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The great molnupiravir swindle

4/30/2022

By : Robyn Chuter
https://robynchuter.substack.com/p/the-great-molnupiravir-swindle?s=r

Australia's drug regulator approved Merck's antiviral drug on the basis of some very shaky studies.

As of the date of writing this article, Australia's drug regulator, the Therapeutic Goods Administration (TGA) has granted provisional approval to eight products for the treatment of COVID-19:

You'll no doubt be shocked to learn that the TGA-approved drugs are all a) investigational, in the sense that they have not been approved to treat any previous disease, and are only in the very early stage of testing for safety and efficacy for COVID-19, and b) very costly compared to the inexpensive drugs, nutraceuticals and dietary and lifestyle changes that have a long history of safe use and have been shown to be more effective than many of their novel competitors. These older, well-tested drugs include those that TGA recommends against using and has made unavailable for prescription for prevention or treatment of COVID-19 (hydroxychloroquine and ivermectin):

MolnupiravirMolnupiravir was first described in 2003. Its discoverers found that it inhibited the growth of bovine viral diarrhoea virus and hepatitis C virus, and proposed that it may be a promising treatment for hepatitis C.
It works by creating errors in the virus’s genetic code, known as mutagenesis. Each time the virus replicates in the presence of molnupiravir, more and more errors accumulate, eventually building up to an “error catastrophe” that stops the virus from functioning.

The problem is, mutagenic drugs may also cause mutations in the RNA of the cells of the individuals taking them. As a BMJ report on molnupiravir explains,
“This happened with the hepatitis C antiviral candidate BMS-986094, for which clinical trials were abandoned quickly after a death and hospital admissions arising from heart and liver toxicity.”
Covid-19: What is the evidence for the antiviral molnupiravir?
Hence, despite having been discovered almost twenty years ago, the drug had never been approved to treat any illness. It was due to enter clinical trials as an influenza drug, but then COVID-19 stepped onto the scene, and molnupiravir’s discoverers envisaged a new application for their red-headed stepchild:
“During the pandemic Emory University struck a deal with the biotechnology company Ridgeback Biotherapeutics to test it as a treatment for covid-19.2 Ridgeback then partnered with the pharmaceutical giant Merck in May 2020 for clinical trials and scale-up.”

Covid-19: What is the evidence for the antiviral molnupiravir?
TGA granted provisional determination for molnupiravir to Merck Sharp & Dohme in August 2021, essentially inviting them to apply for provisional registration of the drug.
Provisional registration was granted on 18 January 2022, on the basis of one Phase 1 (safety and tolerability), one Phase 2 (safety, tolerability and efficacy) and two Phase 3 (large randomised controlled trial) studies. Let’s look at each of the Phase 2 and 3 studies in turn.

Phase 2 studyThe Phase 2 study (called Study 006 in the Australian Public Assessment [AusPAR] Report for Molnupiravir) randomised 202 participants to receive either one of three dosage regimes of molnupiravir (200, 400 or 800 mg twice daily) or placebo. 195 participants completed the study (i.e. received both doses of either drug or placebo).
The study’s end point (i.e. the outcome the study was designed to investigate) was elimination of SARS-CoV-2 viral RNA in patients with COVID-19, which was determined using reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swabs.
Infectivity assays were also conducted to determine whether the virus recovered from the swabs was capable of being transmitted to someone else, and next generation sequencing was carried out to check for mutations caused by the drug.
The results did not exactly inspire confidence in the drug. There was no difference in the time taken to clear the virus between participants who received molnupiravir and those who got the placebo (15 days in each case), and there was no dose response – that is, the drug didn’t work better at higher doses than at lower doses, as one would expect if it was truly effective.

However, the unnamed TGA official tasked with making the decision on whether to approve the drug (“the Delegate”) did his/her best to make a silk purse out of a sow’s ear, taking Merck’s word for it that the drug really did work, if only you held the results up in the correct light, and squinted:
“The sponsor [i.e. Merck] has stated that the results show a reduction in viral detection in the molnupiravir 800 mg group. Based on the overall trend of the data, the Delegate suggested that there was a reduction in viral count in each group. The results were statically [sic] significant only at Day 5 and 7 for the 800 mg group. There was no dose response. The median time to response was similar for the molnupiravir and placebo groups.”

In any case, the end point was of questionable significance, because less than half of those who tested positive on a PCR test before starting to take either molnupiravir or placebo were shedding virus that was capable of infecting someone else, and the vast majority of participants who continued to test positive throughout the study weren’t shedding infectious virus either:

“Analysis of the agreement between SARS-CoV-2 RNA and infectivity results indicated a very low level of agreement between the 2 assays. Infectivity results were negative for every sample that had a negative SARS-CoV-2 RNA result, infectivity results were positive for 45.1% of samples that had a positive SARS-CoV-2 RNA result at Baseline and for 15.6% of all samples that had a positive SARS-CoV-2 RNA result through Day 7 of the study. This would suggest that the virus was not active in many of the samples where the RNA was detected.”

Phase 3 studies
Study 001The first Phase 3 study considered by TGA, MK-4482-001 (designated Study 001 in the AusPAR report) has not been published in a peer-reviewed journal, so TGA relied solely upon data supplied by Merck in its assessment.
Study 001 enrolled 304 participants hospitalised with COVID-19, of whom 293 received at least one dose of either molnupiravir (in three different dosage schedules) or placebo. Treatment duration was 5 days.
And quite simply, the drug didn’t work:
“There was no significant treatment effect from intervention with molnupiravir.”

Interestingly, although 86.5% of participants were rated as having moderate or severe COVID-19, and the prevalence of risk factors for serious outcomes (age over 60, obesity and diabetes) was also high, the majority got better – and quite quickly, too – regardless of treatment:
“The rate of sustained recovery was high overall and similar for participants in the molnupiravir groups compared with those in the placebo group. The median time to sustained recovery was 9 days and the recovery rate ranged from 81.5% to 85.2% in each intervention group at Day 29.”

Besides time to recovery, the study assessed how long it took for participants to test negative on PCR for SARS-CoV-2. 12.5% of these supposed COVID-19 patients didn’t even test positive for the virus at baseline anyway, and there was no difference in how long it took to clear the virus in those who got the drug vs those randomised to placebo, no matter how the investigators tried to slice and dice the data:
“87.5% had detectable SARS-CoV-2 RNA in nasopharyngeal sample at Baseline… A similar decrease from Baseline in SARS-CoV-2 RNA mean titre was observed in all groups at all timepoints in nasopharyngeal and oropharyngeal samples (assessed by quantitative polymerase chain reaction (PCR)).
The slope and magnitude of viral load decay were similar across board and with no clear dose-response relationship across molnupiravir groups. No differences in response across molnupiravir doses and placebo for patients with high viral load (> 106 copies/mL) or lower at baseline RNA titres. The post-hoc analyses did not reveal a different result in terms of reduction of viral load over time among the intervention groups.”

There was a difference in two outcomes of interest. The first was the most serious of all outcomes, death:
“There were 17 deaths, 15 in the treatment groups and 2 in the placebo group.”
Australian Public Assessment Report for Molnupiravir

There were just under three times as many participants in the treatment group as in the placebo group (218 vs 75), so the fact that more than seven times as many deaths occurred in participants who received molnupiravir as in placebo recipients is concerning. But not to the trial investigator, who “did not consider that any deaths were due to the study intervention”. No reason for this judgement call is given in the AusPAR report.
It is truly extraordinary that a clinical trial in which a drug failed the most basic of all tests – whether those who took it were more likely to survive moderate to severe COVID-19 – is considered by TGA to be persuasive evidence for approving that drug.

The second outcome in which there was a significant difference between the drug and placebo was the number of participants who shed mutated versions of SARS-CoV-2.
“A higher mutation rate was observed in post-baseline viral sequences from nasopharyngeal swabs in all molnupiravir intervention groups compared with placebo. Additionally, the proportion of participants with > 3 per 10,000 post-baseline sequence mutations (threshold defined post-hoc) from nasopharyngeal swabs was higher in all molnupiravir intervention groups compared with placebo.”

In summary, Study 001 found that participants who took molnupiravir were more likely to die than those who took placebo, and those who recovered took just as long to do so as those who effectively got no treatment at all, all the while shedding more mutated versions of the virus from their noses. Does that sound like $700 (per treatment course) well spent to you?

Study 002The second Phase 3 study considered by TGA was MK-4482-002 (called Study 002 in the AusPAR report), the results of which were published in The England Journal of Medicine as the MOVe-OUT trial on 10 February 2022 – three days after the final version of the AusPAR report was published.
Hence, the AusPAR report considers the data gathered only up until Interim Analysis 4, involving roughly half of the participants:
“In providing this advice, the ACM [Advisory Committee on Medicine] acknowledged that topline efficacy data from Part 2 of the MOVe-OUT study in 1433 randomised participants has been recently reported but has not yet been evaluated by the TGA. The ACM advised that these data should be provided to the TGA.”

And that turns out to be extremely significant. The interim analysis data considered by TGA concluded that molnupiravir, taken at a dose of 800 mg every 12 hours for 5 days, starting within 5 days of symptom onset, reduced the relative risk of hospitalisation or death in patients with mild to moderate COVID-19 by almost half. 53 out of 377 participants (14.1%) who received placebo were hospitalised or died compared to 28 out of 385 (7.3%) who took molnupiravir, (an absolute risk reduction of 6.8 percentage points).

However, this interim analysis only included 775 participants, followed up until 29 days after commencing treatment.
Findings in the all-randomised sample, which included 1433 participants, were considerably less impressive:
“In the all-randomized modified intention-to-treat population, participants receiving molnupiravir had a lower risk of hospitalization or death through day 29: 6.8% (48 of 709 participants) in the molnupiravir group as compared with 9.7% (68 of 699 participants) in the placebo group (difference, −3.0 percentage points; 95% CI, −5.9 to −0.1).”
Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients
And when only hospitalisations and deaths that were solely attributable to COVID-19 were considered, molnupiravir’s effectiveness started looking even dicier:
“A prespecified supporting analysis specifically evaluating only Covid-19–related hospitalizations or deaths (Fig. S2) showed that 45 of 709 participants (6.3%) in the molnupiravir group and 64 of 699 (9.2%) in the placebo group had hospitalizations or deaths that were considered by the investigators to be Covid-19–related (difference, −2.8 percentage points; 95% CI, −5.7 to 0.0).”

Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients
Furthermore, the confidence intervals for most subgroups of patients – including males, people who began treatment within 3 days of symptom onset, people with both mild and moderate COVID-19, people who already had natural immunity to SARS-CoV-2, people aged over 60, people with diabetes or a serious heart condition, Native Americans and Blacks – includes the zero line, denoting substantial uncertainty that the drug had any therapeutic effect in these subgroups:

Considering that the trial was supposed to test the effectiveness of molnupiravir in people with “laboratory-confirmed Covid-19”, the fact that only 77.6% of participants “had quantifiable RNA confirmed in nasopharyngeal samples at baseline” is a head-scratcher. What were people who didn’t test positive to SARS-CoV-2 doing in the trial in the first place?
It’s also puzzling that molnupiravir apparently reduced the risk of hospitalisation and death without substantially reducing the severity of symptoms:
“There was minimal impact on symptoms.”

