COVID-19: Notes from FDA Vaccine Approval Hearing

Jane Orient, MD — December 14, 2020

        If you are in the first allocation group, you might be lining up for your COVID-19 vaccine.

        The Pfizer messenger RNA (mRNA) vaccine was approved by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) after a 9-hour advisory committee meeting on Dec 10. The Moderna vaccine may follow soon. 

        Committee members were presented the question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?”

        Here are some highlights from the hearing:

        A number of committee members noted that the vaccine trial produced measurable antibodies by lab assay, but the evidence that it reduced clinical COVID-19 was sparse.

        Several committee members objected to the inclusion of 16-to-18-year-olds. This objection was because of the lack of trial data from this age group, and the relatively low reported risk of adverse outcomes in COVID-19 disease in this age group. The response was that inclusion of this age group in the initial approval would allow for future stepwise inclusion of yet younger ages, leading eventually to the incorporation into the standard regimen of childhood vaccinations.

        Another concern was the lack of data on the incidence of longer term adverse events, possibly auto-immune in nature, given that mRNA is an untested technology. Pfizer representatives were asked whether they had prepared additional follow up data since the 2-month data was now a month old. They said that they had not made an interval assessment, as that was not required in the FDA process. The original filing was very burdensome, they noted.

        Several committee members suggested limiting the authorization to high-risk groups, thus providing for a better benefit-to-risk profile, when risk was unknown. The response was that, because of logistics, initially only high risk groups would get the first available doses, and we would know more in the spring. 

        On a vote of 17-5, the committee answered the proposed question in the affirmative. After the vote, the chair abruptly adjourned the meeting without the previously promised second vote on whether to insert the words “to date” after “evidence.” 

        Adverse events (AEs) that were solicited occurred in 18.7% of vaccine recipients vs. 3.9% in the placebo group. Unsolicited, “non-serious” AEs included swollen lymph nodes in 64 with vaccine and 6 with placebo, and Bell’s palsy (see graphic) in 4 with vaccine and 0 with placebo. For the palsy, there was said to be no clear basis for concluding a causal relationship at this time, and that the frequency was consistent with the background rate in the population. 

        Doctors are being encouraged to take selfies when they get vaccinated to use in a promotional campaign on social media.

        If you would like to discuss these issues, contact me at [email protected] or (520) 323-3110.

Jane M. Orient, M.D.

Executive Director, Association of American Physicians and Surgeons

This drawing of a Canadian (Ojibway) Indian mask called “Broken Nose” demonstrates the classic features of Bell palsy: loss of forehead wrinkling, deviation of the mouth to the nonparalyzed side, sagging of the paralyzed side with loss of the nasolabial crease, and the rounder eye suggesting the failure of the upper eyelid to move down when the patient is asked to close his eyes (drawing by William Snavely).- 

COVID-19: Will the Vaccine Save Prisoners?

Jane Orient, MD — Dec. 12, 2020

I hope a loved one is not incarcerated, but all of us need to be concerned about prison health, for humanitarian reasons and also because prisons are breeding grounds for contagious diseases.

The Pfizer vaccine for COVID-19 is expected to arrive in hundreds of sites next week under an Emergency use Authorization (EUA) from the Food and Drug Administration. In Arizona, it will be administered, by appointment only, in centralized drive-thru locations (“pods”) to persons on the 1A allocation list. That includes healthcare workers and nursing home residents—not prisoners.

More than half the inmates at the Arizona State Prison Complex in Yuma test positive for COVID. Staff are getting certified to administer vaccine, when it becomes available, but the vaccine is already too late for more than half. The not-yet-positive inmates are housed separately and required to wear cloth masks when outside their cells. But inside or outside their cells, they are breathing the same air.

Orofecal spread of coronavirus is possible. Virus lives in the GI tract and wastewater for days or weeks. Virus has been isolated from restroom exhaust fans. In one study of environmental contamination, the air sampler had to be quarantined twice despite wearing full protective gear. If virus is aerosolized from flushing toilets, the prison mask policy will be of limited value.

So, what can we do to protect both prisoners and staff? A disproportionate number are minorities, the population most severely affected by the disease.

On Dec 8, the Senate held a second hearing about early treatment for COVID. While none of the witnesses said anything related to politics, or anything critical about vaccination or public health mitigation measures, Sen. Chuck Schumer (D-N.Y.) attacked the hearing, Chairman Ron Johnson (R-Wis.), and witnesses as being political, “anti-science,” and “anti-vaxx”—before a word was said.

There is apparently an Anti-Early-Treatment movement, which confuses being pro-treatment with being “anti-vaxx.” It has specifically discouraged use of hydroxychloroquine (HCQ), but official guidance from the National Institutes of Health (NIH) recommends no treatment for outpatients—except for the recent addition of mostly unavailable new monoclonal antibodies.

In contrast to official therapeutic nihilism, testimony at the hearing provided great hope about ivermectin, which has been called “a miracle drug,” having saved millions from terrible parasitic diseases in Africa and other developing areas. In more than 30 studies completed to date, all studies show effectiveness for COVID-19 in early and late disease and for pre-exposure and post-exposure prophylaxis (PrEP and PEP in HIV/AIDS parlance), as the graphic below shows.

There have been no large-scale randomized controlled trials (RCTs) for use in COVID-19 because of difficulty in obtaining funding. The research money goes to novel drugs and vaccines with huge profit potential. But safety has been shown with nearly 4 billion doses taken by humans since 1981.

Prisoners could be offered the choice to take one dose of ivermectin today and a follow-up dose in perhaps a week. Or they can wait to get infected soon and vaccinated whenever.

If you would like to discuss these issues, contact me at [email protected] or (520) 323-3110.

Jane M. Orient, M.D., Executive Director, Association of American Physicians and Surgeons

Covid Antifragility: Trusting Our Strength in Uncertain Times

By Nate Doromal
Are we as vulnerable to Covid as public health authorities want us to believe? Instead of focusing on our weakness, we should be focusing on becoming more resilient and antifragile.

The message of our fragility is everywhere. We are told, “you’re fragile - don’t go out, stay inside, and follow the rules. Presume you’re already sick and that you caught the virus.” There it is again. You’re weak and fragile. 

The message is reinforced on nearly every news network. Thus, Covid has made the holidays challenging. What was normally a chance to celebrate and enjoy with friends and family can turn divisive as strong feelings arise among the various parties just how serious Covid-19 is. Such discussions can get heated and it can undermine the spirit of the very holidays that bring us together. 

In various states in America, governors have placed stringent restrictions upon the celebration of holidays, going so far as to dictate how long our celebrations can be and how many people can participate.. Any rebuttal, however grounded in rigorous science, that does not conform to their narrative is suppressed. Just do what we say because you’re fragile - be obedient, and everything will be fine. 

Their “we’re here to protect you” messaging is perhaps the most disturbing as it reinforces our alleged weakness. Through repetition, they slowly erode confidence in our strength and increase our dependence upon them. Thinker Nassim Nicholas Taleb, author of Antifragile: Things That Gain From Disorder, observed, “This is the tragedy of modernity: as with neurotically overprotective parents, those trying to help are often hurting us the most.”

The worst danger of the Covid pandemic is that we lose faith and forget our strength and power. We were always a resilient people, both individually and as a community. Covid has shown us the need to utilize our strengths to become more resilient, more antifragile in the face of stress and trying circumstances.

We do not have to listen to the fear messages of the authorities and take them as fact. We can choose to take an antifragile mindset with regards to Covid. Nassim Taleb explains, “Some things benefit from shocks; they thrive and grow when exposed to volatility, randomness, disorder, and stressors and love adventure, risk, and uncertainty.”

How much should we fear Covid-19?

Something that has become clear with the Covid-19 data is that the overall health status of the individual is an important marker for how serious a Covid-19 infection can become. 

An examination of the CDC data indicates that age matters a lot regarding the infection fatality rate and the odds of dying from Covid-19:

  • For ages 0-19 years, the odds of dying from a Covid-19 infection are 3 per one million.
  • For ages 20-49, the odds of dying from a Covid-19 infection are 1 in 50,000.
  • For ages 50-69, the odds of dying from a Covid-19 infection are 1 in 500.
  • For ages 70+, the odds of dying from a Covid-19 infection are 1 in 20.

