by Jon Sanders
Director of the Center for Food, Power, and Life, Research Editor, John Locke Foundation
“Our statewide mask requirement has been in effect since June, and it is still our best weapon in this fight.” So said Gov. Roy Cooper on Nov. 23 as he cited worsening case numbers to justify strengthening his mask order that had been in place for five months. The irony was entirely lost on the governor and media.
Cooper regularly cites “science and data” in his extreme emergency orders. I have examined the science provided by Cooper and state health bureaucrat Mandy Cohen of the Department of Health and Human Services (DHHS) many times and found it lacking when it comes to justifying such extreme measures:
My article on the EPA science advisor, Dr. S. Stanley Young, who challenged Cooper’s case on masks based on his reviews of scientific research, prompted an email from Aaron Fleischauer at DHHS offering this document for DHHS’s case for masks. The document lists 22 studies, all published this year, containing what DHHS states is “overwhelming” “scientific evidence for the protective effect of face masks and respiratory virus infection in healthcare and community settings.” (Of course there is much more research into the question than just these studies.)
What this document, which is not easy to find through searching the DHHS web site independently, should contain is no less than this: a slam-dunk case justifying Cooper’s extreme, open-ended emergency orders.
Why? Because Cooper issued orders against the normal scope of the Emergency Management Act, and Cooper has forced face masks on North Carolinians, even in their own homes at times, at the threat of misdemeanor charges, civil fines, business closures, people being turned away at business doors, people being threatened with trespassing, people being urged by the governor to call the cops on their fellow citizens, and perhaps worse.
After all, Cooper’s decision is not either to force mask-wearing or say nothing. As I wrote in an early review of the Cooper administration’s mask research:
Cooper and his health secretary, Cohen, are well situated to use their respective offices to recommend, to persuade, even to urge people to adopt practices such as wearing face coverings that they believe is healthy and proper. Doing so would reciprocate the respect and trust afforded them by their fellow North Carolinians, their co-equals in the eyes of God and our state constitution.
So the question again is this: Does this research offer a slam-dunk case justifying Cooper’s extreme emergency orders? This series will examine and discuss each study provided here by the Cooper administration, in the order it is presented by the Cooper administration, and ask whether it supports Cooper’s extreme exercise of power, because that is the relevant standard.
Here is the first batch:
Published June 1, 2020, this study is a systematic review and meta-analysis of observational studies, not randomized controlled trials (RCTs), of COVID-19 transmission. Chu et al. were interested in studies of social distancing of 1 meter or more (3.28 feet), face mask use (not cloth masks, but surgical masks, surgical-like masks of 12-16 layers, and N95 respirators), and eye protection. Cooper cited this study among the five “examples of studies studying the effectiveness of face coverings” that he included in his Nov. 23 executive order tightening his mask order against people.
From 38 studies of physical distance, Chu et al. found “moderate certainty” of that “physical distance of more than 1 m probably results” in reduced virus infection. From 39 studies of face masks, Chu et al. had “low certainty” in finding that “Medical or surgical masks might result” in reduced virus infection. They likewise had “low certainty” that “Eye protection might result” in reduced virus infection.
In their discussion Chu et al. reference the Precautionary Principle but also recognize “strong, perhaps opposing, sentiments about policy making during outbreaks” as well as the “scientific uncertainty”:
A counter viewpoint [to the Precautionary Principle approach to policymaking during COVID-19] is that the scientific uncertainty and contextual considerations require a more nuanced approach. Although challenging, policy makers must carefully consider these two viewpoints along with our findings.
Chu et al. had “low certainty” in their findings regarding masks. Low certainty is obviously not enough for extreme emergency orders.
Observational studies as opposed to randomized controlled trials (RCTs) are also unlikely to provide evidence compelling enough for extreme emergency orders. RCTs are considered the gold standard, avoiding recall biases and other confounders in observational studies. Young’s review of RCTs concerning face masks and influenza yielding him this finding: “The evidence from RCTs suggested that the use of face masks either by infected persons or by uninfected persons does not have a substantial effect on influenza transmission.” The statistician explained that the findings meant “the results are consistent with chance.”
