Pandemic & Public Health Literature

4.    Masks

Summary:
While some scientific literature appears to indicate the usefulness of masks, the overwhelming evidence indicates that masks are not helpful in reducing the spread of COVID-19. Rather, it appears that masks increase problems. This is evident at various levels and includes, but is not limited to physiological (e.g. temperature alterations), physical (e.g. rashes, headaches), psychological and social (e.g. effect on communication and impact on human relationships and the dignity of the human person, including, but not limited to, in relation to sexuality) effects observed and reported.

• For additional information/scientific literature please see https://swprs.org/face-masks-evidence/. Some of the papers addressed here may also be on that website.
  
  
• “The existing scientific evidences challenge the safety and efficacy of wearing facemask as preventive intervention for COVID-19. The data suggest that both medical and non-medical facemasks are ineffective to block human-to-human transmission of viral and infectious disease such SARS-CoV-2 and COVID-19, supporting against the usage of facemasks. Wearing facemasks has been demonstrated to have substantial adverse physiological and psychological effects. These include hypoxia, hypercapnia, shortness of breath, increased acidity and toxicity, activation of fear and stress response, rise in stress hormones, immunosuppression, fatigue, headaches, decline in cognitive performance, predisposition for viral and infectious illnesses, chronic stress, anxiety and depression. Long-term consequences of wearing facemask can cause health deterioration, developing and progression of chronic diseases and premature death.” (Vainshelboim, 2021) [NOTE: currently listed by Retraction Watch as Retracted/Withdrawn – see below for additional detail).
  
  
  • One of the reasons given was “The manuscript misquotes and selectively cites published papers. References #16, 17, 25 and 26 are all misquoted.” This potentially relates to the following statements in the manuscript:
    
    
    • “The physical properties of medical and non-medical facemasks suggest that facemasks are ineffective to block viral particles due to their difference in scales [16,17,25]. According to the current knowledge, the virus SARS-CoV-2 has a diameter of 60 nm to 140 nm [nanometers (billionth of a meter)] [16,17], while medical and non-medical facemasks’ thread diameter ranges from 55 μm to 440 μm [micrometers (one millionth of a meter), which is more than 1000 times larger [25].]”
      
      
    • “Among asymptomatic individuals, there was no droplets or aerosols coronavirus detected from any participant with or without the mask, suggesting that asymptomatic individuals do not transmit or infect other people [26].”
      
      
  • [NOTE: The author should have been given an opportunity to respond and clarify their statements and ensure the accuracy of their citations, in addition to the other comments supposedly justifying the retraction. Sadly, citation of wrong source is not an uncommon error in scientific papers. Having said that, here are some potential quotes from those papers that may have been interpreted as potentially implying that the masks are ineffective – note that while the words mask or viral particle size may not occur in the same paper, these papers provide information that can assist in making the conclusion pertaining to the potential efficacy of masks. The reader is asked to make their own judgment based on, but not limited to the information below:
    
    
    • Reference [16] (Wiersinga et al., 2020)
      
      
      • citing (Chia et al., 2020) states “(eg, coughing) or the detection of nucleic acid in the air does not mean that small airborne particles are infectious”.
        
        
      • citing (Goldsmith et al., 2004) states “SARS-CoV-2 has a diameter of 60 nm to 140 nm and distinctive spikes, ranging from 9 nm to 12 nm, giving the virions the appearance of a solar corona
        
        
      • states “Aerosol spread may occur, but the role of aerosol spread in humans remains unclear.”
        
        
    • Reference [17] states “…Diameter varied from about 60 to 140 nm.” (Zhu et al., 2020)
      
      
    • Reference [25] (Konda et al., 2020b)
      
      
      • states “…Although the filtration efficiencies for various fabrics when a single layer was used ranged from 5 to 80% and 5 to 95% for particle sizes of <300 nm and >300 nm, respectively…”
        
        
      • the correction that was uploaded for this paper (Konda et al., 2020a), in Table S2 refers to a thread diameter ranging from 55 μm to 440 μm. Thread diameter has been reported to be of significance in particle penetration (Chattopadhyay et al., 2015; Zangmeister et al., 2020)
        
        
    • Reference [26], in table 1b shows a non-significant difference detection of coronavirus in the section of the table addressing “Droplet particles >5mm” (Leung et al., 2020)
      
      
    • Regarding the reference to asymptomatic spread, from my analysis Reference [26] does not seem to address this. Therefore, if this is the case this would be an error. However as documented elsewhere in this document other citations are available that address this e.g., Acharya et al. (2021).]