It might be helpful too to view the above data in terms of survivability rates to allow people to put their fears into context.

  • For ages 0-19 years, the survivability rate is 99.997%.
  • For ages 20-49, the survivability rate is 99.98%.
  • For ages 50-69, the survivability rate is 99.5%.
  • For ages 70+, the survivability rate is 94.6%.

When viewed this way, it becomes easier to see that in the vast majority of Covid cases, we will recover from the infection and gain immunity to Covid-19.

To be clear, and as stated earlier, our health status influences our health outcomes. The CDC has found that the presence of pre-existing conditions that can markedly affect the severity of the Covid-19 infection. Some of these pre-existing conditions include type 2 diabetes, obesity, hypertension, and smoking. The CDC data indicates that only 6% of people that died from Covid-19 were without pre-existing conditions – the average person dying had 2.6 pre-existing conditions.

This data makes it clear that our health choices matter a lot. Rather than focusing on our weaknesses, we should be focusing on our strengths and what we can control.

Facing the Reality of Covid-19 Head-on

The most important lesson from Covid-19 is that the vast majority of us are surviving Covid-19 without the medical intervention of the authorities. According to CDC estimates, the number of cumulative Covid-19 cases in America may be approaching 100 million. Rather than suggesting that Covid is running rampant, it is a testimony to the strength and wisdom of our body’s immune systems. 

Developed over millions of years of evolution, our immune systems are truly marvelous, protecting us from a wide variety of pathogens and emerging more resilient with each encounter. According to Dr. Andrew Weil: “Whenever the immune system deals successfully with an infection, it emerges from the experience stronger and better able to confront similar threats in the future. Our immune system develops in combat. If at the first sign of infection, you always jump in with antibiotics, you do not give the immune system a chance to grow stronger.” The authorities have tried to convince us that we are fragile glass creatures when the data indicates otherwise.

Dr. Michael Greger, the author of How Not to Die and the website nutritionfacts.org, states: “I continue to be amazed by our bodies’ ability for self-repair. Our bodies want to be healthy if we would just let them. That’s what these new research articles are showing: Even after years of beating yourself up with a horrible diet, your body can reverse the damage, open back up the arteries-even reverse the progression of some cancers. Amazing! So it’s never too late to start exercising, never too late to stop smoking, and never too late to start eating healthier.” Dr. Greger’s research shows how premature deaths can be avoided by simple changes in diet and lifestyle.

But you might object to the above by pointing out that there are millions of vulnerable people in the populace who have those pre-existing conditions or are immune-compromised. You or a direct loved one might be in one of these vulnerable categories. The message I have for you is this: do not forget your strength. There may be people right now who are suffering from Covid, but do not forget the power of your actions to strengthen yourself, no matter how small. It does not help anyone in the world to diminish your strength.

Covid-19 is not going away. Despite prolonged lockdowns and widespread mask mandates, Covid-19 is still present in our society and cases continue throughout the country. Even the much-discussed Covid-19 vaccine is not a panacea; authorities say it will not prevent transmission and there are outstanding safety concerns amongst the leading Covid-19 vaccine candidates. The key lies in making ourselves stronger. 

Focusing on Strengths and the Antifragile Mindset

Truth be told, we can make our bodies stronger, our immune systems more powerful, and can even reverse chronic pre-existing conditions. It’s never too late to take the steps to improve your health and make yourself more resilient to infectious diseases like Covid-19.

There are numerous things we can do to support our immune systems. The importance of diet and proper nutrition comes up time and time again in the literature on immune system functioning. 

There are supplements too that can help increase the resilience of our immune systems against Covid:

Related to diet, there have been recent advances in the knowledge of the gut microbiome and its effect on the immune system, including modulating autoimmune conditions such as allergy, asthma, and primary or acquired immune deficiencies. Research indicates that probiotic foods like kefir have effects that can boost the immune system.

Exercise is of crucial importance to immune system health. According to research, moderate exercise can boost and mobilize our white blood cells of the immune system. Studies have shown that adults that exercise have significantly fewer upper respiratory infections than those that don’t. Additionally, exercise when combined with dietary changes, is a powerful tool to fight obesity. This can reduce the number of pre-existing conditions associated with Covid-19, including hypertension, diabetes mellitusosteoarthritis, and coronary artery disease

Even the simple act of proper breathing can have powerful effects on the immune system. A study done in which participants were trained in yogic breathing showed that the participants had elevated levels of natural killer cells after 12 weeks of practice. There are also numerous testimonials for the power of the Wim Hof Breathing Method to positively influence the immune system, which has been validated in ground-breaking empirical research.

Perhaps one of the most powerful ways to affect the immune system is to have a positive mental attitude. Spiritual teacher Frederick Lenz said: “The most powerful force to maintaining a good immune system is the power of positive thinking and not allowing yourself to be unnecessarily drained emotionally by worries and fears.”

John Hopkins Medicine reports that a positive attitude is associated with improved outcomes across a myriad of health conditions, including traumatic brain injury, stroke, and brain tumors. A study has shown that being optimistic can have a strong effect on the immune system – increased optimism has been shown to lead to a stronger cell-mediated immunity response.

The most important to remember is that the power to deal with Covid-19 was always in your hands. You have always had the means and ability to make yourself stronger and more resilient. It is your choice and yours alone to improve your diet, to consume more fruits and vegetables, to exercise, to get more sunshine, to reach out and connect with your community, and to learn more about the functioning of your own body.

Towards a New Paradigm for Health 

When presented with Covid fear-based messaging from the media warning us of “rampant cases” and “possible deaths,” we can choose to tune in elsewhere. When faced with the fears of our friends and family, we can acknowledge their fears and show them how they are much stronger than they believe.

Covid-19 has shown us that it is high time for a new paradigm in public health, one that acknowledges and empowers the participants in the community, one that recognizes their inherent strength. For far too long has public health and medicine made infectious disease the foremost study of its focus, while forgetting the power of the individual and the importance of his or her health choices.

A new integrative mindset is needed for public health in the 21st century, one that incorporates greater systems and complexity thinking. Our bodies are not a discrete set of parts that function on their own. We are an integrated system that thrives within our environment and within this complex system of systems we thrive. With this mindset, the little choices we make in our lives matter a lot when compounded over time. In this mindset, we are first-hand participants in health as opposed to being seen as mere fragile potential carriers of the disease. We are far more than just our genetics and our environment – our intentions, thoughts, and actions matter a lot.

I’ll finish with a final thought by Nassim Taleb regarding the antifragile mindset: “Wind extinguishes a candle and energizes fire. Likewise, with randomness, uncertainty, chaos: you want to use them, not hide from them. You want to be the fire and wish for the wind.” Let us make ourselves and our people strong.

Expert Is a Four-letter Word

The Earth is flat and the sun revolves around the Earth. Settled science. 

Liberal icon Supreme Court Justice Oliver Wendell Holmes legitimized the science of eugenics when he ruled that the interest of “public welfare” outweighed the interest of individuals in their bodily integrity. Science intersects with public policy.

Scientific journals have published at least 75,000 peer-reviewed papers since the SARS-CoV-2 pandemic started. Some studies had significant design flaws, and many results are contradictory. Nonetheless, experts have stolen our lives, stolen the smiles from children’s faces, and bullied a segment of the population into paralyzing fear. Why? Because someone, somewhere was “following the science.” Which science? Only the science that comports with a particular political agenda? 

The misinformation began with the dire prediction of one of the world’s foremost disease modelers, epidemiologist Dr. Neil M. Ferguson of the Imperial College of London Covid-19 Response Team. He warned that unless the government did something, the pandemic could kill 2.2 million people in the United States. 

Accordingly, channeling Communist China, in March the experts recommended lockdowns to “flatten the curve” of infections. However, a July multi-country analysis revealed that the data “did not support a definitive judgment on the effectiveness” of lockdowns, among other public health interventions. A recent 14-day study involving carefully monitored masked and quarantined U.S. Marine recruits found that the virus can circulate even with the strictest non-pharmaceutical measures. SARS-CoV-2 tests became positive in 2 percent of the recruits. 

