Archive for the ‘research’ Category

Clinical Presentation of Lyme Disease in Patients Living in Germany – Same Story, Different Country

https://danielcameronmd.com/presentation-lyme-disease-patients-germany/

Clinical presentation of Lyme disease in patients living in Germany

Lyme disease presentation in man from Germany holding his hands over his face.
In their article, entitled “Neuropsychiatric and Psychological Symptoms in Patients with Lyme Disease: A Study of 252 Patients,” Hündersen and colleagues describe the clinical presentation, diagnostic process and treatment regimens for 252 Lyme disease patients. [1]
By

The authors collected data via an online questionnaire from 252 Lyme disease patients and a control group of 267 healthy individuals living in Germany to examine the clinical presentation, including neuropsychiatric and psychological symptoms.

The findings revealed that “Lyme disease can cause diverse psychological and neuropsychiatric symptoms. These include limitations in quality of life, sleep, attention, and memory, as well as depressive symptoms.”

Time to diagnosis

The majority of the patients were diagnosed with Lyme disease based on ELISA (53.2%), Western blot (43.7%), and lymphocyte transformation test results (41.7%).

Out of the 252 participants, nearly half (45.5%) recalled an erythema migrans rash, while 74% recalled a tick bite “that possibly triggered Lyme disease.”

It took approximately 8 years to receive a diagnosis following the tick bite.

On average, patients visited almost 8 physicians to obtain a diagnosis.

It took approximately 8 years to receive a diagnosis following the tick bite.  Less than half (46%) received their diagnosis within the first 5 years after the onset of symptoms.

Co-infections

The majority of participants were not diagnosed with or tested for a co-infections.

“A total of 25% of the sample stated that they had (exactly one) co-infection,” the authors explain, while 15% reported having 2 co-infections.

“For patients that suffered from co-infections, Chlamydia infection was particularly common (34.9%), as was the Epstein–Barr virus (34.9%).”

Treatment

Out of the 252 participants, 168 received antibiotic treatment that lasted at least 3 weeks.

Symptoms improved for nearly 73% of these patients.

93% of participants reported a relapse of symptoms after the completion of antibiotic therapy.

“The type of treatment was oral in most cases (47.6%), or a combination of oral and intravenous therapy (48.8%),” according to the authors.

Intravenous antibiotic therapy was prescribed in only 3.6% of the cases.

Authors Conclude:

  • “It became clear that Lyme disease is often diagnosed very late.”
  • “It appears that people suffering from Lyme disease have significantly lower quality of life and sleep and show cognitive impairments when it comes to attention and memory.”
  • “This study shows that 3.1% of Lyme patients were satisfied with their lives and that 37% scored in the lower third of the quality-of-life scale.”
  • “It was also shown that Lyme patients tend to have depressive symptoms.”
References:
  1. Hündersen F, Forst S, Kasten E. Neuropsychiatric and Psychological Symptoms in Patients with Lyme Disease: A Study of 252 Patients. Healthcare (Basel). 2021 Jun 14;9(6):733. doi: 10.3390/healthcare9060733. PMID: 34198647; PMCID: PMC8232147.

________________

**Comment**

This article, right here, encapsulates dire issues that have remain untouched for over 40 years.

  • Abysmal testing is still relied upon for diagnosis
  • Having the EM rash and remembering a tick bite happen far less than we are being told
  • People are still diagnosed and treated late, even though everyone and their dog knows this is a problem
  • Eight years is a long time to suffer, allowing pathogens to travel everywhere in the human body causing untold damage
  • Three weeks of antibiotics is a complete JOKE and is laughable if the consequences weren’t so dire
  • Most were not tested for coinfections.  Since testing for coinfections is just as abysmal as for Lyme – these patients saved a lot of money.  The minus, of course, is not understanding that cases with coinfection involvement are far more difficult to treat and require far more medications for a longer period of time. Lyme literate doctors understand this fact and will diagnose and treat clinically (based upon symptoms – not tests alone)
  • The fact their symptoms improved in 3 weeks doesn’t mean they should end treatment.  In fact, for those with a brain, it indicates antibiotic treatment works and should be continued until they don’t work, and then, they should be changed, not stopped as coinfections often need addressing and require different meds
  • 93% relapsing should prove to the deniers once and for all that the measly 21 days of doxycycline clearly isn’t working. 
  • 93% relapsing should also put to rest the myth that only 10-2-% go onto suffer persistent symptoms. When you count those who were diagnosed and treated late, as these patients were, it is an astounding 60% that go on to suffer debilitating symptoms.
  • The life-altering, debilitating symptoms these poor people suffer with show that this 40-year old experiment must end.  This is barbarism on a scale similar to the Tuskagee experiment

Category:

Activism, Lyme, research, Treatment

TMJ Arthritis Triggered by Lyme Disease

https://danielcameronmd.com/tmj-arthritis-triggered-by-lyme-disease/

TMJ arthritis triggered by Lyme disease

woman with TMJ from Lyme disease holding her jaw

A case report by Weise and colleagues demonstrates that Lyme disease can induce temporomandibular joint (TMJ) pain and may be misdiagnosed as a common temporomandibular disorder (TMD).