• 4.1 Inefficacy of mask mandates
  
  • (Fogen, 2022)
    
    • “The most important finding from this study is that contrary to the accepted thought that fewer people are dying because infection rates are reduced by masks, this was not the case. Results from this study strongly suggest that mask mandates actually caused about 1.5 times the number of deaths or ∼50% more deaths compared to no mask mandates.”
      
      
    • “The mask mandates themselves have increased the CFR [Case Fatality Rate] by 1.85 / 1.58 or by 85% / 58% in counties with mask mandates. It was also found that almost all of these additional deaths were attributed solely to COVID-19. Therefore, this number is most likely underestimated and depends to a large extent on the percentage of people who tested positive for SARS-CoV-2 but did not die with COVID-19 as the underlying cause of death.”
      
      
  • “We did not observe association between mask mandates or use and reduced COVID-19 spread in US states.”  (Guerra and Guerra, 2021)
    
    
  • Although a CDC study (Guy et al., 2021) concluded that “Mask mandates were associated with statistically significant decreases in county-level daily COVID-19 case and death growth rates within 20 days of implementation. Allowing on-premises restaurant dining was associated with increases in county-level case and death growth rates within 41–80 days after reopening.”, the maximum reduction in cases was reported at 81-100 days after implementation of mask mandates, and amounted to 1.8%. The maximum increase in cases relative to the day states allowed on-premises dining was 1.1%.

• 4.2 Potential for significant impact on society (Czypionka et al., 2020)
  
  • “…mask mandates involve a tradeoff with personal freedom, so such policies should be pursued only if the threat is substantial and mitigation of spread cannot be achieved through other means.”

• 4.3 Adverse neurological consequences
  
  
  • Ferrari et al. (2021) – salient points from the abstract:
    
    • “Visual recognition of facial expression modulates our social interactions.”
      
      
    • “Compelling experimental evidence indicates that face conveys plenty of information that are fundamental for humans to interact. These are encoded at neural level in specific cortical and subcortical brain regions through activity- and experience-dependent synaptic plasticity processes.”
      
      
    • “The current pandemic, due to the spread of SARS-CoV-2 infection, is causing relevant social and psychological detrimental effects.”
      
      
    • “…by impacting social interaction, facemasks might impair the neural responses to recognition of facial cues that are overall critical to our behaviors”
      
      
    • “…the lack of salient stimuli might impact the ability to retain and consolidate learning and memory phenomena underlying face recognition.”

• 4.4 Adverse physiological effects
  
  • “Most of the complaints reported by children [this is a reference to complaints addressed in the manuscript by Schwarz et al. (2021) and included “irritability (60%), headache (53%), difficulty concentrating (50%), less happiness (49%), reluctance to go to school/kindergarten (44%), malaise (42%) impaired learning (38%) and drowsiness or fatigue (37%)”] can be understood as consequences of elevated carbon dioxide levels in inhaled air.” (Walach et al., 2021b) [NOTE: currently listed by Retraction Watch as Retracted/Withdrawn]
    
    
  • “We objectified evaluation evidenced changes in respiratory physiology of mask wearers with significant correlation of O2 drop and fatigue (p < 0.05), a clustered co-occurrence of respiratory impairment and O2 drop (67%), N95 mask and CO2 rise (82%), N95 mask and O2 drop (72%), N95 mask and headache (60%), respiratory impairment and temperature rise (88%), but also temperature rise and moisture (100%) under the masks. Extended mask-wearing by the general population could lead to relevant effects and consequences in many medical fields.” (Kisielinski et al., 2021)
    
    
  • “Breathing through N95 mask materials have been shown to impede gaseous exchange and impose an additional workload on the metabolic system of pregnant healthcare workers, and this needs to be taken into consideration in guidelines for respirator use.” (Tong et al., 2015)
    
    
  • “Ventilation, cardiopulmonary exercise capacity and comfort are reduced by surgical masks and highly impaired by FFP2/N95 face masks in healthy individuals.” (Fikenzer et al., 2020)
    