Mandatory mask wearing is another contentious non-pharmaceutical mitigating measure. Our most vocal expert, Dr. Anthony Fauci, told us we didn’t need masks in March 2020. Similarly, in April 2020, WHO reported that “the wide use of masks by healthy people in the community setting is not supported by current evidence.” But in June, based on “observational evidence,” The World Health Organization (WHO) recommended wearing masks to prevent the infected wearer from transmitting the virus to others and/or to protect the wearer against infection. 

A long awaited “gold standard” randomized controlled trial with 6,000 participants found that wearing a mask offered no statistically significant benefit: after one month, about 2 percent of the mask wearers and the non-mask wearers tested positive. 

Evidence aside, masks are likely here to stay. Everyone is begging for a “COVID for Dummies” solution. Masks fit the bill: they are highly visible and they tell the world you are a diligent, caring human being.

Realistically, there is no magic prevention bullet. Until we attain community immunity, treatment is the key to keeping COVID at bay. Unfortunately, the focus in the U.S. has been on the treatment of hospitalized patients. After limited research, in April 2020 Dr. Fauci declared that the newly minted drug, remdesivir at $3,000 per treatment was the “standard of care.” A few short months later, WHO issued a conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity, “as there is currently no evidence” that remdesivir improved survival. 

In many cases treatment in the hospital is too little, too late. Early outpatient treatment has been largely ignored by the U.S. media and medical establishment despite good results across the world. For example, in 4 months, Honduras went from a fatality rate of 14.5 percent to 2.66 percent because of its early treatment regimen, “Catracho”: colchicine, anti-inflammatories, tocilizumab, ivermectin, blood thinners, and hydroxychloroquine.

Sadly, an expert politician, Senator Gary Peters, squandered his opportunity to learn from clinicians and professors about several effective outpatient early treatments with inexpensive generic medications at the November 19, 2020, Hearing on Early Outpatient Treatment: An Essential Part of a COVID-19 Solution. Peters spent his time parroting political talking points about “misinformation” and “disinformation” from treating physicians and shifted the conversation to vaccines as “The Answer.” Ironically, his expert had never treated a single COVID patient. The $1,636,714 in donations Peters received from the health care and pharmaceutical industry adds a layer of “show me the money” to what should have been an informed debate. 

Our politicians and experts have flaunted the science upon which they rely to impose authoritarian measures on the little people. True believers would not put multiple families at risk by breaking quarantine to visit their married mistress, going to hairdressers maskless, walking through an airport maskless, having $350 per plate maskless indoor dinners with lobbyists, or attending a baseball game maskless with folks from different households. Worse yet, pre-election basement Joe Biden displayed photos socializing with his extended family while many had their Thanksgiving dinner for one. 

Early treatment provides an alternative to lockdowns and unproven vaccines. Experts’ behavior demonstrates their disdain for the lumpen proletariat. They are not interested in our health but in our acquiescence to deprivation and loss of control over our own lives. Dr. Fauci finally blurted out the core of the matter: “it’s time to do what you’re told.” 

COVID-19 Won the Presidential Election

One is hard-pressed to deny that Joe Biden is a weak, corruptpathologically lyingcreepy dirty old man who has lived off the government teat for 50 years. And he allegedly won the 2020 presidential election. Are Americans that ignorant? Or has Joseph Stalin’s political philosophy that has been simmering in America for years finally come to fruition? COVID was the not-so-secret agent.

The COVID pandemic was Nancy Pelosi’s stated reason for inserting blanket mail-in voting into a COVID financial relief package several months before the election. This method is a breeding ground for fraud. It is not absentee voting where the voter requests a ballot. With mail-in, a ballot is sent to anyone on the voter rolls—dead or alive. Magically, after all the ballots were mailed out, the CDC announced that people suffering from COVID could vote in person as long as they told the poll workers of their condition.

During his bloody 30-year career, Joseph Stalin (1878-1953) made two immediately pertinent points. First, “Political power does not rest with those who cast votes; political power rests with those who count votes.” 

The second point lays the foundation for the first: “The press is our Party’s sharpest and most powerful weapon.” The Left’s plans for fundamentally changing America were upended by three years of peace and prosperity. Enter the media collaborators. CNN has a permanent sidebar banner with global statistics with no context. There were never stories on recoveries or successful treatments, of which there are many inexpensive, home-based therapies. Many studies demonstrate positive results from the anti-inflammatory antiparasitics hydroxychloroquine and ivermectin, fluvoxasmine (antidepressant), budesonide (inhaled steroid), vitamins D and C, quercetin, and zinc. 

Social media refused to post materials favorable to the President or unfavorable to his opponent. I presume we are supposed to be impressed by Twitter CEO Jack Dorsey testifying that he should not have censored news about Hunter Biden’s internationally sensitive business ventures. Too little, too late. But he knows that. He had a mission to complete: emulate Pravda, censor and manipulate speech, and sway the election. 

We knew this was coming. 60 years ago Nikita Khrushchev predicted of the United States, “your grandchildren will live under communism.” If we didn’t believe Stalin or Khrushchev, maybe we will believe Hollywood. Given the perpetual “2 weeks to flatten the curve” lockdown and the paucity of non-Pravda network news, 50-year-old television shows have become welcome substitutes. The 1967-68 series called The Invaders was premised on aliens from another planet descending upon Earth to “make it their world.” The aliens’ dialogue was eerily familiar to the current authoritarian COVID Great Reset social engineering blather. 

In The Ivy Curtain episode an alien “college” course instructed new alien arrivals that “fear is an emotion that dominates all human behavior.” The aliens would “use fear as a weapon, to twist anxiety into hate, suspicion into violence, cowardice into surrender.” COVID was the convenient vehicle to induce fear. Was The Invaders pure entertainment or allegory? 

On the technical side, 2019’s futuristic Terminator: Dark Fate  is prophetic. When Facebook, Google, Twitter, and big tech hyperbolically propagandizing the coronavirus – excuse me, Skynet’s machines began to overtake humans, the government told the people to hide and isolate for a while. Hiding became the “new normal” until one strong leader inspired humans to fight the machines.

The one-sided news presentation, the post-election fortuitous release of 2 vaccines and revelation of Biden’s lockdown plans, mayors and governors and congresspersons flagrantly attending and planning celebrationsmaskless, opened many eyes to the media’s manipulation. Some voters are feeling like someone who got drunk in Las Vegas and woke up in bed married to a stranger or in a bathtub of ice minus a kidney. Stalin has another thought for these folks: “Words are one thing – deeds something entirely different. Fine words are a mask to cover shady deeds.” Sounds a bit like Barack Obama. President Trump’s words did not do justice to his deeds. Everything was for Americans – more jobs, energy independence, improving national parks, medical choice for veterans, prison reform, advancing historically black colleges, opportunity zones in poor neighborhoods, and on and on.

By contrast, the compassionate Congresswoman Ocasio-Cortez launched the Trump Accountability Project. The hit list included individuals who worked for the Trump for President campaign, Republican National Committee, and affiliated PACs in 2016 or 2020, those who staffed his government, individuals who worked in any role as a political appointee in the Trump Administration, and those who funded him, and the millions of Americans who elected him. This hateful website silenced itself but the Stalinesque sentiment runs deep and is certain to resurface.

I Vote for Early Treatment of Covid-19

The federal election’s mail-in voting chaos should teach us something about government-run medical care. In several cases, the voting process was as purposefully obtuse as the inner workings of our “healthcare system.” 

Our complex system includes the government or private insurers second-guessing your physician’s judgment with a man behind the curtain determining the “medical necessity” of tests or treatment. Is the justification that the physician with scientific knowledge and clinical judgment knows less than the bureaucrat? Or that the bureaucrat’s agenda favors the government pocketbook or his job security over the patients’ best interest?