If people who were assigned to the placebo group didn’t have any worse symptoms of COVID-19 than those taking molnupiravir, why were so many more of them hospitalised? Who made the decision to hospital them, and on what basis, if it wasn’t because they had more severe symptoms? Is it possible that – as has been alleged by Brook Jackson with respect to the Pfizer vaccine trial – some participants were unblinded, meaning that trial doctors would have been able to identify which participants had received molnupiravir and which had received placebo, and therefore could have been biased to direct more placebo participants to be hospitalised, where they would receive more invasive treatments that could hasten their demise (such as mechanical ventilation)?

And why did the New England Journal of Medicine write-up of Study 002 neglect to mention the higher rate of shedding of mutated versions of SARS-CoV-2 that is acknowledged in the AusPAR report?
“Higher viral sequence mutation rates (per 10,000 bp) were observed at Day 5 in
nasopharyngeal samples obtained from participants treated with molnupiravir 200 mg (7.9), molnupiravir 400 mg (6.7) and molnupiravir 800 mg (8.7) compared with placebo (2.0). The highest RNA mutation rate was observed in the molnupiravir 800 mg intervention group at Day 5.”

TGA consulted an unnamed “independent expert” to discuss the significance of this increased mutation rate. I don’t feel particularly reassured by the answer they received:
“The likelihood of mutations resulting in a more virulent strain of SARS-CoV-2 from treatment with molnupiravir over the long-term has not been assessed. It is less likely, but unproven, that virus mutation induced by molnupiravir will increase virulence of SARS-CoV-2.”

Surely it’s important to gain more certainty about such matters before unleashing the 300 000 courses of this inadequately-tested drug already ordered by the Australian government on an unsuspecting and underinformed public? Especially when that taxpaying public will be footing the bill for the gap between the $700 cost of the drug and the $42.50 per script – or $6.80 for concession card holders – that patients will be charged now that the drug has been added to the Pharmaceutical Benefits Scheme (PBS).

Just when you thought that Study 002 couldn’t get any more suspicious, along comes this article, published online ahead of print in March 2022 in the American Journal of Tropical and Medical Hygiene. It points out that the outcomes in participants in the remaining half of the sample who were not included in the interim analysis discussed in the AusPAR report were the reverse of those in the first half. That is, in the second ‘batch’ of participants, the placebo appeared to be more effective than the drug in keeping people alive and out of hospital:

And that wasn’t the only problem they identified. In all, the authors identified six points that are directly relevant to the evaluation of clinical efficacy of molnupiravir:
“1. The authors and sponsors [i.e. Merck] maintain that the interim analysis is the “formal efficacy” analysis, which is inconsistent with the protocol and primary statistical analysis plan.
2. Communication between sponsors and the Data Safety and Monitoring Board (DSMB) was insufficient to avoid inappropriate interim recommendations.
3. The treatment effects reverse when examining only the post-interim data, and are substantially attenuated when examining the full data.
4. The choice effect measure and statistical model for the primary analysis is incorrect.
5. The lost-to-follow-up analysis is unconventional. Conventional intention-to-treat analysis removes statistical significance.
6. Other known molnupiravir trials were not presented in the primary study findings.”
Making Statistical Sense of the Molnupiravir MOVe-OUT Clinical Trial
If the TGA reviewers are as rigorous as they assure us, how did they miss these crucial flaws in study design?
So many questions, so few answers.

Here are a couple more questions:

Why did TGA include so few studies of molnupiravir in its AusPAR report, ignoring other published trials such as this one which found a 282% higher risk of death in people who took molnupiravir, or CTRI/2021/05/033864 and CTRI/2021/08/0354242) which have reported no significant efficacy, but have not yet been published?
Why is TGA downplaying the very real risk that molnupiravir’s mutagenic mechanism of action could cause cancer?
The pharmaceutical company Pharmasset dropped development of NHC (from which molnupiravir was developed) because of mutagenicity, and Emory University chemist Raymond Schinazi “doubted that the small chemical change that turned NHC into molnupiravir could avoid this.”
Researchers demonstrated mutagenic effects in mammal cells back in August 2021, and while Merck employees dismissed their concerns as baseless, the researchers disputed their critics’ claims and doubled down on the potential danger posed by molnupiravir and the unfavourable cost:benefit ratio of the drug for most people who get COVID-19: “This leads to the conclusion that treatment with molnupiravir will lead to mutations in host DNA in dividing cells… Until a better understanding of treatment with molnupiravir is achieved, we would argue that its use should be limited to people with co-factor risks for coronavirus disease 2019 who are likely to receive the greatest benefit while being exposed to the unknown long-term risks of exposure to this mutagen.”
Another paper, published in September 2021, noted that “it has been suggested that exposure to molnupiravir can be mutagenic to host DNA during host DNA replication. Therefore, the potential off-target effects will require further investigation.”A review of antivirals that work through lethal mutagenesis, published in February 2022, called for long-term monitoring of the cancer risk of such drugs: “A registry of a cohort of people who received molnupiravir should be kept to longitudinally monitor the frequency of cancer and other potential outcomes so that the opportunity to understand the risk (or lack thereof) associated with the use of a mutagenic ribonucleoside as an antiviral is not missed.” Another concern raised was that people with weaker immune systems may provide the virus with an evolutionary advantage: “However, for people who fail to clear the virus and maintain a persistent infection, whether treatment with molnupiravir will affect the course of viral evolution remains unknown.”
Yet TGA simply ignored all these studies and accepted Merck’s assurance that “molnupiravir has low risk for genotoxicity and carcinogenicity.” The AusPAR report airily states that “No carcinogenicity studies were submitted. This was considered acceptable based on the proposed intended clinical use of < 6 months (short treatment duration in humans, which is limited to 5 days) and low risk of genotoxicity in mammalian systems. Molnupiravir is unlikely to cause cancer from the proposed clinical use.”
I don’t know about you, but I don’t consider that even a small risk of cancer is worth it, for a drug that fails to deliver on any clinically meaningful outcomes.

And aside from these concerns, there are serious issues around molnupiravir’s reproductive toxicology. Molnupiravir is rated as pregnancy category D: “Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.”
Women of reproductive age are urged to use contraception or abstain from sex while taking molnupiravir and for 4 days afterward, while men must use contraception during treatment and for 3 months afterward. Well, that sounds reassuring.
Molnupiravir has gained regulatory approval (amidst criticisms of a lack of transparency and rigour in the approval process) in the United Kingdom, United States, Japan and South Korea. The European Union, Canada and Switzerland still have applications under consideration. On the other hand, India has excluded molnupiravir from its COVID-19 treatment guidelines over toxicity concerns, and France has cancelled its order for 50 000 doses of molnupiravir, citing efficacy concerns.
Alert readers may recall that Merck, the sponsor of molnupiravir, held the patent on ivermectin until 1996, and continues to market ivermectin under the brand name Stromectol. Merck issued a statement on the use of its Nobel-prize winning antiparasitic drug in February 2021, claiming that there was no evidence that the cheap, safe generic was effective against COVID-19.
I’m sure there’s no connection whatsoever between Merck’s desire to sell a $700 per course patented drug rather than a $1 generic, and TGA making it impossible for doctors to prescribe ivermectin for the prevention or treatment of COVID-19.(In case you were wondering, TGA’s rationale for severely restricting ivermectin prescription is that a) if ivermectin was made more available, it might dissuade people from taking a COVID-19 vaccine, b) social media posts are promoting inappropriate doses – which seems to me to be a pretty good reason to allow doctors to prescribe it rather than run the risk of people dosing themselves using veterinary products or drugs purchased from online overseas pharmacies) and c) that if too many people try to get ivermectin to treat COVID-19, those who need to take it to treat scabies or parasitic disease might face shortages – which could easily be addressed by scaling up production or importation.)
I’ll leave you with a couple of charts from c19-early.com that summarise the results of studies on molnupiravir and ivermectin.

What would you take, or recommend to a vulnerable family member, if you were given the choice?

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Are doctors the new antivaxxers?

4/22/2022

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By : Robin Chuter

https://robynchuter.substack.com/p/are-doctors-the-new-antivaxxers?s=r

A new study finds that roughly one tenth of US primary care physicians don't think vaccines are safe, effective or necessary. Say what?
Judging by reader feedback on last week’s post, Why you need to stop saying “I’m not an antivaxxer, but…”, the rollout of inadequately-tested experimental injections that have patently failed to end the COVID-19 pandemic has caused many people to begin questioning the safety and efficacy of the standard vaccination schedule.

Here are a few examples:

Just as Drs Jay Bhattacharya and Martin Kulldorff feared, the fanaticism of the COVID injection-pushers has fuelled vaccine hesitancy, scepticism, resistance and outright rejection.
Really, that shouldn’t surprise anyone with two functioning brain cells left. If you have to use free donuts, beer, marijuana joints, million dollar lottery tickets, college scholarships and sessions with a prostitute (bring your son – boys as young as 14 permitted, as long as they are accompanied by an adult!), or fines, prison sentences, travel bans and dismissal from their jobs to persuade people to take your product, it’s probably not a great product.

But here’s the real surprise: It’s not just members of the public who are wondering whether vaccines are truly as safe, effective and important as we’ve been told. Many doctors have their doubts too.
A study published on 20 April 2022 in the journal Vaccine has confirmed the worst fears expressed by anthropologist Heidi Larsen in a speech delivered to the World Health Organisation’s Global Vaccine Safety Summit on 3 December 2019 – just weeks before the first case of COVID-19 was identified in Wuhan, China.

Larsen is the director of the Vaccine Confidence Project, which is backed by pharmaceutical companies, the secretive globalist think-tank Chatham House, and a gaggle of not-for-profits and NGOs with deep ties to Big Pharma. She warned the audience of “vaccine safety stakeholders” that her organisation’s research was identifying worrying signs of declining confidence in vaccines among health care professionals (beginning at 1:16:20 in the final video block):
“The other thing that’s a trend and an issue is not just confidence in providers, but confidence of health care providers. We have a very wobbly health professional front line that is starting to question vaccines and the safety of vaccines. That’s a huge problem, because to this day… the most trusted person on any study I’ve seen globally is the health care provider, and if we lose that, we’re in trouble. And we haven’t lost it yet, but… when the front line professionals are starting to question, or they don’t feel like they have enough confidence about the safety to stand up to… the person asking them the questions… I mean in medical school you’re lucky if you have a half day on vaccines, never mind keeping up to date with all this.”

Heidi Larsen – ‘Vaccine Safety in the Next Decade: Why we need new modes of trust building?’
More than two years on, it doesn’t look like that front line is any less wobbly.
According to the newly-published study in Vaccine, titled ‘Imperfect messengers? An analysis of vaccine confidence among primary care physicians’, roughly one tenth of primary care physicians in the US do not believe that vaccines – that is, vaccines in general, not just COVID-19 vaccines/injections – are safe, effective or important.
Specifically, out of a demographically-representative sample of 625 US physicians working in family medicine, internal medicine, or general practice, who were surveyed in mid-May 2021,

10.1% of primary care physicians (PCPs) do not agree vaccines are safe;
9.3% of PCPs do not agree that vaccines are effective; and
8.3% of PCPs do not agree that vaccines are important.

