(Note: Author Updated this article on January 31, 2021)

I’ve been accused of writing this article because of my personal political motivation.  That is not the case. I write this article because my patient’s expect me to treat them based on the actual science that exists, not the interpretative politics and non-evidence based health mandates that so many have recently cowered under, or used as a virtue signaling security blanket.  A number of my patients, and potential patients, have notified me since I first published this article that I upset or angered them, because I haven’t conformed to “everyone else’s opinions.”  My intent in writing this is not to anger anyone, agree with your opinion or to put forth a political agenda.  Just because the media, politicians or city bureaucrats repeat something over and over doesn’t make it true. I share with you the actual science that has been recently made available so that you and I can make an educated judgement on how to act.  Without an understanding of the actual evidence how are you and I to respond when there are so many voices sharing so many differing opinions? If you can’t trust your doctor to follow updated scientific evidence, then who can you trust?

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After graduation from medical residency, I served for four years as my AirForce Reserve unit’s biological/chemical weapons expert & physician. My job was to understand the risks of all the known biologic and chemical weapons that could be used on a human being, including severe viral and bacterial diseases that could pose a threat. My training was specifically focused on how to prevent and treat the effects of these illnesses in those under my care, military or otherwise.

I spent four years reading and researching where and when various types of masks, respirators and protective equipment would and should be used. Never once was a surgical or cloth mask ever found to be effective. Even N95 masks failed the rigors of these encounters.

This week our fearless Dr. Fauci says it’s “common sense” to wear two masks. So, my question to him and all of the other emperors of medicine is, what about three masks?

Even better yet, 10 masks makes even more “common sense!!” Where does this stop? (‘Cause my ears flop over at 11 masks.)

I’m thinking that 100 masks is 100% effective right?

I guess those filtered gas masks really aren’t essential then?!

One surgical mask decreases risk by 1-2% (yes, that’s the benefit of a mask that we’ve been required to wear). You’re more likely to have a 40% COVID risk reduction by throwing salt over your shoulder when you leave the house . . . (that’s the actual placebo effect).

The whole reason for mask wearing is to decrease “asymptomatic” transmission of COVID-19. That means, masks are supposed to decrease your risk of spreading or inhaling this virus when you or the person near you have no symptoms. Initially, we recommended wearing masks, because we did not know how infective the COVID-19 virus was to humans. We also knew that there was limited access to the N95 masks used in the hospital setting.

However, in the last 12 months, we’ve learned a great deal and we have a tremendous amount of data about treating this virus in the outpatient setting.

How Contagious is COVID-19?

What’s the actual risk of spreading the virus when you have no symptoms? It’s about 0.06% if you have prolonged contact (3 hours continuous face-to-face) with a person within six hours of that person having onset of symptoms (i.e. – fever, sore throat, fatigue, headache, loss of taste or smell, or runny nose). It is very rare to be infected at all with COVID-19 asymptomatically if you contact a person 6-9 hours before they have symptoms.

In fact, a recent study revealed there were no positive tests (or asymptomatic spread) among 1,174 close contacts of asymptomatic cases.  So, why are we still wearing masks? Because it is politically convenient, increases fear, and increases your likelihood of getting a vaccine.

Are There Unintended Consequences of Mask Wearing?

Is wearing a mask to decrease a minimal risk by 1% more worth the risk? Increased bacterial and fungal infections that are on the rise as a consequence of chronic and continued daily mask wearing.

I’m seeing patients with increased frequency of facial rashes, fungal infections, non COVID-19 induced bacterial infections. Reports are coming from my colleagues, all over the world, that suggest bacterial pneumonias are on the rise.

Why? Because we are wearing and re-wearing of dirty masks. Untrained members of the public are wearing medical masks, repeatedly… in a non-sterile fashion… They’re becoming contaminated. They’re pulling them off of their car seat, off the rearview mirror, out of their pocket, from their countertop, and they’re reapplying a mask that should be worn fresh and sterile every single time. And, there is no way around this when 330 million people are required to wear a mask to go to Wal-Mart or Costco.

In a recent report in Emerging Infectious Diseases, the U.S. Centers for Disease Control and Prevention (CDC) suggests what experts have stated all along: There is no conclusive evidence that cloth masks protects users from coronavirus, especially since most people do not use them correctly and do not keep them clean.

