Archive for the ‘Treatment’ 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]

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.

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**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

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
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.

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For more on Pfizer’s corruption:

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

Live Every Thursday at 9:00a.m. PT, 11:00a.m. CT, 12:00p.m. ET

Got Science? Are you sure?

‘Doctors And Scientists’ With Brian Hooker, PHD.

Dr. Brian Hooker invites some of the leading voices in science and medicine to break down the studies and weigh in on the controversies so the rest of us have an opportunity to understand the science that drives public health policy and medical progress.

See previous episodes within link as well.

For more:

“We See Clotting – NOT From Virus, but From Spike From ‘Vaccine’ Itself” & CDC Finally Weighs in On Natural Immunity

https://americasfrontlinedoctors.org/2/frontlinenews/we-see-clotting-not-from-virus-but-from-spike-from-vaccine-itself-aflds-medical-director-dr-ryan-cole/  Video Here (Approx. 1 Min)

‘We see clotting – not from virus, but from spike from vaccine itself’: AFLDS Medical Director Dr Ryan Cole

How Dr. Zelenko Bypassed the “HCQ Ban” to Beat COVID

https://plandemicseries.com/zstack/  Video Here  (Approx. 8 Min)

Dr. Zelenko has successfully treated more than 1,450 COVID-19 patients with a 99% success rate using a cocktail of hydroxychloroquine, Zinc Sulfate and Azithromycin.  Since the article in the link was written more than a year ago, the number of people he has treated is undoubtedly much higher.  Also, please note the video within the link has been scrubbed from the internet.  The ‘powers that be’ do not want you to know about successful, cheap, effective treatments.  They want you to take their dangerous, lucrative jab that is linked to more adverse events and death than any other vaccine in history, but they profit from.

Dr. Zelenko also helped author a 52 page COVID “Vaccine” Death report.

The video in the top link has important information to know, including Dr. Zelenko’s COVID protocol that you can obtain over the counter.  No prescription is needed.  Protocols below were derived from the video.  Dr. Zelenko was diagnosed with one of the rarest and most fatal cancers three years ago. 

For the countless lives he’s saved, he was nominated for the Noble Peace Prize.

For COVID prevention:

  • zinc 25 mg 1/day
  • vitamin C 1000 mg 1/day
  • D3 500 IU 1/day
  • Quercitin 500 mg 2/day

For COVID treatment:

  • zinc 50 mg 1/day for 7 days
  • vitamin C 1000 mg 1/day for 7 days
  • D3 5000 IU  1/day for 7 days
  • Quercetin 500 mg 2/day for 7 days

**Dr. Zelenko has developed and is selling a product with all the ingredients included for those who want it**

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For more:

Public health ‘authorities’, bought out scientists and science journals, mainstream and social media, medical groups and Big Pharma all have blood on their hands and should be held accountable for their “fake news” regarding HCQ, ivermectin, and vitamins  for treating COVID. These groups have rightly been called out for ‘fueling confusion and misinformation.”

You get the distinct impression they don’t want people to survive.

Similar to Lyme-land, real doctors are splitting away and forming their own alliances due to being hamstrung by regulators and hospitals literally killing people.

Current Government & Medical COVID policy = “get sicker,”and just take the jab already.

New Guidance for Treatment of Lyme & Other TBD in Pregnancy

https://www.lymedisease.org/lyme-pregnancy-guidance/

New guidance for treatment of Lyme and other TBD in pregnancy

Oct. 27, 2021

from the Lyme Disease Association website:

In a recently published review article,* authors provide a comprehensive summary of treatment options for pregnant patients with less common bacterial, fungal, and viral infections, including several tick-borne diseases (Lyme disease, ehrlichiosis, human granulocytic anaplasmosis, human monocytic ehrlichiosis, babesiosis, and Rocky Mountain spotted fever).

This review provides guidance to clinicians based on the most recently published evidence-based research and expert recommendations.

The review included a search of MEDLINE (inception to March 2021); clinical practice guidelines (both national and international); the CDC website; and additional references from bibliographies of noteworthy articles. The review also provides a list of medications on the WHO Essential Medications List that are used to treat the above infections (*Alyssa P. Gould et al., Drugs in Context-peer reviewed).

A summary of key treatment recommendations from the review article for several tick-borne diseases during pregnancy are as follows:

Lyme disease:

  • Treatment of gestational Lyme disease is essential to reduce adverse outcomes in pregnancy. The data shows adverse outcomes in treated pregnancy is (11–16%) compared to untreated disease (50–60%).
  • Doxycycline should not routinely be used in pregnancy for Lyme disease in order to avoid adverse side effects including transient suppression of bone growth and staining of developing teeth, especially with proven alternatives.
  • Amoxicillin is the preferred treatment in the absence of neurological manifestations or atrioventricular heart block.
  • Ceftriaxone is typically reserved for patients with severe neurological or cardiac manifestations.
  • One study noted a non-significant increase in adverse pregnancy outcomes, such as pregnancy loss, among orally treated (31.6%) compared to parenterally treated (12.1%) pregnant patients.
  • Alternative oral therapy is cefuroxime axetil and parenteral therapies include penicillin G or cefotaxime.
  • Late Lyme disease (often manifesting as Lyme arthritis) may be managed with oral or parenteral β-lactams.

Ehrlichiosis & Anaplasmosis:

  • If infections with anaplasmosis or ehrlichiosis is suspected, treatment should be initiated due to the likelihood of complications and potential for vertical transmission of disease.
  • Rifampin has shown in vitro activity against ehrlichia and has been used successfully in limited case reports of pregnant women with anaplasmosis.
  • Doxycycline has been used successfully to treat ehrlichiosis.
  • Due to a lack of data, these pregnant patients should be closely monitored for resolution of disease.
  • The addition of amoxicillin or cefuroxime is suggested if coinfection with Lyme disease is suspected, as rifampin does not have activity against B. burgdorferi.

Babesiosis:

  • Patients with suspected babesiosis should be treated due to potential complications, including possible vertical transmission to the fetus.
  • Combination therapy is preferred with clindamycin plus quinine.
  • Longer treatment courses or retreatment may be needed in cases with symptoms and/or parasitaemia persisting >3 months. Resolution of parasitaemia should be used to determine treatment course.

Rocky Mountain spotted fever (RMSF):

  • RMSF cases are associated with poor outcomes for the fetus, regardless of the treatment.
  • Prevention is crucial for pregnant patients, and treatment should be provided within 3–5 days of exposure.
  • Doxycycline is the preferred therapy. Treatment course is typically 5–7 days or 3 days after fever resolution.
  • Chloramphenicol is a proposed alternative treatment; but there are concerns for significant adverse effects, including myelosuppression, aplastic anaemia, and grey baby syndrome, specifically at or near birth, and it is associated with higher mortality in RMSF. (chloramphenicol is not available orally in the US).

Read the full review article here.

Read other LDA articles regarding treatment here