As startling as these data points may be to people who have only ever encountered rabidly pro-vaccination doctors, it’s even more fascinating to compare the opinions of doctors to those of the general public. The authors of the new study did just that, juxtaposing the results from a nationwide phone poll conducted in 2018 that asked identical questions of 983 Americans, with the results from their survey of doctors. Take a look:

It’s notable that far fewer physicians than average Joes and Josephines were undecided on vaccine safety, efficacy and importance. And more than three times as many physicians as members of the general public strongly disagreed that vaccines are effective, while more than twice as many strongly disagreed that they are important.
Delving into the factors associated with a lack of confidence in vaccines, the researchers found that having a politically conservative orientation was associated with a decreased probability of holding the opinion that vaccines are safe and effective:
“While the predicted probability that extreme liberals strongly agree that vaccines are safe is 78%, the likelihood that extreme conservative PCPs feel the same way is just 59% – a 19% difference across the full range of the ideological spectrum… Extreme liberals were predicted to be 18% more likely than extreme conservatives to strongly agree that vaccines are effective.”
Wealthier doctors were more likely to believe that vaccines are safe than those who earned less. Given that doctors can earn significant bonuses for meeting insurance company targets for fully vaccinating children in their practice, this link between high confidence in vaccine safety and income may well be a living embodiment of Upton Sinclair’s famous maxim:
“It is difficult to get a man to understand something, when his salary depends on his not understanding it.”
The only other factor that predicted physicians’ views on the safety, efficacy and importance of vaccines – again, referring to vaccines in general rather than COVID-19 vaccines – was whether they themselves had had COVID-19:
“We find that while the predicted probability of strongly agreeing that vaccines are safe is 70% among PCPs who had not had COVID-19, it was only 54% among those who had… While the predicted probability that PCPs who had not had COVID-19 would strongly agree that vaccines are effective was 77%, it was only 64% for those who had… PCPs who contracted COVID-19 are significantly less likely to believe in vaccine importance.”
Almost 95% of the physicians surveyed had received a COVID-19 injection. Around 70% of them expressed strong confidence in the safety of the Moderna and Pfizer shots, whilst less than a third felt the same way about the Johnson & Johnson injection. However, physicians who had contracted COVID-19 themselves were significantly less likely to prefer the Pfizer vaccine over the J&J vaccine.
After presenting their findings, the researchers go on to discuss the implications. And that’s where the study gets interesting. Very, very interesting.
Before I share those implications though, let’s take a side step to look at who the researchers are, and why that matters. Six out of the eight authors are faculty members of Texas A&M, a public land-grant university which, back in 2012, “won an immense federal contract to become a national hub of vaccine production and bioterror preparedness”. The following year, Texas A&M received a $176 million grant from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Department of Health and Human Services, to build an influenza vaccine production plant in collaboration with pharma behemoth GSK. And in July 2021, the university was awarded $10 million in federal funding to administer the Texas Vaccine Outreach and Education Grant program, the stated aims of which were to “support the implementation of COVID-19 vaccine outreach and educational activities aimed at boosting vaccination rates and increasing public confidence in COVID-19 vaccines.”
The seventh author is from the Milken Institute School of Public Health at George Washington University. You might remember the Milken Institute from my article Novavax – hope or hype?, as the host of the October 2019 conference in which New Yorker staff writer, Michael Specter, shared his wet dream of an infectious disease crisis which would “blow the system up”, smashing barriers to the acceptance of novel vaccine technologies.
And the eighth is the author or co-author of papers with titles such as ‘How Right-Leaning Media Coverage of COVID-19 Facilitated the Spread of Misinformation in the Early Stages of the Pandemic in the U.S.’, ‘Knowing less but presuming more: Dunning-Kruger effects and the endorsement of anti-vaccine policy attitudes’, ‘Parent psychology and the decision to delay childhood vaccination’,’Correcting Misperceptions about the MMR Vaccine: Using Psychological Risk Factors to Inform Targeted Communication Strategies’ and ‘Could concern about climate change increase demand for a Lyme disease vaccine in the U.S.?’ (boy, he sure hopes so).
Given the conflicts of interest and strong partisan leanings amongst the authors of the paper, their interpretation of the study findings is hardly surprising.
They fret that primary care physicians may not be the enthusiastic spruikers of COVID-19 injections that the government and media are counting on, and wonder whether a little well-targeted re-education may be required to make them fulfil this role:
“While the majority of primary care physicians are confident in mRNA vaccines, 9.5% and 8.6% of PCPs are only ‘somewhat confident’ or ‘not at all confident’ in the Moderna and Pfizer vaccines, respectively. To the extent that physicians are most likely to pursue promotion activities when they have complete confidence in the vaccines, our findings suggest that a troubling share of physicians may not want to engage in these efforts…
A troubling proportion of primary care physicians lack high levels of vaccine confidence. These physicians may not be well positioned to actively promote COVID-19 vaccination even as political and media narratives push physicians to lead this effort. Interventions aimed at improving vaccine confidence among some physicians may be needed so that all physicians can fulfill needed roles as trusted vaccine communicators.”
The authors are disturbed that doctors are letting the side down (whose side? Big Pharma’s, I guess) when it comes to pushing vaccines for other infectious diseases too:
“It may not always be possible to rely on physicians to encourage vaccination for COVID-19, let alone other vaccine preventable diseases.”
And the idea that politically conservative patients in rural areas may consult conservative doctors who share some of their doubts about vaccine safety and efficacy fills them with dread:
“Conservatives (in the public) with vaccine hesitancy, served by physicians who share their political views, may therefore miss out on opportunities to be presented with information about the benefits of vaccination; especially in rural areas where both hesitancy and self-identification with right-leaning political views are particularly high.”
Oh no, won’t somebody please think of the country bumpkins? I’m sure they’ve never had the good fortune to encounter information about the benefits of vaccination before, given that it’s plastered across the walls of every pharmacy, medical practice and hospital they’ve ever walked into, not to mention on their TV screens and radio airwaves.
And god forbid that they should exercise the right to choose a health care provider who doesn’t sack them from their practice for declining a medical intervention.
The authors are also gravely concerned that these unbelievers will erode the government’s coercive policies to force jabs on virtually everyone, willing or not:
“We cannot take it for granted that all physicians are well positioned to serve as vaccine promotors and furthermore, that interventions may be needed to increase vaccine confidence among some physicians. This is particularly true because these physicians could have an outsized impact on public health, with a single physician lacking trust in vaccine safety capable of writing large numbers of medical exemptions from non-COVID-19 vaccination, reducing the effectiveness of vaccine mandates.”
Oh, say it isn’t so – a doctor who considers it their duty to follow the CDC’s guidelines for screening for medical contraindications before jabbing their patients? The horror! The horror!
Pay close attention to the words chosen to describe conformity to, and deviance from, the officially-sanctioned narrative about the safety and efficacy of vaccines in the following excerpts (my emphasis):
“Vaccine confidence as defined by the CDC reflects the trust that individuals (or providers) have in recommended vaccines and the belief that the processes and policies that lead to new vaccines will create vaccines that are safe and effective.”
“Can we trust physicians to serve as vaccine champions given the low COVID-19 vaccine confidence that exists among some health care workers?”
“Physicians who got COVID-19 after getting vaccinated could potentially have less faith in the COVID-19 vaccines or vaccines in general.”
“Trust”. “Belief”. “Faith”. “Vaccine champions”. Are these appropriate words to use when discussing scientific matters? I don’t know about you, but I don’t care two hoots about whether a doctor has “faith” in a medical procedure or “believes” that it works. And any professional who earnestly believes that their role is to “champion” the products of the industry that has paid out the second-highest total fines for criminal and civil offences of any on earth instantly loses my respect.
What I look for in a medical practitioner is the ability to read scientific literature and the willingness to discuss it, rationally and objectively. Needless to say, I’ve encountered very few such individuals – at least until the manufactured COVID crisis launched me into the orbit of those whom I regard as the last remaining good doctors: dedicated professionals who prioritise the well-being of their patients above the dictates of the state or their own financial and professional aggrandisement.
It’s notable that not once in the entire article was there any discussion of the actual data on the safety or efficacy of any vaccines, including COVID-19 injections. The authors’ implicit assumption is that vaccines – all of them, without exception – are safe and effective as long as the CDC endorses them, and any doctor who isn’t 100% on board with these assertions is misinformed and in need of re-education (which I’m sure they’d be only too happy to provide, if the government and/or Big Pharma – if there’s even a difference between those two entities at this point – would kindly toss them some of that lovely grant money).
In other words, it is an article of faith within the Church of Modern Medicine that vaccines are safe, effective and important, and anyone who doesn’t devoutly believe and piously recite this catechism is a medical heretic who must be hauled before the medical inquisition and forced to recant.
And that is no basis for the practice of medicine. Dave Sackett, the father of evidence-based medicine, famously said:
“Half of what you’ll learn in medical school will be shown to be either dead wrong or out of date within five years of your graduation; the trouble is that nobody can tell you which half—so the most important thing to learn is how to learn on your own.”
Doctors who don’t swallow whole the nostrums of public health “experts”, and who bridle at the notion that their highest duty is to shill for the pharmaceutical industry, are not in need of corporate/government re-education. They’re professionals who take Dave Sackett’s admonition to learn on their own seriously.
And academics such as the authors of the Vaccine paper are a clear and present danger not just to the ability of such doctors to practise medicine according to their best judgement and conscience, but to all members of the public who rely on them to make treatment decisions that are in their patients’ interests, not those of the public health-industrial complex.

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Why you need to stop saying “I’m not an antivaxxer, but…”

4/15/2022

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By: Robyn Chuter
https://robynchuter.substack.com/

If I only had a dollar for every time I’ve heard someone say “I’m not an antivaxxer, but…” in the last two years of the manufactured COVID crisis, I’d be enjoying a holiday in one of the 73 countries that currently welcome travellers who haven’t had an experimental COVID-19 injection.
Wait, scratch that, since I am not permitted to leave my own country because, according to Chief Medical Officer, Professor Paul Kelly, the International Health Regulations (IHR) that Australia signed onto as a member of the World Health Organisation (WHO) oblige nations to restrict outbound travel during pandemics.

Oddly enough though, out of the other 195 countries who are legally bound by the IHR, only two still have outbound travel restrictions in place: Canada – a police state which jails its citizens, seizes their assets and freezes their bank accounts for participating in or supporting a peaceful and lawful protest – and the United Arab Emirates – which conducts public floggings and jails women who report that they’ve been raped. Well, at least Paul Kelly is in good company.

Anyway, back to my point. Most doctors, scientists and even members of the general public who wish to express their concerns about the safety and efficacy of the inadequately-tested, rushed-to-market, liability-free experimental COVID-19 injections without being instantly dismissed as tinfoil hat wearing nutters/baby killers/granny murderers/conspiracy theorists/insert moronic thought-stopper of choice, fall over themselves to lay out their credentials as true believers of the central dogma of the Church of Modern Medicine: that vaccines are the best thing since sliced bread – just not these vaccines:

“I’m not an antivaxxer – I’ve had every other vaccine, including my yearly flu shot.”
“I’m not an antivaxxer – I’ve even had extra ones, for travel.”
“I’m not an antivaxxer – all my kids are up-to-date with their vaccines.”
“I’m not an antivaxxer – I develop vaccines for a living.”
It’s like a scientistic version of Tourette’s. They feel compelled to preface every critical utterance about COVID injections with their tremulous protestation of faith in The Vaccine Science™: “I’m not an antivaxxer!!!”

