Σκάνδαλο στη Γερμανία! Τεστ PCR... ένα ακριβοπληρωμένο σκουπίδι!

Ένα μεγάλο σκάνδαλο ξεσπάει στην Γερμανία, αλλά και σε ολόκληρο τον κόσμο, μετά την δημοσίευση συμπερασμάτων 23 διεθνών ιολόγων, μικροβιολόγων και σχετικών επιστημόνων, που αποδεικνύουν ότι... όλα τα τεστ PCR, σε πραγματικό χρόνο (RT-PCR) βγαίνουν "ΨΕΥΔΩΣ ΘΕΤΙΚΑ"! (Έκθεση Μπόργκερ). Σ΄αυτά τα τεστ βασίστηκε όλη η πολιτική "αντιμετώπισης της πανδημίας". Οι έρευνες, οι δρακόντιες επιστημονικές συμβουλές, για οικονομικά λοκντάουν, για πρόστιμα, ξύλο, συλλήψεις, κοινωνική αποστασιοποίηση. Το σκάνδαλο περιλαμβάνει τον ας τον πούμε "Τσιόδρα της Γερμανίας", επικεφαλής της συμβουλευτικής ομάδας της Μέρκελ, για τον ιό, δόκτωρα Κρίστιαν Ντρόστεν. Από τις 23 Ιανουαρίου του 2020, όταν οι θάνατοι, στην Κίνα, έφταναν μόλις τους 6 νεκρούς, ο Ντρόστεν με αρκετούς συναδέλφους του, στο Ινστιντούτο Ιολογίας του Νοσοκομείου "Σαριτέ", καθώς και με τον επικεφαλής μιας μικρής εταιρίας βιοτεχνολογίας στο Βερολίνο , την "TIB Molbiol Syntheselabor GmbH" δημοσίευσε μία μελέτη, στο επιστημονικό περιοδικό "Eurosurveillance" , του Κέντρου Πρόληψης και Ελέγχου Νόσων της ΕΕ. Το άρθρο είχε τίτλο "Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR" (Eurosurveillance 25 (8) 2020). Ο Ντρόστεν και η ομάδα του ισχυρίζονταν ότι ανέπτυξαν την πρώτη αποτελεσματική δοκιμή, για την ανίχνευση του ιού. Τα νέα χαιρετίστηκαν με άμεση έγκριση του τεστ, από τον διεφθαρμένο Γενικό Διευθυντή του Παγκόσμιου Οργανισμού Υγείας, του ΜΟΝΟΥ μη γιατρού επικεφαλής, Τέντρο Ανχάνομ. Το ίδιο έκανε και η Μέρκελ. Έκτοτε, το τεστ, που υποστηρίζεται από τον Ντρόστεν για τον ιό, έχει εξαπλωθεί μέσω του ΠΟΥ σε όλο τον κόσμο, ως το πιο χρησιμοποιούμενο πρωτόκολλο δοκιμών για να προσδιορίσει εάν ένα άτομο μπορεί να έχει COVID-19. Η πρώτη κίνηση που έκαναν οι 23 επιστήμονες, στις 27 Νοεμβρίου, μετά από μελέτες, ήταν να ζητήσουν από το επιστημονικό περιοδικό, την απόσυρση του "πονήματος" Ντρόστεν, κατηγορώντας αυτόν και την ομάδα του, για "θανατηφόρα" επιστημονική ανικανότητα και ελαττώματα στην προώθηση των τεστ. "Το έγγραφο Corman-Drosten υποβλήθηκε στην Eurosurveillance στις 21 Ιανουαρίου 2020 και έγινε δεκτό για δημοσίευση στις 22 Ιανουαρίου 2020. Στις 23 Ιανουαρίου 2020 το έγγραφο ήταν online." τονίζουν οι επιστήμονες. Και μάλιστα, το πρωτόκολλο δοκιμής του Ντρόστεν είχε αποσταλεί και υιοθετηθεί, από τον ΠΟΥ, ως παγκόσμιο τεστ, που επιβεβαιώνει την ύπαρξη του ιού, στις 17 Ιανουαρίου, ΠΡΙΝ ΚΑΝ ΔΗΜΟΣΙΕΥΤΕΙ, στο επιστημονικό περιοδικό! Τόσο ο Ντρόστεν, όσο και ο συν-συγγραφέας της "έρευνας" δεν αποκάλυψαν, ούτε την σύγκρουση συμφερόντων, που υπήρχε. Ήταν και οι δύο μέλη της συντακτικής ομάδας του επιστημονικού περιοδικού. Ένα ακόμη μέλος της ομάδας του Ντρόστεν, που έδωσε μια κάλυψη φαινομενικής αξιοπιστίας του τεστ, ήταν ο Ολφερτ Λάντ, επικεφαλής της εταιρίας "Tib-Molbiol", στο Βερολίνο, που ανέλαβε την παραγωγή των τεστ και που ούτε κι αυτός αποκάλυψε την δεύτερη ιδιότητα του. Ο ίδιος ο Ντρόστεν και οι επικεφαλής, στο Πανεπιστήμιο Goethe της Φρανκφούρτης, όπου ισχυρίζεται ότι έλαβε το διδακτορικό του το 2003, κατηγορούνται για απάτη πτυχίου. Ο Δρ Markus Kühbacher, ένας ειδικός που διερευνά την επιστημονική απάτη όπως και τις λογοτεχνικές διατριβές, κατηγορεί το Πανεπιστήμιο, για συγκάλυψη μιας διατριβής που ουδέποτε είχε κατατεθεί και έπρεπε να υπάρχει σε τρία αντίτυπα. Τα δύο αντίγραφα "εξαφανίστηκαν" και το τρίτο και μοναδικό έχει υποστεί ζημιά, από το νερό! Ο Ντρόστεν θ΄αντιμετωπίσει κατηγορία, για κατοχή ψευδούς διδακτορικού τίτλου. Με απλά λόγια, όλο το οικοδόμημα του Ιδρύματος Γκέιτζ, της κυβέρνησης Μέρκελ, του ΠΟΥ και του Παγκόσμιου Οργανισμού Φαρμάκων(WEF), όπως και τα μη δοκιμασμένα εμβόλια, στηρίχθηκαν στ΄αποτελέσματα ενός τεστ PCR, που δεν είναι τίποτα παραπάνω από ένα ακριβοπληρωμένο σκουπίδι! Επισυνάπτω την μελέτη των 23 επιστημόνων: https://cormandrostenreview.com/report/?fbclid=IwAR1TzeLoq3mpuJUmealJhSCaeNyEYAyp8qX1gIDCs3MgLWkdy56LCyovv28

Covid-19: Vaccine trials need more transparency to enable scrutiny and earn public trust, say experts