    
  • “This study including 19504 blood donors spanning over one and a half year shows that prolonged use of face mask by blood donors may lead to intermittent hypoxia and consequent increase in hemoglobin mass.” (Setia et al., 2021)
    
    
  • “We discuss how N95 and surgical facemasks induce significantly different temperature and humidity in the microclimates of the facemasks, which have profound influences on heart rate and thermal stress and subjective perception of discomfort.” (Li et al., 2005)
    
    
  • “Wearing an N95 mask for 4 hours during HD [hemodialysis] significantly reduced PaO2 and increased respiratory adverse effects in ESRD [end-stage renal disease] patients” [Note of consideration: this report pertains to data from already compromised patients] (Kao et al., 2004)
    
    
  • Other literature addressing significant changes in skin characteristics on the part of the face covered by a mask including: in skin temperature, redness, hydration and secretions (Park et al., 2021) in addition to eye dryness, acne, skin breakdown and nosebleeds, headaches and bad odors (Shenal et al., 2012; Kisielinski et al., 2021; Kumar and Singh, 2021)

• 4.5 Penetration of viral particles
  
  • “Penetration of cloth masks by particles was almost 97% and medical masks 44%.” (MacIntyre et al., 2015)
    
    
  • “By intention-to-treat analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections [stats] nor against clinical respiratory infection [stats]. Similarly, in a per-protocol analysis, facemask use did not seem to be effective against laboratory-confirmed viral respiratory infections [stats] nor against clinical respiratory infection [stats]…. This trial was unable to provide conclusive evidence on facemask efficacy against viral respiratory infections most likely due to poor adherence to protocol. [however, without justification in article, conclude that “likely due to poor adherence”] (Alfelali et al., 2020)

• 4.6 Inefficiency and inefficacy of masks
  
  • “Conclusions: “There is currently no evidence from RCTs demonstrating that the use of cloth or medical masks prevents the transmission of SARSCoV-2 in the community setting” (Chetty et al., 2021)
    
    
  • Despite the common sense evidence pertaining to masks, as I have indicated previously, papers that seek to minimize or potentially discredit the lack of real impact of masks in real life continue to be published [truly, there is nothing wrong with debate or disagreements – if it allows for a bidirectional flow of arguments and is an effort to seek the truth, but that has not been the case]. Kollepara et al. (2021) state:
    
    
    • “We determined that the studies that did not find masks to be effective were under-powered to such an extent that even if masks were 100% effective, they still would have been unlikely to find a statistically significant result” [NOTE: the sample of studies considered is taken from a “rapid systematic review” published in 2020 (Brainard et al., 2020)]
      
      
    • Authors admit that “…even when a mask does not prevent infection, it may reduce the severity of symptoms and the chance of long-term health damage or death”. This statement (and others) however, is very typical of the current myopic focus that has been characteristic of COVID-19. It ignores the reality of (1) the low mortality/morbidity of the disease and (2) the negative consequences including, but not limited to, the neurobiological, psychosocial, and physiological consequences [i.e., the bigger picture of human behavior] and (3) ignores, among other information, the CDC’s own findings of minimal reduction in spread with mask mandates (Guy et al., 2021).
      
      
    • The only mention of “psycho-social” impact is the following: “We note that psycho-social effects can reinforce the effect of prevention. The more individuals who wear masks, the less stigma that is associated with wearing them, which may make it more likely for others including those who are infectious (whether symptomatic, pre-symptomatic, or asymptomatic) to wear masks”. This statement ignores the reality of the discrimination/segregation/violence that has taken place in society and the impact of such measures.
      
