Unmasking the CDC and More
by Richard Erickson MD
“Juliana is not going to preschool!” My wife had just gotten off the phone with our daughter and now the preschool was requiring MASKS. Only a few days before, our granddaughter had told us how excited she was to be going to preschool in the fall. But why had the policy changed so abruptly?
The City and County of Broomfield Public Health Department was now mandating that all children 2 years or older had to wear a mask in a daycare or a school setting. Our Broomfield City Council with little discussion supported that decision. Did they know that Juliana, a vibrant and healthy 4 year old, had survived three days of a snotty nose with a mild fever due to COVID-19, had robust acquired immunity, and was therefore not at high risk to acquire or spread the disease. Neither did it matter that while visiting the pediatrician's office, her mother could not prevent Juliana from touching her mask repeatedly as the mask slipped down below her nose. Do I need to tell you that the seal around the perimeter of her cloth mask was not airtight? As a retired rheumatologist, my scientific curiosity was aroused. Was there any rigorous evidence that cloth masks, the type normally worn in schools and day care settings, decreased the infection rate of COVID-19, a virus that has an infinitesimal risk of death to healthy children, 10 times less than dying in a car accident. The long term psychological, educational, and physical adverse effects of mask wearing in children has never been studied. Expecting a toddler as young as two, possibly still in diapers, to properly comply with the CDC mask wearer guidelines is the definition of insanity.
My first inquiry was to the Broomfield Public Health Department who referred me to their position paper. Main paragraph one, “The Center for Disease Control and Prevention (CDC) highly recommends universal indoor masking for all teachers, staff, students, and visitors to school, regardless of vaccination status.” (The CDC did not even take the time to mention natural immunity....probably because they still were into acquired immunity denial?) Public policy in Broomfield, Colorado was tightly linked to Atlanta with apparently no questions asked, none. I decided to peruse some of the supporting references used to guide their department's recommendations.
One report was from the CDC's Morbidity and Mortality Weekly Report (MMWR) dealing with the Wood County, Wisconsin, school mask observational study. Within that investigation was a patent disclaimer “it was not possible to determine the specific role that mask-wearing and other disease mitigation strategies played in the low rate of disease spread, and information on school ventilation systems was not obtained.” The good news was that schools could be opened without an undue increased incidence of COVID-19 but how much, if any, the wearing of masks contributed was left unanswered; there had been no comparison control group of students not wearing masks. The lead author, Beth Høeg, affirmed that conclusion on social media.
Next, I reviewed another of the cited studies, the MMWR Georgia school mask report, which correlated improved ventilation to a statistically significant reduction in school COVID-19 infections. In regards to students wearing masks, there was no statistically significant benefit, although the masked students had a very modest decrease in infection rate that could have occurred by chance. Again, this report did not seem to establish robust evidence-based support for our health department's mask mandate. Correlation does not prove causation and weak correlation surely doesn't. (For a more detailed review of this study and many more, “The Case Against Masks at School” can be found in The Atlantic, January 26, 2022, and is highly recommended.)
A RCT, Random Controlled Trial, is where individuals in a population under study are randomly assigned to two or more groups (cohorts) in order to scrutinize one particular variable and minimize other variables (confounders) that could affect the outcome being measured. These are considered the highest level of evidence as they are not just apple to apple, but a “Gala Apple to Gala Apple” type comparison. Since most masks used in schools are cloth, infrequently surgical, and almost never N-95, I looked for RCTs comparing surgical/cloth masks versus no masks. My search turned up only a few that met my specific criteria and neither was focused on a pediatric population. A Denmark RCT comparing individuals who wore surgical masks versus no masks found that masks did not protect the wearers against infection with the coronavirus. The other study compared three cohorts of health care workers randomly assigned to surgical masks, cloth masks and a control group which was composed of no masks or masks of choice. (The investigators did not deem it ethical to have the control group mandated to not wear masks.) Amazingly, the control did slightly better,and certainly no worse, than the cloth mask group!
Then on September 24, 2021 the CDC posted an Emergency Release in their official voice, the MMWR, on the “Association Between K-12 School Mask Policies and School- Associated COVID-19 Outbreaks-Maricopa and Pima Counties, Arizona, July-August 2021.” This was followed by an announcement from Director Rochelle Walensky, “New @CDCMMWR data reinforce the benefits of masks and vaccinations in preventing #COVID19 outbreaks in schools.” AND “New @CDCMMWR finds schools in two Arizona counties w/o a mask requirement were 3.5 times (emphasis added mine) more likely to have a #COVID19 outbreak than schools requiring masks from the start of the school year. CDC recommends universal masking for all K–12 schools.” 3.5 more outbreaks.....!!! Referencing this outbreak result ad nauseum, the national media painted a picture of rampant COVID-19 spread in schools with unmasked students. Not mandating school masks was the nearest thing to modern day child sacrifice! Case closed. Or was it?
