A new mask randomized trial shows that masks work?
Not so fast. There are at least four limitations worth knowing about. This is how to read trials.
Atle Freithem and colleagues report in the British Medical journal the results of a pragmatic randomized control trial. The take-home message is that wearing a surgical mask for 2 weeks during the winter season of 2023 reduced the spread of self-reported viral illness. According to some, the study proves masks work.
First, I commend the authors for running a randomized control trial. Many will know that I interviewed Atle during the covid-19 pandemic and he proposed randomized control trials of school closure. Any randomization adds to the knowledge base here. I supported all of those randomized studies.
Second, having said that, this study does not prove masks work. The primary endpoint of the study is self-reported illness. Over the last 4 years, globally, we have witnessed one of the greatest propaganda campaigns to convince the public that mask work. They have been the topic millions of news hours of coverage. And the constant trumpeting by proponents online.
Given, that many people believe masks work, and given that there is no placebo control or sham control in this study, it is entirely possible the result is driven by the placebo effect alone. If you wear a mask, you feel like you do better. A better endpoint for future mask studies would be some objective measure of viral spread, like serial swabbing, or sero prevalence. This study just tells me that people who wear masks report fewer viral illnesses, not that they actually were infected less or felt better overall. The study does not find a benefit on documented covid-19 infections, though it lacked power for this.
Third, if there's a new virus out there, and it's very deadly, and a vaccine is coming just a few months away, it makes total sense to try to delay getting the virus. But if you're going to be living in a world of these viruses, and they aren't that deadly, like covid is not currently that deadly, you might not get it this year, but you might get it next year. The question isn't, can you avoid getting a virus for a few weeks or a few months? The question is: are you better off wearing a mask year after year? For every winter, and at the end of 5 years or 10 years or 15 years, are you better off? This study's follow-up is just too short.
The analogy I like to use is say you're about to run a marathon. And somebody wants you to take a special energy drink. That energy drink means you run the first mile faster. And that's where the study ends. But obviously you don't care about the first mile, you care about the whole race.
Fourth, if we really did devise away for people to have fewer respiratory viruses each winter season will they really be better off? It's taken for granted that people don't like colds, and I don't like them either. But our knowledge of the immune system is so primitive we have no idea what the impact of annual respiratory illness is. It is entirely possible that there are other domains of health that will be impacted by having fewer respiratory viruses. When I was growing up, parents routinely were happy that their kid got sick, realizing that the sooner they got it over with the better the rest of childhood would go. That wisdom no longer persists today in a world of safetyism, but there is little empirical data on how many infections someone should get and when. Maybe it's not good for a 50-year-old to avoid cold, setting them up for a devastating cold when they're 80.
Fifth, the biggest take-home message of this study is that randomized control trials are possible. Probably of every single academic in the United States, I am the person who has said that most often and most repeatedly. If you cannot run randomized controlled trials of non-pharmacologic interventions, then you should not be mandating them. Anthony Fauci, famously failed America because even though he controlled the research budget, he ran precisely zero studies. His legacy is not one of heroism, but one of scientific failure. I've written about that before for sensible medicine.
In conclusion, if someone tells you this randomized control trial proves that wearing surgical masks work, the only thing they've successfully proven is that their brain doesn't work. Knowing how to read articles should be the fundamental education of medical school, instead it is memorizing trivialities. We need more randomized control trials of masking so we can decide whether or not the few zealots who continue to mask today are doing something sensible, or crazy. Until we get those studies we don't know for sure, though some of us have a guess.
Your take away that RCTs are "possible" is a step too far from the evidence.
This study
1. recruited patients through advertising
2. had all interaction done through email and online surveys
3. gave the treatment group gift cards to buy masks
4. based outcomes on a complicated composite outcome and a lot of mysterious regression
This is an absurd experimental design! Why should we give this study any credence? Just because it was randomized and published?
Here is what's misunderstood about mask science...it is not a "medical" thing....it is an "Exposure science" thing.....and the fundamentals of exposure science are being ignored ...and until you bring those elements into the equation...the conversation around masks is going to be saturated with false ideas....and further...you CAN'T run a randomized control trial until you account for the very science fundamentals that are effecting the mask. Masks don't work to stop transmission,...or do anything useful, that end point is true....but it has very little to do with filtration and seal to the face. It has everything to do with contamination behavior. Hazmat suits only work as good as the contamination behavior of the wearer. BEHAVIOR is 90% of the functionality of ANY PERSONAL TOOL. The only way masks could possibly work on their own is if they made everything that comes out of your mouth get sucked into an alternate dimension. The fact is...when you breathe or cough into the mask....the amount of potential contamination is still at 100% in the immediate area.. its just on surface areas...floor, table over there...the mask...yeah the mask is nothing more than a surface area that collects stuff.....and your breathing just pushes it right out again. ...so...Nothing has been made to disappear or be gone. its all still there....the The Hierarchy of controls...which is the fundamental basis for ALL SAFETY design and protocol...is built the way it is because of the impact BEHAVIOR has on controls. This is why masks and every other piece of personal tool...I mean...PPE...gowns goggles...have a BEHAVIOR protocol that goes along with them. Because it takes such a MASSIVE amount of correct behavior for them to even work properly..( I suppose you just thought you had to do all that cuz what?...superstition?) Behavior is an actual mechanism of the functionality....its not just what the things are made of or how they are designed...those elements are the minor mechanism of function. ....and can be wholly negated...no matter how state of the art it is...by what?...that's right....Behavior. Try using a spoon upside down next time you eat soup. You could distribute hazmat suits to every citizen in a community...and every last one of them would get infected with whatever it is they are trying to protect themselves from...because they would all contaminate themselves and others because they don't know how to use the tool. A better use of your call to do random control trials would be to measure the effects of different contamination behavior regarding masks....where does the contamination go when you breath through it...or when you drop it, or when you shake it or when you hang it in your car mirror or put it in your pocket. You want to prove masks don't work....stop focusing on whether people get infected or not...there's just too many other things in the room ALSO effecting that....instead...show how the trail of contamination, doesn't get stopped, or reduced by your mask. It's a much more convincing visual.