Sunday, July 16, 2023

Case Series: 3rd Pfizer mRNA Booster Triggers Giant Cell Arteritis

A group of physicians at Toho University in Tokyo, Japan conducted a case series study concerning a 77-year old male who developed fever, general fatigue and headache after receiving the third dose of COVID-19 vaccination (Pfizer-BioNTech BNT162b2). Observing nodular (lump-like) swelling plus tenderness of the bilateral temporal arteries, the study team determined that an autoimmune vasculitis affecting large and medium-sized blood vessels known as giant cell arteritis (GCA) was the culprit, likely linked to the mRNA vaccination.

It turns out, although not widely published in American trade media and especially not in mainstream press, COVID-19 mRNA vaccines have been associated with the development of immune-mediated diseases, such as this one--a condition that if left undiagnosed can lead to blindness and stroke due to inflammation and damage to the affected blood vessels.

What is giant cell arteritis?

GCA can also be called temporal arteritis and represents a chronic inflammatory disease mostly impacting the large arteries, but especially the temporal arteries located in the head. Characterized by inflammation and damage to the arterial walls, it can lead to other symptoms and complications. Importantly, if left undiagnosed, GCA can lead to serious complications ranging from permanent vision loss or stroke.

The case series

The Toho University-based group of physician-researchers report in the peer-reviewed journal Medicine that the patient was given methylprednisolone 1000 mg for 3 days. That regimen was followed up with prednisolone 1 mg/kg/d, which was decreased by 10 mg every week to 30 mg. From day 16 of hospitalization, the patient received tocilizumab 162 mg/wk every other week. After a 38-day hospitalization, the doctors tapered his regimen of prednisolone to 30 mg/d as the patient’s condition improved.

Takeaway

The COVID-19 mRNA vaccines are associated with the development of immune-mediated diseases. In this case, the Pfizer-BioNTech third dose triggered immediately thereafter an incident of GCA.

Corresponding author Kaichi Kaneko, based in the University of Toho Department of Internal Medicine, Division of Rheumatology, and colleagues note that doctors should be on the lookout for the signs of mRNA vaccine induced GCA including fever, fatigue and headache, even though these are also standard side effects as well. Should these symptoms persist, GCA may be a factor.

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New Omicron Vaccine will be Obsolete on Arrival

From Rita Rubin, Science Reporter for JAMA: “On June 15, members of the US Food and Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend updating the COVID-19 vaccine composition to a monovalent XBB lineage.”

On June 16, the FDA announced that it had advised manufacturers planning to update their COVID-19 vaccines that they should specifically target XBB.1.5. Scientists from Moderna, Novavax and Pfizer had told the FDA and its advisory committee that their XBB.1.5 monovalent vaccines could be ready to inject into arms by late July or early fall.

Although the FDA decides what antigens the COVID-19 vaccines should include, the US Centers for Disease Control and Prevention (CDC) is responsible for deciding who should get them and when. As soon as the FDA greenlights an XBB.1.5 vaccine, “I’m sure the ACIP will have a specially called meeting to decide how it should be used,” William Schaffner, M.D., chair of the department of preventive medicine at the Vanderbilt University School of Medicine, said in an interview.

ACIP stands for the CDC’s Advisory Committee on Immunization Practices, on which Schaffner serves as the liaison representing the National Foundation for Infectious Diseases, where he is medical director. At the ACIP meeting on an XBB.1.5 vaccine, “I think there will be a rather elaborate discussion on who will receive this vaccine,” Schaffner predicted.”

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Australia: Protecting children takes courage: Just ask Dr Jillian Spencer, a child and adolescent psychiatrist

Julie Sladden

The announcement of the Labor Government’s proposed ‘misinformation’ Bill, while alarming, is not surprising. Anyone paying attention in recent years, especially the last three, will have noticed that our ‘freedom of speech’ has already been significantly curtailed through online censorship, government censorship (thank you, Department of Home Affairs), and self-censorship.

Nowhere has this been more palpable or alarming than the censorship of freedom of inquiry in science and medicine. During the Covid years, we discovered just how captured the medical profession is. Like lifting the lid on Pandora’s box, anyone who spoke out soon discovered the evil treasures in store for those who dared to question the narrative. The result was spectacular and tragic. Doctors who wanted to keep their jobs had to shut up, roll up their sleeves, and work on it. Those who spoke up or questioned the forced jab were marginalised, censored, sacked, or suspended. The message was clear, speak out at your peril. Despite the messaging, I was still shocked at how many capitulated. Surely this was the time we were meant to speak up and ask questions? Especially the hard ones. Isn’t this what we trained for?

Every so often, I meet someone who helps restore my hope in the medical profession. Last week that person was Dr Jillian Spencer, a senior staff Child and Adolescent Psychiatrist who was recently suspended from clinical practice at the Queensland Children’s Hospital. She now faces serious threats to her position, professional career, and livelihood, including potential regulatory action. Her crime, it seems, is to question out loud the affirmation model of transgender care.

Spencer says she is not alone in her concerns, ‘I would say that the vast majority of Child and Adolescent psychiatrists hold very serious concerns about the affirmation model, but to speak up in the current climate or even to take a more cautious clinical approach puts their employment at risk,’ she shared at a recent forum.

If there is any doubt that questioning ‘the narrative’ is dangerous for medical professionals, Spencer can set the record straight. Her experience of raising concerns within the organisation through the ‘proper channels’ has not gone well.