Also, Chu et al. did not study “face coverings” as Cooper’s orders define them — specifically excluding N95 respirators and surgical masks, but requiring coverings that could be almost anything: “synthetic and natural fabrics, including cotton silk, or linen. Ideally , a Face Covering has two (2) or more layers. A Face Covering may be factory-made, sewn by hand, or can be improvised from household items such as scarfs, bandanas t-shirts, sweatshirts, or towels.” (See discussion here.) Chu et al.’s low-certainty findings regarded the more protective surgical masks, surgical-like masks, and N95 respirators.
Finally, Chu et al. specifically advised policymakers to recognize scientific uncertainty, opposing viewpoints, and contextual considerations for a “more nuanced approach.” Extreme emergency orders are the opposite of a nuanced approach.
A rapid systematic review of the efficacy of face masks and respirators against coronaviruses and other respiratory transmissible viruses for the community, healthcare workers and sick patients. International Journal of Nursing Studies (2020).
Received March 24, 2020, this study reviewed 19 RCTs of the efficacy of face mask use, including eight in community settings. The study found that “Medical masks were not effective, and cloth masks even less effective.” It even “suggests cloth masks may increase the risk of infection” but says that finding “may not be generalizable to all homemade masks.”
The Cooper administration’s interest in this study appears to be its conclusion in the face of its findings. MacIntyre et al. wrote, “The study suggests that community mask use by well people could be beneficial, particularly for COVID-19, where transmission may be pre-symptomatic.” Note that the words suggests, could be, and may be are all included in that one sentence.
Interestingly, it also sheds doubt on the “six feet” social distancing rule (or 1–2 meters): “the rule of 1–2 m of spatial separation is not based on good evidence, with most research showing that droplets can travel further than 2 m., and that infections cannot be neatly separated into droplet and airborne.”
If anything, it specifically cautions against the kind of masks in Cooper’s order since “cloth masks may increase the risk of infection.”
Mask use during COVID-19: A risk adjusted strategy. Environ Pollut. (2020). 266(Pt 1):115099.
Received May 6, 2020, this study examines studies over the use of medical masks, surgical masks, and respirators, not cloth or homemade masks. Regarding the “effectiveness” of those masks, it argues from the basis of several studies that “wearing a [medical or surgical] mask [or respirator] is an effective means of preventing respiratory infectious diseases, which could reduce the risk of infection.” It also cites them as “a low-cost intervention” and “a means of raising public awareness of other NPIs [non-pharmaceutical interventions].”
Regarding the “necessity” of wearing those masks, not homemade masks, the study argues from an assumption of necessity undercut by its conclusion that “these evidences implied that wearing masks would be able to reduce the burden of infectious diseases.”
A problem for Wang et al. is the culture in the “many western advanced economies” as opposed to “Asian countries.” In Asian countries, “wearing masks has become pervasive.” Not so in the West, where “many still may view personal protective equipment (PPE) and physical barrier including wearing the mask as contrary to freedom and individualism.”
Wang et al., however, do not propose “requiring the general public to wear masks.” They propose instead that “Rational guidance should be provided concerning the use of masks.” This rational guidance is how to inform the public about wearing masks and adopting (voluntarily) other measures, including “hand hygiene, ventilation improvement, reduction of gatherings, and social and physical distancing.”
Like Chu et al., it concerns medical masks, surgical masks, and respirators, not the face coverings that Cooper ordered for the general public. Probable effects (“could” reduce, “implied” it “would be able to” reduce, etc.) are insufficient for extreme emergency orders.
Furthermore, Wang et al. specifically propose that policymakers provide “rational guidance” to the public regarding mask wearing and other measures so they would adopt them voluntarily — which is different from leveling extreme emergency orders.
Also, changing the culture is no business of an extreme emergency order.
Posted on April 6, 2020, this study reviewed 31 studies on face mask use, most if not all “about use of medical grade (surgical paper masks).” Those are, after all, what are used by “habitual facemask users, usually in Far East countries” and supported by “street scene photography of Hong Kong, Korean, Chinese, and Japanese cities where facemask wearing is common.”
The studies featuring RCTs found that “wearing a facemask may very slightly reduce the odds of developing ILI [influenza-like illness]/respiratory symptoms,” for which there was only “low-certainty evidence.” The study also featured observational studies, the results of which seemed slightly more effective, but there was still only “low certainty evidence” of a “very small” protective effect if masks are worn by the well, and “very low-certainty evidence” of a “very small” protective effect if masks are worn by the sick. Worn by both sick and well, odds were “modestly reduced,” but again, there was only “low certainty evidence” of that. Also note, these were in households, not community settings.
