Archive for the ‘Lyme’ Category

TBDWG – Dr. Dixon Stuck in the Year 2001

Lyme patient and advocate Carl Tuttle tuned into the Tick-borne Disease Working Group Meeting on March 3 & 4 and listened with dismay as Chief of the Bacteriology and Mycology Branch NIAID, NIH – Dr. Dixon referenced the unscientific Klempner Trial that has been used for decades against using further treatment for Lyme/MSIDS patients with remaining symptoms. 

He sent the following to Dixon:  https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/25847056?

700 articles LYME Evidence of Persistence

https://www.dropbox.com/s/n09sk90eo6xz7ua/700%20articles%20LYME%20EvidenceofPersistence-V2.pdf?dl=0

The most disturbing reference for persistent infection originates from the Centers for Disease Control in Fort Collins, Colorado where Borrelia burgdorferi, was grown from the cerebrospinal fluid of Lyme patient Vicki Logan despite prior treatment with intravenous antibiotics.  Her case made the front page of the New York Times Science Times in August of 1993.

Logan’s positive culture and autopsy report were forwarded to past CDC Director Brenda Fitzgerald, MD.

Letter to Brenda Fitzgerald, MD

https://www.dropbox.com/s/xaul84dqmqgbre0/Brenda%20Fitzgerald%20MD%20Director%20CDC.docx?dl=0

In contrast, the Klempner antibiotic trials found no evidence of B. burgdorferi in a total of more than 700 different blood and cerebrospinal fluid samples from 129 patients. That’s not statistically possible Dr. Dixon!

I reached out to Dr. Klempner in 2018 and of course there was no response.

Letter written by Tuttle in 2018 to Dr. Klempner:

Dr. Klempner,

I would like to call attention to the attached study recently identifying chronic Lyme disease in twelve patients from Canada.

Persistent Borrelia Infection in Patients with Ongoing Symptoms of Lyme Disease

http://www.mdpi.com/2227-9032/6/2/33

All of these patients were culture positive for infection (genital secretions, skin “Morgellons” and blood) even after multiple years on antibiotics so there was no relief from current antimicrobials. Some of these patients had taken as many as eleven different types of antibiotics.

In contrast, your 2001 antibiotic treatment study found; “no evidence of B. burgdorferi in a total of more than 700 different blood and cerebrospinal fluid samples from the 129 patients in these studies.”

Two Controlled Trials of Antibiotic Treatment in Patients with Persistent Symptoms and a History of Lyme Disease

http://www.nejm.org/doi/full/10.1056/NEJM200107123450202#article_references#t=references

Not a single positive Dr. Klempner? Doesn’t this statistically prove that your methodology was fatally flawed?

Did you culture skin and genital secretions as the Middelveen paper reports? It would appear that you conveniently stopped looking after your results supported the existing thirty year dogma; chronic Lyme does not exist.

Persistent Lyme disease is not new and has been intentionally/deceitfully suppressed for decades as described in the Vicki Logan case identified in the following letter to past CDC Director Barbara Fitzgerald:

https://www.dropbox.com/s/xaul84dqmqgbre0/Brenda%20Fitzgerald%20MD%20Director%20CDC.docx?dl=0

In 1991 B. burgdorferi had been isolated in culture from Vicki Logan’s CSF (CDC’s laboratory in Fort Collins CO.) despite prior treatment with 21 days of IV cefotaxime and 4 months of oral minocycline.

The dishonest science here in the U.S. has denied chronic Lyme which stifled research to find a curative approach. Now the rest of the world is suffering.

We have lost nearly four decades to this 21st century plague due to the racketeering scheme identified in the RICO lawsuit filed by SHRADER & ASSOCIATES, LLP against the Infectious Disease Society of America, seven IDSA Panelists and eight insurance companies. The U.S. Centers for Disease Control has aligned itself with the seven IDSA Panelists identified in this lawsuit.

https://www.courthousenews.com/wp-content/uploads/2017/11/LymeDisease.pdf

Lyme is an incurable disease when not treated immediately which is spreading across North America and deceitfully misclassified as a low-risk and non-urgent health issue. Patient experience is describing a disease that is destroying lives, ending careers, causing death and disability while leaving victims in financial ruin. Current antimicrobials are ineffective for eradicating all forms of the Borrelia spirochete.

Public outcry has been ignored for decades while the Centers for Disease Control sat on evidence that this infection was not easily treated with a one size fits all treatment approach as dictated by the Infectious Diseases Society of America.

