Masks

The Lucky Rabbit's Foot for Disease Spread

Fabric and surgical masks are under FDA Emergency Use Authorization (EUA). It is for use by the general public and health care personnel as “source control.”

These face masks are not authorized to be personal protective equipment, meaning they DO NOT PROTECT THE USER FROM GETTING DISEASE.

The largest Randomized placebo-control clinical trial with 3030 participants in Demark found that there was no statistically significant difference in COVID19 infection rate between the masked group and the unmasked group. What does that mean?

It don’t work.

Now I welcome anyone else to do another randomized clinical trial on masks to see if they can find statistically significant results (p<0.05 ), but they won’t bother. Why? Fabric and surgical masks WILL NOT PROTECT YOU.

The FDA is saying that this medical product (AKA masks) will keep your germs to yourself, with not one randomized clinical trial that supports the hypothesis that healthy people need source control. “Source control” means preventing the transmission of infection when you breathe, speaking, cough, or sneeze. So the FDA, who authorizes medical products for YOUR benefit now has changed their authorization to recommends you wear products for OTHER people’s benefit.

What proof is there that masks prevent the transmission of infection? The CDC has “Science Brief: Community Use of Cloth Masks to Control the Spread of SARS-CoV-2 | CDC”. They have a list of case studies which really don’t mean anything when it comes to proving that disease spread is being reduced. Also they include models that occurred on the downswing of the pandemic that are not relevant at this time.

The CDC evidence is weak because it includes

• Studies with no control

• Historical control studies

• Experiments that don’t involve humans or disease

• Studies of family transmission

Case studies are like that hair dresser who wore a mask while she was asymptomatic and none of her patrons got sick. But how does one know that this study does not prove asymptomatic transmission is a myth?

Historical control studies are not any better. The disease curve will go up and down related to other natural influences that have nothing to do with intervention. The studies were done during the first wave was coming naturally down. Also COVID was proven to be a seasonal disease and will be lower during the summer months. A problem with these studies is they take a time period where the masks appear to work and ignoring the natural progression of disease. They try to use a model to control for disease progression, but unless you have another comparison population that didn’t wear a mask, the evidence is weak.

If your experiment doesn’t involve actual humans getting disease then I can’t imagine why any scientist thinks that’s relevant. If there isn’t actual humans in the study with an endpoint of getting disease then it shouldn’t even be included in here. Shame on the CDC.

Living with sick symptomatic people makes you sick. Cohabitating with other people is the number 1 cause of spread. The number 1 place to get COVID is in the home. Do masks prevent spread in your home when sick people wear them? Maybe. Does that mean that it will also work on asymptomatic people walking around in the Walmart? No.

Using a product that MAY, (and I say “may” because there isn’t randomized controlled clinical trial evidence), may work in the home on sick people does not translate to being effective for a population of healthy people walking around in the population. None of these were controlled clinical trials.

The CDC likes to pile on a lot of garbage pretending to be evidence of effectiveness. The only study relevant in that list are ONE case control study from Thailand by Doung-Ngern. However, the results of this are negated by the randomized placebo-control study from Denmark. Randomized, placebo-control studies are the gold standard when it comes to evaluating product effectiveness and efficaciousness. The results of a well sampled randomized placebo-control study are more relevant than a case-control study.

I find it highly amusing that the CDC immediacy characterizes the Danish study as being ‘misinterpreted’ while throwing non-randomized studies at you as ‘evidence.’ Laughable. If the mask was a product trying to get FDA approval for disease spread, not ONE of these studies presented by the CDC could be used as evidence of its effectiveness to the FDA.

There is another article done by AEIR The CDC’s Mask Mandate Study:Debunked - AIER, which you can read up on. They did a good job for economists, thought they do know how to look at data, unlike the CDC.

Lets go back to the idea that this mask product is under EUA for “source control” By the FDA. What evidence is there that while you are walking around without symptoms that that a mask will stop you from spreading the disease to others? Does catching your spit in a cloth or fabric masks prevent you from spreading disease? No. There’s no human evidence that catching your spit in a fabric or paper mask prevents disease in others when you are well enough to walk around in public.

It would be an impossible feat to do a randomized clinical trial for the indication of source control. That’s the disturbing part about this. There is no way to prove that masks prevents you from spreading an airborne respiratory disease, especially if you are not showing symptoms. So we are stuck doing this with no evidence that this is working.

Many people want to understand why we don’t just pick the masked and unmasked states and do an analysis. There has been mixed results from picking data from different states with different masking laws because people cherry pick their data to see the results they want. If you look around on the internet, you can find analyses on that data that will give different results. After reviewing the data evidence, the one thing I can tell you is that, if there is an effect with masks in the population, it reduces the spread by <1%. Reducing the spread means you save it for another day. The CDC never made the claim that masks STOP infection, masks only delay it. And from the lack of evidence, I’m not even sure it does that.

This virus is airborne. Masks won’t stop an airborne virus, it won’t stop any virus. The best it can do is slow the spread.

From my perspective as a person who gets products approved by the FDA, ‘source control’ is not an actively pursued FDA indication because it can’t be proven by a randomized placebo-control trial. Every product under FDA EUA use has ongoing clinical trials, except for masks. This means there will never be enough evidence masks are effective at slowing spread that will amount to a marketed label. Which means FACE MASKS WILL NEVER BE APPROVED BY THE FDA FOR SOURCE CONTROL. Eventually the FDA will have to take this product off its EUA list. Then what?

We know they don’t work to protect you. If they did work in the way the CDC claims, it would only delay spread by a minuscule amount of time. Eventually you will get this virus.

COIVD19 is now endemic. Its not going anywhere. If everyone wore a mask for forever, it still won’t stop the spread. Masks will not stop an endemic virus.

Logically, what do we do? Wear masks forever even though you will eventually get and spread the virus? We are just spinning our wheels here with no way out.

You know what is actually proven to slow spread? Reducing the number of people gathering in one place. For example, mandating concerts in Atlantic City do not have 28,000 people huddled together.

The entertainment industry has political influence. Your kids don’t.