      
  • Particles of various common odors (e.g. cigarette smoke) that can still be smelt through the mask, are generally comparable or larger than what has been described for SARS-CoV-2 (Anderson et al., 1989; Gowadia et al., 2009; Alderman and Ingebrethsen, 2011)
    
    
  • “Overall, masks may be effective in interrupting or reducing the spread of respiratory viruses. However, the study conclusions on the effectiveness of N95 respirators over medical masks are contradictory, especially for healthcare workers, and high-quality design evidence for mask use by a special population (such as students and company employees) is rare, and this requires further research. In addition, it is noteworthy that a few adverse effects of wearing masks have been systematically reported in existing high-quality design evidence…Finally, in view of the current research, cloth mask reuse may aggravate the spread of respiratory infection, which needs to be further evaluated.” (Li et al., 2021)
    
    
  • “Fourteen studies were included in this study. One preclinical and 1 observational cohort clinical study found significant benefit of masks in limiting SARS-CoV-2 transmission. Eleven RCTs in a meta-analysis studying other respiratory illnesses found no significant benefit of masks (+/-hand hygiene) for influenza-like-illness symptoms nor laboratory confirmed viruses. One RCT found a significant benefit of surgical masks compared with cloth masks. CONCLUSION: There is limited available preclinical and clinical evidence for face mask benefit in SARS-CoV-2. RCT evidence for other respiratory viral illnesses shows no significant benefit of masks in limiting transmission but is of poor quality and not SARS-CoV-2 specific.” (Nanda et al., 2021) [NOTE: it appears from various comments by the authors in the paper that the reference to “poor quality” refers to minimal control of the many variables that impact mask wearing. However, if this is the case, this does not make the studies and their findings “poor” in quality but rather realistic, given the reality of human interaction – i.e. humans are not meant to be like experimental animals, isolated in a cage and living under controlled conditions!]
    
    
  • “We were unable to detect a reduction in per-population daily mortality, hospital bed, ICU bed, or ventilator occupancy attributable to the implementation of a mask order” (Schauer et al., 2021)
    
    
    • Study also states that “To date, limited published data evaluating the effects of public mask wear on COVID-19 incidence demonstrate a significant (Cheng et al., 2020; Lyu and Wehby, 2020), beneficial effect These studies, however, restricted their analysis to publicly reported COVID-19 infection rates without an evaluation of corresponding hospital resource utilization.”
      
      
  • A review article (MacIntyre and Chughtai, 2015) comparing the outcomes of several studies addressing facemask wearing in healthcare and community settings: Table 1 in the paper summarizes the indications for the use of masks and respirators for selected infectious diseases in Healthcare settings and Community settings. While the indications for both Low risk and High risk situations in Healthcare settings seem to overall recommend some sort of face covering, this is not the case for the community setting, where the recommendations in all cases of Low risk (defined as “home, non-crowded settings”) is that masks are NOT recommended. Masks were recommended for High risk settings (defined as: “crowded settings (such as public transport), pre-existing illness, pregnancy, older age (pandemic influenza), contact with human remains or infected animals (Ebola virus)”) for Ebola and Pandemic influenza. Please note that the recommendations are generally based on CDC and WHO recommendations that, at this point, for various reasons indicated throughout this document, cannot be considered and have not proven themselves as reliable and objective sources for making health-related recommendations.
    
    
  • “We conclude that the protection provided by surgical masks may be insufficient in environments containing potentially hazardous submicrometer-sized aerosols.” (Weber et al., 1993) [NOTE: Literature related to COVID-19 seems to indicate potential presence of both large (larger than 5-10mm) and small particle size (<5mm). However, a particle size of <5mm appears to predominate for pathogens (Fennelly, 2020; Lee, 2020). Additionally, other literature reports sizes as low as 80-200nm (Masters, 2006). Pore sizes for cloth masks are reported to be in the range of 80-500mm (Neupane et al., 2019). N95 masks are claimed to protect against particles larger than 300nm (Ju et al., 2021).
    
    
  • Due to improper wearing of masks (Burgess and Horii, 2012; Konda et al., 2020). 
    
    
  • Reduced protection from viruses –> the longer the mask is worn and due to increased humidity (MacIntyre et al., 2015; Lazzarino et al., 2020)
    
    
  • “The use of surgical facemasks is ubiquitous in surgical practice. Facemasks have long been thought to confer protection to the patient from wound infection and contamination from the operating surgeon and other members of the surgical staff…In light of current NHS budget constraints and cost-cutting strategies, we examined the evidence base behind the use of surgical facemasks. Examination of the literature revealed much of the published work on the matter to be quite dated and often studies had poorly elucidated methodologies. As a result, we recommend caution in extrapolating their findings to contemporary surgical practice. However, overall there is a lack of substantial evidence to support claims that facemasks protect either patient or surgeon from infectious contamination.” (Da Zhou et al., 2015)
    
    
  • “Face mask use in health care workers has not been demonstrated to provide benefit in terms of cold symptoms or getting colds.” (Jacobs et al., 2009)
    
    
  • “In this community-based, randomized controlled trial conducted in a setting where mask wearing was uncommon and was not among other recommended public health measures related to COVID-19, a recommendation to wear 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.” (Bundgaard et al., 2020)
    
    
  • Xiao et al. (2020)
    
    • “The evidence from RCTs [randomized controlled trials] suggested that the use of face masks either by infected persons or by uninfected persons does not have a substantial effect on influenza transmission.”
      