Eleven covid-19 vaccine candidates are in phase III clinical trials. But while the scientists involved have been praised for their speed, others are calling for more transparency to ensure studies are robust and the evidence is sound. Elisabeth Mahase reports “These are unprecedented times and these are unprecedented clinical trials . . . This can’t be business as usual,” says Jason Schwartz, assistant professor of public health at Yale School of Public Health. Schwartz says that transparency is crucial to ensure that the scientific community can review and scrutinise the work but also to build public understanding and confidence in the much anticipated potential covid-19 vaccines. However, not all transparency is equal, he adds. “It needs to be the kind of transparency that isn’t filtered through corporate press releases or statements to investors, or a kind of pseudo-transparency in which the manufacturers are trying to massage or control the message. [It needs to be] real transparency in terms of the kinds of documents and materials that can help the public, and especially the broader scientific community, both understand the design of these trials and ultimately understand how to interpret the results from them.” Show your working A key document to understanding how trials are being run is the study protocol. After pressure from scientists and public health experts, four major protocols of covid vaccine trials have now been made public. These include AstraZeneca’s halted US study of the University of Oxford’s AZD1222 vaccine candidate,1 the Pfizer and BioNTech study of their BNT162b,2 Moderna’s study of its mRNA-1273,3 and the Johnson & Johnson Ad26.COV2.S.4 Additionally, the Oxford team has published the information sheets provided to trial participants,5 a move towards transparency that other companies seem not to have followed. Moderna, Pfizer, and BioNTech did not respond to several BMJ requests for the informed consent forms or offer an explanation as to why they would not publish them. Schwartz credits those trial sponsors that have listened. “The release of the protocols was really important and, as far as I know, an unprecedented step so early in the conduct of the trial . . . The consent documents are certainly important to help us understand the ethics of these trials and help understand how the research subjects are being informed about their participation and the risks and benefits of it.” However, he added that there was plenty more that could be shared in the form of real objective documents about plans, relationships, and scientific standards. Schwartz has called for trial sponsors to share these raw materials to “help the scientific community understand the work that’s ongoing and help the public understand what is usually a process that rarely gets this kind of widespread scrutiny.” Who has oversight? One key area that Schwartz is interested in relates to the independent boards that review the data from these clinical trials. “These data and safety monitoring boards [DSMBs] will be undertaking those interim reviews of the trials and potentially stopping the trial because the evidence is so favourable or, conversely, the evidence is so unfavourable or there’s a serious safety issue. DSMBs are so important, particularly if these vaccines get an expedited review and potential authorisation here in the US by the Food and Drug Administration,” he explains. Despite the importance of the DSMBs, little is known about their standards. “There’s more we can learn about the groups and their approaches [and] plans, since that seems to be a really important lever,” says Schwartz. In the US a joint DSMB has been formed to review unblinded data from several trials being run in the country, including the Moderna, Johnson & Johnson, and AstraZeneca trials, but not Pfizer’s. Although the identity of the board’s 10-15 members has mostly remained confidential, the chair—appointed by the director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci—has been revealed as Richard Whitley. Whitley is a professor of paediatrics and co-division director of paediatric infectious diseases at the University of Alabama. He also sits on the board of directors of the drug company Gilead, for which he was paid roughly $430 000 in 2019.6 The bioethicist Charles Weijer, who specialises in the ethics of health related randomised controlled trials at Western University, Ontario, thinks the entire membership of these DSMBs should be made public. “Public confidence in judgments [made by these groups] will be enhanced by knowing that committee members possess requisite expertise and have no relevant conflicts of interest. While this is not usual practice in clinical trials, this step is required to bolster public trust in covid-19 vaccine research.” Weijer receives consulting income from the drug company Eli Lilly. Schwartz would also like to see more information made public on the contractual agreements between manufacturers and their government sponsors. “[These agreements] have been shielded from public view, and I think that’s detrimental to understanding the nature of these relationships and partnerships,” he says. Ending trials early A key role that DSMBs could play is in stopping vaccine trials early. Fauci, who advises the White House on covid-19, has said this can happen if the boards decide the data are good and a vaccine is safe and effective. He emphasised that those making such a decision “better be sure” that the evidence was good but said there would be a “moral obligation” to get the vaccine to the public earlier if it really was safe and effective.7 At this point, Schwartz says transparency will be crucial. “The real critical moment and opportunity for transparency will be when we get to the point where decisions by regulatory bodies are going to be made based on the products in these trials. And I think that’s where the light will and should shine, with even greater focus.” Being transparent about how such a decision is made will be even more important given the unease that has built up that a vaccine might be approved prematurely. Concerns have grown over potential political pressure to rush out a vaccine before the science is clear since comments made by Donald Trump, in which he hinted that a vaccine could be made available before the 3 November presidential election.8 This seemed to have prompted the heads of nine drug companies—AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck/MSD, Moderna, Novavax, Pfizer, and Sanofi—to sign an open letter committing to submit for approval or emergency use authorisation only after “demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA [the US Food and Drug Administration].”9 And in early October the FDA published new guidance stating that it would require at least two months of follow-up data after trial participants received all doses of a vaccine, leading many people to conclude that a so called “October surprise” was no longer possible.10 But Weijer thinks that those responsible should go further and publicly confirm that they will not end trials early if they get a positive efficacy signal during interim analysis. “We really need safety information on the full planned sample size in order to give us the sort of good grounds to believe not only that a vaccine works but, crucially, that it’s safe,” he says. “We’re going to be giving this vaccine to hundreds of millions of healthy people. To be able to reliably detect a very rare adverse event which is associated with the vaccine—so that’s something that occurs in one in 10 000 people—you need safety data on 60 000 people,” he says. The importance of ensuring that vaccines are not rushed out is something emphasised by experts from the UK Royal Society’s DELVE (Data Evaluation and Learning for Viral Epidemics) initiative,11 which has published a report on the development and implementation of covid-19 vaccines.12 “If vaccines were deployed outside clinical trials before safety and efficacy have been fully established and prove to be ineffective or cause rare but severe side effects during the larger-scale roll-out, they could cause substantial harm and damage public confidence in other vaccines,” DELVE warned. The DELVE team also highlighted the importance of transparency when it comes to the limitations of any vaccine: “Clear, transparent communication can be used to address rational doubts and to enable informed decision-making . . . it should not hide the potential limitations of vaccines including possible limited availability, incomplete protection requiring boosting, and reactogenicity.” The report says that although “negative or complicating factors might lower uptake, their discovery post-rollout is likely to have a far greater negative impact on uptake.” Trial transparency gone awry In September the University of Oxford and AstraZeneca’s vaccine candidate made headlines after the trials were paused around the world (including in the US, UK, Japan, India, Brazil, and South Africa) while an investigation was carried out into a “single event of an unexplained illness.” Experts have made it clear that pauses in vaccine trials are common and a sign that the trial’s oversight process is working.13 While this was the first time a pause of the trial had been announced, it was not actually the first time it had been halted. The patient information sheet from 12 July shows that it was paused earlier in the year after one trial volunteer developed symptoms of transverse myelitis.14 But bioethicist Charles Weijer of Western University, Ontario, told The BMJ that the disclosure of the serious adverse events in the Oxford trial patient information sheet “is not, in my view, adequate.” When he compared different versions of the sheet,15 he noted that while transverse myelitis was initially mentioned, this was then removed and replaced with “vaguer language.” The 11 September version said that volunteers had “developed unexplained neurological symptoms including changed sensation or limb weakness.” It was reported in the media that the second serious adverse event in September may have been transverse myelitis, although this was not confirmed, and that the patient was admitted to hospital as a result. It was then reported that the patient was set to be discharged from hospital, but no further updates have been provided. “Prospective participants are not informed that, if media reports are to be believed, the second case of transverse myelitis was sufficiently severe as to warrant hospital admission,” says Weijer. “Consent documents should contain a clear and accurate description of any serious adverse events. Certainly, they should contain more information than a prospective or current participant could discover with a Google search of the vaccine trial.” The handling of the trial pause has also been criticised in terms of how the information was communicated to the public. “It’s transparency gone awry,” says Jason Schwartz, assistant professor of public health at Yale School of Public Health. “We know we’ve received only very, very fragmentary information about the nature of the events that occurred. Details about what it was were mostly, as I understand it, made public through a call to investors . . . I think there was a failure in terms of how there were just drips of information and uncertainty and missing details to help contextualise what that signal was.” Trials of this vaccine have resumed in Japan, the UK, Brazil, South Africa, and India. Despite this, AstraZeneca’s US based trial has not been restarted, with the Food and Drug Administration recently broadening its safety investigation.16 But this is not the only trial paused because of adverse events. On 12 October Johnson & Johnson announced that it had paused dosing in all its covid-19 vaccine trials while an investigation was carried out into an unexplained illness in a study participant. The company did not seem to be upfront about the issue: the pause was first revealed by the US media outlet STAT.17 It remains to be seen whether lessons from the Oxford and AstraZeneca trial have been learnt. https://www.bmj.com/content/371/bmj.m4042

 

Covid-19 vaccine trials cannot tell us if they will save lives

None of the current trials are designed to detect a reduction in any serious outcome such as hospitalisations, intensive care use, or deaths

Vaccines are being hailed as the solution to the covid-19 pandemic, but the vaccine trials currently underway are not designed to tell us if they will save lives, reports Peter Doshi, Associate Editor at The BMJ today.