As I wrote back in 2017, in my article Vaccines: Science, Undone Science and Anti-Science, the use of the term “antivaxxer” to shut down any and all discussion of vaccination is intellectually lazy and fundamentally anti-science.
In that article, I quoted at length from an editorial in The BMJ by the associate editor of that venerable journal, Peter Doshi, who has been relentless in his pursuit of the truth about COVID-19 injections (see my previous articles WHO’s plan to vaccinate the world, COVID-19 vaccines: Magic bullets or mirages? and If the COVID-19 injections work, why are more people dying? Part 2 for summaries of his fine work).
Doshi’s critique of the weaponisation of the term “antivaxxer” is so lucid and penetrating that I’m going to quote it at length once again:
“Good journalism on this topic will require abandoning current practices of avoiding interviewing, understanding, and presenting critical voices out of fear that expressing any criticism amounts to presenting a ‘false balance’ that will result in health scares.
It does matter if the vast majority of doctors or scientists agree on something. But medical journalists should be among the first to realize that while evidence matters, so too do the legitimate concerns of patients. And if patients have concerns, doubts, or suspicions—for example, about the safety of vaccines, this does not mean they are “anti-vaccine.” Anti-vaccine positions certainly exist in the world, but approaches that label anybody and everybody who raises questions about the right headedness of current vaccine policies—myself included (9)—as “anti-vaccine” fail on several accounts.
Firstly, they fail to accurately characterize the nature of the concern. Many parents of children with developmental disorders who question the role of vaccines had their children vaccinated. Anti-vaccination is an ideology, and people who have their children vaccinated seem unlikely candidates for the title.
Secondly, they lump all vaccines together as if the decision about risks and benefits is the same irrespective of disease—polio, pertussis, smallpox, mumps, diphtheria, hepatitis B, influenza, varicella, HPV, Japanese encephalitis—or vaccine type—live attenuated, inactivated whole cell, split virus, high dose, low dose, adjuvanted, monovalent, polyvalent, etc. This seems about as intelligent as categorizing people into “pro-drug” and “anti-drug” camps depending on whether they have ever voiced concern over the potential side effects of any drug.

Thirdly, labeling people concerned about the safety of vaccines as “anti-vaccine” risks entrenching positions. The label (or its derogatory derivative “anti-vaxxer”) is a form of attack. It stigmatizes the mere act of even asking an open question about what is known and unknown about the safety of vaccines.
Fourthly, the label too quickly assumes that there are “two sides” to every question, and that the “two sides” are polar opposites. This ‘you’re either with us or against us’ thinking is unfit for medicine. Many parents who deliberate on decisions regarding their children’s health ultimately make decisions—such as to vaccinate or not vaccinate—with lingering uncertainty about whether they were right. When given a choice, some say yes to some vaccines and no to others. These parents are not zealots, they are decision makers navigating the gray, acting under conditions of uncertainty in perpetual flux.
And among those uncertainties are the known and unknown side effects that each vaccine carries. Contrary to the suggestion—generally implicit—that vaccines are risk free (and therefore why would anyone ever resist official recommendations), the reality is that officially sanctioned written medical information on vaccines is—just like drugs—filled with information about common, uncommon, and unconfirmed but possible harms.(10) (11)

Although MMR and autism have dominated journalistic coverage of this issue, and journalists have correctly characterized the scientific consensus that rejects any such link1, most journalists have insufficiently acknowledged the fact that bodies such as the Institute of Medicine have “found convincing evidence of 14 health outcomes—including seizures, inflammation of the brain, and fainting—that can be caused by certain vaccines, although these outcomes occur rarely.”(12)
And for 135 other adverse events investigated, the committee concluded “the evidence was inadequate to accept or reject a causal relationship” with vaccines.

Medical journalists have an obligation to the truth. But journalists must also ensure that patients come first, which means a fresh approach to covering vaccines. It’s time to listen—seriously and respectfully—to patients’ concerns, not demonize them.”
Medical response to Trump requires truth seeking and respect for patients
Did those medical journalists listen to Doshi and mend their ways? Hell, no. They doubled down. And the power-mad politicians piled on too, with Michael ‘Mad Dog’ Gunner, the palpably deranged Chief Minister of the Northern Territory, snatching the ‘Everyone I Don’t Like is Hitler’ ball and putting it on play on an entirely new field of his own devising:

According to the spittle-spraying Mr Gunner,
“If you are anti-mandate, you are absolutely anti-vax. I don’t care what your personal vaccination status is.”
First they came for the Communists…

From early on in the manufactured COVID crisis, a chorus of voices raised concerns about the interruptions to “well child” visits and other medical encounters aimed at delivering the childhood vaccine schedule, caused by the imposition of the suite of non-evidence-based control measures collectively titled “lockdown” on populations throughout the world.
The WHO wrung its hands over the impact of lockdowns, noting that “23 million children missed out on basic vaccines through routine immunization services in 2020”. WHO Director-General (and alleged war criminal) Tedros Adhanom Ghebreyesus augured that “multiple disease outbreaks would be catastrophic for communities and health systems already battling COVID-19, making it more urgent than ever to invest in childhood vaccination and ensure every child is reached.”
The US Centers for Disease Control and Prevention (CDC) wailed at the sharp decrease in doses of vaccines ordered by health care providers in the first quarter of 2020, and gnashed its teeth at the decline in the share of five-month-old Michigan babies who were “up-to-date” on vaccines from an average of roughly two-thirds to less than half, during the three months in which stay-at-home orders were in place.

And researchers tore their beards over the skipping of childhood vaccination appointments by 34% of Italian parents, the 36% decline in routine childhood vaccination in Pakistan, the 37% prevalence of intentional vaccination delay in Saudi parents, and the 14.4% decline in vaccination coverage in Colombia.
So, what catastrophic consequences ensued from this decline in childhood vaccination? Plague, pestilence, and great slimy monsters crawling from the deep?
Well, not exactly. In the US, child deaths declined at precisely the same time-point that older age-groups suffered a sharp mortality spike. Here are the total US deaths broken down by age cohort and week, from February to May 2020:

And here are the child deaths, compared to previous years; note the striking decline in under 18 deaths commencing in week 9 (late February):

When broken down further by age cohort, it’s clear that the mortality decline was concentrated in infants under one year of age:

So, at a time when public health experts were warning that skipped childhood vaccination appointments would lead to devastating consequences, roughly 200 fewer infants were dying each week in the US.
Correlation is not causation, of course, and back in June 2020 when these intriguing data trends were first brought to public attention, any connection between fewer childhood vaccinations and reduced infant mortality was purely speculative.

However, scientific discovery proceeds through making observations, and some of the most fruitful observations in terms of sheer potential for hypothesis generation are natural experiments - changes in environmental exposures that allow before-and-after comparisons of outcomes in the same population.

It turns out that the entire US state of Florida took part in a natural experiment on childhood vaccination, apparently as a direct result of the sharp drop in confidence in public health advice that ensued from Florida’s divergence from officially sanctioned (yet unprecedented and non-science-based) COVID containment policies.
When Florida’s governor, Ron DeSantis, broke with CDC guidance and began lifting COVID-19 restrictions in September 2020, the mainstream media’s collective brain exploded in incandescent rage, spewing predictions of biblical-scale carnage that are depicted in this political advertisement framing DeSantis’ policies as the real-life sequel to The Purge franchise (read the YouTube comments; they’re well worth the price of admission):

(Just for the record, my favourite YouTube comment on this was "Does DeSantis have to declare the cost of this ad as a campaign contribution?")
However, disappointingly for the rabid #DeathSantis hashtaggers, the retirement capital of the US ranks 31st out of 51 (50 states plus the District of Columbia) on the all-important metric of age-adjusted COVID deaths, outperforming lockdown meccas (and mainstream media paragons of exemplary COVID response) New Jersey (#14), New York (#16), District of Columbia (#21) and Michigan (#24).

The gap between the apocalyptic predictions of Chief COVID Seer, Anthony Fauci and readily observable reality seems to have prompted some healthy scepticism in Floridians toward public health nostrums. And it didn’t stop with COVID.
As documented by Igor Chudov on his Substack, according to Florida Health, the percentage of children aged 24 to 35 months in the state who were fully compliant with the CDC-recommended childhood vaccination schedule plummeted 14.1 percentage points, from 93.4% in 2020 to 79.3% in 2021.
And what happened to Florida’s infant mortality rate? It dropped by 8.93%. Huh. So no plagues of boils, hail, locusts, darkness and the killing of firstborn children ensued when parents skipped their kids’ jabs? No, just fewer babies dying in their first year of life.

While Igor “I’m not an antivaxxer, but…” Chudov expressed shock and disbelief at his own findings, and practically begged his readers to disprove him, they instead peppered him with links to further research indicating a correlation between increased intensity of childhood vaccination and higher infant mortality rates. If this is your first foray into questioning the value of childhood vaccines, buckle up – you’re in for a wild ride.
So wild that even the most heroic critics of damaging COVID containment policies, such as Drs Jay Bhattacharya and Martin Kulldorff, don’t dare to go there, as my Twitter exchange with them demonstrates:

Still no response from either of these admirable doctors, who remain firmly planted in the “I’m not an antivaxxer, but…” camp. I guess even the most courageous people still have cognitive maps marked with the medical equivalent of “here be dragons”. But I live in hope.

And if you’re interested in that seminal paper I referred to, ‘The questionable contribution of medical measures to the decline of mortality in the 20th century’, you’ll find it here.
You really should read the whole paper, but here’s the money quote:
“With reference to those five conditions (influenza, pneumonia, diphtheria, whooping cough, and poliomyelitis) for which the decline in mortality appears substantial after the point of intervention—and on the unlikely assumption that all of this decline is attributable to the intervention—it is estimated that at most 3.5 percent of the total decline in mortality since 1900 could be ascribed to medical measures introduced for the diseases considered here.”
The questionable contribution of medical measures to the decline of mortality in the 20th century
Note that the “interventions” referred to in the above quote include not just vaccines but antibiotics and diphtheria toxoid; that piddling 3.5% of the reduction in total mortality is shared between an antibiotic, three vaccines and a toxoid.
Far from being “one of the greatest success stories in public health” and “one of the greatest medical achievements of modern civilization“, the McKinlays’ careful analysis suggests that vaccines made little to no discernible contribution to the decline in deaths from measles, influenza, whooping cough and smallpox in the twentieth century, while the impact on poliomyelitis deaths was small.

And while the McKinlays do not mention this, the case definition of poliomyelitis was changed after the polio vaccine was introduced, leading to an artefactual drop in reported cases and deaths which made the vaccine appear more effective than it actually was:
“Prior to the introduction of the vaccine the patient only had to exhibit paralytic symptoms for 24 hours. Laboratory confirmation and tests to determine residual paralysis were not required. The new definition required the patient to exhibit paralytic symptoms for at least 60 days, and residual paralysis had to be confirmed twice during the course of the disease. Also, after the vaccine was introduced cases of aseptic meningitis (an infectious disease often difficult to distinguish from polio) and coxsackievirus infections were more often reported as separate diseases from polio. But such cases were counted as polio before the vaccine was introduced. The vaccine’s reported effectiveness was therefore skewed (Table 1 and Figure 5).”
The polio vaccine: a critical assessment of its arcane history, efficacy, and long-term health-related consequences

So, do us all a favour, and quit using “I’m not an antivaxxer, but…” to preface your critical comments or questions about the efficacy and safety of COVID-19 “vaccines”. They’re not an exceptional case; the entire field of vaccinology is littered with undone science, and it’s high time that indisputable fact was acknowledged, and a serious attempt made to remedy it.