Patients and physicians long for medical visits of days past. You saw your doctor, not the doctor who happened to be available that day. Your doctor saw you as a person, not merely a list of checkboxes on a computer screen. And most importantly, your doctor took the time to listen. And at the end of the visit, the doctor was allowed to charge you what you could afford to pay—not the price fixed by the government or insurer. Now, massive overregulation labels this type of charitable billing as health care fraud. Let’s get back to basics: you pay the doctor for their services and have major medical insurance for the hospital.

If we have totally government-run medical care, our choices are gone and we are at the mercy of politicians.

The intrusion of personal political preferences has no place in free and fair elections—just as in medicine. A civil society does not condone apparent bias and electioneering by state officials. Nor should we tolerate medical elites who haven’t touched a patient in decades telling physicians how to treat their own patients.

While practicing physicians were reading everything they could find about the new coronavirus, the august bureaucrats were busy giving us “expert” advice that proved incorrect. Of course, the experts never admitted their errors and still have their jobs. Meanwhile we continued to see contradictory information, the mischaracterization of positive SARS-CoV-2 antibody tests as new “cases,” and the media announcing all positive tests a “case” (implying an active illness) and overstating deaths attributable to Covid-19. By design, this misinformation kept us off-kilter and willing to let fear rather than common sense rule our lives. Albert Einstein was so right: “blind belief in authority is the greatest enemy of truth.”

Soon it became clear to clinicians that Covid-19 had separate stages of the disease. Stage I, the viral invasion; Stage II, the abnormal inflammatory response to the infection (cytokine storm); Stage III, exaggerated blood clotting response. Clinicians figured out that each stage needed different treatments. And just like with other conditions, the earlier physicians treat the cause of the illness, the better the patient’s outcome. 

Some private practitioners and academicians reported that early use of hydroxychloroquine (HCQ) in Stage I was safe and attenuated the course of Covid-19. President Trump praised the drug’s success. Big mistake. The political winds dictated that HCQ must die (along with some patients). While low-cost, generic treatments emerged, the politicians with their big tech, big Pharma, and media allies ensured that the public would never see the whole picture. In reality fewer people are dying and more people are recovering. But positive news about COVID might have helped the President. 

Scoring political points outweighed saving patients’ lives. When the saga of Covid-19 is told, the role of the intrusion of politics into the practice of medicine will leave a permanent stain. Medicine may suffer from the same distrust as does the integrity of the election process. If there is any doubt that the sainted Dr. Fauci and his ilk are overly influenced by politics and their self-interest, two 30-year-old books should resolve the issue: Good Intentions: How Big Business and the Medical Establishment Are Corrupting the Fight against AIDS by Bruce Nussbaum and And the Band Played On by Randy Shilts. History repeats itself. According to Nussbaum, Fauci loved media attention and “this lacklustre scientist [Fauci] was about to find his true vocation—empire building.”

Many posit that the reason a mentally compromised candidate for the United States presidency could stay in his basement and his running mate could refuse to give a single press conference was that “the fix was in.” Middle East peace, confronting North Korean aggression, reining in Communist China, the release of American hostages, the lowest unemployment in history, and a strong economy were flat out ignored by the media. Instead the media pushed a political “platform” of demonizing a President because of a treatable virus with a low infection-fatality rate. 

Maintaining medical independence is now more important than ever. Covid-19 was merely one weapon in the political arsenal. The “system” cannot be trusted to look out for you.

Masters of COVID Gloom, Lysenkoism, and Squirrels

The media, taking their cue from George Orwell’s 1984’s daily “Two Minute Hate,” provide a constant drumbeat of one-sided political talking points and incomplete statistics about COVID-19. It is designed to wear us down. The recovery of President Trump and many others gives us another side of the picture.

When questioned about motives for the unrelenting negativity, folks say they are following the science. This statement merits an historical note of caution about comingling politics and science. Nikolai Vavilov had data-driven work that was an accurate exposition of agricultural genetics. Unfortunately, Trofim Lysenko’s patently wrong, but Marxist leaning ideas on the science of agriculture caught the eye of Joseph Stalin. Lysenko buried Vavilov’s work, thousands starved, and Vavilov rotted in prison. This episode in science gave rise to an ism: Lysenkoism is any deliberate distortion of scientific facts or theories for purposes that are deemed politically, religiously or socially desirable.

Decades later we are left to tune in to the next episode of political theater, featuring “do as I say, not as I do.” One of Ms. Pelosi’s pastimes is lecturing the President on the value of wearing a mask. Then we see Ms. Pelosi sashaying around with no mask; her designer mask flopping around with her exposed nose (that harbors the bulk of the coronavirus). And in a when the camera’s away, the mice will play moment, Mr. Bidendoffed his ever-present, over-sized mask to speak with Anderson Cooper face to face. And for comic relief, Mr. Biden lowered his mask to cough in his hand—not even his elbow!

Where’s the science? As time has passed and we gain more knowledge and data about the SARS-CoV-2 virus that causes COVID-19, scientists have found several fold lower mortality rates than previously predicted. The CDC has some good news regarding the infection fatality ratio (IFR), the ratio of deaths divided by the number of actual infections with SARS-CoV-2:

  • Age 0-19 years: 0.00003, meaning 99.997% of that age group who get the infection will survive;
  • Age 20-49 years: 0.0002, meaning 99.98% of that age group who get the infection will survive;
  • Age 50-69 years: 0.005, meaning 99.5% of that age group who get the infection will survive;
  • Age 70+ years: 0.054, meaning 94.6% of that age group who get the infection will survive. 

Additionally, in the United States, hospitalizations and deaths are down, cases—even with more testing—are leveling off and more successful treatments are available.

Joe Biden tells us that when he wants to learn about COVID, he consults “the scientists,” one of whom is Ezekiel “let me die when I’m 75” Emanuel. Dr. Emanuel, a breast oncologist, believes we should stay in a lockdown until November 2021. He also is the co-creator of the Complete Lives System.” This medical care rationing system prioritizes persons with “instrumental value,” i.e., individuals with “future usefulness.” Joe Biden should watch his back.

California’s Governor Gavin Newsom has admitted that he saw “the potential” in the COVID crisis for “a new progressive era” in state and national politics. Instead of using the CDC data and science to lift restrictions of the activities of the residents, he established a new parameter: the Equity Metric. No one in a county can open until the test positivity rates in its most disadvantaged neighborhoods are not worse than the overall county positivity rate.

This is just what we need: prolonging lockdowns when data have shown they are harmful to society. The CDC reported that 40 percent of thousands surveyed reported at least one adverse mental or behavioral health condition. Thirteen percent started or increased substance use to cope with stress or emotions related to COVID-19 lockdowns. Eleven percent seriously considered suicide. Moreover, despite increases in telemedicine, evaluations of cardiovascular risk factors have dropped by 50 percent. Between March 1 and April 18, 2020 there was a 46 percent decrease in diagnoses of the six common cancer types. The World Health Organization has finally admitted that lockdowns “make the poor an awful lot poorer.” All of these factors will lead to increase in non-COVID related deaths.

Internationally noted epidemiologists and thousands of physicians from multiple specialties have a solution called “focused protection.” The Great Barrington Declaration posits that “the most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk.”

Squirrels are the cutest little rats with fur you’d ever want to see. But they do carry bubonic plague that is fatal without treatment. We do not kill all the squirrels. Let’s not kill our souls and optimism, terrify our elders into deadly isolation, psychologically cripple our children, and sentence our society to a generation of anxiety and depression, merely to score political points. 

Off the Record with Dr. Adams: Faulty Outrage

So Cavalier!

Trump was cavalier, Trump threw caution to the wind, Trump didn’t respect “the science,” Trump caught Covid due to bad behavior, a culture in the white house of……blah, blah, blah. 

I guess CNN’s body builder in chief, Chris Cuomo caught it some other way. He was busy respecting the science but somehow that little virus found him anyway. Not his fault. And what about the 200,000 people who died from it, I guess they all were cavalier and didn’t respect the science, either. And I guess that the supposed 7,000,000 people who have tested positive were all badly behaved and disrespectful of “the science” and deserved what they got, too. Interesting that the only person on earth who caught the highly contagious bug by being cavalier was that awful orange bad man. Everyone else who caught it was righteous and decent. 

