Researchers Race to Develop Lyme Disease Vaccine

October 28, 2019

https://danielcameronmd.com/researchers-race-to-develop-lyme-disease-vaccine/

RESEARCHERS RACE TO DEVELOP LYME DISEASE VACCINE

It has been nearly two decades since the Lyme disease vaccine LYMErix was pulled off the market by its manufacturer, SmithKline Beecham. The vaccine was designed to prevent the transmission of the tick-borne bacterial agent Borrelia burgdorferi, which causes Lyme disease.

By
LYMErix was withdrawn from the market in 2002 after concerns over its safety. Since then, there has been growing speculation as to whether researchers will ever be able to develop an effective and safe Lyme disease vaccine.

The stakes are high in the race for a new vaccine.

“There will be one more shot at bringing a human Lyme vaccine to market, and if that vaccine fails, the market will essentially disappear,” states Richard Marconi, an immunologist who is working on a vaccine based on a dog vaccine released in 2006. ¹

At the forefront is a European company Valneva, which is in phase 2 clinical trials for a vaccine against 6 strains of Borrelia, writes Shaffer. ¹ The company has obtained a fast-track status from the U.S. Food and Drug Administration (FDA).

Valneva does not use the epitope that was associated with autoimmune reactions that were alleged to occur with LYMErix, Shaffer explains.

Meanwhile, Marconi’s vaccine is targeting an entirely different OspC and is “anticipating better acceptance of such a vaccine because of its track record in pets.” An OspC vaccine has been challenging, in part, due to highly variable protein between strains.

I had a medical practice in Westchester, NY when the LYMErix vaccine was first introduced. That spring, more than 300 doctors and researchers were asked at an international Lyme disease conference how many would personally take the vaccine. Only 3 people raised their hands. The moderator questioned whether the LYMErix vaccine would be marketed successfully if leading experts were reluctant to take the vaccine.

I discussed with my patients the pros and cons of LYMErix, which was about 80% effective at preventing an erythema migrans rash. The vaccine was only 50% effective at preventing “possible Lyme,” according to the package insert.

“Possible Lyme” was defined as a flu-like illness (fever, chills, fatigue, headache, joint or muscle aches) with IgM or IgG Western blot seroconversion, or physician-diagnosed erythema migrans with negative laboratory results.

Meanwhile, there was no available data on the effectiveness or safety of the vaccine for children under age 15. And individuals needed to take 3 doses of LYMErix during 2 tick seasons for the vaccine to be effective. Furthermore, “intermittent boosters were, by all indications, going to be necessary,” explains Shaffer.

But, “the biggest roadblock stemmed from concerns that the vaccine caused an autoimmune reaction in some vaccine recipients.”

If a new vaccine becomes available, individuals may be hesitant to use it, until there is full disclosure regarding the failure of LYMErix. As Pat Smith, president of the Lyme Disease Association, points out, “any new vaccine manufacturer will first need to clarify what went wrong with the previous vaccine.”

“We need to see what happened, what really happened with LYMErix, and it needs to be done in a transparent fashion,” writes Shaffer.

Note: Neither of the new vaccines described by Shaffer addresses protection against co-infections.

Although there’s much focus on vaccines, the future may lie elsewhere.

“The ideal strategy, however, wouldn’t target bacteria or viruses but the tick itself,” writes Shaffer. “Such a vaccine would target proteins in the tick’s saliva or mid-gut to impair tick feeding before the parasite can transmit Lyme disease or any pathogen.”

I had patients who were reluctant to take the LYMErix vaccine. I rarely prescribed it, and never had a patient who experienced an autoimmune reaction.

Ask the Lyme Doctor about vaccines on Facebook Live, Wednesday, October 30th at 8 pm ET.

Sign up to join the discussion!

Dr. Daniel Cameron will begin the conversation with a review of Leah Shaffer’s article addressing Lyme disease vaccines. Q&A will follow.

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**Comment**

Lymerix was a debacle but the manufacturer announced it was withdrawing the vaccine due to a lack of demand.  Yeah right. 

It had serious, serious side effects in both dogs and humans.

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/

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/2017/07/01/pbs-lyme-vaccine/  Even in 2008, Drymon reported:

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 in the first link, he states that Lymerix “practically killed” 229 people according to the VAERS reporting system:

  • 54 young or adult males died by hypertensive cardiovascular disease 1 day after 2nd dose.
  • 63 young or male adults died by hypertensive and cardiovascular arteriosclerotic disease three days after the 2nd dose.
  • 43 young or adult males developed arthritis and neurological symptoms attributed to Lymerix AND committed suicide 7 months after the 2nd dose.
  • 69 young or adult women developed illnesses, including anemia and thrombocytopenia 7 months after the 1st dose and DIED 6 months later an unknown time after the 1st dose with diagnosis of mylofibrosis.