Several covid-19 vaccine trials are now in their most advanced (phase 3) stage, but what will it mean exactly when a vaccine is declared “effective”? 

Many may assume that successful phase 3 studies will mean we have a proven way of keeping people from getting very sick and dying from covid-19. And a robust way to interrupt viral transmission.

Yet the current phase 3 trials are not actually set up to prove either, says Doshi. 

“None of the trials currently underway are designed to detect a reduction in any serious outcome such as hospitalisations, intensive care use, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus,” he writes.

He explains that all ongoing phase 3 trials for which details have been released are evaluating mild, not severe, disease - and they will be able to report final results once around 150 participants develop symptoms.

In Pfizer and Moderna’s trials, for example, individuals with only a cough and positive lab test would bring those trials one event closer to their completion.

Yet Doshi argues that vaccine manufacturers have done little to dispel the notion that severe covid-19 was what was being assessed. 

Moderna, for example, called hospitalisations a “key secondary endpoint” in statements to the media. But Tal Zaks, Chief Medical Officer at Moderna, told The BMJ that their trial lacks adequate statistical power to assess that endpoint.

Part of the reason may be numbers, says Doshi. Because most people with symptomatic covid-19 infections experience only mild symptoms, even trials involving 30,000 or more patients would turn up relatively few cases of severe disease. 

“Hospitalisations and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30,000 people,” he adds. “The same is true regarding whether it can save lives or prevent transmission: the trials are not designed to find out.” 

Zaks confirms that Moderna’s trial will not demonstrate prevention of hospitalisation because the size and duration of the trial would need to be vastly increased to collect the necessary data. “Neither of these I think are acceptable in the current public need for knowing expeditiously that a vaccine works,” he told The BMJ.

Moderna’s trial is designed to find out if the vaccine can prevent covid-19 disease, says Zaks. Like Pfizer and Johnson and Johnson, Moderna has designed its study to detect a relative risk reduction of at least 30% in participants developing lab-confirmed covid-19, consistent with FDA and international guidance.

Zaks also points to influenza vaccines, saying they protect against severe disease better than mild disease. “To Moderna, it’s the same for covid-19: if their vaccine is shown to reduce symptomatic covid-19, they will feel confident it also protects against serious outcomes,” Doshi writes.

But Doshi raises another important issue - that few or perhaps none of the current vaccine trials appear to be designed to find out whether there is a benefit in the elderly, despite their obvious vulnerability to covid-19.

If the frail elderly are not enrolled into vaccine trials in sufficient numbers to determine whether there is a reduction in cases in this population, “there can be little basis for assuming any benefit against hospitalisation or mortality,” he warns.

Doshi says that we still have time to advocate for changes to ensure the ongoing trials address the questions that most need answering.

For example, why children, immunocompromised people, and pregnant women have largely been excluded; whether the right primary endpoint has been chosen; whether safety is being adequately evaluated; and whether gaps in our understanding of how our immune system responds to covid-19 are being addressed.

“The covid-19 vaccine trials may not have been designed with our input, but it is not too late to have our say and adjust their course. With stakes this high, we need all eyes on deck,” he argues.

[Ends]

21/10/2020

Feature: Will covid-19 vaccines save lives? Current trials are not designed to tell us
Journal: The BMJ

Funding: None

Link to Academy of Medical Sciences press release labelling system: https://press.psprings.co.uk/AMSlabels.pdf
Peer reviewed? Yes
Evidence type: Feature
Subjects: Covid-19 vaccine trials

https://www.bmj.com/company/newsroom/covid-19-vaccine-trials-cannot-tell-us-if-they-will-save-lives/?fbclid=IwAR0IQ1AbIzmZDRzYnKIZhKH6ri9U1LaA6N79D4rY3512cBt7oSXfjuvMeUU

DEC 3 Ο Δρ. Wodarg και ο Dr. Yeadon ζητούν διακοπή όλων των μελετών εμβολιασμού του Κορονοιού, Κάλεσμα για να υπογράψετε την ΑΙΤΗΣΗ

 

Ο Δρ. Wodarg και ο Dr. Yeadon ζητούν να σταματήσουν όλες οι μελέτες εμβολιασμού για τον κορονοίο και συνυπογράφουν την αναφορά

2020 ΝΕΑ

Την 1η Δεκεμβρίου 2020, ο πρώην επικεφαλής του τομέα έρευνας αναπνευστικών ασθενειών Dr. Michael Yeadon και ο ειδικός επιδημιολόγος, πνευμονολόγος και πρώην επικεφαλής του τμήματος δημόσιας υγείας Dr. Wolfgang Wodarg υπέβαλαν αίτηση στον EMA, τον Ευρωπαϊκό Οργανισμό Ιατρικής υπεύθυνο για όλη την ΕΕ για την έγκριση φαρμάκων, για την άμεση αναστολή όλων των μελετών εμβολίων SARS CoV 2, ιδίως της μελέτης BioNtech / Pfizer στο BNT162b (αριθμός EudraCT 2020-002641-42).

Ο Dr. Wodarg και ο Dr. Yeadon απαιτούν οι μελέτες - για την προστασία της ζωής και της υγείας των εθελοντών - να μην συνεχιστούν έως ότου υπάρχει διαθέσιμο σχέδιο μελέτης που να είναι κατάλληλο για την αντιμετώπιση των σημαντικών ανησυχιών για την ασφάλεια που εκφράζονται από έναν αυξανόμενο αριθμό γνωστών επιστημόνων κατά του εμβολίου και του σχεδιασμού της μελέτης.

Από τη μία πλευρά, οι αναφέροντες απαιτούν, λόγω της γνωστής έλλειψης ακρίβειας της δοκιμής PCR σε μια σοβαρή μελέτη, πρέπει να χρησιμοποιηθεί η λεγόμενη αλληλουχία Sanger (Sanger sequencing)  . 

Αυτός είναι ο μόνος τρόπος να κάνετε αξιόπιστες δηλώσεις σχετικά με την αποτελεσματικότητα ενός εμβολίου κατά του Covid-19. Βάσει των πολλών διαφορετικών δοκιμών PCR πολύ ποικίλης ποιότητας, ούτε ο κίνδυνος ασθένειας ούτε το πιθανό όφελος του εμβολίου μπορούν να προσδιοριστούν με την απαραίτητη βεβαιότητα, και αυτός είναι ο λόγος για τον οποίο η δοκιμή του εμβολίου στον άνθρωπο είναι ανήθικη.

Επιπλέον, απαιτούν να αποκλειστούν, μπορεί νηα γίνει π.χ. με πειράματα σε ζώα, κίνδυνοι που είναι ήδη γνωστοί από προηγούμενες μελέτες, οι οποίες προέρχονται εν μέρει από τη φύση των κορονοιών. 

Οι ανησυχίες κατευθύνονται συγκεκριμένα στα ακόλουθα σημεία:

Ο σχηματισμός των λεγόμενων ''μη εξουδετερωτικών αντισωμάτων'' ενίσχυση ADE μπορεί να οδηγήσει σε υπερβολική ανοσολογική αντίδραση, ειδικά όταν το εξεταζόμενο πρόσωπο αντιμετωπίζει τον πραγματικό «άγριο» ιό μετά τον εμβολιασμό. 

Αυτή η λεγόμενη ενίσχυση που εξαρτάται από αντισώματα, ADE, είναι από καιρό γνωστή από πειράματα με εμβόλια κορονοιών σε γάτες, για παράδειγμα. Κατά τη διάρκεια αυτών των μελετών, όλες οι γάτες που αρχικά ήταν ανεκτές στο εμβόλιο, μόλις ήρθαν σε επάφή με τον άγριο ιο πέθαναν.(1) (2) (3) (4) (5)

Οι εμβολιασμοί αναμένεται να παράγουν αντισώματα έναντι των ακίδων πρωτεϊνών του SARS-CoV-2. 