Brainard et al. expected “RCTs to under-estimate the protective effect [of wearing surgical-grade masks] and observational studies to exaggerate it.”
Their key conclusion, ignored by the Cooper administration’s summary, is this: “The evidence is not sufficiently strong to support widespread use of facemasks as a protective measure against COVID-19.” They write (again, remember the study concerns surgical-grade facemasks, not homemade cloth masks as ordered by Cooper):
We do not consider that the balance of evidence across all available studies supports routine and widespread use of facemasks in the community. However, using a mask for short periods of time by particularly vulnerable individuals during transient exposure events may be justified.
Those are important features: short periods, particularly vulnerable individuals, transient exposure events. Brainard et al. cite several studies against long-term wear of masks. They note that “facemasks soon become moist with condensation from wearer’s breath (facilitating microbial ingress and growth)” — i.e., inhaling microscopic bacteria leading to other infections. Also, they find that:
Many barriers exists that can make it difficult for individuals to wear facemasks correctly for hours over a multi-day period, including perceived breathing impairment and other discomforts. Facemasks are perceived to or genuinely do interfere with ordinary physical activities such as heavy exertion, sleep, oral hygiene, and eating. Facemasks can be uncomfortable, hot, cause skin rashes or simply fee anti-social.” (References omitted.)
Brainard et al. outright state that “The evidence is not sufficiently strong to support widespread use of facemasks as a protective measure against COVID-19.”
“Low certainty” to “very low certainty” evidence of “very small” protective effects and “slight” to “modest” reductions is not enough for extreme emergency orders. Also, as with Chu et al. and Wang et al. above, this study does not even consider the cloth and homemade masks Cooper has ordered for the general public.
Furthermore, this study specifically cautions against some aspects of mask-wearing inherent in the extents of Cooper’s order. It warns of breathing impairments and other risks of long-term wear. It explicitly cites the danger of breathing in the microbial growth on masks, especially from becoming moist over time from exhalation (i.e., “collecting droplets”). It also warns of interference with ordinary physical activities including heavy exertion (which would include physical exercise as well as playing sports), which incidentally would quickly soak masks with moisture. Cooper requires people at gyms, fitness centers, etc. to wear masks even while “strenuously exercising.”
Masks Do More Than Protect Others During COVID-19: Reducing the Inoculum of SARS- CoV-2 to Protect the Wearer. J Gen Intern Med (2020);1-4.
Received on June 22, 2020, this study tests a new theory for universal masking, that it “reduces the ‘inoculum’ or dose of the virus for the mask-wearer. Authors acknowledge it is “one of the first times” and “one of the first perspectives to discuss this evidence supporting this theory.” The study proceeds from the assumption of “the effectiveness of facial masks,” which in this study includes cloth masks, and moves to test this “unique angle on why universal public masking during the COVID-19 pandemic should be one of the most important pillars of disease control.”
Gandhi et al. find outcomes in Asian countries “accustomed to masking” and some early-mask countries to be “suggestive of this viral inoculum theory.” Those countries “have fared well in terms of rates of severe illness and death,” and even when cases have resurged in those areas after reopening, “case-fatality rate has remained low.”
Of note, Gandhi et al. state that “For this particular pillar of pandemic control to work in the USA, leading politicians will need to endorse and model mask-wearing.” The study does not specifically endorse universal mask orders with enforcement. It does, however, specifically warn against economic shutdowns and lockdowns:
The efforts to preserve life must be balanced against the catastrophic consequences of shutting down economies, which ultimately will lead to more suffering, poverty, and death than the virus itself, especially for the working poor.
However compelling it may sound to a policymaker, a novel theory in the early stages of research cannot be the basis for extreme emergency orders. Changing the culture is no business of an extreme emergency order.
Furthermore, while Gandhi et al. propose that politicians “endorse and model” mask-wearing, they specifically warn against the even deadlier effects of another aspect of Cooper’s order: “shutting down economies.” Cooper has already done that once, and in recent weeks he and Cohen have been threatening to do it again, including most ominously this past weekend.
