Fourteen Randomized, Controlled Trials of Community Masking, Published 2008 to 2021, Are Uniformly Negative, and Underscore the Punitive, Anti-Scientific Futility of Public Mask Mandates
By Dr. Andrew Bostom
In August of 2021, the State of Rhode Island and the Rhode Island Department of Health implemented a school mask mandate which will extend at least into January of 2022. Subsequently, there has been much public debate and outcry about the wisdom and motives behind this heavy-handed policy, including a lawsuit brought by concerned parents.
In a November 2021 Superior Court ruling in the State of Rhode Island, presented with scientific evidence and after hearing testimony from parents, the trial judge found that the prolonged masking of children over the course of a school day caused “irreparable harm” for the children in the state who were forced to wear masks.1
Yet, despite overwhelming research against the , still, by early February of 2022, at the time of this post, Rhode Island’s school mask mandate was still in effect – even as, in recent weeks, Massachusetts, Virginia, Connecticut, Delaware, New Jersey, and Oregon announced they would be ending their mandates.
Worse, on February 8, House and Senate committees in the Rhode Island General Assembly advanced legislation that would allow school mask mandates to be remain in place through the end of March by extending the Governor’s emergency executive powers.
Back in August, the State cited vague guidance by the Centers For Disease Control and Prevention (CDC) as the basis for imposing this mandate, yet history and the most credible studies do not support a policy of universal masking within designated communities.
Between 2008-2020, thirteen negative randomized controlled trials (the gold-standard for studies of medical interventions) on masking were published.2-5 These studies conducted among ~18,000 persons, worldwide, all indicated that masking does not reduce community respiratory virus transmission.
Conversely, the most prominent study that the CDC cited to support its call for the continued masking of children aged 2 and older in school, was not a randomized, controlled trial, had serious design flaws, and may have included factitious data.6
Gold Standard Studies
In our era, randomized, controlled trials have shown, uniformly that face masks are not effective against respiratory virus outbreaks, or epidemics. But with the onset of the coronavirus pandemic and increasing political pressure, suddenly studies appeared claiming the opposite. In reality, none of these studies were of the gold standard caliber; instead a mixture of confounded observational data, unrealistic modelling and laboratory results, and possible fraud.
Taking a look at more credible ‘gold standard’ designs, ten negative studies, focusing primarily on influenza, 2008 to 2016, were “meta-analyzed” [their data “pooled”], confirming the individual negative results.3 Independently validating these pooled findings are the results from a single large randomized controlled trial of masking among another cohort of Hajj pilgrims whose enrollment [n=6338] equaled the sum enrollment of all the 10 studies in the May, 2020 “meta-analysis.” Published online in mid-October, 2020, this “cluster randomized” (i.e., by tent) controlled trial confirmed mask usage did not reduce the incidence of clinically defined, or laboratory-confirmed respiratory viral infections, primarily influenza and/or rhinovirus. Indeed, there was a suggestion masking increased laboratory-confirmed infections by 40%, although this trend was not “statistically significant.”4
Subsequently, Danish investigators published the results during mid-November, 2020 of a randomized, controlled study conducted in 4862 persons which found that masking did not reduce SARS-CoV-2 (covid-19) infection rates to a statistically significant, or clinically relevant extent. Covid-19 infections (detected by laboratory testing or hospital diagnosis) occurred among 1.8% of those assigned masks, versus 2.1% in control participants. Moreover, a secondary analysis including only participants who reported wearing face masks “exactly as instructed,” revealed a further narrowing of this non-significant, clinically meaningless infection rate “difference” to 0.1%, i.e., 2.0% in mask wearers versus 2.1% in controls.5
Finally, a vast (n=342,000) Bangladesh randomized trial of community masking, reported 8/31/21 as preprint, found cloth masks did not prevent SARS-CoV-2 infections. Odd, contradictory findings were described regarding surgical masks: they conferred a minimal, clinically irrelevant overall absolute risk reduction of 0.09%, which was somehow selectively limited only to those over 50 years old.7 However, a re-analysis of the raw data using appropriate statistical methods, found no evidence of benefit of paper masks either, in any subgroup.8
In aggregate from 2008 through August 2021, these fourteen negative randomized controlled trials of community masking for the prevention of respiratory viral infections, including SARS-CoV-2,2-5,7,8 underscore the punitive, anti-scientific fecklessness of public mask mandates
Dr. Andrew Bostom, an adjunct scholar to the RI Center for Freedom & Prosperity is an academic internist, clinical trialist, and epidemiologist. Dr, Bostom was academic faculty for 24-years at Brown University Medical School, and remains affiliated with the Brown University Center For Primary Care and Prevention of Kent-Memorial Hospital.
2) “Surgical Mask to Prevent Influenza Transmission in Households: A Cluster Randomized Trial.”
3) “Nonpharmaceutical Measures for Pandemic Influenza in Nonhealthcare Settings—Personal Protective and Environmental Measures” https://wwwnc.cdc.gov/eid/article/26/5/19-0994_article
4) “Facemask against viral respiratory infections among Hajj pilgrims: A challenging cluster randomized trial” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7553311/pdf/pone.0240287.pdf
5) “Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers”
6) ““The CDC’s Flawed Case for Wearing Masks in School” https://www.theatlantic.com/science/archive/2021/12/mask-guidelines-cdc-walensky/621035/
7) “The Impact of Community Masking on COVID-19: A Cluster-Randomized Trial in Bangladesh”
8) “A note on sampling biases in the Bangladesh mask trial.” https://arxiv.org/abs/2112.01296