By

In the article, “Acute arthritis of the right temporomandibular joint due to Lyme disease: a case report and literature review,” the authors describe a 25-year-old patient who presented to a medical center with acute pain in the right temporomandibular joint and mouth opening disorders.¹

Over a 5-year period, the woman’s distal bite was treated with removable and fixed orthodontic appliances. Three months after the first symptoms, “the patient developed increasing pain in the right TMJ, increasing active mouth opening restriction to 20 mm and a habitual deviation of the lower jaw to the left.”

The patient was initially diagnosed with a total ventral deviation of the discus on the right side without reduction. Treatment with anti-inflammatory medications, a bite splint and a corticosteroid injection, however, were not effective and the woman’s symptoms continued.

Although the patient did not recall a tick bite or EM rash, testing for Lyme disease was positive and she was diagnosed with Lyme arthritis affecting the right temporomandibular joint.

“Early interdisciplinary diagnosis of Lyme disease and early antibiotic therapy are essential to avoid misdiagnosis and unnecessary, sometimes invasive, therapies.”

The patient was prescribed a 3-week course of Cefuroxime. After one week of antibiotic treatment, her symptoms improved.

“It can be assumed that there must have been an infection with Borrelia in the right temporomandibular joint for a longer period of time before the symptoms occurred.”

Lyme disease presenting with TMJ “very often is misinterpreted as a temporomandibular disorder,” the authors state.

“In the case of unclear TMJ problems and when the TMD treatment is not successful,” the authors stress, “the possibility of a [Lyme disease] infection should definitely be considered as a differential diagnosis.”

_______________

**Comment**

This condition is extremely painful.  I’ve had it.

A Lyme disease infection should definitely be considered as a differential diagnosis when ANY joint becomes painful and inflamed, particularly when there’s a fever present.

For more:

Category:

Inflammation, Lyme, Pain Management, research

Japan: Tick-Borne”Yezo Virus” Can Infect Humans

http://

Japan: Researchers discover new tick-borne “Yezo virus” that can infect humans

Oct 27, 2021
Researchers in Japan have discovered a new tick-borne virus that can infect humans and named it ‘Yezo virus,’ as explained a Hokkaido University virologist on Wednesday. The tick borne virus was first noticed in 2019 when a patient developed a fever after a tick bite and had a negative test result of the known tick borne viruses.
Mastuno described the symptoms as such:
“when you are infected with Yezo virus, it may take a couple of days to a maximum of two weeks to show some symptoms like fever or loss of appetite. And then you will have very high fever reaching to the 39 degrees Celsius. And it will last for one week or two weeks.”
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Category:

research, Ticks, Viruses

Another Whistleblower Promptly Fired For Showing Pfizer Falsified Data. Got Science? Are You Sure?

**UPDATE Feb. 18, 2022**

Here is the case filing of the lawsuit against Pfizer:  https://www.documentcloud.org/documents/21206071-brook-jackson-lawsuit

Case 1:21-cv-00008-MJT Filed 01/08/21

Core allegations:

Making or Using False Records or Statements to Cause Claims to be Paid (31 U.S.C. § 3729(a)(1)(B)) 284.

  1. “From 2020 to the present, Defendants knowingly made, used, or caused to be made or used, false records or statements that were material to false and/or fraudulent claims paid or approved by the United States DoD. These false records or statements include the clinical trial protocol Pfizer submitted to the United States and the falsified source documents and data behind Defendants’ trial results and EUA application.

  2. By creating and carrying out their fraudulent schemes, Defendants knowingly and repeatedly violated Section 3729(a)(1)(B) of the False Claims Act. 286. Defendants’ false records were material to Pfizer’s claims for payment for the vaccine at issue. The United States DoD would not have paid Pfizer if it knew that the clinical trial protocol was not complied with by Defendants, because the protocol violations call the integrity and validity of both the entire clinical trial and Pfizer’s EUA into question.

  3. Defendants’ false records also went to the very essence of the bargain the United States contracted for. DoD contracted to purchase vaccines found effective by a valid clinical trial conducted according to the protocol submitted by Pfizer. The integrity of the entire clinical trial was compromised by the trial protocol violations, false source documents, and the false data that resulted, which calls the vaccine’s EUA into question. Had the United States DoD known of Defendants’ false records, it would not have paid Pfizer. 288. Defendants’ use, or causation of use, of material false records was a foreseeable factor in the United States DoD’s loss and a consequence of Defendants’ schemes. By virtue of Defendants’ actions, the United States DoD has suffered actual damages and is entitled to recover treble damages plus a civil monetary penalty for each false and/or fraudulent claim.”