This study put forward by the Cooper administration warns that shutting down the economy bodes “catastrophic consequences … which ultimately will lead to more suffering, poverty, and death than the virus itself, especially for the working poor.”
Face Masks Against COVID-19: An Evidence Review. Proceedings National Academy Sciences (2020).
Compiled on April 4, 2020, this study finds that the evidence for “The positive impact of public mask wearing on this [COVID-19] is ‘scientifically plausible but uncertain.'” Nevertheless, Howard et al. “recommend that public officials and governments strongly encourage the use of widespread face masks in public, including the use of appropriate regulation.” The authors base that recommendation on the following:
Setting aside the significance to Howard et al. of the importance of human ritual and inducing feelings of empowerment and the like, the filtration capacity for cloth masks discussed in the study ranges widely: “household materials had 3% to 60% filtration rate for particles in the relevant size range, finding them comparable to some surgical masks.” Their effectiveness is less for aerosols: “some evidence suggests they may have a partial effect in reducing viral aerosol shedding” (some, suggests, may have). Later they noted that homemade masks weren’t as well-fitted as surgical masks: “the median-fit factor of the homemade masks was one-half that of the surgical masks.”
The authors cite Hong Kong favorably for community mask use and support on more than one occasion, and they also note that “A number of countries have distributed surgical masks (South Korea, Taiwan) from early on while Japan and Singapore are now distributing close masks to their whole population.” They write that “cloth masks may be a pragmatic temporary alternative to surgical masks for the public.”
Making frequent use of the term “pragmatic,” Howard et al. unsurprisingly base their recommendation that “mask use requirements are implemented by governments, or when governments do not, by organizations that provide public-facing services” explicitly on the Precautionary Principle:
The loss of life and economic destruction that has been seen already from COVID-19 is a “morally unacceptable harm.” The positive impact of public mask wearing on this is “scientifically plausible but uncertain” … while researchers may reasonably disagree on the magnitude of transmissibility reduction and compliance, seemingly modest benefits can be massively beneficial in the aggregate due to the exponential character of the transmission process. Therefore, the action of ensuring widespread use of masks in the community should be taken, based on this principle.
“Scientifically plausible but uncertain” is insufficient for extreme emergency orders. It should be self-evident that the Precautionary Principle is no basis for extreme emergency orders.
Probable effects (“some evidence,” “suggests,” “may have,” “may be,” etc.) are insufficient for extreme emergency orders.
Changing the culture is no business of extreme emergency orders — not even to induce a policymaker’s desired new human ritual, inspire feelings of empowerment and self-efficacy, remove feelings of social stigma, or enhance people’s awareness of other practices a policymaker wishes people to adopt.
Face masks: benefits and risks during the COVID-19 crisis. Eur J Med Res. 2020 Aug 12;25(1):32.
Received on May 18, 2020, this study finds “only weak evidence for wearing a face mask as an efficient hygienic tool to prevent the spread of a viral infection.” Matuschek et al. do find “relevant protection” from the use of medical masks “during close contact scenarios by limiting pathogen-containing aerosol and liquid droplet dissemination.”
“Masks for everyday use (temporary masks made from fabric, etc.),” they find, “grant no protection for the user,” and what “limited self-protection for its wearer” a simple mask offers is only when the mask is “worn properly.” Matuschek et al. consider it “safe to assume there is a small risk reduction for droplet transmission” from everyday cloth masks such that they are “commonly recommended for walking, shopping, or using public transportation.” They acknowledge “there is no reliable data concerning the amount of virus particles that can be spread by an asymptomatic person, when keeping at a minimum safe distance.”
Matuschek et al. find greater protection from surgical masks, filtering face pieces (masks used for work among non-toxic dust), and N95 respirators. But those masks also included a greater risk of airflow obstruction or feeling of strained breathing, “especially during physical exertion.” Matuschek et al. write that “Depending on the design, masks can increase the lung’s dead space. In extreme cases, carbon dioxide retention (hypercapnia) can occur with side effects.” They note that “Only few investigations are available and addressing this medical problem.”
Matuschek et al. echo the World Health Organization in warning against improper use of masks, by which their protective effect could be “severely reduced”:
Improper donning or doffing, insufficient maintenance, long or repeated use of disposable masks, no dry cleaning of fabric masks, or using masks made of non-protective material.
