Very weak study in defence of masks

The journal Plos One on Friday slapped an “expression of concern” on the Burnet Institute’s controversial July 2021 paper, which purported to show that mandating masks was the “single most important control measure” that turned around Victoria’s second Covid wave in 2020 “almost overnight”.

In October 2021, experts told news.com.au that the supposed “world-first” study was riddled with basic errors and should never have been published in a major journal, blasting the paper as “crap”, “extremely lightweight” and “very, very low quality”.

The Burnet Institute – an influential public health body that advised the Victorian government on its Covid response – stood by its findings and described the scientists’ comments to news.com.au as “disappointing and unprofessional”.

But Plos One has now acknowledged flaws in the study with a lengthy notice appended to the paper. An expression of concern – one step above a correction but short of a retraction – is used to “alert readers of serious concerns about published work”.

“After publication of this article, readers raised a number of concerns, including about the methodology, the limitations of the study design, and whether the conclusions are fully supported,” Plos One editors wrote in the notice.

“The Plos One editors consulted with two members of the editorial board and a statistical advisor who advised that the study design is associated with a number of weaknesses that are discussed in the article, and which are unavoidable because of ethical issues that would be associated with a randomised controlled trial in the context of a pandemic, but that there were also additional weaknesses.”

For the study, the Burnet Institute looked at photos from The Age newspaper to conclude that mask usage rose from 43 per cent to 97 per cent after the July mandate came into effect.

Medical researcher Dr Kyle Sheldrick told news.com.au in 2021 that it was “hard to think of a worse methodology to answer this question than just looking at which photos are collected by a metropolitan newspaper”.

“I was staggered to see this was published by a major journal,” he said. “If a student came to me and said, I’m going to compare these two sets of photos and draw some conclusion about whether a policy worked, you would send them away to think about it.”

Another researcher, an eminent Australian clinician and scientist who spoke on the condition of anonymity, was equally scathing. “I agree, it’s crap,” he said. “It’s extremely lightweight. I think it’s a totally feeble article. It doesn’t have a rigorous methodology and it is weak in its scientific inference.”

Concerns were also raised about other aspects of the paper, including that it singled out the mask mandate as the key reason for the fall in Covid transmission out of all of Victoria’s sweeping lockdown measures.

Plos One’s editors acknowledged the three main issues raised with the paper – the photographic observation of mask usage, self-reported mask wearing survey data, and unmeasured confounding variables such as curfews, movement restrictions and closures.

On the photos, Plos One’s editors noted it was “unclear whether such images are representative of mask usage in the population”.

They also noted the Survey of Covid-19 Responses to Understand Behaviour (SCRUB) sample size was “small and may not be representative of the population”.

In response, the Burnet Institute’s authors indicated that “the sample sizes were not inappropriately small for the purpose, noting that the high-powered interrupted time series study found a highly statistically significant change in the growth rate of the epidemic that coincided with the mask mandate”.

Plos One’s editors also noted that “the study design could not exclude the possibility of contributions from unmeasured confounding variables, including the implementation of a curfew and movement restrictions on 2nd August 2020 and closure of childcare facilities, schools, and non-essential businesses on 5th August 2020”.

“According to the cumulative expert input received by the Plos One editors, the results of the published study contribute to the field of mask evaluation research, provided results are not overinterpreted and limitations are acknowledged,” they wrote.

“The Plos One editors felt that the conclusions, including those that imply causation, a direct correlation between Covid-19 cases and mask mandates, and the ability of masks for controlling epidemics, were not suitably tempered in light of the limitations of the study design. The Plos One editors issue this expression of concern to inform readers about the above considerations regarding study design and interpretation of the results.”

The Burnet Institute has been contacted for comment.

It comes after a major Cochrane Review – considered the gold standard of evidence-based medicine – earlier this year assessed 78 high-quality scientific studies, and found “wearing masks in the community probably makes little or no difference” when comparing masking with non-masking to prevent Covid.

The bombshell findings proved controversial and sparked a war of words between Karla Soares-Weiser, editor-in-chief of the Cochrane Library, and the study’s lead author Tom Jefferson.

“Many commentators have claimed that a recently-updated Cochrane Review shows that ‘masks don’t work’, which is an inaccurate and misleading interpretation,” Soares-Weiser said in a statement in March.

“[The study’s] wording was open to misinterpretation, for which we apologise. While scientific evidence is never immune to misinterpretation, we take responsibility for not making the wording clearer from the outset.”

Jefferson subsequently hit back at suggestions the apology from Soares-Weiser meant the study had been retracted.

“It was upsetting,” he told journalist Maryanne Demasi. “Cochrane has thrown its own researchers under the bus again. The apology issued by Cochrane is from Soares-Weiser, not from the authors of the review.”