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The strange tale of hydroxychloroquine

4/11/2022

3 Comments

By : Roybn Chuter

Queensland's Chief Health Office has quietly revoked the previous CHO's threat to jail doctors who prescribe hydroxychloroquine for COVID-19. And the official reason doesn't make any sense.
On 12 March 2022, the Chief Health Office (CHO) of Queensland, Dr John Gerrard, revoked a directive issued on 7 April 2020 by previous CHO and now governor of Queensland, Dr Jeanette Young, which imposed criminal sanctions – a fine of up to $13 785 or 6 months in prison – on doctors and pharmacists who prescribed or dispensed hydroxychloroquine for prevention or treatment of COVID-19.
Here’s the original directive issued by Young, in the very early days of the manufactured COVID crisis:

And here is Gerrard’s revocation of that directive:

The revocation was published with little fanfare; a sharp-eyed subscriber to my Substack brought it to my attention on the morning of 6 April (thanks, Timothy!), and that evening, the Murdoch-owned Courier Mail ran an article on it.
Apparently, like Voldemort, hydroxychloroquine gains power from merely having its name spoken: The Courier Mail could not bring itself to use the word “hydroxychloroquine” in the headline or lede, euphemising it as “a certain drug” and then – misleadingly, since it is routinely prescribed for a host of conditions besides malaria – “an antimalarial drug”:

Jodie Munro O’Brien, the Courier Mail ‘journalist’ (I use the term loosely, for reasons that will become evident) tasked with reporting the story, simply reiterated the official government narrative that the ban on prescribing hydroxychloroquine for COVID-19 had been instituted because of fears that off-label use for this purpose would lead to “a supply shortage, leaving those already prescribed the drug for other, unrelated ailments without their medicine.”
If you’re wondering, “Why didn’t the government look for ways to increase the supply of hydroxychloroquine, rather than threatening doctors and pharmacists with six months in the slammer or a fine of nearly 14 grand for making it available to sick people?” then you’re thinking like a journalist. Perhaps you could apply for Ms Munro O’Brien’s job… or perhaps not, since the legacy media prefers stenographers to actual journalists.
And indeed, the hydroxychloroquine supply problem was promptly solved by Queensland businessman Clive Palmer, who bought 40 million doses of the drug from overseas sources by late April 2020 (i.e. just a few weeks after Jeanette Young issued the ban), and donated more than 22 million of them to the national medical stockpile before being informed by a Commonwealth Health Department spokeswoman on 18 June 2020 that “no further donations were required”.
However, despite these facts having been reported in the very newspaper which employs her, Ms Munro O’Brien simply regurgitated the Queensland Health spokeswoman’s illogical explanation for Gerrard’s action:
“A Queensland Health spokeswoman said the revocation of the ban was because there was no longer a supply shortage threat, but the medication was still not approved for Covid-19 treatment.”
Restrictions that threatened doctors with a $13000 fine if they prescribed a certain drug revoked
Say what? The “supply shortage threat” was solved almost two years ago. And since off-label prescription of drugs is perfectly legal and universally practised (accounting for up to 40% of prescriptions for adults and up to 90% in some hospitalised paediatric patients), no “approval” is required for doctors to prescribe hydroxychloroquine for prevention or treatment of COVID-19.

Jeanette Young’s criminalisation of the use of hydroxychloroquine to treat COVID-19 patients was just one of a Series of Unfortunate Events that befell this 65+ year old drug that is included in the World Health Organisation’s Model List of Essential Medicines, in the weeks before and in the months after that body declared that COVID-19 was a “Public Health Emergency of International Concern” (PHEIC, which I presume is pronounced like “fake”) on 30 January 2020.
Mathew Crawford has covered the many twists and turns of this gothic tale in The Chloroquine Wars section of his must-read ‘Rounding the Earth’ Substack, but here is a chronology of some of the most significant events:

On 15 January 2020 – two weeks before WHO declared its PHEIC for COVID-19 – the French medical health agency rescinded its 2008 authorisation of over-the-counter sales of more than 200 commonly-used drugs, including hydroxychloroquine, in community pharmacies. The French government’s restrictions on prescription of the drug escalated over the ensuing months, prompting the formation of a doctors’ collective calling themselves “Let Doctors Prescribe” to advocate for the restoration of physicians’ freedom to exercise their clinical judgment. A representative of the collective, Dr Violette Guérin, complained in late March 2020 that

“Today there is an escalation of directives aimed at restricting [hydroxychloroquine’s] use from the Directorate General of Health. And it remains authorized in the setting where it is the least effective, that is to say in the intensive care units.”
“We want to self-prescribe chloroquine”, asks a group of doctors

On 11 March 2020, Dr John Gerrard treated actor Tom Hanks and his wife Rita Wilson for COVID-19 at Gold Coast University Hospital. No details of the treatment they received have been issued, due to patient confidentiality. However, a retrospective observational cohort study of the first 197 COVID‐19 patients managed by Gold Coast Hospital and Health Service, between February and April 2020, coauthored by Gerrard, clearly shows that chloroquine drugs were in use at the time Gerrard treated Hanks and Wilson: “Twenty‐one patients received hydroxychloroquine (mean duration of therapy 4.4 days), one patient received chloroquine (5 days).” 63 patients were hospitalised (54 for medical reasons and the remainder for “observation”, “public health reasons” and “social reasons”), 5 required intensive care unit admission and 3 required intubation; no patients died. No concerns were expressed in this paper about any toxicity of chloroquine drugs.
On 24 March 2020, the Therapeutic Goods Administration (TGA) announced that GPs and specialists except those practising dermatology, intensive care medicine, paediatrics and child health, physician and emergency medicine, were no longer permitted to prescribe hydroxychloroquine, citing “demand shortages” created by use of the drug for treatment of COVID-19 that “pose… a serious health risk to individuals currently using this medication”. Note that TGA did not raise any safety concerns about the off-label use of hydroxychloroquine to treat COVID-19, merely putative supply issues.
Also on 24 March 2020, the governor of New York, Andrew Cuomo, issued an executive order barring pharmacists from dispensing “hydroxychloroquine or chloroquine except when written as prescribed for an FDA-approved indication; or as part of a state approved clinical trial related to COVID-19 for a patient who has tested positive for COVID-19, with such test result documented as part of the prescription. No other experimental or prophylactic use shall be permitted, and any permitted prescription is limited to one fourteen day prescription with no refills”. In other words, with one stroke of his pen, Cuomo cancelled out physicians’ right to prescribe chloroquine drugs off-label and prevented people who were already taking these drugs for FDA-approved purposes from obtaining a sufficient supply to last them through the 100-day shutdown that he imposed four days earlier, on 20 March.
Then on 28 March 2020, the governors of the US states of Michigan and Nevada issued executive orders prohibiting physicians from prescribing, and pharmacists from dispensing, “hydroxychloroquine and chloroquine to patients for the treatment of COVID-19 outside of a hospital”. Both orders cited the same justification as Jeanette Young – the concern that hoarding of the drug by people afraid of contracting SARS-CoV-2 infection would threaten its availability to people taking it for “a legitimate medical purpose” – thus arrogating to themselves and their bureaucrats, most of whom are not licensed medical professionals, the right to decide what constitutes “legitimate medical purposes”. Furthermore, restricting the drug to hospitalised patients ensured that it could not be used in the early treatment of COVID-19, when its benefits are the most pronounced.
On the same day, 28 March 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) permitting “emergency use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to be distributed from the Strategic National Stockpile (SNS)” (my emphasis) for use in treating people with COVID-19. This implies that there were perfectly adequate reserves of hydroxychloroquine for such purposes, which would have spared the supply available in community pharmacies, thus invalidating the concerns with supply issues that the governors of Michigan and Nevada invoked as the rationale for their executive orders.
On 22 May 2020, one of the world’s most prestigious medical journals, The Lancet, published a study which claimed to draw on a multinational registry comprising 671 hospitals located in six continents. Analysing data supplied by the Surgical Outcomes Collaborative (managed by Surgisphere Corporation), which supposedly included over 96 000 patients hospitalised for COVID-19 between 20 December 2019 and 14 April 2020, the authors concluded that patients treated with chloroquine or hydroxychloroquine (alone or in combination with a macrolide antibiotic, such as azithromycin), had between a 33% and 45% higher chance of dying than those whose treatment did not include a chloroquine drug, as well as up to triple the risk of developing a potentially lethal type of abnormal heart rhythm called ventricular arrhythmia.
There was just one small problem with the Lancet study – the dataset was completely fake. Six days after its publication, on 28 May 2020, more than 120 researchers and medical professionals published an open letter addressed to the study’s authors, and Lancet editor Richard Horton, raising serious concerns about the integrity of the data source, study methodology and statistical analysis.
And on 5 June 2020, Lancet issued a retraction notice, in which the study’s authors claimed that Surgisphere had denied them access to the full dataset for the purposes of independent peer review. No wonder, since the dataset simply did not exist. It subsequently emerged that Surgisphere – a company which had claimed to run one of the largest and fastest hospital databases in the world – had only a handful of employees, few of them with any background in data analysis or scientific background; their “science editor” was actually a science fiction author and fantasy artist (which seems oddly appropriate) while their marketing executive worked as an adult model and events hostess. Apparently, neither the authors of the Lancet study (led by cardiologist Mandeep Mehra, who is a professor at Harvard Medical School as well as a director at Boston’s Brigham & Women’s Hospital) nor the journal’s editorial and peer review team, were capable of discovering these facts for themselves. I’m sure the fact that Mehra’s employer, Brigham & Women’s Hospital, was also running two clinical trials for the drug remdesivir, sponsored by the $1000-per-pill drug’s manufacturer, Gilead, had absolutely nothing to do with Mehra’s lapse in judgement.
However, despite the retraction, the damage to hydroxychloroquine had already been done. On 26 May 2020, the WHO paused recruitment to the hydroxychloroquine arm of its global randomised clinical trial to identify effective treatments for COVID-19, SOLIDARITY, citing the Lancet study as justification. The UK and French regulatory bodies followed suit, halting their national trials of hydroxychloroquine. And while WHO resumed the hydroxychloroquine arm of SOLIDARITY on 3 June (two days before the Lancet retraction), recruitment into these trials had become difficult due to the bad publicity.
On 5 June 2020, the chief investigators of the UK Randomised Evaluation of COVid-19 thERapY (RECOVERY) Trial, which received funding from the Bill and Melinda Gates Foundation and the Wellcome Trust, reported that they had called an early halt to the hydroxychloroquine arm of the study due to interim analysis of data showing “no beneficial effect of hydroxychloroquine in patients hospitalised with COVID-19”. This interim analysis was posted on the preprint server medRxiv on 15 July 2020 and published in the New England Journal of Medicine (NEJM) on 19 November 2020.
The NEJM article concluded that COVID-19 patients given hydroxychloroquine were 9% less likely to be discharged from the hospital alive within 28 days than those who did not receive the drug, and 14% more likely to require mechanical ventilation after hospitalisation.
And on reading the details of the treatment and dosage schedule, these dismal results are no surprise. The trial was not just set up to fail, it was arguably designed to kill patients.
Firstly, treatment began a median of 9 days after symptom onset. Hydroxychloroquine works by inhibiting viral replication, which peaks in the first few days after symptom onset and ceases by around the eight day after onset of symptoms of COVID-19. In other words, by the time patients enrolled in the RECOVERY trial received hydroxychloroquine, it was too late for the drug to provide any clinical benefit to them.
Secondly, those randomised to receive hydroxychloroquine were given 800 mg of the drug at baseline, another 800 mg 6 hours later, followed by 400 mg every 12 hours for the next 9 days or until discharge, whichever occurred earlier. In the Supplementary Appendix, the authors justify this dosage schedule as follows:
“The hydroxychloroquine dose regimen was based on previous pharmacokinetic modelling of plasma and whole blood hydroxychloroquine concentrations in healthy volunteers, the treatment of malaria and in rheumatological conditions. The choice of dose and predicted safety margins were also informed by pharmacometric studies of chloroquine in the treatment of both severe and uncomplicated malaria and in self-poisoning.”
But as David Jayne, professor of clinical autoimmunity at Cambridge University, pointed out, this dosage schedule does not remotely resemble those used for either malaria or rheumatological disease, and substantially exceeds the known toxic dose of hydroxychloroquine. In an article in the British Medical Journal (BMJ), Jayne shared his concerns:

“Current recommended doses for rheumatologic disease are typically 300-400 mg/day and… the maximum dose for malaria has been 800 mg in the first 24 hours. ‘The reasons behind the dose selection in the RECOVERY trial are unclear,’ he says.
‘Hydroxychloroquine overdose is associated with cardiovascular, neurological, and other toxicities, occurring with doses over 1500 mg, and higher doses are associated with fatality.’ He is concerned that hydroxychloroquine toxicity may have contributed to the adverse outcomes and that conclusions based on these results may be unreliable.”
Covid-19: The inside story of the RECOVERY trial

On 15 June 2020, FDA revoked its EUA for chloroquine and hydroxychloroquine. It cited the early termination of the hydroxychloroquine arm of the RECOVERY trial as one of its principal reasons for doing so, but the press release announcing the revocation revealed that some of the mud flung by the discredited Surgisphere data-that-wasn’t had stuck: “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
On 19 June 2020, the hydroxychloroquine arm of WHO’s SOLIDARITY trial was “discontinued for futility“, although WHO only announced that it was terminating the hydroxychloroquine trial on 4 July 2020, on the grounds that the drug produced “little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care.” In fact, the interim results, published in the NEJM, were that hydroxychloroquine increased the risk of death by 19%.
Once again, hydroxychloroquine was administered too late to show benefit (most patients had already been in hospital for two or more days before treatment commenced) and a toxic dose was administered: 800 mg at baseline, another 800 mg after 6 hours, then 400 mg every 12 hours for 10 days. In other words, patients received 2000 mg of hydroxychloroquine in the first 24 hours of treatment – well in excess of the dose of 1500 mg that is known to be potentially fatal.
And WHO had been alerted that its hydroxychloroquine dosage schedule was hazardous back in May 2020 by the Indian Council of Medical Research, which warned that the dose being used in international trials was four times higher than that specified in the protocol set by the Indian government to treat severe COVID-19 patients requiring ICU management.
Low-income nations continued to utilise hydroxychloroquine for pre-exposure prophylaxis and early treatment, with considerable success:

However, in rich Western countries including Australia, the drug’s name was now mud. Other clinical trials which included hydroxychloroquine treatment arms were amended to ditch the drug, including the Australasian COVID-19 Trial (ASCOT) for which Dr John Gerrard was the Gold Coast University Hospital contact.
The National COVID-19 Clinical Evidence Task Force continues to recommend against the use of hydroxychloroquine in any circumstances. It states that “evidence indicates that hydroxychloroquine is potentially harmful and no more effective than standard care in treating patients with COVID-19”, citing the RECOVERY and SOLIDARITY trials as providing the “majority of evidence” for its position without acknowledging the fact that these trials used the drug too late for it to be effective, and employed a known toxic dose.

An open letter sent to Jeanette Young on 29 September 2020 by Federal MPs George Christensen and Craig Kelly, pointing out the flaws in the RECOVERY trial and directing Young to the growing body of evidence supporting the appropriate use of hydroxychloroquine, was met by deafening silence (except by ABC “fact checkers” whose intrepid investigation of the controversy consisted of quoting a TGA statement and asking the executive director of the National COVID-19 Clinical Evidence Task Force, Julian Elliott, for his opinion on the MPs’ claims).
Young extended the hydroxychloroquine ban, which had been due to expire on 2 October 2020. By this time, the probability that hydroxychloroquine was ineffective for early treatment of COVID-19 was nearing 1 in 1 million:

After considering these facts, several important questions arise:

Why did multiple jurisdictions in rich countries impose restrictions on doctors’ ability to use hydroxychloroquine for pre-exposure prophylaxis and early treatment of COVID-19 in outpatient settings, all at around the same time, and all citing the same demonstrably false rationale (the concern that supply of the drug to people who were already taking it for non-COVID-related conditions would be compromised, when ample amounts were already in national stockpiles, or were quickly obtained)? Unless one is a coincidence theorist, this coordination hints at an organised hit job on hydroxycholoroquine, a cheap generic that is one of the world’s most widely prescribed drugs, with a long history of safe use, even in pregnancy and breastfeeding.
Why did the RECOVERY and SOLIDARITY trials use a dosage schedule of hydroxychloroquine that is known to be toxic and potentially fatal? And why did they restrict the use of the drug to advanced stages of COVID-19 when their own clinical trial protocols made it clear that the researchers understood that its mechanism of action as an antiviral was no longer relevant once patients had passed the viral replication stage?
What does Queensland’s Chief Health Officer, John Gerrard, know about the use of hydroxychloroquine for treatment of COVID-19? He presided over the infectious diseases department of Gold Coast University Hospital during the first wave of infections in early 2020, when chloroquine drugs were used to treat more than 10% of COVID-19 patients. What are the real reasons for his revocation of Jeanette Young’s directive, given that the rationale proffered by the Queensland Health spokeswoman – that there were no longer any supply concerns – is demonstrably false, the supply problem having been solved nearly two years prior (and indeed, 5 months before Young renewed the directive)?
And finally, why have doctors simply acquiesced to the dramatic erosion of their right to practise medicine, including the right to prescribe TGA-approved medicines off-label if the scientific literature provides evidence of potential benefit – which it very clearly does, in the case of properly-prescribed hydroxychloroquine?

I guess the Courier Mail‘s hard-hitting journalist, Jodie Munro O’Brien, will be working tirelessly to get us answers to all these questions, any day now.

https://robynchuter.substack.com/p/the-strange-tale-of-hydroxychloroquine?s=r
https://empowertotalhealth.com.au/

3 Comments

"Major study confirms ivermectin useless against COVID-19"

4/9/2022

0 Comments

By Ludwig Van
https://100monkey.substack.com/

I'm not a scientist, but something about the latest ivermectin study in Fairfax does not add up.
Sure, "Major study confirms ivermectin useless against COVID-19" makes a compelling headline, and for many it will settle the argument on the side of "THE SCIENCE"…but what does the study really say?
Does it really cut the mustard in light of the 80+ positive trial results from studies for this potential miracle drug?

It is important to note that this is not the first randomised controlled study (RCT) that has been done on ivermectin and Covid-19.
There have been 33 RCTs involving 7,100 people in total with a 56% positive result for ivermectin, cutting hospitalisations and death in half for those who have been given it.
Early treatment was by far the most effective with 60% recovery rate compared to placebo. Late treatment was only 23% effective in comparison.

The meta study suggests giving ivermectin in the early stages of Covid can save lives and even, to a lesser extent, later on in the disease progression.
If you include all studies, including observational, 129,000 people have been trialed with a 65% positive outcome.
The media has been silent on the overwhelming positive studies that have come out over the past 2 years, but for some reason jumped at the chance to publish anything negative, such as the following study which currently seems to be the toast of the town in the strange world of MSM.

The Reis Study ‘ Effect of Early Treatment with Ivermectin among Patients with Covid-19’

The study took 1,358 people out of 10,467 patients, 6,952 who were excluded because they were either A not eligible or B excluded themselves. Out of the 3,515 leftover, 1,358 patients were allocated to the ivermectin study with 679 given 400 μg of ivermectin per kilogram per day for 3 days, and the other 679 received a placebo for either 1, 3, or 14 days. (This is not nearly enough by the way. Most experts recommended giving ivermectin for a week, or until symptoms subsided)
Out of this 679 in the placebo group, only 288 people followed the protocol to 100% adherence in other words, they dropped out of the study) to the end of the study, while 624 of the ivermectin group followed protocol by 100%.
While the ivermectin arm of the study only saw around 9% drop out or discontinue using the drug (which they had no idea was ivermectin or placebo)

Why did 60% of the placebo arm of the study drop out?
Was it so obvious that they were not receiving a placebo that they decided that it wasn’t worth it?
Or even worse, they physically couldn’t go on any further.
Obviously, this is just speculation on my part, but there was no explanation given for the disparity in numbers by the authors so speculation is the best we can do in this instance.
Knowing this, how on earth did the authors come up with a total of 111 people having a primary outcome event when only 288 people completed the study?
This not only does not make any sense but invalidates the study completely.

A primary outcome was measured by whether the patient spent more than 6 hours in an emergency department within 28 days of starting treatment.

Anyone who was admitted to an emergency department less than 24 hours after starting the protocol was not counted and then excluded from the study. Considering 60% in the placebo arm dropped out of the study before finishing, how many hospital admissions out of the 679 were admitted within 24 hours and not counted?
Now, let’s take a look at the results after the obvious manipulation was done to water down the effectiveness of ivermectin.

As you can see, even with their flawed and sketchy data, ivermectin beat the placebo in nearly every avenue.
In this study, your risk of death was 12.0% lower, your risk of mechanical ventilation was 23.0% lower and your risk of hospitalisation was 17.0% lower. None of these were mentioned in the trial summary or article parroting the trial summary.

So as you can see, this was a positive study. The results were statistically significant and it was not reported as such by the authors of the study or the presstitutes tasked with fear-mongering propaganda.
Now let’s look at the safety and efficacy data of ivermectin before it was demonized by big pharma;
Ivermectin was discovered in 1975. Below are just some of the FACTS about this incredibly safe drug.

Ivermectin as a drug has an amazing and very good safety profile. It has been used safely for 40 years in humans (yes, not just horses!)
There have been over 4 billion doses given to humans.
“There are several reports of ivermectin toxicity in animals following ‘off-label’ use, yet in humans, in general, only a very low-level incidence of serious adverse side effects (SAE) has been reported. Analysis of the first 11 years of mass global Mectizan® use identified a cumulative incidence of one SAE case per 1 million treatments”. (10)
It won the Nobel prize for its discovery by William C. Campbell and Satoshi Ōmura after they discovered its analog Avermectin was effective against infections caused by roundworm parasites.
It’s listed by WHO as an ‘Essential Medicine’ in most developing countries and is so safe and widely used that you can buy it over the counter.
It is generally considered safer than Aspirin.

