The current debate about mask-wearing has arisen from the claim by world health authorities that there is a new virus called SARS-Cov-2 that causes a new illness called COVID-19 and can be spread from one person to another. While this article will focus on masks specifically, it should be noted that these claims are entirely unsubstantiated.
While this might be enough to dissuade some people from believing in the mask fallacy, others may remain sceptical. For this reason, what follows is a discussion about the current research on masks and whether or not there exists any evidence in favour of their widespread use.
Scientific research on mask effectiveness and the importance of randomised controlled trials
It is important to understand that the ‘gold standard’ in scientific research is the randomised controlled trial (RCT) [1] and it is these studies that should be analysed when trying to understand if there is a benefit to wearing a mask in the context of COVID-19. The whole point of a randomised control trial is to eliminate bias and ascertain meaningful results.
Hariton & Locascio (2018) explain the importance of RCTs for effectiveness research:
“Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Although no study is likely on its own to prove causality, randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome.” [1]
There is not a single RCT study on mask wearing that shows wearing a mask can prevent flu-like/respiratory illness. Dr. Denis Rancourt makes this point in his controversial paper titled Masks Don’t Work: A Review of Science Relevant to COVID-19 Social Policy [2]. He states:
“There have been extensive randomized controlled trial (RCT) studies, and meta-analysis reviews of RCT studies, which all show that masks and respirators do not work to prevent respiratory influenza-like illnesses, or respiratory illnesses believed to be transmitted by droplets and aerosol particles.”
One mistake often made by those who promote the use of masks is referencing observational/geographical studies or, even worse, studies based on computer models. These kinds of studies are wrought with bias and any scientist will tell you that they should never be relied upon to support the implementation of any kind of serious health policy.
Computer models are unable to give us any meaningful data about reality. This was clearly demonstrated by the monumentally inaccurate predictions of Dr. Neil Ferguson from imperial college London, whose severely flawed COVID-19 model formed the basis for the global lockdowns [3].
The importance of sticking to RCTs is emphasised by Dr. Rancourt who has done excellent research detailing how masks don’t work. Despite this, other academics have attacked his research.
For example, Dr. Kyle Johnson, a supposed specialist in busting ‘pseudoscience’, refuted Dr. Rancourt’s findings in a lengthy paper titled A (Complete) Debunking of Denis Rancourt’s Argument That “Masks Don’t Work.” [4]. However, a quick read through the paper shows that Johnson’s primary sources are… observational studies and models, the exact kinds of studies that we have established as being wholly inadequate and inferior to RCTs.
Dr. Johnson admits that RTCs are necessary for testing drugs, but says they are not necessary for testing the effectiveness of masks. With this utterly ridiculous statement, Johnson is attempting to remove the primary body of evidence for the ineffectiveness of mask wearing.
RCTs are the highest quality of evidence we have available for assessing the effectiveness of face masks. Neglecting high-quality studies in favour of low-quality studies that support your opinion is poor science. Secondly, the CDC themselves stated in a paper titled Non pharmaceutical Measures for Pandemic Influenza in Nonhealthcare Settings – Personal Protective and Environmental Measures [5] that “RCTs provide the highest quality of evidence”.
In a video debate with Dr. Rancourt, Johnson came off as childlike, over-emotional and rude while Rancourt remained calm, collected and logical in his responses [6]. Rancourt was the clear victor (how could it be otherwise?).
At one point in the debate, Johnson asked Rancourt, “how is it possible that masks don’t work?” This question is unimportant. The fact remains that there is no policy-grade research to back-up the widespread wearing of facemasks of any sort. In fact, there is much evidence to suggest it may be dangerous.
