nazi medicine

A global team of experts has found 10 FATAL FLAWS in the main test for Covid and is demanding it’s urgently axed. As they should
Peter Andrews,, Dec 1 2020

Peter Andrews is an Irish science journalist and writer based in London. He has a background in the life sciences, and graduated from the University of Glasgow with a degree in genetics

A peer review of the paper on which most Covid testing is based has comprehensively debunked the science behind it, finding major flaws. They conclude it’s utterly unsuitable as a means for diagnosis, and the fall-out is immense. Last week, I reported on a landmark ruling from Portugal, where a court had ruled against a governmental health authority that had illegally confined four people to a hotel this summer. They had done so because one of the people had tested positive for Covid in a polymerase chain reaction (PCR) test, but the court had found the test fundamentally flawed and basically inadmissible. Now the PCR testing supremacy under which we all now live has received another crushing blow. A peer review from a group of 22 international experts has found 10 “major flaws” in the main protocol for such tests. The report systematically dismantles the original study, called the Corman-Drosten paper, which described a protocol for applying the PCR technique to detecting Covid. The Corman-Drosten paper was published on Jan 23 2020, just a day after being submitted, which would make any peer review process that took place possibly the shortest in history. What is important about it is that the protocol it describes is used in around 70% of Covid kits worldwide. It’s cheap, fast, and absolutely useless. Among the fatal flaws that totally invalidate the PCR testing protocol are that the test:

  • is non-specific, due to erroneous primer design
  • is enormously variable
  • cannot discriminate between the whole virus and viral fragments
  • has no positive or negative controls
  • has no standard operating procedure
  • does not seem to have been properly peer reviewed

Oh dear. One wonders whether anything at all was correct in the paper. But wait! It gets worse. As has been noted previously, no threshold for positivity was ever identified. This is why labs have been running 40 cycles, almost guaranteeing a large number of false positives: up to 97%, according to some studies. The cherry on top is that among the authors of the original paper themselves, at least four have severe conflicts of interest. Two of them are members of the editorial board of Eurosurveillance, the sinisterly named journal that published the paper. And at least three of them are on the payroll of the first companies to perform PCR testing! The 22 members of the consortium that has challenged this shoddy science deserve huge credit. The scientists, from Europe, the USA, and Japan, comprise senior molecular geneticists, biochemists, immunologists, and microbiologists, with many decades of experience between them. They have issued a demand to Eurosurveillance to retract the Corman-Drosten paper, writing:

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.

It is difficult to overstate the implications of this revelation. Every single thing about the Covid orthodoxy relies on ‘case numbers,’ which are largely the results of the now widespread PCR tests. If their results are essentially meaningless, then everything we are being told, and ordered to do by increasingly dictatorial governments, is likely to be incorrect. For instance, one of the authors of the review is Dr Mike Yeadon, who asserts that, in the UK, there is no ‘second wave’ and that the pandemic has been over since June. Having seen the PCR tests so unambiguously debunked, it is hard to see any evidence to the contrary.

Why was this paper rushed to publication in January, despite clearly not meeting proper standards? Why did none of the checks and balances that are meant to prevent bad science dictating public policy kick into action? And why did it take so long for anyone in the scientific community to challenge its faulty methodology? These questions lead to dark ruminations, which I will save for another day. Even more pressing is the question of what is going to be done about this now. The people responsible for writing and publishing the paper have to be held accountable. But also, all PCR testing based on the Corman-Drosten protocol should be stopped with immediate effect. All those who are so-called current ‘Covid cases,’ diagnosed based on that protocol, should be told they no longer have to isolate. All present and previous Covid deaths, cases, and ‘infection rates’ should be subject to a massive retroactive inquiry. And lockdowns, shutdowns, and other restrictions should be urgently reviewed and relaxed. Because this latest blow to PCR testing raises the probability that we are not enduring a killer virus pandemic, but a false positive pseudo-epidemic. And one on which we are destroying our economies, wrecking people’s livelihoods and causing more deaths than Covid-19 will ever claim.