The report actually says, “To our knowledge, only 1 randomized controlled trial has been conducted to examine the efficacy of cloth masks in healthcare settings, and the results do not favor use of cloth masks. More randomized controlled trials should be conducted in community settings to test the efficacy of cloth masks against respiratory infections.”

So, why, again, are we wearing these masks?

Should We Still Be Hiding In Our Homes?

Six months after the the largest variant of the five coronavirus sub-types appeared with it’s ugly little glycoprotein envelope and infective RNA fusion peptide coating, many states and countries are still in a quarantine or lock-down.  Initially, because of the rapid infection rate that was seen in Italy and China, health experts recommended quarantine of the general population in order to keep hospital systems and medical providers from being overwhelmed.  However, the “overwhelm” has been quite underwhelming.  This begs answer to four very important questions:

• Should we still be quarantined?
• Should we still be wearing a mask when in public?
• Should businesses still be shut down?
• Should we wait for a vaccine?

This is the first time in history that large scale quarantine of the healthy across the country was ever used.  The sole purpose was to control the number of severe cases requiring intensive care and ventilator use.    Multiple mathematical models predicted that hundreds of thousands would die based upon statistics seen in Italy and China.

In early February, 2020, we were concerned that risk of death as high as 5.5% in our initial data from Italy and China.  Limited N95 masks and protective equipment was available.  In agreement with the CDC and WHO, I recommended everyone wear a mask, take drastic infection precautions and quarantine to prevent risk of transmission (Davies A, et al., Aug 2013).

Because viruses like COVID-19 and influenza are so small, a single layer cloth mask and or surgical mask has only been shown to decrease your risk of viral infection or transmission to others by 1-2%.  Triple layer cloth masks with central interfacing layer give 3% – 20% reduction of infection risk based on the studies we have in the medical literature (Disaster Med Public Health Preparedness. 2013;7:413-418).  At the time we learned about this virus, our understanding was that any protection was better than no protection.

Underwhelming

Yet, as this virus crossed our shores, traveled over the amber waves of grain and ascended the majestic purple mountains of majesty, the overwhelming number of patients hitting the hospital in droves isn’t what we saw.  A few areas like New York and Washington State were hit hard, but not nearly as predicted.  The large numbers of deaths seen in these states is because of their decision to send thousands of recovering COVID-19 patients into nursing homes, exposing those over 65 at greatest risk for death, to this virus.

Some claim that this is because we quarantined the healthy, yet if this were the case, infections would begin to rise as soon as lock-downs were lifted.  Yet, no surge has come in the last three to four weeks, not even a blip.  And Sweden, who only quarantined the sick and the elderly at high risk, has not seen the overwhelming surge of death so many predicted.

As of June 18th, eight weeks from the time we began opening up businesses, elective surgeries and letting people go back to work, the death count from COVID-19 continued to fall.  If social distancing and mask wearing was really effective, significant rise in infections and COVID-19 deaths should have escalated in mid-May (5-6 days after exposure).  Yet, in states like Arizona COVID-19 death counts continued to fall.

Quarantine of the Healthy

In all of history, we have never seen any benefit to quarantining the healthy.  In fact, quarantine of the healthy has been demonstrated to be unhealthy for a “well population” (Brooks SK, et al., Lancet, Feb 2020).  Based on scientific evidences we have today, despite what our politicians say, there is no reason to quarantine those that are not ill.  Seeing all this data over the last two weeks dramatically changed my perspective on this virus.

Asymptomatic Transmission

“Oh no, Dr. Nally!  You can’t say that, because this virus can be transmitted when you’re not symptomatic!”  Yes. I’ve heard that argument for the last three months. And it is unfounded.

The main reason for quarantine was the fear of asymptomatic transmission.  Early editorial reports (these were not actually controlled studies, they were opinion reports based on a case review) showed that the virus “may” be spread prior to a person showing symptoms via respiratory secretions.  Initial data in seven very small presumptive editorial case reports out of China, Singapore and Germany postulated that this could occur in 40-50% of those infected (1,2,3,4,5,6,7).   Yet all of these articles were case reports of 1-10 people and the exact mechanism of transmission was observational only and is still unknown.