Once again your studies were fatally flawed while supporting the controlling dogma leaving hundreds of thousands if not millions worldwide with a persistent infection and absolutely no relief. We have another AIDS on our hands.

Carl Tuttle

Independent Researcher

Lyme Endemic Hudson, NH

Cc: Michael F. Collins, Chancellor

____________________

**Comment**

Some of you may be wondering about the Klempner trial, which can be found here:  https://www.ncbi.nlm.nih.gov/pubmed/11450676

Countering the Klempner Trial, here is a 2012 Study showing retreatment can be beneficial:  https://www.sciencedirect.com/science/article/pii/S1551714412002030

Article explaining flaws in the Klempner Trial:  https://www.lymedisease.org/lymepolicywonk-new-study-reveals-fatal-flaws-in-nih-klempner-trial-statistical-analysis-is-this-error-human-incompetence-or-worse/

Excerpt:

Clinical trials usually require that patients improve, but not that they return to perfect health.  DeLong found that the Klempner trial set the level for determining treatment success excessively high. For instance, in the seronegative arm of the trial, treatment success required that patients not simply return to the norm for the general population, but instead surpass the norm by essentially one full standard deviation.  That type of success is unheard of in clinical trials.

Many researchers say that small sample size trials are unethical because they can literally steer scientists down the wrong path.  That’s what the Klempner study did.  It was a waste of money, a waste of time, and it has led research down the wrong path for the last 10 years.

Second, the Klempner team could have avoided “overstating” its findings and highlighted the potential for error.  The ethical implications of exaggeration in science are understood by other scientific societies.  For example, the code of conduct for the American Chemical Society states: “Public comments on scientific matters should be made with care and accuracy, without unsubstantiated, exaggerated, or premature statements.”

Instead, the Klempner study concluded flatly that retreatment was ineffective. 

Also, Embers et al. found Persistence of Borrelia burgdorferi in Rhesus Macaques following Antibiotic Treatment of Disseminated Infection:  https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0029914

For fun, I did a little sleuthing on Dr. Klempner (who is behind the new Lyme vaccine)

Klempner was optimistic. “We’ve learned some very important lessons from the LYMErix debacle, as I think some people would categorize it,” he said. “It certainly remains the only safe and effective vaccine that’s been pulled from the market.”

During LYMErix’s brief stint on the market, Clarke was among the recipients. Having had Lyme disease twice, she decided to try the vaccine. Even after receiving the final LYMErix shot, Clarke said she got Lyme disease for a third time.

So Dr. Klempner, a man with rife conflicts of interest, states emphatically that LYMErix was “safe and effective” despite the plethora of people & dogs who developed Lyme-like symptoms.

 

 

 

 

Unusual Case of Suspected Lyme Disease in Patient With Ear Pain

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6906891/

. 2019 Oct-Dec; 11(4): 160–162.
Published online 2019 Nov 26. doi: 10.4103/jgid.jgid_75_19
PMCID: PMC6906891
PMID: 31849437

An Unusual Case of Suspected Lyme Neuroborreliosis in a Patient Presenting with Ear Pain

Abstract

We report a case of suspected Lyme neuroborreliosis (LNB) where the patient’s sole symptom was chronic, intermittent episodes of unilateral ear pain. This case was unusual because this patient did not show any other neurological or extraneurological symptoms of Lyme disease. LNB is a manifestation of infection by Borrelia burgdorferi spirochetes that can manifest in a number of different clinical presentations depending on the nervous system dissemination of the bacteria. Most commonly, these neurological findings present as peripheral nerve radiculopathies, but rarer involvement of the central nervous system (CNS) can occur if a patient goes untreated. Most often, CNS involvement presents as meningitis with increased lymphocytes but can, in rarer cases, involve the spinal cord or brain parenchyma.

The diagnosis of LNB was made after the patient was found to have suspicious lesions in the spinal cord and brain parenchyma on magnetic resonance imaging as well as cerebrospinal fluid Borrelia antibody index was consistent with CNS Lyme disease. We discuss this case as a unique clinical presentation of suspected LNB and the diagnostic findings associated with this infection.

_________________

**Comment**

Nothing surprises me about Lyme disease anymore.  “Not everything is Lyme, but Lyme CAN be anything.”  Truer words were never spoken.

 

 

Dogs With Proteinuria Found to Have Exposure to Rickettsia, Ehrlichia, and Lyme Disease

https://www.ncbi.nlm.nih.gov/pubmed/31916316/

2020 Jan 8. doi: 10.1111/jvim.15610. [Epub ahead of print]

A retrospective study of vector-borne disease prevalence in dogs with proteinuria: Southeastern United States.