Covid-19 vaccines: where are the data?
Jose M Martin-Moreno et al, BMJ, Nov 27 2020

Through press releases, three pharmaceutical companies recently announced the interim, positive results of their covid-19 vaccine candidates clinical trials. Firstly, Pfizer/BioNTech presented the initial results for their mRNA based BNT162b2 vaccine, which showed that it was 90% effective in preventing covid-19. The vaccine was tested on 43,538 participants and, so far, there have been 94 confirmed cases. They will submit to the US Food and Drug Administration (FDA) for approval when the safety profile has reached a pre-determined milestone. In the meantime, Pfizer has continued to market the vaccine. Secondly, the Data Safety Monitoring Board, appointed by the National Institutes of Health (NIH) for the phase III study of the MODERNA mRNA-1273 vaccine candidate against covid-19, confirmed its trial met the statistical criteria pre-specified in the study protocol, with a vaccine efficacy of 94.5%. Thirdly, the University of Oxford and AstraZeneca, announced that their adenovirus-based vaccine ChAdOx1 nCoV-2019 was safe and also, in the preliminary findings of a peer-reviewed phase II/III trial, as triggering a seemingly encouraging immune response in older age groups included in the trial. In a subsequent press release, they reported that in the phase III trial of about 20k participants, the vaccine was around 70% efficacious. This week it has also transpired that some of the participants were, in error, given a first dose which was half of what was intended. These participants were all under the age of 55. Doubts have now been raised about how Oxford and Astra Zeneca have handled the release of their preliminary results, given the dosing error and what that could mean for the efficacy of the vaccine.

All these data for the different vaccines are potentially very promising, but none of the phase III trials have been published in peer reviewed journals or analysed by age group, gender and case description (asymptomatic, mild, severe), virus transmissibility after immunisation, or duration of protection. As public health professionals, we believe that the results of clinical trials, whether interim or final, should be subject to an appropriate systematic process, and then published in peer-reviewed professional journals. Reporting the covid-19 vaccine trial results in press releases before publication in journals is neither good scientific practice nor does it help to build public trust in vaccines. If trial data for covid-19 candidate vaccines are prematurely announced, this may threaten the integrity and credibility of the trials. This could distort what should be a rigorous peer review process. We believe that data and conclusions should not be released as credible before the scientific community can judge the validity of those claims by assessing a complete account of what was done.

The process of reporting on the clinical trials and the concurrent marketing of the covid-19 vaccines also raises concerns about the basis on which the many candidate vaccines at advanced stages of development can be assessed. Since companies are asking governments to place orders at an early stage, this raises a question about the minimum amount of data that companies should release publicly during the marketing process. It is crucial that the WHO, as a credible neutral body, should appoint a group of experts to compile an updated list of the current status of the clinical trials and to specify how to communicate the results. We believe that this should be within the WHO framework of The Access to COVID-19 Tools (ACT) Accelerator initiative. This overview should identify all aspects of the vaccine production and the trial methodology. For example, production methods should specify all the ingredients including antigens, adjuvants, stabilisers, antibiotics and preservatives. Companies should be encouraged to publish a paper with their trial design, methods and results in a peer-reviewed journal. And given that we should strive to publish these papers as rapidly as possible, journals should prioritise them, and ensure rigour and timeliness in their peer-review process. The scientific publication should at least include the following:

  • detailed study design
  • method of recruiting participants
  • sample size in total and by study arm.
  • main characteristics of the study population including age, gender, ethnicity, health status and other key variables.
  • detailed features of the vaccine
  • storage requirements
  • dose
  • route of administration and schedule
  • trial duration
  • total accrual time
  • loss to follow-up, as specified in the standard protocols for clinical trials investigating vaccines.