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.”

 

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Lyme Vaccine

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Line Immunoblot Assay for Tick-Borne Relapsing Fever and Findings in Patient Sera From Australia, Ukraine, & the USA

October 27, 2019

https://www.mdpi.com/2227-9032/7/4/121

Line Immunoblot Assay for Tick-Borne Relapsing Fever and Findings in Patient Sera from Australia, Ukraine and the USA

by Jyotsna S. Shah 1,2,*, Song Liu 2, Iris Du Cruz 1, Akhila Poruri 1, Rajan Maynard 3, Mariia Shkilna 4, Mykhaylo Korda 4, Ivan Klishch 4, Stepan Zaporozhan 4, Kateryna Shtokailo 4, Mykhaylo Andreychyn 4, Raphael B. Stricker 5 and Ranjan Ramasamy 2
Healthcare 2019, 7(4), 121; https://doi.org/10.3390/healthcare7040121
Received: 11 July 2019 / Revised: 25 September 2019 / Accepted: 16 October 2019 / Published: 21 October 2019
(This article belongs to the Special Issue Lyme Disease and Related Tickborne Infections)
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Browse Figures
Abstract
Tick-borne relapsing fever (TBRF) is caused by spirochete bacteria of the genus Borrelia termed relapsing fever Borreliae (RFB). TBRF shares symptoms with Lyme disease (LD) caused by related Lyme disease Borreliae (LDB). TBRF and LD are transmitted by ticks and occur in overlapping localities worldwide. Serological detection of antibodies used for laboratory confirmation of LD is not established for TBRF. A line immunoblot assay using recombinant proteins from different RFB species, termed TBRF IB, was developed and its diagnostic utility investigated. The TBRF IBs were able to differentiate between antibodies to RFB and LDB and had estimated sensitivity, specificity, and positive and negative predictive values of 70.5%, 99.5%, 97.3%, and 93.4%, respectively, based on results with reference sera from patients known to be positive and negative for TBRF. The use of TBRF IBs and analogous immunoblots for LD to test sera of patients from Australia, Ukraine, and the USA with LD symptoms revealed infection with TBRF alone, LD alone, and both TBRF and LD. Diagnosis by clinical criteria alone can, therefore, underestimate the incidence of TBRF. TBRF IBs will be useful for laboratory confirmation of TBRF and understanding its epidemiology worldwide. View Full-Text
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Category:

Lyme, research, Testing, Tickborne Relapsing Fever

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Parenting When Children Have Lyme Disease: Fear, Frustration, Advocacy

https://www.mdpi.com/2227-9032/7/3/95

Parenting When Children Have Lyme Disease: Fear, Frustration, Advocacy

by Emilie M. Gaudet 1, Odette N. Gould 1,* and Vett Lloyd 2
Healthcare 2019, 7(3), 95; https://doi.org/10.3390/healthcare7030095
Received: 30 June 2019 / Revised: 1 August 2019 / Accepted: 3 August 2019 / Published: 8 August 2019
(This article belongs to the Special Issue Lyme Disease and Related Tickborne Infections)
View Full-Text Download PDF

Browse Figure
Abstract
Increasing numbers of Canadians, including children and adolescents, are being infected with Borrelia burgdorferi and contracting Lyme disease. In the present study, we provided a qualitative analysis of written correspondence produced by 23 parents of children and adolescents with Lyme disease. The goal of this study was to investigate how medical and psychological issues were highlighted by parents describing their family’s Lyme disease experiences. The results suggest a series of four stages in these families where satisfactory treatment had not been obtained over months or years.
The experiences of parents evolved from feelings of worry for the child to frustration with the lack of a helpful treatment, to mistrust of physicians’ actions, and, in some case, to a rejection of the conventional health care system as a whole. Improved diagnostic testing and treatment guidelines, as well as family-centered practices of medical care were proposed as important features for improving the experiences of families living with Lyme disease. View Full-Text
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Category:

Lyme, research

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Disulfiram Psychosis Update #2

For those of you reading my posts I’ve thought of a few other things for practitioners and patients to be aware of.