Abstract

BACKGROUND:

Proteinuria is a risk factor for progressive kidney injury in dogs. Enhanced understanding of potential associations between canine vector-borne diseases (CVBD) and proteinuria is needed.

OBJECTIVES:

To determine the proportion of evaluated proteinuric dogs exposed to ≥1 CVBD, including Babesia spp., Ehrlichia spp., spotted-fever group Rickettsia, Bartonella spp., Anaplasma spp., hemotropic Mycoplasma spp., Borrelia burgdorferi, and Dirofilaria immitis, and to determine if demographic or clinicopathologic differences exist between proteinuric dogs exposed to CVBD versus proteinuric dogs with no evidence of CVBD exposure.

ANIMALS:

Two-hundred nine proteinuric dogs, concurrently tested for CVBD, which were examined at a single academic veterinary hospital between January 2008 and December 2015.

METHODS:

Retrospective cross-sectional study. Demographic, clinicopathologic, and CVBD test results were extracted from medical records. A multivariable logistic regression model was used to assess associations between CVBD and selected variables.

RESULTS:

Based on serology and polymerase chain reaction testing,

  • 34% of proteinuric dogs (72/209) were exposed to ≥1 CVBD
  • Exposure to Rickettsia spp. (19%)
  • Ehrlichia spp. (12%)
  • B. burgdorferi (9%)

The CVBD exposure was lower in dogs tested in autumn or spring, higher in intact dogs, and higher in dogs with lower serum albumin and higher serum creatinine concentrations.

CONCLUSIONS AND CLINICAL IMPORTANCE:

Exposure to CVBD, particularly exposure to Rickettsia spp., Ehrlichia spp., and B. burgdorferi was found in proteinuric dogs from the southeast United States. Additional controlled prospective studies examining a potential causal relationship between CVBD and proteinuria are warranted.

__________________

**Comment**

The question of course is – does this also happen in humans and to what degree?

 

Four Borrelia Species Found in Ticks in North-Eastern Germany

https://www.ncbi.nlm.nih.gov/pubmed/32106890

2020 Feb 27;13(1):106. doi: 10.1186/s13071-020-3969-7.

Borrelia miyamotoi and Borrelia burgdorferi (sensu lato) identification and survey of tick-borne encephalitis virus in ticks from north-eastern Germany.

Abstract

BACKGROUND:

Ixodes ricinus is the most common tick species in Europe and the main vector for Borrelia burgdorferi (sensu lato) and tick-borne encephalitis virus (TBEV). It is involved also in the transmission of Borrelia miyamotoi, a relapsing fever spirochete that causes health disorders in humans. Little is known regarding the circulation of Borrelia species and the natural foci of TBEV in north-eastern Germany. The goal of this study was to investigate the infection rates of Borrelia spp. and of TBEV in I. ricinus ticks from north-eastern Germany.

METHODS:

Ticks were collected by flagging from 14 forest sites in Mecklenburg-Western Pomerania between April and October 2018. RNA and DNA extraction was performed from individual adult ticks and from pools of 2-10 nymphs. Real time reverse transcription PCR (RT-qPCR) targeted the 3′ non-coding region of TBEV, while DNA of Borrelia spp. was tested by nested PCR for the amplification of 16S-23S intergenic spacer. Multilocus sequence typing (MLST) was performed on B. miyamotoi isolates.

RESULTS:

In total, 2407 ticks were collected (239 females, 232 males and 1936 nymphs). Female and male I. ricinus ticks had identical infection rates (both 12.1%) for Borrelia spp., while nymphal pools showed a minimum infection rate (MIR) of 3.3%. Sequencing revealed four Borrelia species: B. afzelii, B. garinii, B. valaisiana and B. miyamotoi.

  • Borrelia afzelii had the highest prevalence in adult ticks (5.5%) and nymphs (MIR of 1.8%)
  • Borrelia miyamotoi was identified in 3.0% of adults and registered the MIR of 0.8% in nymphs
  • Borrelia valaisiana was confirmed in 2.5% adult ticks and nymphs had the MIR of 0.7%
  • B. garinii was present in 1.1% of adults and showed a MIR of 0.1% in nymphs
  • The MLST of B. miyamotoi isolates showed that they belong to sequence type 635.
  • No tick sample was positive after RT-qPCR for TBEV RNA.