It’s funny but I do remember reading way back in May that New York Governor, and honorary physician, Andrew Cuomo mentioned that 66% of the people hospitalized in NY State with the Chinese virus were people who had been in quarantine for at least 2 weeks at home. Hmmm, ‘splain that, Ricky. 

That was really big, and totally ignored news. It basically states straight out that people can get this no matter how hard they try to hide from it. It clearly demonstrates that lockdowns don’t prevent infection. It suggests that we ought to come out from under our rocks and live our lives because hiding in the cave doesn’t confer immunity.  But that story didn’t work for the democrats. It didn’t make Donald Trump look bad so we are just going to ignore it. Orange man dismissive, orange man careless. That is pretty insulting to all the rest of the people who contracted the Wuhan virus, as did the President, through no fault of their own. And why are we always mad at him and blaming him? Where is the outrage against CHINA? They did this to us. He didn’t.  

The Canary in the Constitutional Mine Is Gasping

Constitution Day passed us by without the celebration it richly deserved. Limiting the powers of the federal government is at the core of our Constitution. Ten years ago, the Affordable Care Act tested the limits of federal powers. The barely-noticed federal takeover of student loans, the mandated purchase of health insurance from a limited list of insurers with a limited list of doctors were only the start. The federally defined “essential” medical services were a roadmap for future government controls. We are now living through the consequences of government deciding what activities are “essential” in the lives of normal, sentient human beings.

Some congresspersons and assorted social justice warriors are treating the Constitution like the COVID-susceptible residents of New York nursing homes: expendable. Or like the 26,000 dementia patients whose death was hastened by the isolation resulting from unscientific lockdowns. 

The First Amendment is irrelevant for those whom the leftist mob detests. The mob and its social media enablers reserve freedom of speech for high-minded virtue signalers. Conservatives or libertarians need not apply. COVID-19 provided a justification for abridging freedom of assembly and religious freedom. Is openly professing one’s faith not essential to our well-being? Certainly, religious services where congregations can easily be instructed on safely participating in group worship presents less risk than sauntering through Walmart.

The Second Amendment erosion continues despite gutting police departments and the resultant rapidly increasing violent crime, including 710 more homicides than this time last year. Within hours after a would-be assassin used a handgun to ambush two law enforcement officers, Joe Biden called for a ban on “weapons of war.” Are we to fend for ourselves with kitchen knives and pointy-headed garden gnomes? 

The abandonment of the Fourth Amendment’s prohibition against unreasonable search and seizure is on the table as the rumblings about mandatory COVID-19 vaccines get louder.  

We are seeing new methods to erode the Fifth Amendment’s prohibition of the government “taking” of private property by “eminent domain” that go far beyond the infamous 2005 Kelo decision. In Kelo, the Supreme Court liberals expanded the Constitution’s “public use” to include a public “purpose.” The Court concluded that the government could take property from one private owner and transfer it to another private party because the public would benefit from the economic development and increased tax revenue. Sadly, the project for which the plaintiff lost her family home was never built. As dissenting Justice Sandra Day O’Connor noted, “Nothing is to prevent the State from replacing any Motel 6 with a Ritz-Carlton, any home with a shopping mall, or any farm with a factory.” In short, a “public purpose” can be anything the government wants it to be.

We are taking baby steps toward Marx’s ideal society without private property. California, as usual, is the canary in our free society’s coal mine. New legislation will allow 3 homes on single family lots across the state. The federal rules that Joe Biden wants to revive will facilitate cramming us into high-density suburban concrete jungles. How did the “stack and pack” housing in New York City where COVID-19 spread like wildfire work out? 

The COVID-19 mandates and lockdowns all but ignore the Ninth Amendment that enshrines the principle that we have natural rights that need not be enumerated.

The Tenth Amendment—perhaps the most powerful amendment—has been lost in the COVID-19 shuffle. Our leaders have ignored the law of the land that provides that when it comes to inalienable rights, the people are ultimately in charge.

The Twelfth Amendment confirms that electors, not the popular vote, shall elect the president despite Mrs. Clinton’s assertions to the contrary. The United States must guarantee that all states, not just New York City and California, have a voice in presidential elections. 

The Thirteenth Amendment will no longer have meaning when we are all slaves to Uncle Sam’s whims. 

Universal mail-in voting and the attendant fraud grossly weakens the Fifteenth Amendment. 

As Marx predicted, a socialist society would begin by the violent seizure of the government by the people. To achieve their goals, Communist revolutionaries killed at least 100 million people. Appearing to follow in those footsteps, the Marxist Black Lives Matter Foundation, Inc. is decorating the streets with communist symbols and burning down neighborhoods—much to the displeasure of the local Black residents. At least 26 deathsare attributable to the “peaceful protests.” News anchors are calling for “burning the f**** thing down” or “blow the system up” if their demands (having nothing to do with racial justice) are not met. 

The leftists would like to “reimagine” the Constitution out of existence. When the mobs usher in a government-run dystopia, the Fourteenth Amendment’s equal protection clause will merely ensure that we will all “equally share in our misery.” 

Rescue the canary. Fight for our Constitutional republic and our freedoms.

Mask Facts

Curated by Marilyn Singleton, MD, JD

COVID-19 is as politically-charged as it is infectious. Early in the COVID-19 pandemic, the WHO, the CDC and NIH’s Dr. Anthony Fauci discouraged wearing masks as not useful for non-health care workers. Now they recommend wearing cloth face coverings in public settings where other social distancing measures are hard to do (e.g. grocery stores and pharmacies). The recommendation was published without a single scientific paper or other information provided to support that cloth masks actually provide any respiratory protection. Let’s look at the data.

The theory behind mask wearing:
*Source control: Cloth mask can trap droplets that come out of a person’s mouth when they cough or sneeze.
*Protection: Personal Protective Equipment – only N95 masks.

Transmission of SARS-CoV-2

Note: A COVID-19 (SARS-CoV-2) particle is 0.125 micrometers/microns (μm); influenza virus size is 0.08 – 0.12μm; a human hair is about 150 μm.

*1 nm = 0.001 micron; 1000 nm = 1 micron; micrometer (μm) is the preferred name for micron

*1 meter is = 1,000,000,000 [trillion] nm or 1,000,000 [million] microns

*For a complete explanation of aerosols and airborne particles, please see Understanding Particle Size and Aerosol-based Transmission by Steve Probst, https://www.4cconference.com/wp-content/uploads/2020/07/Understanding-Particle-Size-and-Aerosol-Based-Transmission.pdf

Droplets
Virus is transmitted through respiratory droplets produced when an infected person coughs, sneezes or talks. 

Larger respiratory droplets (>5 μm) remain in the air for only a short time and travel only short distances, generally <1 meter. They fall to the ground quickly. https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30245-9/fulltext

This idea guides the CDC’s advice to maintain at least a 6-foot distance.

Small (<5 μm) aerosolized droplets can remain in the air for at least 3 hours and travel long distances. (up to 27 ft.) https://www.nejm.org/doi/pdf/10.1056/NEJMc2004973?articleTools=true;

https://www.cidrap.umn.edu/covid-19/podcasts-webinars/special-ep-masks;

https://www.nap.edu/catalog/25769/rapid-expert-consultation-on-the-possibility-of-bioaerosol-spread-of-sars-cov-2-for-the-covid-19-pandemic-april-1-2020

Air currents
In air conditioned environment these large droplets may travel farther. 

Ventilation
Even the opening of an entrance door and a small window can dilute the number of small droplets to one half after 30 seconds. This is clinically relevant because poorly ventilated and populated spaces, like public transport and nursing homes, have high SARS-CoV-2 disease transmission despite physical distancing. (This study looked at droplets from uninfected persons). https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30245-9/fulltext

Humidity
Since 1961, experiments showed that viral-pathogen-carrying droplets were inactivated within shorter and shorter times, as ambient humidity was increased. Dryness drives the small aerosol particles. See e.g., Review: https://aaqr.org/articles/aaqr-20-06-covid-0302

Conclusions
The preponderance of scientific evidence supports that aerosols play a critical role in the transmission of SARS-CoV-2. Years of dose response studies indicate that if anything gets through (and it always does, irrespective of the mask), then you are going to be infected.