‘The process is to raise concerns internally (within an organisation) so that you’re doing it professionally and appropriately, rather than having to speak out. But when I pushed that to the maximum internally, it went very badly. So now I’m in the position of speaking out (publicly). The majority of child psychiatrists (are silent) for good reasons and self-preservation. The good reasons being wanting to be available to help people and to not be perceived as biased. But also, a lot of it is fear. And I don’t think my case has helped either, as I’m at risk for my employment and my (registration). It’s very serious. And so, I can’t blame them.’

But the costs of speaking out extend beyond the doctor involved. Patient care and service delivery stand to suffer too.

‘The danger of speaking out is that you lose the capacity to help more people,’ Spencer shares. ‘For example, a gender-questioning young person might be reluctant to see me now that I’ve spoken out, and that’s not something I want because I want young people to feel comfortable with me. My job is to listen and understand and to do what I can to help them.’

Now, this job is on hold indefinitely. However, Spencer is undeterred. Rather than quietly waiting for the ‘powers that be’ to hand down judgment, she demonstrates a commitment to her convictions by continuing to speak out. Loudly and often. To an outsider, it would appear Spencer has reached a point of reluctant acceptance of her situation and that she might as well go ‘all in’. Arriving at this point has come through painful reflection, ‘dark times’, and the realisation that the organisation Spencer has served faithfully for decades has apparently abandoned her.

‘It’s a really difficult employment situation,’ says Spencer. ‘Some people say, “Well, if your organisation is doing something that you disagree with, then the appropriate pathway is to resign.” But if you’ve been with an organisation for 20 years, you feel a part of that organisation. I feel like part of the family and part of changing the culture internally. It’s part of my job.’

‘People say “You need to resign or accept it.” But it’s also a responsibility to try and help your organisation do the right thing and… ‘speak up for safety.’

Listening to her speeches, presentations, and interviews, it is hard to argue that Spencer is motivated by anything other than safety. Child safety appears at the core of her message time and again.

‘It’s a really hard situation for child and adolescent psychiatrists… and for any mental health clinicians who work with children. Because there’s a lot of organisational and social pressure to affirm children,’ Spencer shares. ‘But when we start to look at the evidence base behind the affirmation model, we find the studies have major flaws, and they don’t show sufficient benefit to outweigh the risks and the harms.’

‘Previously, our discipline always took a developmental approach, which means that the years of childhood and adolescence were understood to be a period of incredible growth and change. We didn’t label children with long-term conditions, such as personality disorders, because we knew that a lot of conditions would ease with maturity, and indeed, the eleven studies that were conducted before the affirmation model was in use when they used a watchful waiting approach found that 60 to 90 per cent of children with gender dysphoria became comfortable in their own bodies with maturity.’

‘I assure you that this is not part of a culture war. This is a really serious child protection issue. We entered our field to try to assist children to thrive, but the gender clinics have been set up, and psychiatrists are being forced to affirm the social transition of all children and go along with the idea that puberty blockers and cross-sex hormones will lead to benefit.’

Spencer’s words highlight the dangerous waters our children are in. Treatment pathways and models of care are being imposed while the evidence is unclear, pathways that have modalities with irreversible and devastating consequences for children in terms of fertility, sexual and long-term health. Anyone who would step into these waters without a cautious approach does not understand the potential ramifications.

One of the arguments used to justify support for the use of cross-sex hormones and puberty blockers is mental distress and the risk of suicide in those experiencing gender dysphoria, as highlighted in a recent Four Corners report. However, Spencer paints a broader picture. ‘There’s no evidence to show that the social transition or the use of puberty blockers or cross-sex hormones reduces the death rate or improves psychological functioning.’

‘What we know from the eleven studies that were conducted before the affirmation model was in use – so that’s when they didn’t use puberty blockers and cross-sex hormones – is that the vast majority of (children with gender dysphoria) grew up to become comfortable with their body if they’re allowed to go through the full course of adolescence.’

‘My personal opinion is that we could disallow the prescription of puberty blockers… (and)… Australia aligned itself with all the European countries that have conducted systematic reviews of the evidence behind puberty blockers and cross-sex hormones. From those systematic reviews, they realised that no child should be prescribed puberty blockers outside of a clinical research trial or in exceptional circumstances. And in the UK, they’ve even gone further in recommending caution around social transition.’

In voicing concerns at a recent rally, Spencer stumbled on another issue facing doctors who dare speak out. Soon after, the hospital told Spencer she allegedly broke the Queensland public services Code of Conduct through her public statements. It’s an allegation Spencer contests, saying she was speaking as a private citizen. In the speech, Spencer neither identifies herself as a doctor nor makes mention of her role or employer. The question is, where does a doctor’s autonomy begin and the employer’s jurisdiction end?

Have we already entered the era where the reach of our employers and regulatory authorities extends fully into our capacity to speak publicly anywhere?

The AHPRA Code of Conduct for medical professionals outlines several expectations of health professionals to question, examine and discuss the potential risks and benefits of treatment in addition to advocating for vulnerable communities, including children. It would seem, therefore, that Dr Spencer is simply doing her job.

‘We are not being allowed any professional discretion,’ she argues. ‘It is incredibly distressing to be forced into harming other people’s children, or otherwise face the potential loss of one’s career, livelihood or to be cast out of the workplace as has happened to me. But this is too important, so I will not be silenced.’

Dr Spencer is calling for an urgent Federal inquiry into the model of care for the treatment of children with gender dysphoria.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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