Safety and efficacy evaluation should identify the primary and secondary endpoints. Results need to be presented systematically, with precise statistical analyses and specification of the overall efficacy and sub-group efficacy (with confidence intervals), and adverse effects analyses by age group and sex. The authors also need to discuss the strengths and limitations of the trial. There are other relevant questions that the company should discuss, such as the possible impact of carrying out the trial in a limited time. In addition, the authors must present the current understanding of the following:

  • estimates of how long after immunisation it takes to be protected
  • the estimated duration of protection
  • whether vaccination will prevent transmission
  • to what extent violations of the cold-chain affect the efficacy of the vaccine
  • could there be atypical disease in vaccinated subjects.

Governments, public health professionals and society as a whole must support fair and equitable access for every country. To help with the logistical and practical aspects of making this happen, all the information from the clinical trials must have incontrovertible credibility. In summary, with covid-19 vaccines there are reasons to be hopeful, but we need to address the concerns. We strongly advocate for the need to define a standard protocol on what data must be released before a company starts to market its vaccine. This should be complemented with guidelines on how to compare the benefits of each new vaccine as it becomes available. We believe the WHO is best suited to coordinate such a process.

Jose M Martin-Moreno is professor of preventive medicine and public health at the Medical School and INCLIVA-Clinical Hospital, University of Valencia, Spain, and Honours’ committee chair, Association of Schools of Public Health in the European region.

John Middleton is honorary professor of public health, Wolverhampton University, and president of the Association of Schools of Public Health in the European region.

Mohamud Sheek-Hussein is associate professor, Institute of Public Health, College of Medicine & Health Sciences, UAE University, Al-Ain, UAE.

Manfred S Green is professor of epidemiology and public health, and head of the International MPH Program, School of Public Health, University of Haifa, Israel.

Competing interests: None declared.

Pfizer and Moderna’s “95% effective” vaccines: let’s be cautious and first see the full data
Peter Doshi, BMJ, Nov 26 2020

In the US, all eyes are on Pfizer and Moderna. The topline efficacy results from their experimental covid-19 vaccine trials are astounding at first glance. Pfizer says it recorded 170 covid-19 cases (in 44k volunteers), with a remarkable split: 162 in the placebo group versus 8 in the vaccine group. Meanwhile Moderna says 95 of 30k volunteers in its ongoing trial got covid-19: 90 on placebo versus 5 receiving the vaccine, leading both companies to claim around 95% efficacy. Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown. Third, these results reflect a time point relatively soon after vaccination, and we know nothing about vaccine performance at 3, 6, or 12 months, so cannot compare these efficacy numbers against other vaccines like influenza vaccines (which are judged over a season). Fourth, children, adolescents, and immunocompromised individuals were largely excluded from the trials, so we still lack any data on these important populations. I previously argued that the trials are studying the wrong endpoint, and for an urgent need to correct course and study more important endpoints like prevention of severe disease and transmission in high risk people. Yet, despite the existence of regulatory mechanisms for ensuring vaccine access while keeping the authorization bar high (which would allow placebo-controlled trials to continue long enough to answer the important question), it’s hard to avoid the impression that sponsors are claiming victory and wrapping up their trials (Pfizer has already sent trial participants a letter discussing “crossing over” from placebo to vaccine), and the FDA will now be under enormous pressure to rapidly authorize the vaccines.

But as conversation shifts to vaccine distribution, let’s not lose sight of the evidence. Independent scrutiny of the underlying trial data will increase trust and credibility of the results. There also might be important limitations to the trial findings we need to be aware of. Most crucially, we need data-driven assurances that the studies were not inadvertently unblinded, by which I mean investigators or volunteers could make reasonable guesses as to which group they were in. Blinding is most important when measuring subjective endpoints like symptomatic covid-19, and differences in post-injection side-effects between vaccine and placebo might have allowed for educated guessing. Past placebo-controlled trials of influenza vaccine were not able to fully maintain blinding of vaccine status, and the recent “half dose” mishap in the Oxford covid-19 vaccine trial was apparently only noticed because of milder-than-expected side-effects. (And that is just one of many concerns with the Oxford trial.)