Ωστόσο, οι πρωτεΐνες ακίδων περιέχουν επίσης ομόλογες πρωτεΐνες συγκυτίνης, οι οποίες είναι απαραίτητες για το σχηματισμό του πλακούντα σε θηλαστικά όπως οι άνθρωποι. Πρέπει να αποκλειστεί απολύτως ότι ένα εμβόλιο κατά του SARS-CoV-2 θα μπορούσε να προκαλέσει ανοσολογική αντίδραση κατά της συγκυτίνης-1, καθώς διαφορετικά θα μπορούσε να οδηγήσει τις εμβολιασμένες γυναίκες σε στειρότητα αόριστης διάρκειας

Τα εμβόλια mRNA από την BioNTech / Pfizer περιέχουν πολυαιθυλενογλυκόλη (PEG). 

Το 70% των ανθρώπων αναπτύσσουν αντισώματα έναντι αυτής της ουσίας - αυτό σημαίνει ότι πολλοί άνθρωποι μπορούν να αναπτύξουν αλλεργικές, δυνητικά θανατηφόρες αντιδράσεις στον εμβολιασμό.

Η πολύ σύντομη διάρκεια της μελέτης δεν επιτρέπει ρεαλιστική εκτίμηση των μακροχρόνιων αποτελεσμάτων. Όπως και στις περιπτώσεις ναρκοληψίας μετά τον εμβολιασμό της γρίπης των χοίρων, εκατομμύρια υγιείς άνθρωποι θα εκτεθούν σε απαράδεκτο κίνδυνο εάν χορηγηθεί έγκριση έκτακτης ανάγκης και έπειτα θα ακολουθήσει η δυνατότητα παρακολούθησης των μακροχρόνιων επιπτώσεων του εμβολιασμού. Ωστόσο, η BioNTech / Pfizer υπέβαλε αίτηση για έγκριση έκτακτης ανάγκης την 1η Δεκεμβρίου 2020.

ΠΡΟΣΚΛΗΣΗ ΓΙΑ ΒΟΗΘΕΙΑ: Ο Δρ Wodarg και ο Dr. Yeadon ζητούν από όσο το δυνατόν περισσότερους πολίτες της ΕΕ να υπογράψουν την αίτησή τους στέλνοντας το ηλεκτρονικό ταχυδρομείο που προετοιμάστηκε εδώ στον EMA.

Το προσχέδιο του e-mail

Dear Sir or Madam, I am hereby co-signing the petition of Dr. Wodarg and Dr. Yeadon to support their urgent request to stay the Phase III clinical trial(s) of BNT162b (EudraCT Number 2020-002641-42) and other clinical trials. The full text of the petition of Dr. Wodarg and Dr. Yeadon can be found here: 

https://2020news.de/wp-content/uploads/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits.pdf 

I hereby respectfully request that EMA act on the petition of Dr. Wodarg and Dr. Yeadon immediately. 

Regards

Το Ονοματεπώνυμο σας

ΠΡΟΣ

press@ema.europa.eu

ΘΕΜΑ

petitionEMA@corona-ausschuss.com

https://halithheia.blogspot.com/2020/12/wodarg-dr-yeadon.html?m=1&fbclid=IwAR2RGl0JGxR45Hh3OWMLArWE9dap7ZY_x-tAhG1eosskbRWWVUp5EiNzX0Y

Genevieve Briand COVID19 deaths.A look at US data

Δείτε πως αλλοιώνουν τις στατιστικές ,για να δημιουργήσουν μια "πανδημία" .Η "θανατηφόρα ασθένεια" που δεν αυξάνει την συνολικη θνησιμότητα

https://www.schillingshow.com/wp-content/uploads/2020/11/FireShot-Capture-049-A-closer-look-at-U.S.-deaths-due-to-COVID-19-The-Johns-Hopkins-News_-web.archive.org_.pdf

External peer review of the RTPCR test to detect SARS-CoV-2 reveals 10 major scientific flaws at the molecular and methodological level: consequences for false positive results.

 

ABSTRACT

In the publication entitled “Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR” (Eurosurveillance 25(8) 2020) the authors present a diagnostic workflow and RT-qPCR protocol for detection and diagnostics of 2019-nCoV (now known as SARS-CoV-2), which they claim to be validated, as well as being a robust diagnostic methodology for use in public-health laboratory settings. 

In light of all the consequences resulting from this very publication for societies worldwide, a group of independent researchers performed a point-by-point review of the aforesaid publication in which 1) all components of the presented test design were cross checked, 2) the RT-qPCR protocol-recommendations were assessed w.r.t. good laboratory practice, and 3) parameters examined against relevant scientific literature covering the field. 

The published RT-qPCR protocol for detection and diagnostics of 2019-nCoV and the manuscript suffer from numerous technical and scientific errors, including insufficient primer design, a problematic and insufficient RT-qPCR protocol, and the absence of an accurate test validation. Neither the presented test nor the manuscript itself fulfils the requirements for an acceptable scientific publication. Further, serious conflicts of interest of the authors are not mentioned. Finally, the very short timescale between submission and acceptance of the publication (24 hours) signifies that a systematic peer review process was either not performed here, or of problematic poor quality.  We provide compelling evidence of several scientific inadequacies, errors and flaws.

Considering the scientific and methodological blemishes presented here, we are confident that the editorial board of Eurosurveillance has no other choice but to retract the publication.

https://cormandrostenreview.com/report/?fbclid=IwAR2h04ALeer4nYlqf-ZCMgsS4nJTB3DxX98iZMQnr5nljk14A_RdSZDoCWY

Why Face Masks Don’t Work: A Revealing Review

 Yesterday’s Scientific Dogma is Today’s Discarded Fable

by John Hardie, BDS, MSc, PhD, FRCDC

Introduction
The above quotation is ascribed to Justice Archie Campbell author of Canada’s SARS Commission Final Report. 1 It is a stark reminder that scientific knowledge is constantly changing as new discoveries contradict established beliefs. For at least three decades a face mask has been deemed an essential component of the personal protective equipment worn by dental personnel. A current article, “Face Mask Performance: Are You Protected” gives the impression that masks are capable of providing an acceptable level of protection from airborne pathogens. 2 Studies of recent diseases such as Severe Acute Respiratory Syndrome (SARS), Middle Eastern Respiratory Syndrome (MERS) and the Ebola Crisis combined with those of seasonal influenza and drug resistant tuberculosis have promoted a better understanding of how respiratory diseases are transmitted. Concurrently, with this appreciation, there have been a number of clinical investigations into the efficacy of protective devices such as face masks. This article will describe how the findings of such studies lead to a rethinking of the benefits of wearing a mask during the practice of dentistry. It will begin by describing new concepts relating to infection control especially personal protective equipment (PPE).

Trends in Infection Control
For the past three decades there has been minimal opposition to what have become seemingly established and accepted infection control recommendations. In 2009, infection control specialist Dr. D. Diekema questioned the validity of these by asking what actual, front-line hospital-based infection control experiences were available to such authoritative organization as the Centers for Disease Control and Prevention (CDC), the Occupational Safety and Health Association (OSHA) and the National Institute for Occupational Safety and Health (NIOSH). 3 In the same year, while commenting on guidelines for face masks, Dr. M. Rupp of the Society for Healthcare Epidemiology of America noted that some of the practices relating to infection control that have been in place for decades, ”haven’t been subjected to the same strenuous investigation that, for instance, a new medicine might be subjected.” 4 He opined that perhaps it is the relative cheapness and apparent safety of face masks that has prevented them from undergoing the extensive studies that should be required for any quality improvement device. 4 More recently, Dr. R. MacIntyre, a prolific investigator of face masks, has forcefully stated that the historical reliance on theoretical assumptions for recommending PPEs should be replaced by rigorously acquired clinical data. 5 She noted that most studies on face masks have been based on laboratory simulated tests which quite simply have limited clinical applicability as they cannot account for such human factors as compliance, coughing and talking. 5