Going further, they stress that the “mask must fit airtight to the skin” and that taking off the mask must be done carefully since that “the outside of the mask should not be touched.” Furthermore, “Breathing dampens the mask” and with “excessive moisture, the masks become airtight,” causing air to flow unfiltered along the edges, “losing the protective effect to both the wearer and the environment.” Not exchanging or washing masks regularly means “pathogens can accumulate in the mask,” not just COVID-19 — and that the risk of spreading those pathogens “might be critically increased.”
Findings of “only weak evidence” of “limited” to “no protection” cannot be enough for extreme emergency orders.
Furthermore, Matuschek et al. specifically caution against some aspects of mask-wearing inherent in the extents of Cooper’s order. For example, Cooper’s requirement that restaurants, etc. “have all Guests wear Face Coverings (including at their table) when they are not actively drinking or eating” would necessarily require the very kind of improper donning and doffing and touching of masks leading to pathogenic accumulation they warn against. Cooper’s requirement that people at gyms, fitness centers, etc. wear masks even while “strenuously exercising” would also lead to excessive moisture dampening the masks losing their protective effect and leading to pathogenic accumulation. Cooper’s orders affecting workplaces all across the state also would tend to workers’ “long or repeated use” of masks.
Received on April 30, 2020, this study relies on mathematical modeling to estimate the “likely effectiveness of facemasks,” which include homemade masks. Rather than provide another “complex” model that “encounter challenges of analysis and interpretation in all but the most expert hands,” Stutt et al. offer “a simple modeling framework to examine the probable effectiveness of facemask wearing in combination with lock-down periods on the dynamics of COVID-19 epidemics.” They propose that their work “provides an objective and logical approach to examining the key question of whether, or not, the public should be advised to wear facemasks in the current COVID-19 pandemic.”
These models make numerous simplifying assumptions and rely on numerous variables given values “arbitrarily defined” or “arbitrarily set in the absence of detailed data.” Stutt et al. assume multiple lockdown periods will be necessary along with mask wearing on an “18-month time scale.” A key assumption in their model is 100 percent probability of infection without wearing a mask.
Stutt et al. cite Hong Kong as a superior example of mask wearing. On the other hand, they say, a “human factor that may reduce facemask adoption in the West is cultural, because the use of facemasks is not common in public, and there is an implication that the facemask wearer considers others as a threat.” They write that “it is necessary to change this view” in the West,
which could be achieved if the message is conveyed by a facemask was “my facemask protects you, your facemask protects me.” Indeed, it is probable that making facemasks into fashion items may be another route to changing the culture surrounding facemask use in public. A further positive effect from this cultural changewould be to reinforce the message that it is necessary to keep to a safe distance from one another. This educational message could be conveyed easily by the government and the popular press.
Results from a simplified mathematical model with “arbitrarily set” and “arbitrarily defined” variables cannot be the basis for extreme emergency orders. Nor can questionable assumptions built into the model.
Furthermore, this model’s assumption of four-plus lockdown orders in conjunction with mask-wearing over 18 months is simply untenable for an extreme emergency order and counter to other research put forward by the Cooper administration (see Gandhi et al., Brainard et al., Chu et al., MacIntyre et al., and Matuschek et al. above).
Changing the culture is no business of extreme emergency orders. It is clear from the Cooper administration’s messaging, however, that they have adopted this study’s perspective about messaging (“my facemask protects you, your facemask protects me”) in order to change the culture.
Face Masks Considerably Reduce COVID-19 Cases in Germany: A Synthetic Control Method Approach. Institute of Labor Economics (2020).
Originally circulated in June 2020, this paper is very important to the Cooper administration. It was one of the studies Cooper listed among the five “examples of studies studying the effectiveness of face coverings” that he included in his Nov. 23 executive order tightening his mask order against people. It was also among the three studies presented before the General Assembly by state health bureaucrat Mandy Cohen on June 17, a week before Cooper first leveled his mask order on people (discussed here).