The Maricopa-Pima County School observational study had been produced at warp speed and I had more questions than answers. Seeking greater detail, I emailed the lead author, Dr Jehn, in October 2021. She promptly replied and clarified how the data was collected. As the expression goes, “The devil is in the details.” What I found in reviewing how “epidemiologically linked cases” were linked was profoundly unsettling. I assumed I must be missing something obvious but received no replies from emails to random published epidemiologists. Then on December 16, 2021, The Atlantic magazine carried the article “The CDC's Flawed Case for Wearing Masks in School” pointing out weaknesses in the study design. David Zweig's excellent expose outlined numerous concerns which I had, such as not accounting for vaccination rates and possible detection bias which would favor a greater number of cases in the unmasked student cohort. Weeks before, I had detected two different possible major study design flaws; one in the use of the outcome measure and the other one on how cases were linked. What follows below appears to nullify the final conclusion of the study, that schools with unmasked students had 3.5 times more COVID-19 outbreaks than schools with masked students.
The first major question I had was, “Why did the investigators choose the CSTE, Council for State and Territorial Epidemiologists, 2020 outbreak definition as the final outcome measure?” Ascertaining whether an infection was acquired at school, at a party, or a large family gathering is not straight forward nor easy. And the term OUTBREAK sounds so very, very terrifying to the average reader! CSTE defines an outbreak as “two or more laboratory-confirmed COVID-19 cases among students or staff with onsets within a 14-day period who are epidemiologically linked, do not share a household, and were not identified as close contacts of each other in another setting during standard case investigation or contact tracing.” The CSTE has this caveat patently posted, “Public health investigation within these setting can be complex........... particularly in areas experiencing substantial (emphasis added mine) community transmission ...” At the beginning of the observational study, the 7-day case rate in Maricopa County was 161 per 100,000 person and by the end had almost doubled. The CDC defines case rates as low transmission, moderate transmission, substantial transmission, and high transmission ( ≥ to 100 per 100,000). Unequivocally, the area surrounding the schools being studied fell squarely in the fourth category. This should have raised serious questions about the choice of the final outcome measure, “outbreaks”, in a community with an extremely high transmission rate. To quote a famous statistics aphorism, “If you torture the data long enough, it will confess.”
A non negotiable rule for collecting information when comparing two groups in an observational study is that one must collect data from each group in an identical fashion, always. This appears to not have been done in how cases were “epidemiologically linked” between schools with masks versus schools without masks. Perhaps a simple fishing analogy from my childhood days will help explain what transpired before going into the more detailed discussion below. When growing up, I caught bait fish using a weighted net cast over schools of minnows. A 6 foot bait fish net always caught more bait per throw than a 3 foot net .....always. Any 10 year old can tell you that!
According to the study author, “All of the cases that were included in outbreaks reported close contact with another case in a specified time period.” So how does the CDC, the publisher of the MMWR, define the term “close contact?” To be considered a close contact in a school where students did not wear a mask, the following criteria had to be met: “close contact through proximity and duration of exposure: Someone who was less than 6 feet away from the infected person for a cumulative total of 15 minutes or more over a 24 hour period.” But in the counting of close contacts in masked schools, close is defined as closer, much closer. The CDC definition of close contact was modified in masked schools according to the following: “Exemption: In the K-12 indoor classroom setting......the close contact definition excludes(emphasis added mine) students who were between 3 to 6 feet of an infected student, if both the infected student and the exposed student(s) correctly and consistently wore well-fitting masks the entire time.” To use the bait net analogy, the net was much, much bigger in capturing “epidemiologically linked cases” at the unmasked schools. Bigger nets always catch more fish, always. Now lets apply some simple math. If you double the radius of the circle defining who is a close contact, r, the “net” increases proportionately by r2, or a factor of 4. Mighty close to the increased 3.5 odds ratio difference found. Coincidence? The next question was “Why me” and not the CDC reviewers?