Covering the nose and mouth for infection control started in the early 1900s when the German physician Carl Flugge discovered that exhaled droplets could transmit tuberculosis. 4 The science regarding the aerosol transmission of infectious diseases has, for years, been based on what is now appreciated to be “very outmoded research and an overly simplistic interpretation of the data.” 6 Modern studies are employing sensitive instruments and interpretative techniques to better understand the size and distribution of potentially infectious aerosol particles. 6 Such knowledge is paramount to appreciating the limitations of face masks. Nevertheless, it is the historical understanding of droplet and airborne transmission that has driven the longstanding and continuing tradition of mask wearing among health professionals. In 2014, the nursing profession was implored to “stop using practice interventions that are based on tradition” but instead adopt protocols that are based on critical evaluations of the available evidence. 7

A December 2015 article in the National Post seems to ascribe to Dr. Gardam, Director of Infection Prevention and Control, Toronto University Health Network the quote, “I need to choose which stupid, arbitrary infection control rules I’m going to push.” 8 In a communication with the author, Dr. Gardam explained that this was not a personal belief but that it did reflect the views of some infection control practitioners. In her 2014 article, “Germs and the Pseudoscience of Quality Improvement”, Dr. K Sibert, an anaesthetist with an interest in infection control, is of the opinion that many infection control rules are indeed arbitrary, not justified by the available evidence or subjected to controlled follow-up studies, but are devised, often under pressure, to give the appearance of doing something. 9

The above illustrate the developing concerns that many infection control measures have been adopted with minimal supporting evidence. To address this fault, the authors of a 2007 New England Journal of Medicine (NEJM) article eloquently argue that all safety and quality improvement recommendations must be subjected to the same rigorous testing as would any new clinical intervention. 10 Dr. R. MacIntyre, a proponent of this trend in infection control, has used her research findings to boldly state that, “it would not seem justifiable to ask healthcare workers to wear surgical masks.” 4 To understand this conclusion it is necessary to appreciate the current concepts relating to airborne transmissions.

Airborne Transmissions
Early studies of airborne transmissions were hampered by the fact that the investigators were not able to detect small particles (less than 5 microns) near an infectious person. 6 Thus, they assumed that it was the exposure of the face, eyes and nose to large particles (greater than 5 microns) or “droplets” that transmitted the respiratory condition to a person in close proximity to the host. 6 This became known as “droplet infection”, and 5 microns or greater became established as the size of large particles and the traditional belief that such particles could, in theory, be trapped by a face mask. 5 The early researchers concluded that since only large particles were detected near an infectious person any small particles would be transmitted via air currents, dispersed over long distances, remain infective over time and might be inhaled by persons who never had any close contact with the host. 11 This became known as “airborne transmission” against which a face mask would be of little use. 5

Through the use of highly sensitive instruments it is now appreciated that the aerosols transmitted from the respiratory tract due to coughing, sneezing, talking, exhalation and certain medical and dental procedures produce respiratory particles that range from the very small (less than 5 microns) to the very large (greater than a 100 microns) and that all of these particles are capable of being inhaled by persons close to the source. 6, 11 This means that respiratory aerosols potentially contain bacteria averaging in size from 1-10 microns and viruses ranging in size from 0.004 to 0.1 microns. 12 It is also acknowledged that upon their emission large “droplets” will undergo evaporation producing a concentration of readily inhalable small particles surrounding the aerosol source. 6

The historical terms “droplet infection” and “airborne transmission” defined the routes of infection based on particle size. Current knowledge suggests that these are redundant descriptions since aerosols contain a wide distribution of particle sizes and that they ought to be replaced by the term, “aerosol transmissible.” 4, 5 Aerosol transmission has been defined as “person –to – person transmission of pathogens through air by means of inhalation of infectious particles.” 26 In addition, it is appreciated that the physics associated with the production of the aerosols imparts energy to microbial suspensions facilitating their inhalation. 11

Traditionally face masks have been recommended to protect the mouth and nose from the “droplet” route of infection, presumably because they will prevent the inhalation of relatively large particles. 11 Their efficacy must be re-examined in light of the fact that aerosols contain particles many times smaller than 5 microns. Prior to this examination, it is pertinent to review the defence mechanism of the respiratory tract.

Respiratory System Defences
Comprehensive details on the defence mechanisms of the respiratory tract will not be discussed. Instead readers are reminded that; coughing, sneezing, nasal hairs, respiratory tract cilia, mucous producing lining cells and the phagocytic activity of alveolar macrophages provide protection against inhaled foreign bodies including fungi, bacteria and viruses. 13 Indeed, the pathogen laden aerosols produced by everyday talking and eating would have the potential to cause significant disease if it were not for these effective respiratory tract defences.

These defences contradict the recently published belief that dentally produced aerosols, “enter unprotected bronchioles and alveoli.” 2 A pertinent demonstration of the respiratory tract’s ability to resist disease is the finding that- compared to controls- dentists had significantly elevated levels of antibodies to influenza A and B and the respiratory syncytial virus. 14 Thus, while dentists had greater than normal exposure to these aerosol transmissible pathogens, their potential to cause disease was resisted by respiratory immunologic responses. Interestingly, the wearing of masks and eye glasses did not lessen the production of antibodies, thus reducing their significance as personal protective barriers. 14 Another example of the effectiveness of respiratory defences is that although exposed to more aerosol transmissible pathogens than the general population, Tokyo dentists have a significantly lower risk of dying from pneumonia and bronchitis. 15 The ability of a face mask to prevent the infectious risk potentially inherent in sprays of blood and saliva reaching the wearers mouth and nose is questionable since, before the advent of mask use, dentists were no more likely to die of infectious diseases than the general population. 16

The respiratory tract has efficient defence mechanisms. Unless face masks have the ability to either enhance or lessen the need for such natural defences, their use as protection against airborne pathogens must be questioned.

Face Masks
History: Cloth or cotton gauze masks have been used since the late 19th century to protect sterile fields from spit and mucous generated by the wearer. 5,17,18 A secondary function was to protect the mouth and nose of the wearer from the sprays and splashes of blood and body fluids created during surgery. 17 As noted above, in the early 20th century masks were used to trap infectious “droplets” expelled by the wearer thus possibly reducing disease transmission to others. 18 Since the mid-20th century until to-day, face masks have been increasingly used for entirely the opposite function: that is to prevent the wearer from inhaling respiratory pathogens. 5,20,21 Indeed, most current dental infection control recommendations insist that a face mask be worn, “as a key component of personal protection against airborne pathogens”. 2

Literature reviews have confirmed that wearing a mask during surgery has no impact whatsoever on wound infection rates during clean surgery. 22,23,24,25,26 A recent 2014 report states categorically that no clinical trials have ever shown that wearing a mask prevents contamination of surgical sites. 26 With their original purpose being highly questionable it should be no surprise that the ability of face masks to act as respiratory protective devices is now the subject of intense scrutiny. 27 Appreciating the reasons for this, requires an understanding of the structure, fit and filtering capacity of face masks.

Structure and Fit: Disposable face masks usually consist of three to four layers of flat non-woven mats of fine fibres separated by one or two polypropylene barrier layers which act as filters capable of trapping material greater than 1 micron in diameter. 18,24,28 Masks are placed over the nose and mouth and secured by straps usually placed behind the head and neck. 21 No matter how well a mask conforms to the shape of a person’s face, it is not designed to create an air tight seal around the face. Masks will always fit fairly loosely with considerable gaps along the cheeks, around the bridge of the nose and along the bottom edge of the mask below the chin. 21 These gaps do not provide adequate protection as they permit the passage of air and aerosols when the wearer inhales. 11,17 It is important to appreciate that if masks contained filters capable of trapping viruses, the peripheral gaps around the masks would continue to permit the inhalation of unfiltered air and aerosols. 11

Filtering Capacity: The filters in masks do not act as sieves by trapping particles greater than a specific size while allowing smaller particles to pass through. 18 Instead the dynamics of aerosolized particles and their molecular attraction to filter fibres are such that at a certain range of sizes both large and small particles will penetrate through a face mask. 18 Accordingly, it should be no surprise that a study of eight brands of face masks found that they did not filter out 20-100% of particles varying in size from 0.1 to 4.0 microns. 21 Another investigation showed penetration ranges from 5-100% when masks were challenged with relatively large 1.0 micron particles. 29 A further study found that masks were incapable of filtering out 80-85% of particles varying in size from 0.3 to 2.0 microns. 30 A 2008 investigation identified the poor filtering performance of dental masks. 27 It should be concluded from these and similar studies that the filter material of face masks does not retain or filter out viruses or other submicron particles. 11,31 When this understanding is combined with the poor fit of masks, it is readily appreciated that neither the filter performance nor the facial fit characteristics of face masks qualify them as being devices which protect against respiratory infections. 27 Despite this determination the performance of masks against certain criteria has been used to justify their effectiveness.2 Accordingly, it is appropriate to review the limitations of these performance standards.

