Author of Retracted Study on Harm of Mask-Wearing by Children Says Removal Was ‘Political’

The lead author of a now-retracted research note that claimed children’s masks trapped dangerously high concentrations of carbon dioxide says JAMA Pediatrics’ decision to pull the paper was politically motivated.

The research note titled “Experimental Assessment of Carbon Dioxide Content in Inhaled Air With or Without Face Masks in Healthy Children: A Randomized Clinical Trial,” authored by Harald Walach and colleagues, was published in June. Based on measurements of carbon dioxide in air inhaled by 45 children between 6 and 17 years of age, the study found that children wearing face masks were inhaling carbon dioxide levels “deemed unacceptable by the German Federal Environmental Office by a factor of 6.” The researchers concluded that their findings “suggest that children should not be forced to wear face masks.”

JAMA Pediatrics retracted the research letter on July 16. In a retraction notice, Dr. Dmitri Christakis and Dr. Phil Fontanarosa cited “numerous scientific issues” raised about the study methodology, including concerns about whether the proper device was used to measure carbon dioxide levels and if the measurements were an accurate reflection of carbon dioxide levels in inhaled air, along with “issues related to the validity of the study conclusions.”

“In their invited responses to these and other concerns, the authors did not provide sufficiently convincing evidence to resolve these issues, as determined by editorial evaluation and additional scientific review,” Christakis and Fontanarosa wrote.

“Given fundamental concerns about the study methodology, uncertainty regarding the validity of the findings and conclusions, and the potential public health implications, the editors have retracted this Research Letter.”

But Walach, who holds a doctorate in clinical psychology from the University of Basel, Switzerland, told Just The News in an emailed statement that JAMA didn’t specify how he failed “to provide sufficiently convincing evidence” to back his conclusions.

“I would actually also like to see how those conclusions were reached, but I am afraid that there was no solid conclusion,” he told the outlet. Walach pointed to “potential public health implications” as a “key phrase” in the retraction notice that, to him, suggests “the retraction was political, because some people did not like our data.”

Walach’s study has, thus far, drawn 21 official comments, most of which are critical. In a written response to the comments (docx), Walach and colleagues defended their research.

“Facts are not constituted by single studies, but by multiple replications and discourse,” they wrote. “This is the first peer-reviewed study of carbon dioxide content under face masks in children in a short measurement set-up. The measurements, we contend, are valid and were conducted by individuals with high content expertise.

“If someone doubts our results, the way to go is not to claim they are wrong without proof, but to produce better and different results.”

This comes as the American Academy of Pediatrics (AAP) on July 19 issued updated guidelines for school reopening, urging all staff and children over the age of 2 to wear masks in schools, regardless of vaccination status, a posture that is stricter than the mask-wearing guidance issued by the Centers for Disease Control and Prevention (CDC).

The AAP called its new guidance a “layered approach,” which includes recommendations for building ventilation, quarantining, as well as enhanced cleaning and disinfection.

The association said universal masking is necessary because much of the student population is not eligible for vaccines, and “masking is proven to reduce transmission of the virus and to protect those who are not vaccinated.”

There has been just one randomized-control trial during the pandemic, carried out in Denmark. The researchers found that wearing a “surgical mask when outside the home among others did not reduce, at conventional levels of statistical significance, incident SARS-CoV-2 infection compared with no mask recommendation.”

Senators in New Jersey recently held a hearing to explore the efficacy and negative effects of mask mandates in schools for children. They found that the scientific evidence doesn’t support such mandates.

Mask wearing amid the COVID-19 pandemic has become a hot-button issue, with some questioning the efficacy of facial coverings and others opposing mandates on grounds of personal liberty. Advocates, on the other hand, have broadly taken a better-safe-than-sorry approach in the face of underpowered efficacy studies, while generally viewing mandates as a minor inconvenience that helps protect people who are prone to serious complications if they get infected.