The CDC made its recommendations on wearing masks based on these seven presumptive editorial cases between January and May, 2020. Recent nursing home case report data from April and May looked at 76 people in two nursing homes, 50% of those with positive infections were asymptomatic for the first 5-6 days.  The report implies that those with COVID-19 must have had the potential to spread the disease 3-4 days before onset of symptoms.  All of our social distancing and mask wearing has been based on upon these seven very small presumptive case reports and/or medical editorials.  Never in medical history has sweeping health recommendations or mandates been made on editorial reports alone.

It is very important to note a recent larger population study of 455 patients was performed looking at infected members of families and those living in close quarters over 2-4 weeks. The researchers findings were opposite that of the seven small case reports above and concluded that the likely hood of asymptomatic SARS-CoV-2 transmission was “weak.”

The assumption that viral infections can be transmitted in the asymptomatic state comes from the Ghandi study, and others, that 30-50% of asymptomatic influenza patients can spread the flu a full 3-4 days prior to showing any symptoms, and in some cases up to 7 days prior to symptom onset.  We’ve assumed that is the case with COVID-19, but that isn’t what the larger study demonstrated.

Have we or do we currently quarantine the healthy or institute social distance because of asymptomatic influenza spreading risk?  No.

Do we quarantine the healthy or social distance because of the highly contagious croup or whooping cough (that is still prevalent on our southern border)?  No.

But, these are the same editors and journals that have been telling us for the last 50 years that eating fat makes us fat. So, we must trust them, right?  Wait, didn’t the New England Journal of Medicine and the Lancet both just retract “ground breaking” articles on COVID-19 because of falsified data that was never peer reviewed?

The fear of asymptomatic spread is therefore a mute point, as it is roughly identical to the flu.  And it has infectious similarities to other infectious diseases like whooping cough (pertussis) and the croup (para-influenza virus).  If the only actual large study of COVID-19 demonstrates that asymptomatic droplet based spread is weak, then why have we created fear and economic collapse for a virus that is less likely to spread in the asymptomatic person than the flu, croup, or whooping cough?

Risk Factor for Disease Severity

These three maladies (hypertension, diabetes & coronary artery disease) are the three most common medical problems that I see in my clinic, and they affect 85% of the people in my practice.  All three are caused and driven by hyperinsulinemia.

Hyperinsulinemia is defined as an elevated insulin production (2-30 times normal) when ingesting any form of carbohydrate or starch.  It starts 15-20 years before the onset of diabetes and is the cause of hypoglycemia, elevated fasting blood sugar, pre-diabetes, metabolic syndrome, chronic kidney disease, idiopathic neuropathy, hypertension and coronary artery disease.

Elevated insulin, even small elevations, puts a load on the immune system.  The higher your insulin response to starches or sugars, the more likely you are to have hypertension, diabetes and heart disease.  We found that those with elevated insulin levels and those over 45 years old with stressed immune systems are the most susceptible to severe COVID-19 infection.

We know that those who do get severely ill are those over 45 with immune system compromise and/or hyperinsulinemia. A very interesting fact was published in The Lancet. The authors found that the highest rates of death occurred in those with current hypertension, diabetes and/or coronary artery disease (heart disease or atherosclerosis of the arteries).

Interestingly, Italy, Spain and Portugal have the highest incidence of metabolic syndrome (hyperinsulinemia) across all of Europe.  It stands to reason that they have also been hit the hardest with a virus that is focused on this form of immune-compromise.

Corona-Virus is Quite Common

The corona-virus, traditionally, causes a simple common cold.  In fact, 2% of the population are asymptomatic carriers of the six corona-virus strains that are known to infect humans.  And this class of virus is responsible for 10% of respiratory infections yearly around the world (Cascella M, et al. 2020 Apr 6. In: StatPearls.).

Should We Still Be In Quarantine?

Should we still be in quarantine? The answer is therefore “no.”

What we should be focused on is limiting exposure to those with the greatest risk like those in nursing homes, care centers, populations of elderly (over 65 years old), and those with known risk for suppressed immunity.  Our focus, efforts and funds should be spend keeping these populations from exposure to COVID-19.

Should we still be wearing masks in public?