Performance Standards: Face masks are not subject to any regulations. 11 The USA Federal Food and Drug Administration (FDA) classifies face masks as Class II devices. To obtain the necessary approval to sell masks all that a manufacturer need do is satisfy the FDA that any new device is substantially the same as any mask currently available for sale. 21 As ironically noted by the Occupational Health and Safety Agency for Healthcare in BC, “There is no specific requirement to prove that the existing masks are effective and there is no standard test or set of data required supporting the assertion of equivalence. Nor does the FDA conduct or sponsor testing of surgical masks.” 21 Although the FDA recommends two filter efficiency tests; particulate filtration efficiency (PFE) and bacterial filtration efficiency (BFE) it does not stipulate a minimum level of filter performance for these tests. 27 The PFE test is a basis for comparing the efficiency of face masks when exposed to aerosol particle sizes between 0.1 and 5.0 microns. The test does not assess the effectiveness of a mask in preventing the ingress of potentially harmful particles nor can it be used to characterize the protective nature of a mask. 32 The BFE test is a measure of a mask’s ability to provide protection from large particles expelled by the wearer. It does not provide an assessment of a mask’s ability to protect the wearer. 17 Although these tests are conducted under the auspices of the American Society of Testing and Materials (ASTM) and often produce filtration efficiencies in the range of 95-98 %, they are not a measure of a masks ability to protect against respiratory pathogens. Failure to appreciate the limitations of these tests combined with a reliance on the high filtration efficiencies reported by the manufacturers has, according to Healthcare in BC, “created an environment in which health care workers think they are more protected than they actually are.” 21 For dental personnel the protection sought is mainly from treatment induced aerosols.

Dental Aerosols
For approximately 40 years it has been known that dental restorative and especially ultrasonic scaling procedures produce aerosols containing not only blood and saliva but potentially pathogenic organisms. 33 The source of these organisms could be the oral cavities of patients and/or dental unit water lines. 34 Assessing the source and pathogenicity of these organisms has proven elusive as it is extremely difficult to culture bacteria especially anaerobes and viruses from dental aerosols. 34 Although there is no substantiated proof that dental aerosols are an infection control risk, it is a reasonable assumption that if pathogenic microbes are present at the treatment site they will become aerosolized and prone to inhalation by the clinician which a face mask will not prevent. As shown by the study of UK dentists, the inhalation resulted in the formation of appropriate antibodies to respiratory pathogens without overt signs and symptoms of respiratory distress. 14 This occurred whether masks were or were not worn. In a 2008 article, Dr. S. Harrel, of the Baylor College of Dentistry, is of the opinion that because there is a lack of epidemiologically detectable disease from the use of ultrasonic scalers, dental aerosols appear to have a low potential for transmitting disease but should not be ignored as a risk for disease transmission. 34 The most effective measures for reducing disease transmission from dental aerosols are pre-procedural rinses with mouthwashes such as chlorhexidine, large diameter high volume evacuators, and rubber dam whenever possible. 33 Face masks are not useful for this purpose, and Dr. Harrel believes that dental personnel have placed too great a reliance on their efficacy. 34 Perhaps this has occurred because dental regulatory agencies have failed to appreciate the increasing evidence on face mask inadequacies.

The Inadequacies
Between 2004 and 2016 at least a dozen research or review articles have been published on the inadequacies of face masks. 5,6,11,17,19,20,21,25,26,27,28,31 All agree that the poor facial fit and limited filtration characteristics of face masks make them unable to prevent the wearer inhaling airborne particles. In their well-referenced 2011 article on respiratory protection for healthcare workers, Drs. Harriman and Brosseau conclude that, “facemasks will not protect against the inhalation of aerosols.” 11 Following their 2015 literature review, Dr. Zhou and colleagues stated, “There is a lack of substantiated evidence to support claims that facemasks protect either patient or surgeon from infectious contamination.” 25 In the same year Dr. R. MacIntyre noted that randomized controlled trials of facemasks failed to prove their efficacy. 5 In August 2016 responding to a question on the protection from facemasks the Canadian Centre for Occupational Health and Safety replied:

• The filter material of surgical masks does not retain or filter out submicron particles;
• Surgical masks are not designed to eliminate air leakage around the edges;
• Surgical masks do not protect the wearer from inhaling small particles that can remain airborne for long periods of time. 31

In 2015, Dr. Leonie Walker, Principal Researcher of the New Zealand Nurses Organization succinctly described- within a historical context – the inadequacies of facemasks, “Health care workers have long relied heavily on surgical masks to provide protection against influenza and other infections. Yet there are no convincing scientific data that support the effectiveness of masks for respiratory protection. The masks we use are not designed for such purposes, and when tested, they have proved to vary widely in filtration capability, allowing penetration of aerosol particles ranging from four to 90%.” 35

Face masks do not satisfy the criteria for effectiveness as described by Drs. Landefeld and Shojania in their NEJM article, “The Tension between Needing to Improve Care and Knowing How to Do It. 10 The authors declare that, “…recommending or mandating the widespread adoption of interventions to improve quality or safety requires rigorous testing to determine whether, how, and where the intervention is effective…” They stress the critical nature of this concept because, “…a number of widely promulgated interventions are likely to be wholly ineffective, even if they do not harm patients.” 10 A significant inadequacy of face masks is that they were mandated as an intervention based on an assumption rather than on appropriate testing.

Conclusions
The primary reason for mandating the wearing of face masks is to protect dental personnel from airborne pathogens. This review has established that face masks are incapable of providing such a level of protection. Unless the Centers for Disease Control and Prevention, national and provincial dental associations and regulatory agencies publically admit this fact, they will be guilty of perpetuating a myth which will be a disservice to the dental profession and its patients. It would be beneficial if, as a consequence of the review, all present infection control recommendations were subjected to the same rigorous testing as any new clinical intervention. Professional associations and governing bodies must ensure the clinical efficacy of quality improvement procedures prior to them being mandated. It is heartening to know that such a trend is gaining a momentum which might reveal the inadequacies of other long held dental infection control assumptions. Surely, the hallmark of a mature profession is one which permits new evidence to trump established beliefs. In 1910, Dr. C. Chapin, a public health pioneer, summarized this idea by stating, “We should not be ashamed to change our methods; rather, we should be ashamed not to do so.” 36 Until this occurs, as this review has revealed, dentists have nothing to fear by unmasking. OH

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Oral Health welcomes this original article.