The River Cities’ Reader, the publication that published Rancourt’s original paper, reviewed the various submissions refuting Rancourt’s thesis but maintained that none could provide evidence for the effectiveness of wearing a mask. In an article on their website titled Still No Conclusive Evidence Justifying Mandatory Masks [7] the author states:
“We received many submissions against and for Rancourt’s paper. After reviewing the attempted refutations, we remain resolute in our original support for his conclusions. Not one proved Rancourt’s analysis of the randomized controlled tests to be false or misleading. Nor did any of the attempted refutations answer or overcome any of Rancourt’s concerns regarding potential harm from mandated mask wearing.”
The research on masks is clear: they don’t work
A groundbreaking Danish randomized controlled trial on mask-wearing to prevent COVID-19 reveals no benefit from wearing a facemask[8]. The authors of the study battled to get their results published, with three major medical journals rejecting the study.
Finally, the study was accepted by the Annals of Internal Medicine. Though there is much more to discuss, this study alone demolishes the notion that masks of any kind are effective at reducing the spread of COVID-19.
Scientists have conjectured that the study was rejected because the results failed to align with the mainstream narrative about masks. In other words, medical journals rejected well-conducted medical research because they didn’t like the results. Let that sink in.
In a study titled Rapid Expert Consultation on the Effectiveness of Fabric Masks for the COVID-19 Pandemic (April 8, 2020) [9], experts state that “the current level of benefit, if any, is not possible to assess.”
A review titled Masks for prevention of viral respiratory infections among health care workers and the public (published July 2020) [10] examined RCTs and systematic reviews on the use of face masks to prevent respiratory disease. The findings of the review are as follows:
“Overall, the use of masks in the community did not reduce the risk of influenza, confirmed viral respiratory infection, influenzalike illness, or any clinical respiratory infection”.
A study titled PEER simplified tool: mask use by the general public and by health care workers [11] examined the systematic review conducted by Dugre et al (2020) in which researchers analysed RCTs on mask effectiveness. The findings of the study, once again, lend absolutely no evidence to the claim that masks reduce respiratory illness.
The above-mentioned study reveals that the results of two RCTs showed no benefit from wearing a mask out in public. Furthermore, lab-confirmed influenza rates remained the same in both the mask-wearing group and the non-mask-wearing group.
RCTs examining the effectiveness of wearing a mask at home after a family member became sick also found that wearing a mask did not reduce the risk of contracting a flu-like illness or confirmed influenza.
Another RCT titled A cluster randomised trial of cloth masks compared with medical masks in healthcare workers [12] found that wearing a cloth mask may increase your risk of illness due to moisture retention, reuse and poor filtration. The study, concluded that: “… as a precautionary measure, cloth masks should not be recommended for HCWs [health care workers].”
The same study found infection rates from cloth masks were three times higher when compared to no masks.
In the CDC paper mentioned previously, Xiao et al (2020) examined 14 RCTs and found that:
“Although mechanistic studies support the potential effect of hand hygiene or face masks, evidence from 14 randomized controlled trials of these measures did not support a substantial effect on transmission of laboratory-confirmed influenza.” [5]
This essentially means that while the mechanism behind these measures (hand washing, mask wearing) is supported, actual real-life data, in the form of RCTs, shows no benefit.
This highlights an important point. There are many people who claim mask wearing works due to the reduction of ‘infectious’ aerosols and particles in the air and the filtration of some of these particles. However, these theories of ‘infectious aerosols’ just don’t hold up when examining the data from RCTs.
This brings us back to the point that germs do not cause disease and therefore talk of ‘infectious aerosol particles’ or droplets is entirely irrelevant and cannot be used to validate mask wearing.
In July 2020, the Centre for Evidence Based Medicine (CEBM), an organisation that ‘develops, promotes and disseminates better evidence for healthcare’, published an article titled Masking lack of evidence with politics [13]. The article examined 12 RCTs on mask wearing and concluded that:
“Masks alone have no significant effect in interrupting the spread of ILI [influenza-like illness] or influenza in the general population, nor in healthcare workers.”
The authors do admit that “recent reviews using lower quality evidence found masks to be effective.” It is this ‘lower quality’ evidence that is continually being cited by those who promote the ‘pro mask’ propaganda.