CONCLUSIONS:

The prevalence of B. miyamotoi in I. ricinus ticks registered similar levels to other reports from Europe suggesting that this agent might be well established in the local tick population.

The detection of B. burgdorferi (s.l.) indicates a constant circulation in tick populations from this region.

___________________

**Comment**

If four borrelia species were discovered in German ticks, it’s highly likely these same ticks are transmitting to humans. German patients are sunk if doctors are utilizing worthless CDC 2-tiered testing as it ONLY uses one strain, which isn’t even discussed in this paper (B. burgdorferi).

Borrelia afzelii, miyamotoi, and garinii ALL are pathogenic to humans.

This 2004 article shows they found valaisiana in the cerebrospinal fluid in a, “61-year-old man with a history of spastic paraparesis, which is strong clinical evidence of advanced neuroborreliosis.” They further state, “This report is the first of genetic detection of B. valaisiana in CSF, which indicates a probable association of this genospecies with disease in humans.”  https://wwwnc.cdc.gov/eid/article/10/9/03-0439_article

Sixteen years later we still don’t know if valaisianna is pathogen to humans.

This, right here, is why we don’t need more climate data.
We need to know what is causing disease in humans, and how to detect it (test), and treat it.

For more:  https://madisonarealymesupportgroup.com/2018/11/07/ticks-on-the-move-due-to-migrating-birds-and-photoperiod-not-climate-change/

Potential Treatment For Lyme Disease Kills Bacteria That May Cause Lingering Symptoms, Study Finds (In a Petri Dish & Mice)

http://med.stanford.edu/news/all-news/2020/03/potential-treatment-for-lingering-lyme-disease.html

Potential treatment for Lyme disease kills bacteria that may cause lingering symptoms, study finds

Screening thousands of drugs, Stanford scientists determined that in mice, azlocillin, an antibiotic approved by the Food and Drug Administration, eliminated the bacteria that causes Lyme disease.

By TRACIE WHITE, a science writer in the Office of Communications. Email her at tracie.white@stanford.e

MAR 12, 2020

For decades, the routine treatment for Lyme disease has been standard antibiotics, which usually kill off the infection. But for up to 20% of people with the tick-borne illness, the antibiotics don’t work, and lingering symptoms of muscle pain, fatigue and cognitive impairment can continue for years — sometimes indefinitely.

A new Stanford Medicine study in lab dishes and mice provides evidence that the drug azlocillin completely kills off the disease-causing bacteria Borrelia burgdorferi at the onset of the illness. The study suggests it could also be effective for treating patients infected with drug-tolerant bacteria that may cause lingering symptoms.

“This compound is just amazing,” said Jayakumar Rajadas, PhD, assistant professor of medicine and director of the Biomaterials and Advanced Drug Delivery Laboratory at the Stanford School of Medicine. “It clears the infection without a lot of side effects. We are hoping to repurpose it as an oral treatment for Lyme disease.” Rajadas is the senior author of the study, which was published online March 2 in Scientific Reports. The lead author is research associate Venkata Raveendra Pothineni, PhD.

“We have been screening potential drugs for six years,” Pothineni said. “We’ve screened almost 8,000 chemical compounds. We have tested 50 molecules in the dish. The most effective and safest molecules were tested in animal models. Along the way, I’ve met many people suffering with this horrible, lingering disease. Our main goal is to find the best compound for treating patients and stop this disease.”

Hunting for alternative drug

Frustrated by the lack of treatment options for Lyme disease patients with lingering symptoms, Rajadas and his team began hunting for a better alternative in 2011. In 2016, they published a study in Drug Design, Development and Therapy that listed 20 chemical compounds, from about 4,000, that were most effective at killing the infection in mice. All 20 had been approved by the Food and Drug Administration for various uses. One, for instance, is used to treat alcohol abuse disorder.

 

In this most recent study, azlocillin, one of the top-20 contenders, was shown to eclipse a total of 7,450 compounds because it is more effective in killing B. burgdorferi and causes fewer side effects. Lyme disease affects more than 300,000 people annually, according to the Centers for Disease Control and Prevention. It can affect various organs, including the brain, skin, heart, joints and nervous system, and cause heart problems and arthritis if untreated. Symptoms include fever, headaches, chills, and muscle and joint pain.

Traditional antibiotics, such as doxycycline, are effective as an early course of treatment for the infection in the majority of patients, but it remains unclear why these drugs fail to treat 10% to 20% of patients, Rajadas said.