The financial interests
The authors of the Reis, Lopez-Medina study clearly state time and time again in their disclosure statement that there were no conflicts of interest in the funding of the study, from people or organisations such as the Bill & Melinda Gates Foundation, Google or AstraZeneca. But reading into the two “not for profit” groups that donated to this study, you can clearly see that this is a lie.
As you can see in the disclosure statement below, the author ticked no to any conflicts of interest..

The following excerpt is from IVMmeta regarding the financial conflicts of interest and likely data manipulation of the study:
“Two ivermectin trials to date involve very large financial conflicts of interest [López-Medina, Reis] — companies closely involved with the trial or organizers stand to lose billions of dollars if ivermectin efficacy becomes more widely known. The design of these trials favors producing a null outcome as detailed in [López-Medina, Reis]. Note that biasing an RCT to produce a false positive result is difficult (suppressing adverse events is relatively easy [Evans]), but biasing a trial to produce a false negative result is very easy — for example, in a trial of an antiviral that works within the first 24 hours of symptom onset, trial organizers only need to avoid treating people within the first 24 hours; or with a disease like COVID-19, organizers only need to select a low-risk population where most people recover quickly without treatment. We note that, even under the very suboptimal designs, these trials produced positive results, although without statistical significance.”

The major donors of the study were a group called the Rainwater Charitable Foundation which in 2018 was given $19,681,052 by the Fort Worth Children’s Partnership (FWCP).
The FWCP was given $211,300 by the (drum roll please) Bill & Melinda Gates Foundation in 2020.
Fast Grants was the other contributor, which is made up of a group of billionaires which include, The Audacious Project which is funded by Bill Gates, The Chan Zuckerberg Initiative, which the Facebook founder has essentially made his own version of the Bill & Melinda Gates Foundation. At the initiative, Zuckerberg funds & “creates tools'' in order to identify NEW ways to treat disease, something that an effective Ivermectin would render useless If it was found to treat not just Covid, but the list of other diseases that it is touted to be able to treat.
Zuckerberg actively funds the “neutral” FastGrants to the tune of millions of dollars, as do other tech heavyweights like Jack Dorsey, Reid Hoffman, Elon Musk, Chris and Crystal Sacca.
Schmidt Futures (Eric & Wendy Schmidt from Google) give money to FastGrants while also actively funding new DNA sequencing and new technologies merging AI and Biologics with their collaboration with the Broad institute to “connect biology & machine learning for understanding programs of life”.
Where have we heard this machine-human hybrid talk before, “cough cough”? Did someone say Klaus Shwab & the World Economic Forum?

Google is also directly funding the parent company of AstraZeneca, Vaccitech, which was responsible for the viral vector and blood clot-inducing vaccine Oxford-AstraZeneca.
Currently, Fast Grants is funding 24 different Sars-COV-2 vaccines as well as discrediting its biggest (and cheapest) rival, Ivermectin. Not including any vaccines funded by individual investors.
Not sure how you read it, but to me, this is a massive conflict of interest and has big tech, big pharma, and Bill Gates fingerprints all over it!
As I said at the start of this article, I am not a scientist nor I am a doctor. But I do have a basic understanding of the terminology used in scientific studies and even I can see this for what it is.
I’ve only begun to scratch the surface of the lies and fraud that have gone into this paper.
I have heard rumors that this very paper has been doing the rounds in the peer review circles for around 6 months, trying to find scientists and journals corrupt enough to give it the tick of approval for publication, and even with this, it still shows positive efficacy for treating Covid-19 in the early stages.
The efforts that have gone into discrediting this drug have been nothing less than extraordinary. And this only tells us one thing. This drug works, and if the truth is allowed to come out, the ‘Pandemic’ would be over.
This is something that the ‘powers-that-be’ cannot allow to happen.

Brisbane Times Article

https://web.archive.org/web/20220401141543/https://www.brisbanetimes.com.au/national/major-study-confirms-ivermectin-useless-against-covid-19-20220330-p5a9bp.html

Ivermectin Meta Study

https://ivmmeta.com/

The BBC’s recent article “False Science” disintegrates under scrutiny.

https://bird-group.org/the-bbcs-recent-article-false-science-is-disintegrating-under-scrutiny/

NEJM full study

https://www.nejm.org/doi/10.1056/NEJMoa2115869

Disclosure statement

https://www.nejm.org/doi/suppl/10.1056/NEJMoa2115869/suppl_file/nejmoa2115869_disclosures.pdf

Nobel Prize 2015

https://www.nobelprize.org/prizes/medicine/2015/press-release/

Fort worth charitable foundation & the gates foundation

https://www.gatesfoundation.org/about/committed-grants/2020/08/inv021297

Zuckerberg Foundation & Pharma

https://www.pharmaceutical-business-review.com/news/facebooks-mark-zuckerberg-announces-3bn-funding-to-help-cure-diseases-5012395/

Broad Institute & Schmidt Futures

https://www.broadinstitute.org/news/broad-institute-launches-eric-and-wendy-schmidt-center-connect-biology-machine-learning

Ivermectin Toxicity

https://www.cell.com/trends/parasitology/fulltext/S1471-4922(14)00126-3

FastGrants Donor List

https://fastgrants.org/

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Novavax - hope or hype?

4/1/2022

1 Comment

By - Robyn Chuter

I have had more requests to write an article about the Novavax COVID-19 vaccine1 than about any other topic during the entire manufactured crisis of the past two years. I’ve been holding back until I felt I had enough information to make it worth your while to read. I’ll be adding to this article as more data come in, so check back in on it from time to time.

As one of my correspondents put it, the Novavax vaccine is “being subtly pushed by doctors to get the people who for various reasons did not want the usual culprit vaccines [i.e. the mRNA and viral vector injections, which many resisted due to concerns about novel technologies and adverse reactions] but who may be persuaded that this one is different”.
It’s a strange state of affairs when a product’s marketing angle is “Not nearly as dangerous as its competitors!”… but here we are.

So just what is the Novavax shot, what technology is used to produce it, who is making it, what’s in it, is it safe, and is it effective at reducing the risk of infection with SARS-CoV-2 and the development of COVID-19?
What is the Novavax injection?The Novavax vaccine, officially designated “SARS-CoV-2 rS (NVX-CoV-2373)”, is branded in Australia as Nuvaxovid, for reasons presumably best known to its sponsors who no doubt spent a small fortune on focus groups to pick a catchy name for their product.
Unlike traditional vaccines against viral diseases, which are produced by growing viruses in chicken eggs, then harvesting the virus from the eggs and either attenuating (weakening) or inactivating (killing) it, Nuvaxovid uses recombinant DNA technology.

Recombinant technology is a relative newcomer to the vaccine manufacturing space; the US Food and Drug Administration (FDA) approved the first recombinant influenza vaccine in 2013.
Recombinant vaccines are created synthetically, by inserting a gene that codes for a viral protein that triggers the human immune system – known as an antigen – into a baculovirus (a virus that infects invertebrates) to produce a “recombinant” baculovirus. Host cells are then deliberately infected with the recombinant baculovirus, forcing them to make many copies of the viral antigen. The antigen is then collected, purified, and combined with chemicals that ramp up the immune system’s response to antigens – known as adjuvants – to produce a vaccine.
In the case of the Novavax shot, the viral antigen is a modified version of the spike protein of the original Wuhan strain of SARS-CoV-2, the host cells are derived from the immature ovaries of the pupae of fall armyworm moths (Spodoptera frugiperda), and the adjuvant is Matrix-M, which is a combination of two saponins (soap-like substances) derived from the sap of the soapbark tree (Quillaja saponaria) encased in cholesterol nanoparticles to reduce their toxicity to human cells. The spike proteins harvested from the moth cells are assembled onto synthetic lipid nanoparticles, each displaying up to 14 spike proteins.

Who makes the Novavax vaccine?Novavax, a company based in the US state of Maryland, describes itself as “a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases.”
Novavax claims that they have “more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS”. Yet, just like mRNA injection producer Moderna, Novavax had never brought any of its candidate vaccines to market until the unprecedented global response to COVID-19 crisis helped to “blow the system up”, smashing barriers to the acceptance of novel vaccine technologies in just the way that New Yorker staff writer, Michael Specter, salivated over in the October 2019 Milken Institute gabfest on developing a universal flu vaccine (start watching around 8:10 for Specter’s spiel):
How does a for-profit organisation persist since 1987, continuing to pay staff and pull in funding for its research and development, without managing to produce a single marketable product? I guess it pays to have friends in the right places.

And Novavax certainly appears to have the right kind of friends, managing to attract funding from the Bill Gates-founded Coalition for Epidemic Preparedness Innovations (CEPI) to the tune of up to US$388 million for its COVID-19 vaccine candidate, along with a cool US$1.6 billion from the US government-sponsored Operation Warp Speed program to fast-track the development of vaccines for COVID-19. The US Department of Defense awarded Novavax a $70 million contract for producing their vaccine in June 2020, despite the Phase 1 (preliminary immunogenicity and safety) trial having only begun in May 2020, with results not reported until July 2020 – a month after the contract was inked.
What’s in the Novavax vaccine?In addition to the bioengineered spike protein, the TGA Product Information document lists the following excipients:

Dibasic sodium phosphate heptahydrate
Monobasic sodium phosphate monohydrate
Sodium chloride
Polysorbate 80
Sodium hydroxide (for adjustment of pH)
Hydrochloric acid (for adjustment of pH)
Water for Injections
Adjuvant (Matrix M)
- Quillaja saponaria saponins fraction A
- Quillaja saponaria saponins fraction C
- Cholesterol
- Phosphatidyl choline
- Monobasic potassium phosphate
- Potassium chloride

While most of these ingredients are quite innocuous, polysorbate 80 is associated with an increased risk of colorectal cancer when consumed as a food additive, and is linked to hypersensitivity systemic reactions (such as anaphylaxis), kidney and liver toxicity and increased susceptibility of cells to oxidative stress when used in drugs that enter the bloodstream. Polysorbate 80 also facilitates the transport of drugs across the blood brain barrier, the structure which hinders the entry of most substances into the delicate neural tissue that comprises the brain. The implications of this for a drug that contains a spike protein which is known to cause inflammation within the brain and suspected to be responsible for the fatigue and neuropsychiatric symptoms that characterise both acute and long COVID, are deeply concerning. Does the presence of polysorbate 80 in the Novavax shot increase uptake of spike protein into the brain? And if so, how does this affect the risk of stroke, vascular dementia, and cognitive dysfunction?
These are the types of questions that one would expect to be answered in preclinical studies, that is, studies performed on laboratory animals (sorry, vegans, but if you’re going to take pharmaceutical products, you have to know that vast numbers of rodents, primates and other non-human animals are tortured and sacrificed by this industry every year). So…
What did the studies on Nuvaxovid show?The preclinical Australian Product Information document for Nuvaxovid states only that genotoxicity tests (i.e. studies to detect damage to chromosomes) were carried out only the Matrix-M adjuvant, not on the whole product, and that

“Carcinogenicity studies were not performed. The components of the vaccine are not expected to
have carcinogenic potential.”