Source: The Epoch Times

4 responses to “Author of Retracted Study on Harm of Mask-Wearing by Children Says Removal Was ‘Political’”

  1. Good summary. The docx of the response to critics is no longer available — do you know an alternative?

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  2. I did not find it by searching the string ““Facts are not constituted by single studies, but by multiple replications and discourse”

    Like

  3. The text below is the original article itself (since retracted).
    “Experimental Assessment of Carbon Dioxide Content in Inhaled Air With or Without Face Masks in Healthy Children-
    A Randomized Clinical Trial”
    Harald Walach, PhD1; Ronald Weikl, MD2; Juliane Prentice, BA3; et al Andreas Diemer, PhD, MD4; Helmut Traindl, PhD5; Anna Kappes, MA6; Stefan Hockertz, PhD7
    Author Affiliations Article Information
    JAMA Pediatr. Published online June 30, 2021. doi:10.1001/jamapediatrics.2021.2659
    Many governments have made nose and mouth covering or face masks compulsory for schoolchildren. The evidence base for this is weak.1,2 The question whether nose and mouth covering increases carbon dioxide in inhaled air is crucial. A large-scale survey3 in Germany of adverse effects in parents and children using data of 25 930 children has shown that 68% of the participating children had problems when wearing nose and mouth coverings.

    The normal content of carbon dioxide in the open is about 0.04% by volume (ie, 400 ppm). A level of 0.2% by volume or 2000 ppm is the limit for closed rooms according to the German Federal Environmental Office, and everything beyond this level is unacceptable.4

    Methods
    We measured carbon dioxide content in inhaled air with and without 2 types of nose and mouth coverings in a well-controlled, counterbalanced, short-term experimental study in volunteer children in good health (details are in the eMethods in Supplement 1). The study was conducted according to the Declaration of Helsinki and submitted to the ethics committee of the University Witten/Herdecke. All children gave written informed consent, and parents also gave written informed consent for children younger than 16 years. A 3-minute continuous measurement was taken for baseline carbon dioxide levels without a face mask. A 9-minute measurement for each type of mask was allowed: 3 minutes for measuring the carbon dioxide content in joint inhaled and exhaled air, 3 minutes for measuring the carbon dioxide content during inhalation, and 3 minutes for measuring the carbon dioxide content during exhalation. The carbon dioxide content of ambient air was always kept well under 0.1% by volume through multiple ventilations. The sequence of masks was randomized, and randomization was blinded and stratified by age of children. We analyzed data using a linear model for repeated measurements with P < .05 as the significance threshold. The measurement protocol (trial protocol in Supplement 2) is available online.5 Data were collected on April 9 and 10, 2021, and analyzed using Statistica version 13.3 (TIBCO).

    Results
    The mean (SD) age of the children was 10.7 (2.6) years (range, 6-17 years), and there were 20 girls and 25 boys. Measurement results are presented in the Table. We checked potential associations with outcome. Only age was associated with carbon dioxide content in inhaled air (y = 1.9867 – 0.0555 × x; r = –0.39; P = .008; Figure). Hence, we added age as a continuous covariate to the model. This revealed an association (partial η2 = 0.43; P < .001). Contrasts showed that this was attributable to the difference between the baseline value and the values of both masks jointly. Contrasts between the 2 types of masks were not significant. We measured means (SDs) between 13 120 (384) and 13 910 (374) ppm of carbon dioxide in inhaled air under surgical and filtering facepiece 2 (FFP2) masks, which is higher than what is already deemed unacceptable by the German Federal Environmental Office by a factor of 6. This was a value reached after 3 minutes of measurement. Children under normal conditions in schools wear such masks for a mean of 270 (interquartile range, 120-390) minutes.3 The Figure shows that the value of the child with the lowest carbon dioxide level was 3-fold greater than the limit of 0.2 % by volume.4 The youngest children had the highest values, with one 7-year-old child’s carbon dioxide level measured at 25 000 ppm.

    Discussion
    The limitations of the study were its short-term nature in a laboratory-like setting and the fact that children were not occupied during measurements and might have been apprehensive. Most of the complaints reported by children3 can be understood as consequences of elevated carbon dioxide levels in inhaled air. This is because of the dead-space volume of the masks, which collects exhaled carbon dioxide quickly after a short time. This carbon dioxide mixes with fresh air and elevates the carbon dioxide content of inhaled air under the mask, and this was more pronounced in this study for younger children.