References
1. Ontario Ministry of Health and Long-term Care. SARS Commission-Spring of Fear: Final Report. Available at: http://www.health.gov.on.ca/english/public/pub/ministry_reports/campbell06/campbell06.html
2. Molinari JA, Nelson P. Face Mask Performance: Are You Protected? Oral Health, March 2016.
3. Diekema D. Controversies in Hospital Infection Prevention, October, 2009.
4. Unmasking the Surgical Mask: Does It Really Work? Medpage Today, Infectious Disease, October, 2009.
5. MacIntyre CR, Chughtai AA. Facemasks for the prevention of infection in healthcare and community settings. BMJ 2015; 350:h694.
6. Brosseau LM, Jones R. Commentary: Health workers need optimal respiratory protection for Ebola. Center for Infectious Disease Research and Policy. September, 2014.
7. Clinical Habits Die Hard: Nursing Traditions Often Trump Evidence-Based Practice. Infection Control Today, April, 2014.
8. Landman K. Doctors, take off those dirty white coats. National Post, December 7, 2015.
9. Sibert K. Germs and the Pseudoscience of Quality Improvement. California Society of Anesthesiologists, December 8, 2014.
10. Auerbach AD, Landfeld CS, Shojania KG. The Tension between Needing to Improve Care and Knowing How to Do It. NEJM 2007; 357 (6):608-613.
11. Harriman KH, Brosseau LM. Controversy: Respiratory Protection for Healthcare Workers. April, 2011. Available at: http://www.medscape.com/viewarticle/741245_print
12. Bacteria and Viruses Issues. Water Quality Association, 2016. Available at: https://www.wqa.org/Learn-About-Water/Common-Contaminants/Bacteria-Viruses
13. Lechtzin N. Defense Mechanisms of the Respiratory System. Merck Manuals, Kenilworth, USA, 2016
14. Davies KJ, Herbert AM, Westmoreland D. Bagg J. Seroepidemiological study of respiratory virus infections among dental surgeons. Br Dent J. 1994; 176(7):262-265.
15.  Shimpo H, Yokoyama E, Tsurumaki K. Causes of death and life expectancies among dentists. Int Dent J 1998; 48(6):563-570.
16. Bureau of Economic Research and Statistics, Mortality of Dentists 1961-1966. JADA 1968; 76(4):831-834.
17. Respirators and Surgical Masks: A Comparison. 3 M Occupational Health and Environment Safety Division. Oct. 2009.
18. Brosseau L. N95 Respirators and Surgical Masks. Centers for Disease Control and Prevention. Oct. 2009.
19. Johnson DF, Druce JD, Birch C, Grayson ML. A Quantitative Assessment of the Efficacy of Surgical and N95 Masks to Filter Influenza Virus in Patients with Acute Influenza Infection. Clin Infect Dis 2009; 49:275-277.
20. Weber A, Willeke K, Marchloni R et al. Aerosol penetration and leakage characteristics of masks used in the health care industry. Am J Inf Cont 1993; 219(4):167-173.
21. Yassi A, Bryce E. Protecting the Faces of Health Care Workers. Occupational Health and Safety Agency for Healthcare in BC, Final Report, April 2004.
22. Bahli ZM. Does Evidence Based Medicine Support The Effectiveness Of Surgical Facemasks In Preventing Postoperative Wound Infections In Elective Surgery. J Ayub Med Coll Abbottabad 2009; 21(2)166-169.
23. Lipp A, Edwards P. Disposable surgical face masks for preventing surgical wound infection in clean surgery. Cochrane Database Syst Rev 2002(1) CD002929.
24. Lipp A, Edwards P. Disposable surgical face masks: a systematic review. Can Oper Room Nurs J 2005; 23(#):20-38.
25. Zhou Cd, Sivathondan P, Handa A. Unmasking the surgeons: the evidence base behind the use of facemasks in surgery. JR Soc Med 2015; 108(6):223-228.
26. Brosseau L, Jones R. Commentary: Protecting health workers from airborne MERS-CoV- learning from SARS. Center for Infectious Disease Research and Policy May 2014.
27. Oberg T, Brosseau L. Surgical mask filter and fit performance. Am J Infect Control 2008; 36:276-282.
28. Lipp A. The effectiveness of surgical face masks: what the literature shows. Nursing Times 2003; 99(39):22-30.
29. Chen CC, Lehtimaki M, Willeke K. Aerosol penetration through filtering facepieces and respirator cartridges. Am Indus Hyg Assoc J 1992; 53(9):566-574.
30. Chen CC, Willeke K. Characteristics of Face Seal Leakage in Filtering Facepieces. Am Indus Hyg Assoc J 1992; 53(9):533-539.
31. Do surgical masks protect workers? OSH Answers Fact Sheets. Canadian Centre for Occupational health and Safety. Updated August 2016.
32. Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres. American Society of Testing and Materials, Active Standard ASTM F2299/F2299M.
33. Harrel SK. Airborne Spread of Disease-The Implications for Dentistry. CDA J 2004; 32(11); 901-906.
34. Harrel SK. Are Ultrasonic Aerosols an Infection Control Risk? Dimensions of Dental Hygiene 2008; 6(6):20-26.
35. Robinson L. Unmasking the evidence. New Zealand Nurses Organization. May 2015. Available at: https://nznoblog.org.nz/2015/05/15/unmasking-the-evidence
36. Chapin CV. The Sources and Modes of Transmission. New York, NY: John Wiley & Sons; 1910.

Letter by Dr. Stephen Malthouse, MD to Dr. Bonnie Henry, B.C Provincial Health Officer

 

OPEN LETTER

Stephen Malthouse, MD
Denman Island, BC V0R 1T0

October 2020

Dr. Bonnie Henry,
British Columbia Provincial Health Officer,
Ministry of Health,
1515 Blanshard Street,
Victoria, BC V8W 3C9

Dear Dr. Henry,

I am a physician who has been in family medical practice in BC for more than 40 years and a member of the College of Physicians and Surgeons of BC since 1978.

I am writing this letter with the hope that you will be able to clarify the basis of your decision-making that has led our provincial government, health ministry, regional health officers, hospitals, medical staff, WorkSafe BC, businesses, and everyday citizens to follow pandemic policies that do not appear based on high-quality scientific research and, in fact, appear to be doing everyone a great deal of harm.¹

The early intent of mitigation measures to “flatten the curve”, when we knew very little about SARS-CoV-2, its mode of transmission, and the severity of COVID-19, was reasonable. I believe that most physicians in Canada, myself included, whether active or retired, prepared themselves to take part on the front lines for the expected COVID-19 tsunami. Very soon it was apparent that the expected overwhelming of the hospital system was not going to occur, and now BC physicians have questions about the appropriateness of your public health policies.

The epidemiological evidence clearly shows that the “pandemic” is over and no second wave will follow. The evidence has been available for at least 4-5 months and is irrefutable.^2-4 Yet, in spite of this substantial body of research, your office is perpetuating the narrative that a pandemic still exists and a second wave is expected. This false story is being used to justify public health policies that appear to have no health benefits, have already caused considerable harm, and threaten to create more harm in the future.

As you are aware, Sweden took an entirely different approach and, as of mid-September, their infection rate reached an all-time low and Covid-19 related deaths were at zero; 22 of 31 European countries, most of which enacted strict lockdowns, had higher infection rates. Sweden has also largely escaped the financial ruin and catastrophic mental health problems experienced in other countries, including Canada and the U.S.A.

Dr. Lawrence Rosenberg, Montréal’s medical officer, has stated “this COVID virus is much like the seasonal flu”. A group of over 400 Belgian doctors have stated “COVID is not a killer virus, but a treatable condition”. Eighteen Canadian doctors wrote the Ontario Premier, Doug Ford, stating “your policies risk significantly harming our children with lifelong consequences”. The Ontario policies are very similar to those of British Columbia.

In 2011, a review of the literature by the British Columbia Centres for Disease Control that sought to evaluate the effectiveness of social distancing measures such as school closures, travel restrictions, and limitations on mass gatherings as a means to address an influenza pandemic concluded that “such drastic restrictions are not economically feasible and are predicted to delay viral spread, but not impact overall mortality”. [Italics added]

Specifically, there appears to be no scientific or medical evidence for^5-6

1. Self-isolation of asymptomatic people
2. social distancing
3. facemasks
4. arbitrary closure of businesses
5. closure of schools, daycares, park amenities, and playgrounds
6. the discontinuance of access to education, medical, dental, chiropractic, naturopathic, hearing, dietary, therapeutic, and other support for the physically and mentally disabled, particularly special needs children with neurological disorders
7. the closing down of or restrictions on religious places of worship.

According to the CDC Pandemic Severity Index, none of these measures have been warranted. The Great Barrington Declaration, signed by more than 30,000 health scientists and medical doctors from around the world, adds support for this statement.