  • Thus, any respiratory protection respirator or mask must provide a high level of filtration and fit to be highly effective in preventing the transmission of SARS-CoV-2.  (Works for TB that is 3 μm)
  • Public health authorities define a significant exposure to COVID-19 as face-to-face contact within 6 feet with a patient with symptomatic COVID-19 that is sustained for at least a few minutes (and some say more than 10 minutes or even 30 minutes). 
    • The chance of catching COVID-19 from a passing interaction in a public space is therefore minimal.

MASKS
Filter Efficiency and Fit
*Data from a University of Illinois at Chicago review
https://www.cidrap.umn.edu/news-perspective/2020/04/commentary-masks-all-covid-19-not-based-sound-data

  • HEPA (high efficiency particulate air) filters are 99.97 – 100% efficient. HEPA filters are tested with particles that are 0.125 μm (the size of SARS-CoV-2)
  • Masks and respirators work by collecting particles through several physical mechanisms, including diffusion (small particles) and interception and impaction (large particles)

OSHA/CDC:  A surgical mask is not a respirator. It cannot be used to protect workers who perform or assist with aerosol-generating procedures, which may create very fine aerosol sprays. A surgical mask can only be used to protect workers from contact with the large droplets made by patients when they cough, sneeze, talk or breathehttps://www.osha.gov/dts/guidance/flu/healthcare.html

Laboratory Studies
Filter efficiency was measured across a wide range of small particle sizes (0.02 to 1 µm) at 33 and 99 L/min.

  • N95 filtering facepiece respirators (FFRs) are constructed from electret (a dielectric material that has a quasi-permanent electric charge.) An electret generates internal and external electric fields so the filter material has electrostatic attraction for additional collection of all particle sizes. As flow increases, particles will be collected less efficiently.
  • N95.  A properly fitted N95 will block 95% of tiny air particles down to 
    0.3 μm from reaching the wearer’s face. https://www.honeywell.com/en-us/newsroom/news/2020/03/n95-masks-explained
    • But even these have problems: many have exhalation valve for easier breathing and less moisture inside the mask. 
    • An N-95 mask helps protect the wearer from others, but it does not filter exhaled air passing through the exhaust valve.  No source control.
    • A 2010 study found that all the cloth masks and materials had near zero efficiency at 0.3 µm, a particle size that easily penetrates into the lung (SARS-CoV-2 is 0.125 µm) https://www.cidrap.umn.edu/news-perspective/2020/04/commentary-masks-all-covid-19-not-based-sound-datahttps://academic.oup.com/annweh/article/54/7/789/202744
      • T-shirts — 10% efficiency
      • Scarves — 10% to 20% efficiency
      • Cloth masks — 10% to 30% efficiency
      • Sweatshirts — 20% to 40% efficiency
      • Towels — 40% efficiency.
      • A 2014 study evaluated 44 masks, respirators, and other materials with similar methods and small aerosols (0.08 and 0.22 µm). https://aaqr.org/articles/aaqr-13-06-oa-0201
        • N95 FFR filter efficiency was greater than 95%. 
        • Medical masks — 55% efficiency 
        • General masks — 38% efficiency
        • Handkerchiefs — 2% (one layer) to 13% (four layers) efficiency.
      • Conclusion: Wearing masks (other than N95) will not be effective at preventing SARS-CoV-2 transmission, whether worn as source control or as personal protective equipment (PPE)
        • N95 masks protect health care workers, but are not recommended for source control transmission. 
        • Surgical masks are better than cloth but not very efficient at preventing emissions from infected patients. Cloth masks – they must be 3 layers, add static electricity by rubbing with rubber glove. 
        • The cloth that serves as the filtration for the mask is meant to trap particles being breathed in and out. But it also serves as a barrier to air movement because it forces the air to take the path of least resistance, resulting in the aerosols going in and out at the sides of the mask.

Human Studies

  • Strikingly, cloth masks resulted in significantly higher rates of infection than medical masks, and also performed worse than the control arm, some of whom may have worn masks.
    • The virus may survive on the surface of the face masks
    • Self-contamination through repeated use and improper doffing is possible. A contaminated cloth mask may transfer pathogen from the mask to the bare hands of the wearer. 
    • Moisture retention, reuse of cloth masks and poor filtration may result in increased risk of infection.
    • Cloth masks should not be recommended for health care workers, particularly in high-risk situations.
  • Review of N95 and surgical masks against respiratory infection (2016) https://www.cmaj.ca/content/cmaj/188/8/567.full.pdf
    From January 1990 to December 2014.  6 clinical studies: 3 randomized controlled trials (RCTs), 1 cohort study and 2 case–control studies, and 23 surrogate exposure studies. In the meta-analysis of the clinical studies, “we found no significant difference between N95 respirators and surgical masks in associated risk of (a) laboratory-confirmed respiratory infection, (b) influenza-like illness, or (c) reported work-place absenteeism.”
  • Review of masks and N95s against respiratory infection (2017) https://doi.org/10.1093/cid/cix681
    Separate meta-analyses of 6 randomized controlled trials (RCTs) and 23 observational studies conducted during the 2003 SARS pandemic. Compared to medical masks, N95 respirators provided greater protection against clinical respiratory illness (CRI) and bacterial respiratory illness (BRI). These 2 outcomes were common in these trials (average risks of 8.7% and 7.3%, respectively). Compared to masks, N95 respirators conferred superior protection against clinical respiratory illness and laboratory-confirmed bacterial, but not viral infections or influenza like illness (ILI). Self-reported assessment of clinical outcomes was prone to bias. Evidence of a protective effect of masks or respirators against verified respiratory infection was not statistically significant.
  • *Randomized Controlled Trial: N95 vs Medical Masks in health care workers (HCWs) against influenza (2019). https://jamanetwork.com/journals/jama/fullarticle/2749214
    2862 randomized participants, 2371 completed the study and accounted for 5180 HCW-seasons. Among outpatient health care personnel, N95 respirators (8.2%) vs medical masks (7.2%) resulted in no significant difference in the incidence of laboratory-confirmed influenza. 90% said they wore the mask all the time.
  • Review of N95 respirators versus surgical masks against influenza (2020) https://doi.org/10.1111/jebm.12381
    6 randomized controlled trials (RCTs) involving 9,171 participants were included. (2015-2020). There were no statistically significant differences in preventing laboratory-confirmed influenza, laboratory-confirmed respiratory viral infections, laboratory-confirmed respiratory infection and influenza-like illness using N95 respirators and surgical masks. Meta-analysis indicated a protective effect of N95 respirators against laboratory-confirmed bacterial colonization. The use of N95 respirators compared with surgical masks is not associated with a lower risk of laboratory-confirmed influenza.
  • CDC Review since 1946 – influenza (2020): Nonpharmaceutical Measures for Pandemic Influenza in Nonhealthcare Settings—Personal Protective and Environmental Measures.” 
    There is limited evidence for their effectiveness in preventing influenza virus transmission either when worn by the infected person for source control or when worn by uninfected persons to reduce exposure. “In our systematic review, we identified 10 RCTs that reported estimates of the effectiveness of face masks in reducing laboratory-confirmed influenza virus infections in the community from literature published during 1946–July 27, 2018….In pooled analysis, we found no significant reduction in influenza transmission with the use of face masks…Our systematic review found no significant effect of face masks on transmission of laboratory-confirmed influenza….Proper use of face masks is essential because improper use might increase the risk for transmission.” https://wwwnc.cdc.gov/eid/article/26/5/19-0994_article
  • A study of 4 patients in South Korea (2020)
    Known patients infected with SARS-CoV-2 wore masks and coughed into a Petrie dish. “Both surgical and cotton masks seem to be ineffective in preventing the dissemination of SARS–CoV-2 from the coughs of patients with COVID-19 to the environment and external mask surface.” https://www.acpjournals.org/doi/10.7326/M20-1342
  • A study different types of face coverings – non-clinical setting (Aug 2020) https://advances.sciencemag.org/content/early/2020/08/07/sciadv.abd3083
    A person wears a face mask and speaks into the direction of an expanded laser beam inside a dark enclosure. Droplets that propagate through the laser beam scatter light, which is recorded with a cell phone camera. A simple computer algorithm then counts the droplets seen in the video. They used a black box, a laser, and a camera. “The laser beam is expanded vertically to form a thin sheet of light, which they shined through slits on the left and right of the box.” The is a hole in the front of the box where a speaker can talk into it. A camera is placed on the back of the box to record light that is scattered in all directions by the respiratory droplets that cut through the laser beam when they talk. 
    • The N95, led to a droplet transmission of below 0.1%. 
    • Cotton and polypropylene masks, some of which were made from apron material, proved beneficial, showing a droplet transmission ranging from 10% to 40%. 
    • Knitted mask released a higher number of droplets, with up to 60 percent droplet transmission.
    • Neck fleece, which had 110% droplet transmission (10% higher than not wearing a mask).
    • Speaking through some masks (particularly the neck fleece, bandanas) seemed to disperse the largest droplets into a multitude of smaller droplets … which explains the apparent increase in droplet count relative to no mask in that case.