    This leads in turn to impairments attributable to hypercapnia. A recent review6 concluded that there was ample evidence for adverse effects of wearing such masks. We suggest that decision-makers weigh the hard evidence produced by these experimental measurements accordingly, which suggest that children should not be forced to wear face masks.

    Back to top
    Article Information
    Accepted for Publication: June 7, 2021.

    Published Online: June 30, 2021. doi:10.1001/jamapediatrics.2021.2659

    Retraction: A notice of retraction was published on July 16, 2021.

    Corresponding Author: Harald Walach, PhD, Poznan University of the Medical Sciences, Pediatric Clinic, ul. Szpitalna 27/33, PL-60-572 Poznań, Poland (harald.walach@uni-wh.de).

    Author Contributions: Dr Walach (principal investigator) had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: All authors.

    Acquisition, analysis, or interpretation of data: Walach, Weikl, Diemer, Traindl, Kappes, Hockertz.

    Drafting of the manuscript: Walach, Traindl.

    Critical revision of the manuscript for important intellectual content: Walach, Weikl, Prentice, Diemer, Kappes, Hockertz.

    Statistical analysis: Walach.

    Administrative, technical, or material support: Weikl, Prentice, Diemer, Traindl, Kappes, Hockertz.

    Supervision: Weikl, Diemer, Traindl, Kappes, Hockertz.

    Other–liaising with all other authors: Walach.

    Conflict of Interest Disclosures: None reported.

    Funding/Support: Mediziner und Wissenschaftler für Gesundheit, Freiheit und Demokratie eV, a public charity, has organized this study and covered only essential expenses, such as travel.

    Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    Data Sharing Statement: See Supplement 3.

    References
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    Xiao J, Shiu EYC, Gao H, et al. Nonpharmaceutical measures for pandemic influenza in nonhealthcare settings —personal protective and environmental measures.  Emerg Infect Dis. 2020;26(5):967-975. doi:10.3201/eid2605.190994 PubMedGoogle ScholarCrossref
    2.
    Matuschek C, Moll F, Fangerau H, et al. Face masks: benefits and risks during the COVID-19 crisis.  Eur J Med Res. 2020;25(1):32. doi:10.1186/s40001-020-00430-5PubMedGoogle ScholarCrossref
    3.
    Schwarz S, Jenetzky E, Krafft H, Maurer T, Martin D. Corona children studies “Co-Ki”: first results of a Germany-wide registry on mouth and nose covering (mask) in children. Published 2021. Accessed June 15, 2021. https://www.researchsquare.com/article/rs-124394/v1
    4.
    Mitteilungen der Ad-hoc-Arbeitsgruppe Innenraumrichtwerte der Innenraumlufthygiene-Kommission des Umweltbundesamtes und der Obersten Landesgesundheitsbehörden. [Health evaluation of carbon dioxide in indoor air].  Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz.  2008;51(11):1358-1369. doi:10.1007/s00103-008-0707-2PubMedGoogle ScholarCrossref
    5.
    Walach H, Weikl R, Traindl H, et al. Is carbon dioxide content under nose-mouth covering in children without potential risks? a measurement study in healthy children. Published April 14, 2021. Accessed June 15, 2021. https://osf.io/yh97a/?view_only=df003592db5c4bd1ab183dad8a71834f
    6.
    Kisielinski K, Giboni P, Prescher A, et al. Is a mask that covers the mouth and nose free from undesirable side effects in everyday use and free of potential hazards?  Int J Environ Res Public Health. 2021;18(8):4344. doi:10.3390/ijerph18084344 PubMedGoogle ScholarCrossref

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  4. Items like this need to be sent to the Governors of all states. We are a free nation so far and it would be nice to keep it that way. My concern in looking for info was that parents need to be in charge of their children as to wearing/notwearing masks.

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