“Some researchers think this may be due to drug-tolerant bacteria living in the body and continuing to cause disease,” said Rajadas, who is also a member of the Lyme Disease Working Group at Stanford. “Others believe it’s an immune disorder caused by bacteria during the first exposure, which causes a perpetual inflammation condition. Whatever the cause, the pain for patients is still very real.”

Azlocillin comes out on top

The drug, which is not on the market, was tested in mouse models of Lyme disease at seven-day, 14-day and 21-day intervals and found to eliminate the infection. For the first time, azlocillinwas also shown to be effective in killing drug-tolerant forms of B. burgdorferi in lab dishes, indicating that it may work as a therapy for lingering symptoms of Lyme disease.

Pothineni and Rajadas have patented the compound for the treatment of Lyme disease and are working with a company to develop an oral form of the drug. Researchers plan to conduct a clinical trial. 

Rajadas is also a professor of bioengineering and therapeutic sciences at the University of California-San Francisco.

Other Stanford co-authors are Hari-Hara S. K. Potula, PhD, senior research scientist; postdoctoral scholars Aditya Ambati, PhD, and Venkata Mallajosyula, PhD; senior research scientist Mohammed Inayathullah, PhD; and intern Mohamed Sohail Ahmed.

A researcher at Loyola College in India also contributed to the work.

The study was funded by the Bay Area Lyme Foundation and Laurel STEM Fund.


Those who go on to experience lingering symptoms are 40-60% of all patients:  https://madisonarealymesupportgroup.com/2019/02/25/medical-stalemate-what-causes-continuing-symptoms-after-lyme-treatment/ We keep being told it’s only 10-20% when that group only includes those diagnosed and treated early.  It doesn’t and shouldn’t included a larger group of 30-40% who are diagnosed and treated late.  Add the two groups and you have up to 60% going on with chronic symptoms.  That’s a big deal and should warrant much more attention than it’s currently getting.
The study mentions –
  • disulfiram:  Excerpt:  An interesting drug candidate identified in the study was the alcohol dehydrogenase inhibitor, disulfiram. Though the drug is used as a treatment of alcohol abuse, recently its anticancer potential has also been discovered. It has been known to make complexes with metal ions and cause the disruption of the proteasome, leading to death of the cancer cells. Similarly, the metabolites of the drug molecule have been known to significantly inhibit the growth of a number of bacterial species, including the biofilm-forming Pseudomonas aeruginosa.62 The drug molecule has a good bioavailability, and it passes the blood–brain barrier to show its effect in the central nervous system. Though most of the studies are concerned to the use of the drug molecule in alcoholism yet, being a safe, FDA-approved molecule, the drug can be repurposed for its antibacterial potential.  Study here:  https://flightpath.bio/wp-content/uploads/2020/02/liegner.pdf
  • azlocillin and cefataxime:   Excerpt:  As we observe that azlocillin sodium and cefotaxime acid show low MIC values, we studied time kill studies to determine the rate of antimicrobial activity. In our observation, both azlocillin sodium and cefotaxime acid reduced Borrelia no 3-log10-unit (99.9%) between 48 hours and 72 hours at concentrations 2.5 μM and 5 μM, respectively.  Study here:  https://flightpath.bio/wp-content/uploads/2020/03/s41598-020-59600-4.pdf
Azlocillin is currently only available overseas and in IV form but a company called Flightpath biosciences https://flightpath.bio/pipeline/ is working on an oral formulation and says it has demonstrated in vivo efficacy in mice. This could be a good alternative to Disulfiram as it doesn’t carry some of the risks associated with DSF and doesn’t require a whole lifestyle change.
From their website:

Azlocillin was approved as Azlin® by the FDA on September 3rd, 1982 as a semisynthetic broad spectrum penicillin antibiotic to treat Pseudomonas aeruginosa via intravenous administration. Commercially, the drug was safe and well tolerated and had a limited side effect profile, with warnings and contraindications related only to a patient history of penicillin sensitivities.

In laboratory plate experiments, our scientific team demonstrated that azlocillin significantly inhibited the growth of drug-tolerant Borrelia burgdorferi (Bb) bacteria in a manner far better than doxycycline (the standard of care).

Azlocillin also reduced Lyme disease related inflammation in mice infected with Bb for seven days, compared to the saline control, telismartin, and doxycycline. Upon completion of additional pharmacokinetic and efficacy studies in animals at Tulane University, we hope to advance FP-101 into clinical trials in acute and PTLDS indications in the near future.  https://flightpath.bio/pipeline/