A Randomized Control Trial (RCT), the gold standard for scientific evidence in the medical community, was released on Tuesday in the Annals of Internal Medicine. The results from the RCT study deal a major blow to advocates of N95 and surgical masks as effective means to “stop Covid.”
As the study details, 1009 health care workers in four countries who provided direct care to patients with suspected or confirmed COVID-19 were given either N95 respirators or medical masks and tracked over the course of 9 weeks. The study was not able to “blind” the participants due to the visible differences in the masks.
It should be noted that two of these medical settings experienced no major reported outbreaks of Covid-19, which may skew the perceived efficacy of the masks.
The most critical and surprising finding from the study is that N95 respirators did not significantly outperform “medical masks.” The results were based on PCR test for Covid-19 infection and testing for nucleocapsid antibodies (which reveals exposure to the SARS-CoV-2 virus). This is a vital point for reasons that will be discussed below.
In this chart of “cumulative hazard,” which is based on a Cox Proportional-Hazards model that displays calculated risk over time, the masks performed similarly.
Beyond the cumulative hazard model, a statistical breakdown of the results are provided below.
The RT-PCR confirmed Covid-19 infections are charted above. Canada: 6.1% with medical mask, 2.2% with N95. Israel: 35.3% with Medical Mask, 23.5% with N95. Pakistan: 3.2% with medical mask, 2.1% with N95. Egypt: 35% with medical mask, 38% with N95. All sites: 10.46% with medical mask, 9.27% with N95. The disparity in reported cumulative hazard rates can be visualized below.
Beyond the results showing no substantial difference between medical masks and N95 masks, there are a few confounding issues. First, there is tremendous variation in reported Covid outbreaks at the sites, which throws into question the perception of overall reduction in hazard from wearing either medical masks or N95 respirators.
In Canada, 23 units had “no outbreaks.” In Israel, there were outbreaks reported in both facilities. In Pakistan, there were “no clusters or outbreaks reported.” And at 6 hospital sites in Egypt, outbreaks were reported over five weeks.
In addition to the limited number of outbreaks at these facilities, distorting the efficacy of mask and respirator wearing in higher transmission settings, the participants self-reported very few contacts with Covid-19 positive family and community members.
The second confounding issue is universal masking. Masks may plausibly impair the transmission of droplet-spread SARS-CoV-2 for a limited period of exposure time. But when the virus is aerosolized, masks are not designed to keep the virus from being exhaled through a mask or from penetrating a mask.
Thus, the “solution” of forcing everyone to wear N95 respirators becomes extremely problematic. N95 respirators are not designed to be worn for long hours each day by the general public. As can be seen from the supplement to the study, there were a number of Adverse Events reported for both medical mask and N95 respirator wearers.
There were Adverse Events reported for 11% of all medical mask wearers and 13.6% for all N95 respirator wearers. These AEs included: Discomfort, skin irritation, and headaches.
The researchers’ conclusion about the study is that the reduction in Covid exposure risk by wearing medical masks or N95 masks is equivocal.
“Among health care workers who provided routine care to patients with COVID-19, the overall estimates rule out a doubling in hazard of RT-PCR–confirmed COVID-19 for medical masks when compared with HRs of RT-PCR–confirmed COVID-19 for N95 respirators,” the researchers concluded. “The subgroup results varied by country, and the overall estimates may not be applicable to individual countries because of treatment effect heterogeneity.”
Dr. Scott Gottlieb, a Pfizer board member and former FDA Chief, earlier admitted that cloth masks don’t work.
“Cloth masks aren’t going to provide a lot of protection, that’s the bottom line,” he said. “This is an airborne illness. We now understand that. And a cloth mask is not going to protect you from a virus that spreads through airborne transmission. It could protect better through droplet transmission, something like the flu, but not this coronavirus.”
When confronted with the data that the cloth masks don’t work, one expert, CNN medical analyst Dr. Leana Wen argued that people be forced to wear surgical masks.
“Leana Wen, public health professor at George Washington University and an emergency physician, has urged the public to wear high-quality masks and described cloth masks as, ‘little more than facial decorations’,” the Hill reported. “She said cloth masks should not be considered an acceptable form of face covering and that the U.S. should require and distribute medical-grade surgical masks.”
When Dr. Wen’s advice was exposed as misleading, she moved on without missing a beat to argue everyone should wear N95 masks.
It’s well past time for the CDC to update their mask guidance to recommend N95, KN95, or KF94 masks. Covid is airborne. Omicron is extremely contagious. The federal government should recommend the highest quality masks, and make them available free of charge. @CNNSitRoom pic.twitter.com/bT8pUbCtYm
— Leana Wen, M.D. (@DrLeanaWen) January 12, 2022
However, we now know the efficacy of N95 masks, especially when worn by the general public, has been grossly exaggerated.
This was not the only Randomized Control Trial to test masks. A famous Danish study eventually published in March 2021 at the same journal, the Annals of Internal Medicine, showed that there was no statistically significant difference in Covid risk between wearing a mask and not wearing a mask.
The critical thing to note about both studies is that they used antibody tests for SARS-CoV-2 antibodies as a gauge for mask efficacy. As reported earlier, the Centers for Disease Control and Infection (CDC) tracks the seroprevalence of nucleocapsid antibodies that are an indicator of SARS-CoV-2 exposure on its serohub.
Serohub shows that as of July 2022, 97% of the American public had been exposed to the SARS-CoV-2 virus.
This means that it did not matter whether one wore a mask or did not wear a mask, whether one was vaccinated or not vaccinated, whether one socially distanced or did not socially distance, whether one was in a lockdown or wasn’t in a lockdown, virtually everyone was exposed to the coronavirus during the pandemic. At the end of the day, the Covid-19 pandemic will have a 99.9% survival rate.
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OPINION: This article contains commentary which reflects the author's opinion.