRANTING FINAL APPROVAL OF THE CLASS ACTION SETTLEMENT:
https://www.lymediseaseassociation.org/images/NewDirectory/Government/Vaccines/2003_Vaccine_Judgement_Final_Sttle_Apprvl..pdf

In addition please see the following study reporting adverse neurological complications:  Int J Risk Saf Med. 2011;23(2):89-96. doi: 10.3233/JRS-2011-0527.
Neurological complications of vaccination with outer surface protein A (OspA).
Marks DH1. http://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.
________________________________

Dr. Zaoutis, to my knowledge there was no follow-up research to determine why this class of patient suffered the reaction they experienced. Is there a genetic predisposition that could give a similar reaction to the next OspA vaccine?
It would appear that Plotkin has used your journal as a pulpit to broadcast his propaganda. The peer-review process in this case was unsuccessful in determining suitability for publication.

Respectfully Submitted,
Carl Tuttle
Lyme Endemic Hudson, NH
Cc: Julie Weber-Roark MANAGING EDITOR
Attorney Daniel Dutko of Hanszen Laporte
The Honorable Chris Smith and Collin Peterson
Paul Spearman, MD, FPIDS: President, Pediatric Infectious Diseases Society

________________

For more:  https://madisonarealymesupportgroup.com/2018/09/20/lemons-lyme-by-stanley-plotkin/

https://madisonarealymesupportgroup.com/2018/07/01/lyme-vaccine-fail-safety-ignored/

https://madisonarealymesupportgroup.com/2018/07/22/why-we-care-so-strongly-about-a-potential-lyme-vaccine/

https://madisonarealymesupportgroup.com/2017/07/01/pbs-lyme-vaccine/

https://madisonarealymesupportgroup.com/2018/01/28/the-secret-x-files-the-untold-history-of-the-lymerix-vaccine/

https://madisonarealymesupportgroup.com/2016/08/04/vaccine-injuries-and-the-lyme-connection/