The Scientific Truth About Mask Mandates

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

Background

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.

References

1) https://www.abc6.com/content/uploads/2021/11/h/b/PC-2021-5915-decision-mask-mandate.pdf

2) “Surgical Mask to Prevent Influenza Transmission in Households: A Cluster Randomized Trial.”

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0013998

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”

https://www.acpjournals.org/doi/full/10.7326/M20-6817

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”

https://www.poverty-action.org/sites/default/files/publications/Mask_RCT____Symptomatic_Seropositivity_083121.pdf

8) “A note on sampling biases in the Bangladesh mask trial.” https://arxiv.org/abs/2112.01296

 

 

 

 

 

 

Analysis of research data performed by Dr. Andrew Bostom Natural Immunity Should be Included as a Vaccine Exemption.

Ashish Jha’s Improper Comparison of Pediatric Polio and Covid-19 Vaccinations

by Andrew Bostom, M.D., M.S., and Michelle Cretella, M.D.

Within 10 days of the 11/2/21 Advisory Committee on Immunization Practices (ACIP) interim recommendation for use of Pfizer’s covid-19 mRNA vaccine in children aged 5-11 years old, Dean of the Brown University School of Public Health, Dr. Ashish Jha claimed in an 11/11/21 Washington Post oped.

  • “If today’s misinformation, politicization and anti-vaccine sentiment existed in the United States in the 1950s, would the polio vaccine have received the same level of uptake?”

Hard data on childhood polio versus covid-19 disease severity, and direct juxtaposition of the polio and covid-19 vaccine trials, reveals a very different reality.

A 1957 JAMA publication analyzed polio mortality between 1915 and 1954 in U.S. children aged up to 14 years old, prior to mass polio vaccination efforts. Despite a steady decline due to the expanding development of natural immunity, the average polio death rate among these children, including the major outbreaks, was an alarming 5.7%. Rhode Island, through October 31st in 1953, alone, recorded 289 clinical pediatric polio cases, with 15 deaths, a 5.2% fatality rate.

These data stand in stark contrast to the near zero childhood covid-19 mortality, overall, and perhaps literally zero, among children free of chronic comorbidity. Rhode Island has had zero primary cause pediatric covid-19 deaths, and the American Academy of Pediatrics, per its recording system, maintains, “In states reporting, 0.00%-0.03% of all child COVID-19 cases resulted in death.” An elegant study from a national database in Germany reported concordant findings, noting,

  • “The lowest risk was observed in children aged 5-11 without comorbidities. In this group, the ICU admission rate was 0.2 per 10,000 (2 per 100,000) and case fatality could not be calculated, due to an absence of cases”

Dr. Vinay Prasad’s pellucid commentary on the German analysis, referenced these additional salient data:

  • For healthy kids, the risk of death is 3 per 1,000,000 with no deaths reported in kids older than 5.
  • Kids 5 to 11 have a risk of going to the ICU of 2 in 100,000; 0 died.
  • Among kids who died of COVID-19, 38% were already on palliative/ hospice care.

Juxtaposing the polio and covid-19 pediatric vaccine trials highlights consistent, equally glaring discordances.

The controlled (both placebo and observational controls) 1954 polio vaccine field trial recruited ~1.83 million total children, with ~1.35 million in the paralytic polio analysis. Pfizer’s Covid-19 mRNA vaccine randomized, controlled trial in 5 to 11 year-olds enrolled ~2300.

516 total cases of paralytic polio accumulated in the 1954 polio field trial, and vaccination reduced its incidence by 71.1% and 62.4%, relative to the placebo and observational-control groups, respectively. The Pfizer covid-19 vaccine randomized, placebo-controlled trial in 5 to 11 year-olds recorded zero cases of severe covid-19, despite recruiting ~20% with comorbidities. Covid-19 vaccination did reduce mildly symptomatic, covid-19 by “90.7%,” based on “3 cases in the BNT162b2 group and 16 cases in the placebo group (noting the 2:1 randomization of vaccine: placebo)”. Additionally, “No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.”

 In summary, the 1954 polio vaccine trial for an order of magnitude more lethal, and crippling childhood disease than covid-19, assessed ~650-fold the number of children evaluated in Pfizer’s covid-19 vaccine trial. Polio vaccination in the 1954 trial prevented 374 cases of paralytic polio. Covid-19 vaccination in Pfizer’s trial prevented 13 cases equivalent to self-limited colds. Moreover, notwithstanding overwrought concerns about pediatric “long covid,” a December, 2021 Pediatric Infectious Diseases Journal review of 14 studies of this ostensible syndrome, concluded,

  • Evidence for long COVID in children and adolescents is limited, and all studies to date have substantial limitations or do not show a difference between children who had been infected by SARS-CoV-2 and those who were not.

 Dr. Jha’s comparison equating pediatric polio and covid-19 vaccination does not pass muster. Informed, dissenting medical opinions leery of mass, indiscriminate childhood covid-19 vaccination campaigns, should not be vilified.

Andrew Bostom, M.D. MS, is an adjunct scholar to the RI Center for Freedom & Prosperity. He is an academic clinical trialist and epidemiologist, who is currently a Research Physician at the Brown University Center For Primary Care and Prevention of Kent-Memorial Hospital in Rhode Island.

Michelle Cretella, M.D., is Executive Director of the American College of Pediatricians. She is a Rhode Islander who practiced pediatrics with a special interest in behavioral health for 15 years.