This provisional paper found that compulsory face mask orders “reduced the cumulative number of registered COVID-19 cases between 2.3% and 13% over a period of 10 days after they became compulsory” in various regions in Germany. Mitze et al. derived those findings by comparing the regions’ actual known COVID-19 cases under the mask mandate with their computer models’ predictions of cases in those regions without the mandates. They created “synthetic” control versions of those regions comprising a weighted average of similar regions with similar regional characteristics but no mask mandates.
Their initial focus was on the region of Jena, the the first municipal region in Germany to order mask-wearing (on April 6), and then on other municipal regions that mandated face masks after Jena but by April 22. Mitze et al. note that “The mask regulations in Germany do not require a certain type” of mask.
Mitze et al. found large effects in reducing the growth rate of COVID-19 infections for Jena (compared with their synthetic control Jena) from being the first to mandate face masks. They found very small effects for the other regions, however. They suggest those very small effects might owe to “behavioral adjustments,” i.e., voluntary mask-wearing taking place in other regions before their own mandates (which then would hide the effects of mask-wearing as measured by when it was mandated). They, therefore, viewed finding even a small effect in the other regions as indicative that mask mandates have very large effects in reducing the growth rate of COVID-19 infections.
They ventured that “We believe that the reduction in the growth rate of infections by 40% to 60% is our best estimate of the effects of face masks.” They wrote in their conclusion, “The most convincing argument stresses that Jena introduced face masks before any other region did so.” Going further, however, Mitze et al. went so far as to “stress that 40 to 60% might still be a lower bound” and even hazarded that the effects of masks on reducing the growth rate of COVID-19 infections “might have been even greater if masks had been introduced earlier.”
From estimating a large effect for the first region to mandate face masks as opposed to a “synthetic” control model, they therefore explained away small effects in other early-mandate regions by suggesting spillover effects from the first region. Then they doubled down by stating a belief the reduction in the growth rate of infections could be 40% to 60%, and then decided that “might still be a lower bound” and then that it “might have been even greater.”
In Appendix C, readers learn that Mitze et al. had abandoned testing four other early-mandate regions. They had found positive results from mask mandates in two of those regions. For a third region, however, they found “very small or unclear” results. As for the fourth, “it even seems to be the case that masks increased the number of cases relative to the synthetic control group.”
Their findings were positive but uncertain, and at best only could support being a first-mover in terms of mandating mask-wearing, which North Carolina was not. They were also based on comparisons with computer modeled results. These aspects offer far too much uncertainty upon which to base an extreme emergency order.
Mitze et al. take a Procrustean approach to their findings, highlighting large results from one region, suggesting smaller results from other regions to be indicative of actually large results, and chopping out of their analysis the regions with “very small or unclear” results or a finding that “masks increased the number of cases.” Such research is unreliable and cannot be the basis of an extreme emergency order.
Posted September 1, 2020, this study conducted serial cross-sectional surveys in June via SurveyMonkey.com to look at the association between self-reported mask wearing, social distancing, and COVID-19 transmission, and also “the effect of statewide mandates on mask uptake.” Rader et al. found high self-reported mask-wearing in grocery stores reported in June of 84.6%, and a lower proportion wearing masks while visiting friends and family (40.2%). They found a significant change whereby a 10% increase in self-reported mask wearing more than tripled the odds of controlling disease transmission.
Interestingly, this significant finding was not due to state mask mandates. The study appears to buttress the wisdom of promoting voluntary rather than coerced adoption of mask-wearing. Rader et al. found that “Following state mandates, there was no significant change in mask uptake.” They noted that “The absence of a statistical change in mask wearing two weeks following state-wide mandates highlights the point that regulation alone may not drive increased masking behavior.” Rader et al. noted that another report had “found no substantial effect of mask mandates in conjunction with other interventions.” One reason could be, as they point out, that they cannot disaggregate what other, various preventative hygiene and risk avoidance behaviors people may adopt either with or without mask-wearing.
In conclusion, Rader et al. note the “mixed evidence on the effect of mask mandates” along with “a strengthening body of evidence on the effect of masks” to recommend that “policy makers should consider innovative strategies for evaluating and increasing mask usage to help control the pandemic.”
If anything, this study counsels against state mask mandates as unnecessary and indeed redundant. Rader et al. find “no significant change in mask uptake” from mask mandates. They recommend policymakers instead consider “innovative strategies for evaluating and increasing mask usage” voluntarily. Extreme emergency orders are the opposite of innovative strategies.