    Access: Case 1:21-cv-00008-MJT Filed 01/08/21

https://www.bmj.com/content/375/bmj.n2635.full

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635

 
Paul D Thacker, investigative journalist
Author affiliations
Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management

On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection

Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated. (See link for article)

Important excerpt:

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594, NCT04955626, NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Speaking off the record, other employees confirmed that the fired employee’s concerns were valid:
  • “Everything that you complained about was spot on.”
  • “I don’t think it was clean data. It’s a crazy mess.”
  • “I’ve never had to do what they were asking me to do, ever, It just seemed like something a little different from normal—the things that were allowed and expected.”
  • One employee with over 4-dozen clinical trials under her belt said she had never experienced such a “helter skelter” work environment.
  • Ventavia lacked enough employees to test trial participants who reported COVID-like symptoms, which is important because symptomatic COVID was the trial’s primary endpoint.  An FDA review showed that swabs were not taken from 477 people with suspected COVID.

____________________

For more on Pfizer’s corruption:

https://live.childrenshealthdefense.org/shows/doctors-and-scientists-with-brian-hooker-phd  Video Here from Oct. 28, 2021

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Activism, research, Treatment, vaccines, Viruses

58% of Infant Deaths Reported to VAERS Occurred Within 3 Days of Vaccination, Research Shows & ‘This is Really a Giant Experiment’

58% of Infant Deaths Reported to VAERS Occurred Within 3 Days of Vaccination, Research Shows

By  Brian Hooker, Ph.D., P.E.

© [8/3/21] Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

In a new research paper published in the journal Toxicology Reports, author Neil Z. Miller found that out of a total of 2,605 infant deaths reported to VAERS between 1990 and 2019, 58% occurred within three days of vaccination, and 78% occurred within seven days of vaccination.

In a new research paper published in the journal Toxicology Reports, author Neil Z. Miller reports on the relationship between sudden infant death syndrome (SIDS) death and the timing of vaccination, based on the Center for Disease Control and Prevention’s (CDC) Vaccine Adverse Events Reporting System (VAERS) database.

SIDS is defined as the sudden and unexpected death of an infant that remains unexplained after a thorough investigation. Although there are no specific symptoms associated with SIDS, an autopsy often reveals congestion and edema of the lungs and inflammatory changes in the respiratory system, according to the National Center for Health Statistics Vital Statistics of the United States 1988, Volume II, Mortality, Part A, Public Health Service, 1991.

Prior to contemporary vaccination programs, SIDS — sometimes referred to as “crib death” — was so infrequent it was not mentioned in infant mortality statistics.

After the national immunization campaigns were initiated in the U.S. in the 1960s, for the first time in history, most U.S. infants were required to receive several doses of DPT, polio, measles, mumps and rubella vaccines.

Shortly after, in 1969, medical certifiers presented a new medical term — sudden infant death syndrome.

In 1973, the CDC’s National Center for Health Statistics added a new cause-of-death category — SIDS — to the World Health Organization’s International Classification of Diseases (ICD).

By 1980, SIDS had become the leading cause of postneonatal mortality (deaths of infants from 28 days to one year old) in the U.S.

As Miller points out in his article, the ICD category for vaccine-related death, or cause of death as “prophylactic inoculation and vaccination,” was eliminated when the ICD was revised in 1979 — despite the fact that this information would be useful in trying to understand the relationship between vaccination and death.

But Miller, a medical research journalist and the director of the Thinktwice Global Vaccine Institute, provides an alternative route for establishing such a correlation — by observing the temporal relationship between vaccines and reported infant deaths, including SIDS deaths, in the CDC’s VAERS database.

Miller found that out of a total of 2,605 infant deaths reported to VAERS from 1990 through 2019, the majority “clustered” in close temporal proximity to vaccination — 58% occurred within three days of vaccination, and 78% occurred within seven days of vaccination.

Miller found the excess deaths within these ranges were statistically significant (p<0.00001), meaning the chance that this result is random is less than 0.001%.

The same type of clustering was present in the 1,048 reports of infant deaths (out of the total 2,605) reported to VAERS specifically as SIDS.

According to Miller, if there were no correlation between vaccination and infant deaths, one would expect to see an even spacing of deaths within the time range reported prior to vaccination —- not a clustering of deaths as Miller found.

Miller included a comprehensive literature review in his paper refuting the “official” claim that the SIDS epidemic was curtailed by having infants sleep on their backs — as recommended by the “Back to Sleep” campaign, initiated in 1992 by the American Academy of Pediatrics.