      
    • “Two studies in university settings assessed the effectiveness of face masks for primary protection by monitoring the incidence of laboratory-confirmed influenza among student hall residents for 5 months (Aiello et al., 2010; Aiello et al., 2012). The overall reduction in ILI or laboratory-confirmed influenza cases in the face mask group was not significant in either studies (Aiello et al., 2010; Aiello et al., 2012).”
      
      
  • MacIntyre et al. (2015)
    
    • “Cloth masks also had significantly higher rates of ILI [influenza-like illness] compared with the control arm.”
      
      
    • “Penetration of cloth masks by particles was almost 97% and medical masks 44%.”
      
      
    • “…and the results caution against the use of cloth masks…Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection…as a precautionary measure, cloth masks should not be recommended for HCWs [healthcare workers]…”
      
      
  • “Meta-analyses suggest that regular hand hygiene provided a significant protective effect (OR=0.62; 95% CI 0.52-0.73; I²=0%), and facemask use provided a non-significant protective effect (OR=0.53; 95% CI 0.16-1.71; I²=48%) against 2009 pandemic influenza infection.” (Saunders-Hastings et al., 2017)
    
    
  • Example of some papers with potential problems in study design or interpretation:
    
    • Aiello et al. (2012)
      
      • “Our findings show a significant reduction in the rate of ILI [influenza-like illness] among participants randomized to the face mask and hand hygiene intervention during the latter half of the study period, ranging from 48% to 75% when compared to the control group. We also observed a substantial (43%) reduction in the incidence of influenza infection in the face mask and hand hygiene group compared to the control, but this estimate was not statistically significant.”
        
        
      • “There were no substantial reductions in ILI [influenza-like illness] or laboratory-confirmed influenza in the face mask only group compared to the control.”
        
        
      • Summary of Conclusions: Masks on their own do not help; masks and hand sanitizer reduced transmission, however, results are ambiguous as to whether the reduction was statistically significant. Study flawed (despite CDC involvement in design) – no hand hygiene alone group, therefore it cannot be determined whether the reduced transmission was simply due to hand hygiene alone, given that the mask-alone group showed no reduction.
        
        
    • MacIntyre and Chughtai (2020)
      
      • “The study suggests that community mask use by well people could be beneficial, particularly for COVID-19, where transmission may be pre-symptomatic. The studies of masks as source control also suggest a benefit, and may be important during the COVID-19 pandemic in universal community face mask use as well as in health care settings.”
        
        
      • Summary of Conclusions: Paper flawed – Conclusion in abstract (see above) is not supported by the information in the paper; potential significant conflict of interest; significant conflicting conclusions from papers reviewed; unsubstantiated/unsupported claims and extrapolations/projections; misrepresents the information from some of the papers reviewed (e.g. Aiello et al., 2012); contradicts their own previous work (MacIntyre et al., 2015).
        
        
    • Abaluck et al. (2021)
      
      • 7.9% (27,116) reported COVID-like symptoms (from 342,126); From the 7.9%, 40.3% (10,592) consented to have blood collected.
        
        
      • The following statements and the findings indicating a very minimal symptomatic seropositivity (i.e. displayed both symptoms and were seropositive for the antibody) further questions the significance of the findings. 
        
        
        • “Our trial is therefore designed to track the fraction of individuals who are both symptomatic and seropositive.”
          
          
        • “Not all symptomatic seroprevalence is necessarily a result of infections occurring during our intervention; individuals may have pre-existing infections and then become symptomatic (perhaps caused by an infection other than SARS-CoV-2).”
          