  1. The Purell Sanitizer, located in each and every hospital room was a trigger for psychosis.  Hand sanitizers are up to 60% alcohol – a no, no for those using Disulfiram/Antabuse. I could smell the nurses a mile away. I also learned from a nurse that Purell is killing nurses due to liver toxicity. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2954566/“Based upon an average of 30 hand rubbings per healthcare professional per day, it can be assumed that a healthcare worker may be exposed to a maximum 5,500 mg/m3 per work shift, five times above the recommended occupational time weighted average limit. Thus, in order to answer the question posed in the title, studies on spatial and temporal variability of alcohol emission from ABHRs in real world situations and studies on certain high risk individuals are needed.”
    According to the FDA says hand sanitizers are contributing to superbugs such as MRSA. Also, Triclosan degrades to dioxins in the body which are also toxic. A 2014 study  found that triclosans spurred the growth of breast cancer cells, and another study found they can kill brain cells. Other studies have found it interferes with hormones.  https://www.newsmax.com/health/Headline/illness-washing-hands-sanitizers/2014/12/23/id/614647/  This entire issue was ameliorated by having a sign placed outside my room so those coming in would either use soap and water or gloves when entering.
  2. Certain flowers also set me off.  I’m afraid I can’t tell you which ones but if anyone else suffers from a toxic reaction to disulfiram, keep all plants out of the room.

When I say “set me off,” these items would cause me to have a psychotic episode – even when I was nearly being discharged. All it took was a flower delivery person who had used Purell and I about had to stay longer in the hospital.

For more: https://madisonarealymesupportgroup.com/2019/10/14/november-2019-lyme-support-meeting-oct-meeting-canceled-due-to-reaction-to-disulfiram/

https://madisonarealymesupportgroup.com/2019/10/15/disulfiram-psychosis-update/

 

 

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Lyme, Treatment

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5 Thyroid Lies Your Endocrinologist May Try to Tell You

October 26, 2019

https://www.holtorfmed.com/5-thyroid-lies-endocrinologist-may-try-tell/?

5 Thyroid Lies Your Endocrinologist May Try to Tell You

By Holtorf Medical Group

Originally Posted January 2015
Updated September 2019

Endocrinologists, whose “specialization” is the endocrine system — which includes the thyroid gland — are sometimes the worst offenders when it comes to providing dubious information about your thyroid diagnosis and treatment.

Get smart, and discover the five lies that your endocrinologist may try to tell you.

1. “Your TSH is Normal.”

Integrative doctors consider the Thyroid Stimulating Hormone (TSH) test to be only one of many tests to diagnose and manage thyroid disease. TSH, however, is considered the “gold standard” test by many endocrinologists. Too bad they don’t even agree on the cutoff points for the reference range for this test.

Learn about what’s in a complete thyroid panel and get a FREE lab slip here.

Some endocrinologists consider any number within the reference range (it’s around .40 to 4.0 at many US labs) “normal,” and others feel that TSH must be as high as 10 for a diagnosis of hypothyroidism. And many endocrinologists don’t test Free T4, and Free T3 — the actual circulating thyroid hormones — or antibodies that detect autoimmune thyroid disease. So, you could have sub-normal levels of T4 and T3, and/or antibodies that show that your thyroid gland is in self-destruct mode, but if your TSH is within the reference range, the endocrinologist may say it’s “normal.”

2. “Natural Desiccated Thyroid Drugs Aren’t FDA-Regulated, They’re Not Consistent, They’re Not Safe, They’re Off the Market, They’re Made from Cows”

Natural desiccated thyroid (NDT) is prescription thyroid hormone replacement, made from the dried thyroid gland of pigs. It’s also known as natural thyroid, thyroid extract, and is available as a generic, or as brands, including Nature-throid, Thyroid WP, Armour, and Erfa.

It’s shocking how many endocrinologists are misinformed about these drugs. Here are the facts:

  • Natural desiccated thyroid drugs ARE regulated by the FDA. All prescription drugs in the US are FDA-regulated.
  • These drugs are regularly checked through rigorous quality-control processes, and are as consistent as other thyroid drugs. Just as with synthetic levothyroxine drugs (like Synthroid), when inconsistent batches are detected, they are recalled.
  • When properly prescribed, NDT drugs are as safe and effective as other thyroid hormone replacement drugs.
  • NDT is not off the market, it’s legally available in the US, Canada, and a number of other countries.
  • NDT brands available in the US are made from pigs — not from cows.

Learn more about NDT here.

3. “Hypothyroidism Doesn’t Cause Weight Gain”

Many endocrinologists claim that the thyroid, despite being the master gland of metabolism, has nothing to do with weight. People with undiagnosed thyroid disease often report substantial weight gain prior to diagnosis, and even after diagnosis, losing weight can become difficult, if not sometimes impossible, for people with hypothyroidism, or after surgery to remove the thyroid gland. Endocrinologists often accuse thyroid patients on restrictive diets of “eating too much” and tell marathon runners with thyroid problems that they need to do even more exercise to lose weight. They simply don’t understand how the complex ways that the thyroid is linked to body weight.