The subsequent rate of SIDS dropped by an annual average of 8.6% between 1992 and 2001. However, the neonatal mortality rate due to “suffocation in bed” increased during that same time at an average annual rate of 11.2%.

Other similar causes of infant death also increased significantly during this period, as reported by Miller. Further, from 1999 through 2015, the U.S. SIDS rate declined 35.8%. while infant deaths due to accidental suffocation increased 183.8 %.

Miller also affirms his main results from the paper (i.e., the temporal clustering of SIDS deaths with vaccination) through the discussion of seven additional peer-reviewed studies and two confidential reports.

On average, these authors found that substantial proportions of infant deaths occurred within one day (mean = 25%), three days (mean = 49%) and seven days (mean = 71%) post-vaccination, matching the results of the present study.

Mechanistically, vaccine injury has been tied to SIDS multiple times. Matturri et al. (2014) examined 13 SIDS deaths occurring within seven days of a hexavalent vaccine.  Analysis of the brainstem and cerebellum of the deceased infants showed brain edema and congestion in all victims.

The authors hypothesized that “several compounds and immuno-potentiation adjuvants of the hexavalent vaccine might easily go beyond the blood-brain barrier, which in the first year of life is still immature and quite permeable, inducing neuronal molecular alterations in DNA, RNA and proteins of brainstem neurons regulating vital functions, with consequent fatal disorganization of respiratory control in particularly predisposed infants.”

Specifically, these authors implicated aluminum-based adjuvants in the dysregulation of respiratory control.

Scheibner and Karlsson (1991) monitored infant breathing during sleep before and after the DPT vaccination, revealing an increase in episodes where breathing nearly ceased or stopped completely. These episodes, which continued for several weeks post-vaccination, were not seen prior to vaccination.

Despite the official insistence that SIDS deaths are not caused by vaccination, as Miller points out, the National Vaccine Injury Compensation (NVICP) is set up to compensate families of individuals who are injured and/or die from vaccine administration.

Death from vaccination is compensated with $250,000 for “pain and suffering” to family members of the deceased victim. Conditions typically leading to death that are considered “table injuries” to be compensated under the NVICP include anaphylaxis and encephalopathy or encephalitis.

‘Healthy babies just don’t die for no apparent reason’

Kari Bundy, who lost her son after his four-month vaccinations, said she’s always been “flabbergasted” at the denial of the medical community of the link between SIDS and vaccines. “For me, it was too obvious to even attempt to ignore,” Bundy said.

Bundy lost her third-born child, Mason, in 2011.

“A few days after his routine four-month vaccinations, my husband and I discovered his dead body in the middle of the night, laying on his side, his body still warm,” Bundy said

Mason’s autopsy came back “unremarkable,” aside from some thymic petechiae, which is the most common gross finding in SIDS cases at autopsy.

“I was assured time and time again that he had not suffocated,” Bundy said.

When Mason died, Bundy learned if you can’t pay for a funeral, you can’t have one. So a few months after Mason’s death, she founded a nonprofit called Mason’s Cause, to provide grants to cover funeral costs for families who had experienced the loss of a child under the age of 1.

“I never wanted any parent to experience this devastating loss and not be able to bury their child,” Bundy said. She continued running the charity for just under 2 years, during which time she worked with 94 different families who experienced the death of a child under age 1.

Of those 94 infant deaths, 87 died from SIDS, or from causes “unknown.” Of the SIDS cases, 81 — or 93% — died within seven days of routine vaccinations.

“When I realized SIDS seemed to be undeniably related to vaccines, I realized I could no longer dedicate my life to running a charity that would help bury babies,” Bundy said. “That’s when I realized I wanted to save babies by speaking out about the real risks of vaccination.”

Bundy, who works for Children’s Health Defense as translations coordinator, said she’s grateful for research like Miller’s because it shows what she and all SIDS parents already knew — healthy babies don’t just die for no apparent reason.

Listen to the interview with Neil Miller, author of the study of SIDS and vaccines, on the “Right on Point” Podcast by clicking on top link.

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https://www.theblaze.com/news/ben-carson-covid-vaccinations-children-giant-experiment

Dr. Ben Carson blasts COVID vaccinations for children: ‘This is really a giant experiment’

Sarah Taylor, November 01, 2021
Excerpt from article:
“Plus, we don’t know what the long-term impact of these vaccines is, so this is really sort of a giant experiment,” Carson explained. “Do we want to put our children at risk, when we know that the risk of the disease to them is relatively small, but we don’t know what the future risks are? Why would we do a thing like that? It makes no sense whatsoever.” Dr. Ben Carson

For more:

Category:

Activism, research, vaccines