The process for publication of a medical investigation starts with a clinical question, review of all previously published literature, meticulous study design, objective collection of data (results), statistical analysis, and a final conclusion. The next step is submission to the editor of the journal, who may reject the manuscript, send it back to the author(s) for a rewrite, or consider the submitted manuscript worthy of peer review without further changes. Afterwards the manuscript is vetted by outside neutral reviewers (referees) who are not associated with the author or his/her institution. Further revisions may be required with a give and take process before the final manuscript is published. The peer review process is rigorous and ensures a high standard for the reader. The methodology is transparent so limitations in the study can be detected that are not stated in the article. After publication, letters to the editor may be printed which draw attention to a weakness in the study. Though very messy and time consuming, quality science requires the free exchange of ideas to progress on a firm foundation. Always.
The CDC is a federal agency. The director is a political appointee of the President of the United States with no requirement for Senate confirmation. In the MMWR supplement “Public Health Then and Now”, October 7, 2021, it states, “the content published in MMWR constitutes the official voice of its parent, CDC. One sign of this is the absence in MMWR of any official disclaimers. Although most articles that appear in the MMWR are not “peer-reviewed” in the way that submissions to medical journals are to ensure that the content of MMWR comports with CDC policy, every submission to MMWR undergoes a multilevel clearance process before publication. This includes review by the CDC director or designate, top scientific directors at all CDC organizational levels, and an exacting review by MMWR editors.” All peer review is internal. No outside comments on any reports in the MMWR are ever published but are purported to be reviewed. So why did the Maricopa-Pima County school mask report apparently fall through the cracks? I will let the reader decide.
That we as a country, are even having to address the issue of masks in a school setting, with unsettled science after almost two years into the pandemic, is a national disgrace. Cloth masks in a school setting may help, I just don't know. Deciding on fear, not facts, means a donnybrook in the public square or should I liken it to an adult food fight in the school cafeteria? With billions going to the NIH, “why the lack of scientific information after so many months?” A recent preprint on Medrxiv, “NIH Funding of COVID-19 research in 2020: a Cross Sectional Study” helps shed some light on the problem. The number of grants in 2020 under the heading of “Social Determinants of Health” was 278. How many for face masks or transmission in schools? ....2 each! I am all for equity studies in health, but with COVID-19 impacting 10s of millions of children this appears grossly out of balance. Where was Fauci in all this? Perhaps spending too much time on the nightly news?
Finally, I cannot finish without taking a brief look at the country which drew the ire of Time magazine in an October 14, 2020 article titled “The Swedish COVID-19 response, It Shouldn't Be a Model for the Rest of the World.” Swedish schools were open for those 16 and younger with no masks required. A report in the NEJM February 18, 2021, “Open schools, COVID-19, and Child and Teacher Morbidity in Sweden,” pointed out some reassuring outcomes for their unique response to the pandemic and should have caused pause for reflection. No child in Sweden had died and the risk to school teachers was not greater than any other non-medical profession.
By January 2022, Sweden did have 15 pediatric COVID-19 deaths while the United States had 862. Every one is a tragedy. But of course you say, “not so fast, the US has many more children.” Correct. Good, you are thinking critically. The pediatric population (<18 years old) in the US is around 73.1M to Sweden's 2.2 M. So in order to make a fair comparison in mortality, one first needs to adjust the absolute number by 73.1 ÷ 2.2 or 33.2. If Sweden had the same size pediatric population as the US, the adjusted mortality number would be 15 x 33.2 or 498. (Normally per capita would be the best way to present the data but I am attempting to make a point.) Using this adjustment to the Swedish pediatric mortality figure, the US had 862 - 498 or 364 more COVID-19 pediatric deaths than Sweden, a full 70% higher. That is a sobering statistic which needs a deep dive into whether some other factor or factors are at work here. Was there an unnecessary loss of human life to our youngest members?
Hopefully with the Omicron variant, the worst of the pandemic will be behind us. How this unprecedented event was mismanaged reveals some serious structural issues at the NIH and CDC.
And how is my granddaughter doing with home schooling? She's learned her ABCs and 1,2,3s and is now reading simple books and performing single digit addition. Play groups are fun. My hope is that she will choose a STEM field.....I know she could make a constructive contribution 20 years from now. She is already asking lots of questions. So should we.
Addendum (2/9/22): On February 3, 2022, our Broomfield Public Health Department lifted the mask mandate. ( The schools in the Boulder Valley School District, one of the school disctricts in our county, has still have a mask requirement.) The reason stated was new scientific evidence without citing any new evidence. Draw your own conclusions about why this changed.