          
      • Relative to WHO-Defined COVID-19 Symptoms (Figure 2): “We find clear evidence that the intervention reduced symptoms: we estimate a reduction of 11.9% (adjusted prevalence ratio 0.88 [0.83,0.93]; control group prevalence = 8.59%; treatment group prevalence = 7.60%)…In this sample we continue to find an effect overall and an effect for surgical masks, but see no effect for cloth masks.”
        
        
      • Relative to Symptomatic Seroprevalence by Age (Figure 3): “In surgical mask villages, we observe a 23.0% decline in symptomatic seroprevalence among individuals aged 50-60 (adjusted prevalence ratio of 0.77 [0.59,0.95]) and a 34.7% decline among individuals aged 60+ (p = 0.001) (adjusted prevalence ratio of 0.65 [0.46, 0.85]).”
        
        
      • “Our estimates suggest that mask-wearing increased by 28.8 percentage points, corresponding to an estimated 51,347 additional adults wearing masks in intervention villages, and this effect was persistent even after active mask promotion was discontinued. The intervention led to a 9.3% reduction [Figure 1, p=0.043] in symptomatic SARS-CoV-2 seroprevalence (which corresponds to a 103 fewer symptomatic seropositives) and an 11.9% reduction [Figure 2, p=0.000], in the prevalence of COVID-like symptoms, corresponding to 1,587 fewer people reporting these.”
        
        
        • Concerns: NOT addressed explicitly in this paragraph is that there was NO statistically significant decrease in 40-50 year old and <40 year old subjects. These results need, like other papers, to be interpreted in the context of other evidence, including the counter evidence that exists in relation to mask wearing, in addition to the other impacts (e.g. psychological, physiological, etc.). Thus, taking the information mentioned above into consideration, in addition to other scientific literature including, but not limited to, the Bundgaard study (Bundgaard et al., 2020), the fact that mask wearing in those <50 years old was not significantly different highlights that it is not the masks that are related to symptomatic seroprevalence (or else common sense dictates that all ages should have demonstrated significant decreases) but additional factors including, but not limited to comorbidities.
          
          
      • Other Concerns:
        
        • Potential for coercion?
          
          • Governmental: “The sample excludes 4 villages because of lack of government cooperation to perform the intervention.”
            
            
          • Questionable appropriate consent for participation of villagers: Consent is only addressed in regards to blood collection.
            
            • “…observations were not limited to adults from enrolled households.”
              
            • “After 5 weeks of surveillance in wave 1, it was clarified that surveillance staff should only record mask-wearing behavior of people who appear to be 18 years or older. Prior to this, some surveyors included children (especially older children) in their counts.”
              
              
        • Potential impact of financial incentives: Despite all claims, concerns remain in terms of the impact of financial incentives (in a population that is extremely poor – Could this study have been carried out in a developed country?) potentially influencing the results. 

• 4.7 Increased spread
  
  • The potential for increased spread of the virus due to its presence on the outer surface of masks or due to increased touching of the eyes (Isaacs et al., 2020; Lazzarino et al., 2020).

• 4.8 Substantial psychosocial impact
  
  • The physiological and psychological impact are not independent of each other and the former may potentially impact the latter (Roberge et al., 2012; Scheid et al., 2020). The psychosocial impact of masks include:
    
    
    • Their potential to interfere with communication, appropriate care and well-being of patients (Isaacs et al., 2020; Marler and Ditton, 2021).
      
      
    • Fatigue, anxiety, or claustrophobia, impaired cognition (Shenal et al., 2012; Kumar and Singh, 2021).
      
      
    • Confusion in the interpretation of emotions due to interference with the recognition of facial expressions, and impediment in interpersonal relationships irrespective of whether there are pre-existing psychopathologies or not (Critchley et al., 2000; Carbon, 2020).
      
      
    • The potential to interfere with the appropriate detection of natural chemicals (pheromones) that are potentially involved in the bonding involved in natural human relationships (Savic et al., 2009).
      
      
  • “Those who wore their masks all of the time had higher mean IES-R [Impact of Events Scale-Revised] scores…and higher mean CES-D [Center for Epidemiologic Studies—Depression Scale]…” [NOTE: The reference to higher IES scores in relation to mask wearing is indicative of higher levels of PTSD symptoms; CES-D addresses depressive symptoms] (Hawryluck et al., 2004)