However, as discussed, low-quality evidence is not suitable for determining whether masks should be mandated, which is an unprecedented measure that has never been instituted before with the possibility of serious negative health effects. Furthermore, the high-quality evidence (RCTs) show no benefit from mask wearing.
Given the choice between low-quality evidence and high-quality evidence, it stands to reason that one should always follow the high-quality evidence. It is therefore puzzling, and quite frankly disturbing, as to why so many countries have mandated mask-wearing.
The authors of the CEBM article recognise this fact and state, in relation to geographical/observational studies that show a benefit from mask wearing, that it is “unwise to infer causation based on regional geographical observations as several proponents of masks have done”.
Essentially what this means is that one cannot measure mask effectiveness from these kinds of studies as, in addition to bias, there are simply too many other variables involved.
In his paper titled Face masks, lies, damn lies and public health officials: “a growing body of evidence” [14] Dr Rancourt further emphasises the fact that there is no quality research to back up the mandating of mask wearing. He states that:
“There is no policy-grade evidence to support forced masking on the general population, and that all the latest-decade’s policy-grade evidence points to the opposite: NOT recommending forced masking of the general population. Therefore, the politicians and health authorities are acting without legitimacy and recklessly.”
Later in the same paper, Rancourt analyses studies which are claimed by health authorities to provide evidence of mask effectiveness. He demonstrates that these studies cannot be considered ‘policy-grade’ and in fact do not contribute any new evidence despite the continual assertion of a ‘growing body of evidence’ to support mask wearing. Furthermore, none of them are RCTs.
Among those analysed includes a study by Chu (2020) [15] that was funded by the World Health Organisation (bias alert), and a study conducted by researchers with links to 3M (a major mask and respirator manufacture) [16].
The precautionary principle
Health officials have blatantly disregarded the precautionary principle when it comes to formulating COVID-19 mask policy. Medical doctor Antonio Lazzarino, in his response to a study calling for the widespread use of surgical masks, describes the precautionary principle as follows:
“The precautionary principle aims at preventing researchers and policy makers from neglecting potentially-harmful side effects of interventions. Before implementing clinical and public health interventions, one must actively hypothesise and describe potential side effects and only then decide whether they are worth being quantified or not.” [17]
In his letter, Dr. Lazzarino describes various potential adverse effects that may arise from the widespread use of face masks and suggests, quite rightly, that it is unwise to implement such measures without a clear understanding of the repercussions. Lazzarino states that “it is not time to act without evidence”.
The various unknowns surrounding the adverse health effects of widespread, mandatory mask wearing together with the clear evidence provided by RCTs that masks do not stop the spread of influenza-like illness should have been enough to dissuade health authorities from implementing mandatory mask policies. Sadly, this was not the case.
Conclusion
RCTs, the gold standard when it comes to effectiveness research, provide no evidence to suggest that wearing a mask is effective at reducing influenza-like/respiratory illness. Those who promote mask wearing ignore this high-quality evidence in favour of low-quality observational/geographical studies and computer models, which are prone to bias and inaccuracies.
This adherence to poor quality research in determining health policy around masks is not only ‘unwise’ but extremely dangerous, especially when the potential adverse effects of mandatory mask-wearing are considered.
We must demand that governments and health authorities abolish mandatory mask laws and adhere to high-quality, unbiased, scientific research when constructing health policies.
References
[1] Hariton, E., & Locascio, J. J. (2018). Randomised controlled trials – the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG : an international journal of obstetrics and gynaecology, 125(13), 1716. https://doi.org/10.1111/1471-0528.15199.
[2] Rancourt, D, G. (2020). Masks Don’t Work: A Review of Science Relevant to COVID-19 Social Policy. 10.13140/RG.2.2.14320.40967/1.
[3] Dayaratna, K. (2020). Failures of an Influential COVID-19 Model Used to Justify Lockdowns. The Heritage Foundation. Found here: https://www.heritage.org/public-health/commentary/failures-influential-covid-19-model-used-justify-lockdowns.