As noted above, cloth masks provide only very minimal (20-40%) protection from bacteria and almost no protection (1-2.3%) from viral infections.   The two studies that do exist about effectiveness of mask wearing during viral infections to prevent spread demonstrate that adherence is very difficult and that transmission of viral infections is not statistically different between those wearing masks and those not wearing masks (MacIntyre CR et al., Cowling BJ et al.).  Because we now know that this virus is similar to influenza in risk for death, general healthy populations should have no need to wear masks.  Wearing of a mask actually increases the likely-hood of infection by increased frequency of touching your face.  It also perpetuates a climate of risk and fear.  It, also, implies that if required, mask should be a covered cost of medical provision at the State and Federal levels.  As you can see, even the NIH director over NIAID, Anthony Fauci, MD, the one person in the country with the most experience in pandemic infectious disease, has trouble wearing a mask in public.

Second, there are a number of other medical problems including exacerbation of headache and migraines that occurs with chronic use of both surgical and N95 masks.  For those who have COPD, mask wearing can exacerbate hypercapnia (increased carbon dioxide levels causing slowed respiration, confusion and fatigue). Mask wearing can also cause chronic hypoxia (reduced oxygenation) which has been shown to increase risk of cancer growth.  In cases where patients with pulmonary fibrosis or impaired lung function wear masks for prolonged periods, syncope or loss of consciousness has been documented.

Therefore, wearing a mask for prolonged periods of time when it is not medically justified is not recommended and in many cases dangerous to your health.

Despite this, and the fact that there is significant doubt as to asymptomatic transmission of this virus, mandates to wear face masks in public were decreed across Arizona today.

Should businesses be shut down?

If our ultimate goal was to “flatten the curve,” and protect hospitals from being overwhelmed, then we were successful at doing that in mid-April.  Some communities rightfully extended that quarantine to the end of April.  However, there has been no justifiable evidence to suggest that healthy people cannot go back to work, feed their families, pay their mortgages and provide for themselves.  In fact, multiple states including Wisconsin, Kansas, & Michigan have had Federal courts overturn draconian quarantine measures enacted by over-reaching emergency gubernatorial orders.

How accurate are the tests anyway?

The accuracy and predictive values of SARS-CoV-2 tests have not been systematically evaluated, and the sensitivity of testing likely depends on the precise RT-PCR assay, the type of specimen obtained, the quality of the specimen, and duration of illness at the time of testing.

In a study of 51 hospitalized patients in China with positive SARS-CoV-2 RT-PCR test (mainly on throat swabs), 15 patients (29 percent) had a negative initial test and only were diagnosed by serial testing [Fang Y, et al., Radiology 2020]. In a similar study of 70 patients in Singapore, initial nasopharyngeal testing was negative in 8 patients (11 percent) [Lee TH, et al. Clin Inf Dis 2020]. In both studies, rare patients were repeatedly negative and only tested positive after four or more tests.

Seven additional studies (including two unpublished reports) that evaluated RT-PCR performance, the estimated rates of false-negative results were 100 percent on the day of exposure, 38 percent on day 5 (estimated as the first day of symptoms), 20 percent at day 8, and 66 percent at day 21 [Kucirka LM, et al., Ann Int Med 2020].

And even though manufacturers are pushing the new antibody testing, antibody testing with IgG and/or IgM tests are frequently falsely positive [Guo L, et al., Clin Infect Dis 2020] and have been shown to be erroneous 20-30% of the time.  The accuracy and time to antibody detection vary with the particular test used. Studies evaluating the specificity of serologic tests in a broad population are lacking; in particular, the rate of cross-reactivity with other coronaviruses is a potential concern, and IgM tests are prone to false-positive results.

In the first week since symptom onset, fewer than 40 percent had detectable antibodies; by day 15, IgM and IgG were detectable in 94 and 80 percent, respectively.

In the United States, several serologic tests have been granted emergency use authorization by the FDA for use by laboratories certified to perform moderate- and high-complexity tests [FDA.gov]. The FDA highlights that serologic tests should not be used as the sole test to diagnose or exclude active SARS-CoV-2 infection. The sensitivity and specificity of many of these serologic tests are uncertain.

Should We Wait For A Vaccine?

As a preface to this section, please be aware that I am a very strong proponent of safe and effective vaccine use.  Because the RNA vaccines are so new, long-term efficacy, safety and adverse reaction studies are essential before these vaccines can be recommended across the board.  It takes at least 4-5 years to 1) bring a vaccine to market and 2) complete adequate safety studies.