In contrast to a normal saline placebo, early phase trials suggested that systemic and local adverse events are common in those receiving vaccine. In one Pfizer trial, for example, more than half of the vaccinated participants experienced headache, muscle pain and chills, but the early phase trials were small, with large margins of error around the data. Few details from the large phase 3 studies have been released thus far. Moderna’s press release states that 9% experienced grade 3 myalgia and 10% grade 3 fatigue Pfizer’s statement reported 3.8% experienced grade 3 fatigue and 2% grade 3 headache. Grade 3 adverse events are considered severe, defined as preventing daily activity. Mild and moderate severity reactions are bound to be far more common. One way the trial’s raw data could facilitate an informed judgment as to whether any potential unblinding might have affected the results is by analyzing how often people with symptoms of covid-19 were referred for confirmatory SARS-CoV-2 testing. Without a referral for testing, a suspected covid-19 case could not become a confirmed covid-19 case, and thus is a crucial step in order to be counted as a primary event: lab-confirmed, symptomatic covid-19. Because some of the adverse reactions to the vaccine are themselves also symptoms of covid-19 (e.g. fever, muscle pain), one might expect a far larger proportion of people receiving vaccine to have been swabbed and tested for SARS-CoV-2 than those receiving placebo. This assumes all people with symptoms would be tested, as one might expect would be the case. However the trial protocols for Moderna and Pfizer’s studies contain explicit language instructing investigators to use their clinical judgment to decide whether to refer people for testing. Moderna puts it this way:

It is important to note that some of the symptoms of COVID-19 overlap with solicited systemic ARs that are expected after vaccination with mRNA-1273 (eg, myalgia, headache, fever, and chills). During the first 7 days after vaccination, when these solicited ARs are common, Investigators should use their clinical judgement to decide if an NP swab should be collected.

This amounts to asking investigators to make guesses as to which intervention group patients were in. But when the disease and the vaccine side-effects overlap, how is a clinician to judge the cause without a test? And why were they asked, anyway? Importantly, the instructions only refer to the first seven days following vaccination, leaving unclear what role clinician judgment could play in the key days afterward, when cases of covid-19 could begin counting towards the primary endpoint. (For Pfizer, 7 days after the 2nd dose. For Moderna, 14 days.) In a proper trial, all cases of covid-19 should have been recorded, no matter which arm of the trial the case occurred in. (In epidemiology terms, there should be no ascertainment bias, or differential measurement error). It’s even become common sense in the Covid era: “test, test, test.” But if referrals for testing were not provided to all individuals with symptoms of covid-19, for example because an assumption was made that the symptoms were due to side-effects of the vaccine—cases could go uncounted.

Data on pain and fever reducing medicines also deserve scrutiny. Symptoms resulting from a SARS-CoV-2 infection (e.g. fever or body aches) can be suppressed by pain and fever reducing medicines. If people in the vaccine arm took such medicines prophylactically, more often, or for a longer duration of time than those in the placebo arm, this could have led to greater suppression of covid-19 symptoms following SARS-CoV-2 infection in the vaccine arm, translating into a reduced likelihood of being suspected for covid-19, reduced likelihood of testing, and therefore reduced likelihood of meeting the primary endpoint. But in such a scenario, the effect was driven by the medicines, not the vaccine. Neither Moderna nor Pfizer have released any samples of written materials provided to patients, so it is unclear what instructions, if any, patients were given regarding the use of medicines to treat side-effects following vaccination, but the informed consent form for Johnson and Johnson’s vaccine trial provides such a recommendation:

Following administration of Ad26.COV2.S, fever, muscle aches and headache appear to be more common in younger adults and can be severe. For this reason, we recommend you take a fever reducer or pain reliever if symptoms appear after receiving the vaccination, or upon your study doctor’s recommendation.

There may be much more complexity to the “95% effective” announcement than meets the eye—or perhaps not. Only full transparency and rigorous scrutiny of the data will allow for informed decision making. The data must be made public.

Peter Doshi, associate editor, The BMJ.
Competing interests: I have been pursuing the public release of vaccine trial protocols, and have co-signed open letters calling for independence and transparency in covid-19 vaccine related decision making.

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