[4] Johnson, D, K. (2020). A (Complete) Debunking of Denis Rancourt’s Argument That “Masks Don’t Work.”. 10.13140/RG.2.2.22021.37603.
[5] Xiao, J., Shiu, E., Gao, H., Wong, J. Y., Fong, M. W., Ryu, S….Cowling, B. J. (2020). Nonpharmaceutical Measures for Pandemic Influenza in Nonhealthcare Settings—Personal Protective and Environmental Measures. Emerging Infectious Diseases, 26(5), 967-975. https://dx.doi.org/10.3201/eid2605.190994.
[6] Digi Debates. (2020). (FULL) Digi-Debates. The Face Mask Debate. Digi Debates [YouTube Channel]. Found here: https://www.youtube.com/watch?v=AQyLFdoeUNk.
[7] McGreevy, T. (2020). Still No Conclusive Evidence Justifying Mandatory Masks. River Cities’ Reader. Found here: https://www.rcreader.com/commentary/still-no-conclusive-evidence-justifying-mandatory-masks.
[8] Bundgaard, H. et al. Effectiveness of Adding a Mask Recommendation to Other Public Health Measures to Prevent SARS-CoV-2 Infection in Danish Mask Wearers. Annals of Internal Medicine. November 18, 2020. Found here: https://www.acpjournals.org/doi/10.7326/M20-6817.
[9] National Academies of Sciences, Engineering, and Medicine. Rapid Expert Consultations on the COVID-19 Pandemic: March 14, 2020–April 8, 2020. Washington (DC): National Academies Press (US); 2020 Apr 30. Rapid Expert Consultation on the Effectiveness of Fabric Masks for the COVID-19 Pandemic (April 8, 2020) Available from: https://www.ncbi.nlm.nih.gov/books/NBK556964/.
[10] Dugré, N., Ton, J., Perry, D., Garrison, S., Falk, J., McCormack, J., Moe, S., Korownyk, C. S., Lindblad, A. J., Kolber, M. R., Thomas, B., Train, A., & Allan, G. M. (2020). Masks for prevention of viral respiratory infections among health care workers and the public: PEER umbrella systematic review. Canadian family physician Medecin de famille canadien, 66(7), 509–517.
[11] Moe, S., Dugré, N., Allan, G. M., Korownyk, C. S., Kolber, M. R., Lindblad, A. J., Garrison, S., Falk, J., Ton, J., Perry, D., Thomas, B., Train, A., & McCormack, J. (2020). PEER simplified tool: mask use by the general public and by health care workers. Canadian family physician Medecin de famille canadien, 66(7), 505–507.
[12] MacIntyre CR, Seale H, Dung TC, et al. (2020). A cluster randomised trial of cloth masks compared with medical masks in healthcare workers. BMJ Open 2015;5:e006577. doi: 10.1136/bmjopen-2014-006577.
[13] Jefferson, T., Haneghan, C. (2020). Masking lack of evidence with politics. Centre for Evidence-Based Medicine. Available from: https://www.cebm.net/covid-19/masking-lack-of-evidence-with-politics/.
[14] Rancourt, D, G. (2020). Facemasks, lies, damn lies and public health officials: “a growing body of evidence”. DOI: 10.13140/RG.2.2.25042.58569.
[15] Chu DK, Akl EA, Duda S et al. “Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis”. Lancet. 2020; 395(10242): 973-1987. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31142-9/.
[16] MacIntyre CR, Chughtai AA. “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”. Int J Nurs Stud. 2020; 108(103629). https://www.sciencedirect.com/science/article/pii/S0020748920301139.
[17] Lazzarino, A. (2020). Rapid Response: Covid-19: important potential side effects of wearing face masks that we should bear in mind. BMJ 2020;369:m1435. https://www.bmj.com/content/369/bmj.m1435/rr-40