Study from France

https://swprs.org/face-masks-evidence/ (Swiss Policy Research)
Johns Hopkins, 9/21/2020

Negative Effects of Masks 
Air inside the mask is definitely stale.  In filtering particles, the mask makes it harder to breathe. 

  • Decreased PaO2
    • 2004. End stage renal disease patients during dialysis x 4 hours. 39 patients, mean 57 y/o. 70% had decreased PaO2 (from 100 to 92); increased respiratory rate 16 to 18; increased chest discomfort (3 to 11 patients); increased respiratory distress (1 to 17); 19% had hypoxemia. https://pubmed.ncbi.nlm.nih.gov/15340662/
    • One 2008 study of surgeons in the OR found a small drop in SpO2 (peripheral capillary O2 saturation). Scientists looked at O2 levels of surgeons wearing masks while performing surgery and found: “Our study revealed a decrease in the oxygen saturation of arterial pulsations (SpO2 went from 98 to 96) and a slight increase in pulse rates compared to preoperative values in all surgeon groups.” http://scielo.isciii.es/pdf/neuro/v19n2/3.pdf
  • Increased CO2 – This may be merely theoretical. It is hard to tell if the headaches experienced by HCWs with N95s is CO2 or having a strap around the head.
    • Carbon dioxide molecules freely diffuse through the masks, allowing normal gas exchange while breathing.
    • CO2 is present in the atmosphere at a level of about 0.04% (400ppm). According to the U.S. Department of Agriculture / OSHA, carbon dioxide becomes toxic at concentrations above 4 percent (40,000ppm); symptoms at 5-10,000 ppm. 10,000 ppm has been measured behind mask.
  • Scandinavian 2005 HCW study: 37.3% reported face-mask-associated headaches, 32.9% reported headache frequency >6 times per month. 7.6% had taken sick leave from March 2003 to June 2004 (mean 2 days; range 1-4 days) and 59.5% required use of abortive analgesics because of headache. https://pubmed.ncbi.nlm.nih.gov/16441251/
  • Japanese 2009 study with similar headache results. “Use of surgical face masks to reduce the incidence of the common cold among health care workers in Japan: A randomized controlled trial” https://pubmed.ncbi.nlm.nih.gov/19216002/
  • While there are some articles reporting OSHA tests, it is not clear they were proper tests. 
    • Some people have mistakenly claimed that OSHA standards (e.g., the Respiratory Protection standard, 29 CFR 1910.134; the Permit-Required Confined Space standard 29 CFR 1910.146; and the Air Contaminants standard, 29 CFR 1910.1000) apply to the issue of oxygen or carbon dioxide levels resulting from the use of medical masks or cloth face coverings in work settings with normal ambient air (e.g. healthcare settings, offices, retail settings, construction). These standards do not apply to the wearing of medical masks or cloth face coverings in work settings with normal ambient air). These standards would only apply to work settings where there are known or suspected sources of chemicals (e.g., manufacturing facilities) or workers are required to enter a potentially dangerous location (e.g., a large tank or vessel). https://www.osha.gov/SLTC/covid-19/covid-19-faq.html
  • But when asked should we be worried about CO2, mask proponents say, “No” because you can exhale around the sides of the mask. Of course, this defeats the purpose. https://pubmed.ncbi.nlm.nih.gov/16441251/
  • Moisture retention, reuse of cloth masks, frequency and effectiveness of cleaning, and poor filtration may result in increased risk of infection. 
  • Self-contamination through repeated use and improper doffing is possible.  The virus may survive on the surface of the mask.  The pathogen goes from mask to bare hands.
  • “Mask mouth” reported by dentists.  Wearing masks increases dryness, which leads to decrease in saliva. It is the saliva that fights bacteria. Result is decaying teeth, receding gum lines and seriously sour breath. Gum disease — or periodontal disease — will eventually lead to strokes and an increased risk of heart attacks” https://nypost.com/2020/08/05/mask-mouth-is-a-seriously-stinky-side-effect-of-wearing-masks/
  • World Health Organization (WHO, June 5, 2020)
    “The likely disadvantages of the use of mask by healthy people in the general public include: 
    • potential increased risk of self-contamination due to the manipulation of a face mask and subsequently touching eyes with contaminated hands;
    •  potential self-contamination that can occur if non- medical masks are not changed when wet or soiled. This can create favourable conditions for microorganism to amplify; 
    • potential headache and/or breathing difficulties, depending on type of mask used; 
    • potential development of facial skin lesions, irritant dermatitis or worsening acne,
    • when used frequently for long hours;(50) 
    • difficulty with communicating clearly; 
    • potential discomfort;(41, 51) 
    • a false sense of security, leading to potentially lower 
    • adherence to other critical preventive measures such as physical distancing and hand hygiene; 
    • poor compliance with mask wearing, in particular by young children; 
    • waste management issues; improper mask disposal leading to increased litter in public places, risk of contamination to street cleaners and environment hazard; 
    • difficulty communicating for deaf persons who rely on lip reading; 
    • disadvantages for or difficulty wearing them, especially for children, developmentally challenged persons, those with mental illness, elderly persons with cognitive impairment, those with asthma or chronic respiratory or breathing problems, those who have had facial trauma or recent oral maxillofacial surgery, and those living in hot and humid environments.” 
  • The Hamburg Environmental Institute warned of the inhalation of chlorine compounds in polyester masks as well as problems in connection with face mask disposal.

Positive Mask Studies

  • A U.S. study of airborne transmission (May 2020) https://www.pnas.org/content/117/26/14857
    Study claimed that masks had led to a decrease in infections in three global hotspots (including New York City). This did not take into account the natural decrease in infections and other measures. The study was so flawed that over 40 scientists recommended that the study be withdrawn.
  • A U.S. study comparing states with mask mandates (June 2020).https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.00818
    Study concluded that mandatory masks had led to a decrease in infections in 15 states. The study did not take into account that the incidence of infection was already declining in most states at that time. A comparison with other states was not made.
  • A U.S. study comparing masks, lockdowns in various countries (June 2020). https://www.medrxiv.org/content/10.1101/2020.05.22.20109231v3.full.pdf
    Study concluded that countries with mandatory masks had fewer deaths than countries without mandatory masks. But the study compared African, Latin American, Asian and Eastern European countries with very different infection rates and population structures.

Conclusions from Organizations

“Advice to decision makers on the use of masks for healthy people in community settings:
The wide use of masks by healthy people in the community setting is not supported by current evidence and carries uncertainties and critical risks.
“Medical masks should be reserved for health care workers. The use of medical masks in the community may create a false sense of security, with neglect of other essential measures, such as hand hygiene practices and physical distancing, and may lead to touching the face under the masks and under the eyes, result in unnecessary costs, and take masks away from those in health care who need them most, especially when masks are in short supply.” 

“Masks are effective only when used in combination with frequent hand-cleaning with alcohol-based hand rub or soap and water.” WHO acknowledges that most people do not use masks properly.