Let’s start by looking at the effectiveness of current RNA viral vaccines. The most common RNA vaccine currently in use is the influenza vaccine, quadravalent (four flu strains) and high dose (five flu strains) versions.  Over the last 20 years, the percentage of seniors getting flu shots increased sharply from 15% to 65%. It stands to reason that flu deaths among the elderly should have taken a dramatic dip due to increased flu vaccination each year.

Instead, as you can see above, influenza deaths among the elderly continued to climb. It was hard to believe, so researchers at the National Institutes of Health set out to do a study adjusting for all kinds of factors that could be masking the true benefits of the shots. But no matter how they crunched the numbers, they got the same disappointing result: flu shots had not reduced deaths among the elderly.

It’s not what health officials hoped to find.  I was shocked when I read these studies.  Two studies, here and here, demonstrate that yearly flu vaccine for those over age 65 does nothing to decrease influenza related death. These studies funded by the government in 2005 and 2006 were suppressed and I never heard about them. Yet the CDC still emphasizes to the elderly, “Get your flu shot.”

One reason these vaccines are ineffective is that viruses like influenza and corona-viruses are highly antigenic.  That means that there are hundreds of strains and the virus is changing rapidly.  Influenza has over 600 strains.  Our current high dose vaccine only covers five of these strains.

SARs-CoV-2 (COVID-19) is known to have over 160 strains. “There are too many rapid mutations to neatly trace a COVID-19 family tree.” Said Peter Forster, geneticist at the University of Cambridge.  “We used a mathematical network algorithm to visualize all the plausible trees simultaneously.” (Proceedings of the National Academy of Sciences, 2020).  Dr. Forster’s research identifies 160 genomes within the hundreds of additional variants of the three central COVID-19 strain variants.

The other very fascinating concern found when making RNA virus vaccines is the potential to increase susceptibility to other viruses.  In a Department of Defense study, looking at 6000 military personal vaccinated in the 2017-2018 season, those who got the influenza vaccine demonstrated an increases susceptibility to corona-viruses by 36%. Those who were vaccinated with the flu vaccine had additional increased susceptibility to non-influenza viruses by 15%, and increased susceptibility to human metapneumovirus by 59%.

A second influenza study demonstrated an increased risk of para-influenza virus in adults (increased by 4.6% of vaccinated adults and only 2.6% of unvaccinated adults.)  Though the researchers dismissed it as calculation error, the p value reflects that the vaccine played some roll (P=0.04) in the increased susceptibility.

Herd Immunity? Maybe in 200 Years

Do the math on a vaccine that covers only four out of 600+ strains like the quadravalent influenza vaccine.  For a vaccine to create “herd immunity,” currently being touted across the airwaves as the way to return to normal, it would require the average human to be vaccinated every year for 100 years, and would take 200-400 years to create any semblance of herd immunity.  And, that’s after 4-5 years studying the safety of a vaccine in large populations.

Influenza and HPV, the two most widely used RNA vaccines, still have a number of post-market adverse reactions including: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, and paresthesia (tingling of the extremities) (Package-Insert—Gardasil.pdf; Package-Insert—Fluzone High Dose.pdf).  Though these adverse events occur more rarely, it is essential you and I understand the risks of these newer RNA vaccines.

Conclusion

In summary, our focus should be shifting to protecting our elderly and immune-compromised.  The evidence does not support quarantine of the healthy.  Evidence does not support general public mask wearing.  And there is no evidence that continued business closure is beneficial.

What can you and I do?

• Reduce your risk of hyperinsulinemia.  Follow a carbohydrate restricted diet, exercise, control blood sugar, blood pressure, cholesterol and limit risk factors that suppress your immune system. Quit smoking, vaping, etc.
• Actively engage your congressman or congresswoman.  What are they are doing to assist/protect the seniors, nursing home patients, and shut-in’s in your area?
• Let your governor or mayor hear your voice. What damage has quarantine has done to your livelihood and those of your family?
• Get educated about your civil liberties and do not let anyone take them under the guise of an emergency.
• Ensure your loved ones, especially the elderly and immune suppressed, understand the truth about their risk of infection.

Don’t be afraid to go outside and be a human being again.