Jefferson claimed Soares-Weiser, in response to media pressure, had “gone outside the normal channels and made decisions without any consultation with the authors of the review”.

“It is unacceptable,” he said. “We are the copyright holders of the review, so we decide what goes in or out of the review. We do not change our reviews on the basis of what the media wants.”

https://www.news.com.au/technology/science/human-body/burnet-institute-mask-study-hit-with-expression-of-concern-notice-by-journal-plos-one/news-story/fb467b8bb49c852803c490f6c1e69152

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Face masks may raise risk of stillbirths, testicular dysfunction and cognitive decline due to build-up of carbon dioxide, study warns

Face masks may raise the risk of stillbirths, testicular dysfunction and cognitive decline in children, 'explosive' new research suggests.

A review of dozens of studies on face coverings suggested they can cause mild carbon dioxide poisoning when worn over long periods.

The German academics who carried out the research believe masks create a pocket of dead space between the mouth and mask, which traps the toxic gas.

They say the build-up of CO2 in pregnant women's bodies could cause complications for the unborn fetus. They point out that CO2 also contributes to oxidative stress, which can affect cognition and cause testicular issues in men.

But independent doctors have questioned the conclusions of the study — which never directly looked at health complications and mask use, describing the link as 'unlikely'.

Alluding to the surge in stillbirths during the pandemic, the German researchers said: 'Circumstantial evidence exists that popular mask use may be related to current observations of a significant rise of 28 percent to 33 percent in stillbirths worldwide.'

'[And] reduced verbal, motor, and overall cognitive performance of two full standard deviations in scores in children born during the pandemic,' the researchers wrote in the paper, published in the journal Heliyon.

But the study could not conclusively prove that the masks were directly responsible for any of these complications.

Dr Stuart Fischer, an emergency care physician in New York, questioned whether there was a 'toxic buildup' of CO2.

He said: 'I wouldn’t say this happens, because the body adjusts the pH, the acid/base balance very quickly. Respiratory acidosis due to facemasks is unlikely although short-term side effects might affect people with chronic lung disease.'

The German research team gathered data from 43 previously published studies on exposure to CO2, mask-wearing and pregnancy.

They found that after wearing a mask for more than five minutes, CO2 levels in the inhaled air rose to between 1.4 percent and 3.2 percent.

One mask study conducted in Germany, researchers measured the CO2 concentration of air behind surgical masks worn by 15 healthy men. Within 30 minutes, the CO2 concentration rose to roughly 2.8-3.2 percent.

In another study in Italy, scientists measured the air under surgical masks worn in a lab and found a concentration between 0.22 and 0.29 percent within five minutes.

Masks provide breathing resistance and create a dead space that traps CO2, leading to more inhaled and re-breathed CO2, the reviewers said.

The gas makes up around 0.04 percent of all inhaled air, for comparison, and the Department of Agriculture said safe levels should be below 0.5 percent for eight-hour exposure.

The researchers then looked at studies that focused on the effect of similar CO2 levels on animals such as mice and rats.

Mammals such as mice and rats with prolonged exposed to 0.3 percent carbon dioxide gave birth to offspring which had 'irreversible neuron damage', the review found.

In total, the researchers looked at studies dating back from the start of the scientific databases they searched until November 30, 2021.

The main caveat of the research is that the studies looking at the potential toxic effects of carbon dioxide are animal studies - because these experiments would not be ethical in humans.

The researchers also noted that none of the studies in their review looked directly at mask use and miscarriages, infertility and neurodevelopment disorders.

The researchers also noted that the exact effects of toxic levels of CO2 on unborn life is not known in great detail.

Carbon dioxide is known to contribute to oxidative stress, which the researchers suggested would hinder fetal development.

Dr Kevin Bass, cell and molecular biology PhD student, said on Twitter that the new paper was 'explosive'.

But he said: 'We do not have any good evidence in pregnant women... of the long-term effects of mask-wearing and therefore no evidence that these effects occur in women.'

He added: 'All we have are animal studies and a clear indication that changes in CO2 concentrations do occur in mask-wearing women.'

Stillbirths and pregnancy complications rose during the Covid pandemic, and preeclampsia and other pregnancy complications were blamed on the virus.

Factors other than mask-wearing are likely to be at play, such as hospital closures and delayed care.

It comes after three years of fierce debate about the effectiveness of masks.

Mask mandates on transportation systems in America were backed by penalties of up to $3,000 for repeat offenders.

Former director of the National Institute of Allergy and Infectious Diseases Dr Anthony Fauci initially advised people not to wear masks, which he later claimed because he was concerned there would not be enough for healthcare workers.

He went on to advise that everyone should wear a mask.

https://www.dailymail.co.uk/health/article-11982039/Face-masks-raise-risk-stillbirths-testicular-issues-cognitive-decline-study-says.html

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