Fact: The thyroid is intricately linked to blood sugar, hunger and satiety, hunger/weight loss hormones like insulin and leptin, energy, basal metabolism, and many other factors that have a firm hold on whether you gain or lose weight. Getting the thyroid diagnosed and optimally treated is required for weight loss — but many thyroid patients may also need to address insulin and leptin resistance, lowered metabolism, and other issues — before successful weight loss.

4. If You Have a Suspicious Nodule, We Need to Take Out Your Thyroid Gland”

Some thyroid patients have nodules — lumps in the gland. A suspicious nodule may be large in size, growing quickly, or have suspicious characteristics in imaging tests like a CT scan or ultrasound, or on a radioactive uptake test. Before recommending surgical removal, however, a nodule should typically undergo a fine needle aspiration (FNA) biopsy, to assess whether the nodule is cancerous. If it is cancerous, then the treatment typically does involve surgical removal. However, a substantial number of these FNA biopsies come back indeterminate or inconclusive.

If you have FNA testing on a suspicious nodule, and the result is that it is indeterminate or inconclusive, ask for a Veracyte Afirma Thyroid Analysis test, before agreeing to surgery. This test is performed on your FNA biopsy results, and can eliminate most inconclusive results, to determine quite accurately whether the nodule is cancerous. Since some inconclusive nodules are benign, this test can help you avoid surgery and a lifetime of hypothyroidism afterwards.

Learn about the different types of thyroid nodules here.

5. “You Need to See a Psychiatrist”

Conventional endocrinology says that if you are a patient with hypothyroidism and you’re receiving levothyroxine treatment (not a T4/T3 treatment or natural thyroid, which they claim is not needed), and you have a TSH anywhere within the reference range, and you still don’t feel well, your endocrinologist should recommend a consultation with a psychiatrist. This is what was disseminated in the 2014 Hypothyroidism Guidelines, created and promoted by the American Thyroid Association (with funding from levothyroxine manufacturers.)

If you are hypothyroid, are taking only levothyroxine (like Synthroid, Levothroid, Levoxyl, Tirosint, Unithroid), have a TSH within the reference range, and you still don’t feel well — before you head off to a psychiatrist’s couch, it may be time to find a new doctor — typically, an integrative, holistic physician — who can…

  • determine whether your TSH is optimal, and not just within the range.
  • make sure your Free T4 and Free T3 are tested, and optimized with medication (including T3 or natural desiccated thyroid if necessary).
  • look at your Reverse T3 levels, and determine whether or not you may have some thyroid transport or conversion problems that are contributing to symptoms, and treat them.
  • advise you regarding other issues, including adrenal balance, nutritional deficiencies, and hormone imbalances.

Finding a Knowledgeable Thyroid Doctor

If you’ve heard any of these lies, it’s time to find a new doctor! Locating an effective and knowledgeable thyroid physician can seem daunting and unending, but there is hope!

At Holtorf Medical Group, our physicians are trained to provide you with cutting-edge testing and innovative treatments to properly diagnose and treat your thyroid condition, optimize your health and improve your quality of life. If you have been diagnosed with hypothyroidism, but aren’t getting the treatment you need or if you have symptoms associated with thyroid dysfunction, call us at 877-508-1177 to see how we can help you!

Learn more about thyroid disease and how our practice treats it in this FREE Thyroid 101 e-book.

Click Here to Download Thyroid 101

Resources

1. Kent Holtorf, MD. “Understanding Local Control of Thyroid Hormones: (Deiodinases Function and Activity).”https://www.nahypothyroidism.org/deiodinases/
2. Kent Holtorf, MD. “Thyroid Hormone Transport.” https://www.nahypothyroidism.org/thyroid-hormone-transport/
3. Kent Holtorf, MD. “Diagnosis of Hypothyroidism: Are we getting what we want from TSH testing?”https://www.nahypothyroidism.org/how-accurate-is-tsh-testing/
4. Kent Holtorf, MD. “Why Doesn’t My Endocrinologist Know All of This?” https://www.nahypothyroidism.org/why-doesnt-my-doctor-know-all-of-this/

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**Comment**

The tiny thyroid gland is the body’s thermostat.  If you find your hands and feet are always cold and your hair lacks luster or falls out – consider your thyroid. Supplementing is inexpensive and can make all the difference in the world to how you feel.  Lyme/MSIDS patients often have issues with their thyroid.

My doctor also uses the following formula to determine if a person needs to supplement with additional T3:

Take Total T3 and divide by Reverse T3. The total should be at least 12. If it is lower than 12 you need to supplement with T3.  Also – Cytomel, the brand name of the prescription drug liothyronine, has many additives that are toxic as well as costs three times the compounded form. I get mine from a compounding pharmacy that uses olive oil as the filler.  Women’s International Pharmacy (WIP) is right here in Madison:  https://www.womensinternational.com

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thyroid

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