But on June 8, 2020:  The World Health Organization has changed its stance on wearing face masks during the COVID-19 pandemic. People over 60 and people with underlying medical conditions should wear a medical-grade mask when they’re in public and cannot socially distance.” The general public should wear a three-layer fabric mask in those situations. Admitting that this was despite evidence with randomized controlled trials. “The use of a mask alone is insufficient to provide an adequate level of protection or source control, and other personal and community level measures should also be adopted to suppress transmission of respiratory viruses.”

  • Dr. Nancy Messonnier, director of the Center for the National Center for Immunization and Respiratory Diseases. 
    https://www.cdc.gov/media/releases/2020/t0131-2019-novel-coronavirus.html
    “We don’t routinely recommend the use of face masks by the public to prevent respiratory illness,” said on January 31. “And we certainly are not recommending that at this time for this new virus.”
  • The Centers for Disease Control and Prevention (CDC)
    https://www.cdc.gov/flu/professionals/infectioncontrol/maskguidance.htm
    In March 5, 2019 regarding the flu: “Masks are not usually recommended in non-healthcare settings; however, this guidance provides other strategies for limiting the spread of influenza viruses in the community:
    *Cover their nose and mouth when coughing or sneezing,
    *Use tissues to contain respiratory secretions and, after use, to dispose of them in the nearest waste receptacle, and
    *Perform hand hygiene (e.g., handwashing with non-antimicrobial soap and water, and alcohol-based hand rub if soap and water are not available) after having contact with respiratory secretions and contaminated objects/materials.
  • From the New England Journal of Medicine, Universal Masking in the Covid-19 Era, July 9, 2020; https://www.nejm.org/doi/full/10.1056/NEJMp2006372
    “We know that wearing a mask outside health care facilities offers little, if any, protection from infection. Public health authorities define a significant exposure to Covid-19 as face-to-face contact within 6 feet with a patient with symptomatic Covid-19 that is sustained for at least a few minutes (and some say more than 10 minutes or even 30 minutes). The chance of catching Covid-19 from a passing interaction in a public space is therefore minimal. In many cases, the desire for widespread masking is a reflexive reaction to anxiety over the pandemic.” 
    But later the authors said “A growing body of research shows that the risk of SARS-CoV-2 transmission is strongly correlated with the duration and intensity of contact: the risk of transmission among household members can be as high as 40%, whereas the risk of transmission from less intense and less sustained encounters is below 5%.  This finding is also borne out by recent research associating mask wearing with less transmission of SARS-CoV-2, particularly in closed settings.”https://www.nejm.org/doi/full/10.1056/NEJMc2020836
  • Holland’s Medical Care Minister Tamara van Ark
    https://www.thesun.co.uk/news/uknews/12292821/face-masks-not-necessary-say-holland-scientists/
    “Despite a global stampede of mask-wearing, data show that 80-90 percent of people in Finland and Holland say they “never” wear masks when they go out, a sharp contrast to the 80-90 percent of people in Spain and Italy who say they “always” wear masks when they go out. “From a medical point of view, there is no evidence of a medical effect of wearing face masks, so we decided not to impose a national obligation.” 

Panel: Recommendations on face mask use in community settings (March 2020)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7118603/

WHO

  • If you are healthy, you only need to wear a mask if you are taking care of a person with suspected SARS-CoV-2 infection.

China

  • People at moderate risk of infection: surgical or disposable mask for medical use.
  • People at low risk of infection: disposable mask for medical use.
  • People at very low risk of infection: do not have to wear a mask or can wear non-medical mask (such as cloth mask).

Hong Kong

  • Surgical masks can prevent transmission of respiratory viruses from people who are ill. It is essential for people who are symptomatic (even if they have mild symptoms) to wear a surgical mask.
  • Wear a surgical mask when taking public transport or staying in crowded places. It is important to wear a mask properly and practice good hand hygiene before wearing and after removing a mask.

Singapore

  • Wear a mask if you have respiratory symptoms, such as a cough or runny nose.

Japan

  • The effectiveness of wearing a face mask to protect yourself from contracting viruses is thought to be limited. If you wear a face mask in confined, badly ventilated spaces, it might help avoid catching droplets emitted from others but if you are in an open-air environment, the use of face mask is not very efficient.

USA

  • Centers for Disease Control and Prevention does not recommend that people who are well wear a face mask (including respirators) to protect themselves from respiratory diseases, including COVID-19.
  • US Surgeon General urged people on Twitter to stop buying face masks.

UK

  • Face masks play a very important role in places such as hospitals, but there is very little evidence of widespread benefit for members of the public.

Germany

  • There is not enough evidence to prove that wearing a surgical mask significantly reduces a healthy person’s risk of becoming infected while wearing it. According to WHO, wearing a mask in situations where it is not recommended to do so can create a false sense of security because it might lead to neglecting fundamental hygiene measures, such as proper hand hygiene.

Final Thoughts

  • Surgical masks are loose fitting. They are designed to protect the patient from the doctors’ respiratory droplets.  There wearer is not protected from others airborne particles
  • People do not wear masks properly. Most people have the mask under the nose. The wearer does not have glasses on and the eyes are a portal of entry.  If the virus lands on the conjunctiva, tears will wash it into the nasopharynx.
  • Most studies cannot separate out hand hygiene.
  • The designer masks and scarves offer minimal protection – they give a false sense of security to both the wearer and those around the wearer. 
    **Not to mention they add a perverse lightheartedness to the situation.
  • If you are walking alone, no mask – avoid folks – that is common sense.
  • Children under 2 should not wear masks – accidental suffocation and difficulty breathing in some
  • Even if a universal mask mandate were imposed, several studies noted that folks do not use the mask properly, over-report their wearing.  Additionally, how would the mandate be enforced?
  • The positive studies are models that assume universality and full compliance
  • If wearing a mask makes people go out and get Vitamin D – go for it. In the 1918 flu pandemic people who went outside did better.  Early reports are showing people with COVID-19 with low Vitamin D do worse than those with normal levels. Perhaps that is why shut-ins do so poorly. https://www.medrxiv.org/content/10.1101/2020.04.08.20058578v4

Wash your hands ———- If you are sick, stay home!

Objects and surfaces

  • Person to person touching
  • The CDC’s most recent statement regarding contracting COVID-19 from touching surfaces: “Based on data from lab studies on Covid-19 and what we know about similar respiratory diseases, it may be possible that a person can get Covid-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose or possibly their eyes,” the agency wrote. “But this isn’t thought to be the main way the virus spreads. https://www.cdc.gov/media/releases/2020/s0522-cdc-updates-covid-transmission.html 
  • Chinese study with data taken from swabs on surfaces around the hospital
    https://wwwnc.cdc.gov/eid/article/26/7/20-0885_article?deliveryName=USCDC_333-DM25707
    • The surfaces where tested with the PCR (polymerase chain reaction) test, which greatly amplifies the viral genetic material if it is present. That material is detectable when a person is actively infected. At the time of the study, it was thought to be the most reliable test. Because of the amplification of the viral material, there are many false positives. It is not clear that the mere presence of virus means it is infectious.
      • Computer mouse (ICU 6/8, 75%; General ward (GW) 1/5, 20%) 
      • Trash cans (ICU 3/5, 60%; GW 0/8)
      • Sickbed handrails (ICU 6/14, 42.9%; GW 0/12) 
      • Doorknobs (GW 1/12, 8.3%) 
      • 81.3% of the miscellaneous personal items were positive: 
        • Exercise equipment
        • Medical equipment (spirometer, pulse oximeter, nasal cannula) 
        • PC and iPads
        • Reading glasses 
        • Cellular phones (83.3% positive for viral RNA)
        • Remote controls for in-room TVs (64.7% percent positive) 
        • Toilets (81.0% positive)
        • Room surfaces (80.4% of all sampled)
        • Bedside tables and bed rails (75.0%)
        • Window ledges (81.8%)
        • Plastic: up to 2-3 days 
        • Stainless Steel: up to 2-3 days 
        • Cardboard: up to 1 day 
        • Copper: up to 4 hours 
        • Floor – gravity causes droplets to fall to the floor. Half of ICU workers all had virus on the bottoms of their shoes