“Not expected to have carcinogenic potential”? What about the demonstrated colon cancer-accelerating effect of polysorbate 80? Sure, carcinogenesis has only been demonstrated so far with oral dosing of polysorbate 80, but the mechanism of action is promotion of inflammation, which is known to increase the risk of all manner of cancers. And since the spike protein itself triggers inflammation, there may be a synergistic effect on cancer promotion when polysorbate 80 is delivered in combination with spike protein.
Clinical trials – Phase 1 & 2Moving onto studies in humans (clinical trials), a combined Phase 1/2 trial to evaluate safety and immunogenicity in 131 healthy Australian adults concluded that the product – which was tested in a number of different formulations – induced higher antibody levels than infection with SARS-CoV-2, as well as a robust T cell response, and had an acceptable safety profile, with no serious adverse events. Notably, however, only those who received the vaccine reported adverse reactions ranked as “severe” (i.e. none occurred in the placebo group) and severe reactions were more common after the second shot than after the first:

A larger Phase 2 trial enrolling 1288 participants from the US and Australia once again found a stronger neutralising antibody response after vaccination than in convalescent sera – that is, the antibodies from vaccinated individuals were better at killing SARS-CoV-2 than antibodies from people who had recovered from infection, but notably, both were tested against the original Wuhan version of the virus (“wild type”) which was no longer in circulation at the time the study took place, having long since been replaced by a series of variants.
Once again, moderate to severe adverse reactions were more frequent after the second shot than the first. They also occurred more frequently in the higher-dose version of the vaccine. One vaccine recipient developed myocarditis three days after the second dose, and was hospitalised.

Clinical trials – Phase 3
1. The UK studyThe first Phase 3 trial to be published, in June 2021, randomised over 15 000 UK adults to receive either two doses of the lower dose version of the Novavax vaccine, or saline placebo injection, three weeks apart. The triumphant conclusion of the study was that the two-dose regimen “conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 [Alpha] variant”. But what does this actually mean?
The primary end point of the trial was the “first occurrence of virologically confirmed symptomatic mild, moderate, or severe Covid-19 with onset at least 7 days after the second dose among participants who were seronegative at baseline, as determined by the results of testing for anti–nucleocapsid antibody. Symptomatic Covid-19 was defined according to the criteria of the FDA.”
In other words, anyone who reported even the mildest of generic respiratory viral symptoms such as cough, headache or fever and who returned a positive PCR test was declared to “have COVID-19”, even though PCR is not suitable for diagnosing infection. The cycle threshold used for PCR testing was not specified.
Furthermore, there is a 40-100% increased risk of SARS-CoV-2 infection for two weeks after the first Pfizer COVID-19 injection, but since the efficacy calculations in the UK trial excluded all “cases” of COVID-19 that occurred in the 4-week period between the first shot and 1 week after the second shot, it is not known whether the same negative efficacy occurs with the Novavax vaccine.
What is known is that out of the two deaths related to COVID-19 that were reported during the trial (one in the vaccine group and one in the placebo group), “the death in the vaccine group occurred in a 53-year-old man in whom Covid-19 symptoms developed 7 days after the first dose; he was subsequently admitted to the ICU for treatment of respiratory failure from Covid-19 pneumonia and died 15 days after vaccine administration.”
Just in case you missed it, the Novavax vaccine did not reduce the risk of dying of COVID-19. Furthermore, while the authors made much of the fact that the five reported cases of “severe COVID” all occurred in the placebo group, only one of these five required hospital treatment. Three of these “severe” cases attended the emergency department but were not admitted, while the fifth was treated at home.
And oddly, the Novavax shot showed no statistically significant benefit in non-white participants:
So, this much-touted trial demonstrated that Nuvaxovid

Did not prevent death from COVID-19 (1 death each in the placebo and vaccine group)
Did not prevent hospitalisation (1 hospitalisation for COVID-19 in the placebo group, one for immune-mediated myocarditis in the vaccine group)
Reduced the absolute risk of developing any symptom of COVID-19 in the first three months after shot #2 + one week by 1.23% (from 1.37% in the placebo group to 0.14% in the vaccine group).

The trial did not assess whether the vaccine blocked transmission of SARS-CoV-2.

2. The US/Mexico studyJust under 30 000 US and Mexican adults aged over 18 were recruited for this trial, which took place in the first half of 2021, when the Alpha variant was still dominant in North America. Vaccine efficacy was calculated at 90.4%, using the same criteria as in the UK trial: any symptom of COVID-19, along with a positive PCR test, occurring at least 7 days after the second dose.
In all, 14 such “cases” of COVID-19 occurred within the roughly 2 month follow-up time in the 17 312 people who received two doses of the Novavax vaccine per protocol, vs 63 “cases” in the 8140 placebo recipients.
10 moderate and 4 severe cases of COVID-19 were reported in the placebo group (although none appear to have required hospitalisation), and none in the vaccine group. No deaths from COVID-19 occurred in either group.
Efficacy in Latinos was lower than in either non-Latino white, or black people:
Once again, adverse events were reported by more people who received the vaccine than the placebo, and were more frequent after the second vaccine dose. Severe local reactions after dose #2 occurred in less than 1% of placebo recipients vs 6.7% of vaccine recipients. Severe systemic reactions occurred in 2.1% of placebo recipients after dose #2 vs 12.1% of vaccine recipients.
In summary, the US/Mexico trial found that Nuvaxovid:

Did not prevent death or hospitalisation from COVID-19.
Reduced the absolute risk of developing any symptom of COVID-19 in the first two months after shot #2 + one week by 0.69% (from 0.77% in the placebo group to 0.08% in the vaccine group).
Resulted in significantly increased risk of severe local and systemic reactions compared to placebo, particularly after the second dose.

As with the UK trial, this study did not assess whether the vaccine presents transmission of SARS-CoV-2.

3. The South Africa studyIn this study, 4387 South African adults (94% HIV-negative and 6% HIV-positive) received two doses of either Nuvaxovid or placebo, during a period in which the Beta variant of SARS-CoV-2 was dominant. Using the same criteria as for the UK and US trials, vaccine efficacy was found to be just 49.4% overall, and 60.1% in HIV-negative participants. In roughly 60 days of follow-up, symptomatic COVID-19 was observed in 15 participants out of the 1357 in the vaccine group who completed the study per protocol, and in 29 participants out of the 1327 in the placebo group.
No COVID-related deaths or hospitalisations occurred in either the vaccine or placebo group, and only one of the 29 “cases” of COVID-19 that occurred in the placebo group was rated as severe.
Medically attended adverse events and serious adverse events occurred more often in the vaccine group than in the placebo group (13 vs. 6 medically attended adverse events and 2 vs. 1 serious adverse events).
In summary, the South African trial found that Nuvaxovid:

Did not reduce the risk of hospitalisation or death from COVID-19.
Reduced the absolute risk of developing any symptom of COVID-19 in the first two months after shot #2 + one week by 1.08% (from 2.19% in the placebo group to 1.11% in the vaccine group).
Doubled the risk of experiencing a medically attended adverse event or serious event.

And, as with the UK and US/Mexico trials, the South African study did not assess whether the vaccine presents transmission of SARS-CoV-2.
The TGA granted provisional approval to Nuvaxovid on these data????You’ll forgive me for being just a little underwhelmed by the efficacy data on the Novavax shot. The three flagship trials on which TGA granted provisional approval for Nuvaxovid show no mortality benefit and no reduction in hospitalisation risk. They also don’t demonstrate any community benefit, because prevention of transmission of SARS-CoV-2 wasn’t an endpoint.
The trade-off for the 0.69-1.23% reduction in your risk of developing any respiratory tract symptom with a positive PCR test for SARS-CoV-2 is a significantly elevated risk of severe local and systemic adverse reactions.
In addition to the two myocarditis cases identified in the Phase 1/2 trial and the UK trial, the European Medicine Agency’s assessment of Nuvaxovid identified a third case, which occurred in a participant in the placebo group who was given the vaccine after the follow-up period was completed.
Hypertension (high blood pressure) was also identified as an adverse reaction to Nuvaxovid; a pooled safety analysis found 4 serious adverse events of hypertension as well as 13 severe cases of hypertension. They also noted more serious adverse events of prostate cancer (5 in the vaccine group vs 0 in the placebo group) and stroke (7 vs 1).
ATAGI’s advice contradicts the TGAThe conflict of interest-ridden Australian Technical Advisory Group on Immunisation (ATAGI) issued a statement on the use of Novavax COVID-19 vaccine (Nuvaxovid) which contradicts the product information document issued by TGA.
For example, TGA takes a cautious approach to use in pregnancy and breastfeeding:
ATAGI, on the other hand, throws caution to the wind:
TGA acknowledges that there is scant data on efficacy and safety in immunocompromised people, and none on “mixing and matching” Nuvaxovid with other COVID-19 vaccines:
ATAGI makes no such acknowledgement of the lack of data and has no qualms whatsoever about tacking a dose of Nuvaxovid onto a primary course of a different type of COVID-19 vaccine:
What are we to make of this conflicting guidance – and why is ATAGI permitted to issue recommendations that contradict the TGA, without providing any of the evidence that TGA says is missing, in support of its position?
Adverse event reports call for cautionNuvaxovid was only granted provisional approval in Australia in late January 2022, but adverse event reports are already piling up.
AuxVaxSafety, which solicits adverse event reports from a subset of vaccine recipients on the third day after vacination, reports that 2 in 100 Australians who received Nuvaxovid have sought their doctor’s advice or presented to an emergency department in the days after their first dose, and 15% were unable to attend work or school or perform normal duties.
As of 18 March 2022, 233 adverse reactions to Nuvaxovid had been reported to TGA’s Database of Adverse Event Notifications (DAEN), including 61 cases of chest pain, 29 cases of chest discomfort, 8 of pericarditis and 6 of hypertension, along with 60 cases of headache, and 56 cases of paraesthesia (a sensation of pricking, tingling, or creeping on the skin having no objective cause and usually associated with injury or irritation of a sensory nerve or nerve root).
There are some rather graphic descriptions of three of these adverse reactions, drawn from social media posts made by the people who suffered them, here.
Even if adverse reactions to the Novavax vaccine are rarer than to the AstraZeneca, Pfizer and Moderna shots, any risk at all is, in my opinion, a completely unacceptable price to pay for a product that offers no clinically meaningful benefit to individuals nor any social benefit.
So, don’t bother inviting me to join your Novastan cult. I’m staying in the control group.
For information on my private practice, please visit Empower Total Health. I am a Certified Lifestyle Medicine Practitioner, with an ND, GDCouns, BHSc(Hons) and Fellowship of the Australasian Society of Lifestyle Medicine.
1
Unlike the mRNA and viral vector injections, Novavax’s product does fulfil the technical definition of a vaccine as a preparation containing either a live, dead or attenuated pathogen or toxin.

https://robynchuter.substack.com/
https://empowertotalhealth.com.au/

1 Comment

The great molnupiravir swindle

Are doctors the new antivaxxers?

Why you need to stop saying “I’m not an antivaxxer, but…”

The strange tale of hydroxychloroquine

"Major study confirms ivermectin useless against COVID-19"

Novavax - hope or hype?

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