Surprisingly, the recommendation for reducing COVID-19 morbidity and mortality by supplementing with vitamin D, a measure that is supported by high-quality research, has been absent from your frequent public broadcasts and professional bulletins.⁷ Optimizing nutrition is a convenient, inexpensive, and safe method of improving immune resistance and has been confirmed through numerous studies for both prevention and treatment of COVID-19. As far as I am aware, you have never mentioned something as simple as vitamin D supplements for our most vulnerable citizens. Yet, it was the promise to protect these same citizens that was used to justify the lockdown of a healthy population and the closure of businesses.

Why are you still using PCR testing? The Deputy Chief Medical Officer for Health in Ontario has publicly stated that the PCR test yields over 50% false positives. A New York Times investigative report found that PCR testing yields up to 90% false positives due to excessive amplification beyond the recommendations of the manufacturer. The PCR test was never designed, intended or validated to be used as a diagnostic tool. Even the Alberta Health Services COVID-19 Scientific Advisory Group has stated “clinical sensitivity and specificity values have not been determined for lab developed RT-PCR testing in Canada”.⁸ Despite expert consensus, you continue to use this inappropriate and inaccurate test to report so-called “cases” and justify your decisions.^9-18

The public health definition of a “case” is very broad. As all experienced doctors know, a “case” is a patient with significant symptoms who is often hospitalized. A “case” is not a person who simply has a questionably positive PCR test and presents with no symptoms or an unrelated diagnosis. Pictures of healthy young adults standing in line to get PCR tests, with a cell phone in one hand and a Starbucks coffee in the other, are everywhere in the media. These are not sick people and do not need testing.

Nevertheless, your public announcements repeatedly emphasize that the “case” counts are rising and we are in big trouble. Recently, “out-of-control” case counts were used to justify a second lockdown in Ontario and Quebec. Curfews have been put into place. People are being asked to risk their livelihoods to make sacrifices for the general good, based on Public Health’s misrepresentation of “cases” as sick people.

Meanwhile, hospitalizations, ICU admissions, and deaths from COVID-19 have dropped to pre-pandemic levels. Where are all the patients?

Why not simply tell the public that

• the PCR testing is not reliable and is meaningless for diagnosing COVID-19
• positive PCR test results do not represent sick patients,
• rarely are people now becoming ill from SARS-CoV-2,
• provincial hospitals are essentially empty of COVID-19 patients,
• decisions should not be based on “cases” in the news,
• the morbidity/mortality of COVID-19 has not exceeded seasonal influenza,
• the median age of death from COVID-19 in Canada was 85 years,
• the pandemic is over, and
• no second wave is coming?

It is your duty as the provincial health officer to provide facts, not propaganda, and make every effort to stop the public panic. The only reason for emphasizing “cases” is to induce more fear and thereby compliance in the name of promised safety.

Why are children being pursued with a new rinse-and-spit saliva test that is also based on a worthless PCR test? Children have been terrorized and are being given the message that they can never be trusted not to infect their family and friends — essentially, that they are naturally bad. The insistence on covering their faces with masks, a proven useless and even harmful measure, only worsens this sense of shame. The psychological fallout from such messaging is going to be horrific. One only needs to walk down Main Street to already see the catastrophic effects of these messages on the mental and emotional health of families.

The excess death toll from partial lockdowns, social distancing and other public health measures is staggering. The Canadian media reports that provincial measures have been shown to create 12:1 more deaths than the virus; there has been a 40% increase in heart attack deaths in Canada from fear, anxiety and cancelled hospital procedures; suicide and drug overdose deaths have increased and outnumber COVID-19 deaths by a ratio of 3:1; suicides have doubled in BC since April; and anxiety and depression, food insecurity, domestic violence, and child abuse have skyrocketed. With unnecessary school closures, the ability of teachers to identify children subject to abuse and malnourishment has been curtailed. Many of our friends, family and patients died alone, terrified, and isolated against their will in facilities and nursing homes. That cruel policy was unjustified and inhuman.

How is it possible that a doctor with your previous training and experience did not anticipate the collateral damage of your public health policies – the economic disruption, the psychological and physical health consequences, and the deaths from despair?

The mainstream media has created a religion out of public health, one based on superstition, not science, with the power to rule over an obedient public. The news channels have raised you to almost saint-like status. Tea towels, shoes and murals have been designed to celebrate your accomplishments. Yet, your public directives do not make sense, contradict the research, and are causing people a great deal of harm. As a fellow doctor, I appeal to you to re-examine your policies and change direction before Public Health causes irreparable damage to our province’s health and economic well-being. That about-face will require you to meet the obligations of your office.

Sincerely,

Stephen Malthouse, MD
Member, College of Physicians and Surgeons of British Columbia,
Denman Island, British Columbia

 

1. 1. http://ocla.ca/wp-content/uploads/2014/01/OCLA-Report-2020-1-Criticism-of-Government-Response-to-COVID19.pdf
   2. https://docs4opendebate.be/en/#petitie
   3. https://www.flixxy.com/is-the-pandemic-over.htm
   4. https://hubpages.com/politics/Pfizer-Chief-Science-Officer-Second-Wave-Based-on-Fake-Data-of-False-Positives-for-New-Cases-Pandemic-is-Over
   5. The Doctor Is In: Scott Atlas and the Efficacy of Lockdowns, Social Distancing, and Closures https://www.youtube.com/watch?v=biC4nHPYtbA
   6. https://www.sott.net/article/434796-The-Science-is-Conclusive-Masks-and-Respirators-do-NOT-Prevent-Transmission-of-Viruses
   7. https://www.cimadoctors.ca/cima-covid-19-policy/
   8. Alberta Health Services COVID-19 Scientific Advisory Group. How do the testing characteristics for the Alberta Health Services lab-developed test for COVID-19 differ between samples collected from nasal, nasopharyngeal, and throat swabs? 15 April 2020 [Internet]. https://www.albertahealthservices.ca/assets/info/ppih/if-ppih-covid-19-sag-comparison-of-testing-sites-rapid-review.pdf (accessed 16 May 2020).
   9. https://bpa-pathology.com/covid19-pcr-tests-are-scientifically-meaningless/
   10. https://www.msn.com/en-us/news/us/antibody-tests-for-covid-19-wrong-half-the-time-cdc-says/ar-BB14DD2E
   11. https://www.nytimes.com/2020/08/29/health/coronavirus-testing.html
   12. http://republicbroadcasting.org/news/bombshell-who-coronavirus-pcr-test-primer-sequence-is-found-in-all-human-dna/
   13. https://childrenshealthdefense.org/news/covid-19-testing-pcr-a-critical-appraisal/
   14. https://bpa-pathology.com/covid19-pcr-tests-are-scientifically-meaningless/
   15. Zhang GH et al. Potential false-positive rate among the ‘asymptomatic infected individuals’ in close contacts of COVID-19 patients.J.CN, 2020 Mar 5;41(4):485-488.
   16. https://bpa-pathology.com/covid19-pcr-tests-are-scientifically-meaningless/
   17. Insert from sample COVID testing kit: RealStar® SARS-CoV-2 RT-PCR Kit 1.0 For research use only! The RealStar® SARS-CoV-2 RT-PCR Kit 1.0 is a reagent system, based on realtime PCR technology, for the qualitative detection and differentiation of lineage B-betacoronavirus (B-βCoV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) specific RNA. For research use only (RUO)! Not for use in diagnostic procedures.[Italics added]
   18. Insert from sample COVID testing kit: LightMix® Modular SARS-CoV Assays. Roche continues to monitor the virus, SARS-CoV-2, that causes coronavirus disease 2019 (COVID-19) and is pleased to announce the availability of the LightMix Modular Assays used to detect this virus. These assays are for Research Use Only (RUO*) on the LightCycler® 480 and/or cobas z 480 instruments, and Roche is the exclusive distributor for these assays. The MagNA Pure 96 instrument or High Pure Viral Nucleic acid kit can be used for extraction. The three LightMix Modular assays are used to detect the SARS and CoV genes outlined in the table below in human tracheal aspirates or bronchoalveolar lavage samples from individual human donors. These assays are not intended for use as an aid in the diagnosis of coronavirus infection. [Italics added]
   19. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm

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