Kevin Kavanagh, MD

The United States is currently undergoing a horrific escalation in Coronavirus disease 2019 (COVID-19) patients and it is evident that the healthcare industry has learned far too little from previous spikes, apparently adopting a strategy of simply hoping the virus would go away. We have not yet seen COVID-19’s peak and are already experiencing alarming supply and medical staff shortages. The Governor of North Dakota advocated for allowing asymptomatic COVID-19 nurse carriers to return to work, taking care of 

. A strategy which received immediate pushback from the medical industry. A policy which shows little understanding of the infectivity of the virus and the dangers of enhanced severity of illness as viral load exposure increases.

At the same time we are facing a shortage of 

 (PPE). We have not restocked our supplies or significantly increased our production capabilities. We are merely treading water. Faced, as of this writing, with greater than three times the number of cases as the last surge, along with exponential growth with no end in sight, there is little hope healthcare workers can safely treat patients without a drastic change in policy and a more productive and secure supply line.

This lackadaisical attitude toward the pandemic is not only evident by our inadequate preparedness and failure to gear up for the “dark winter,” but also by our flagrant ignoring of public health guidance as evidenced by the all too willing public participation in massive events to advocate for candidates and to celebrate victories. Punches were pulled and the silence heard from our leaders to condemn these activities was deafening. The virus wins and spreads throughout our communities.

All frontline workers have been put in harm’s way. One study from Massachusetts evaluated 104 employees of a single grocery story in Boston. They found 20% tested positive for SARS-CoV-2 and being young, 76% had no symptoms. Thus, they were working and potentially spreading the virus. Let’s not forget that having no symptoms from a viral infection which damages every organ of the body, may well cause symptoms decades later as cardiac and pulmonary 

For healthcare workers the situation is even worse. Taking care of COVID-19 patients exposes them to a much higher viral load which places them at higher risk for developing severe COVID-19. In Scotland, one-sixth of all COVID-19 hospitalizations are healthcare workers or their 

. And those healthcare workers who were patient facing (directly taking care of patients) were at a threefold-increased risk compared to non-patient facing healthcare workers.

Thus, frontline workers are not only placing themselves in danger, but also their families. And unlike earlier supposition, once a household member becomes infected, SARS-CoV-2 spreads rapidly within the family unit. A recent study found that 53% of 191 household contacts developed a secondary infection from another household member, and that 75% of these infections occurred within 5 days of 

And no one is accurately tracking the dead. On October 25, 2020, National Nurses United estimated that approximately 2000 frontline healthcare workers’ 

. As of November 13, 2020, the US Centers for Disease Control and Prevention (CDC) has confirmed 797 healthcare workers deaths, but because of inaccuracies in the reporting data this figure 

Despite these deaths, effective tracking and investigation of worker safety is not taking place. OSHA oversees worker safety in 28 states. As of August 13, 2020, OSHA has only issued 4 citations related to SARS-CoV-2 and of September 18, 2020, OSHA has only opened inspections on only 191 out of 8909 worker complaints related to 

. This is a dismal example of worker safety assurance.

, but in actuality a much better safety net is needed for it appears lifelong disability is all too common from COVID-19 infections which result in hospitalization. It is becoming evident that the “long-hauler” syndrome which results in chronic incapacitation, occurs just as commonly in those with mild versus severe COVID-19. Almost a third of “mild” COVID-19 patients are partially depending upon the care of others three months after their 

The healthcare workers in the United States have a long history of placing their lives at risk to save their patients, but we need to give them the safest possible working environment and the supplies they need. At a minimum, presumptive disability should be available for frontline workers who do incompletely recover from COVID-19. And if we are unwilling to provide this protection for them and their families, we should at least activate the Defense Production Act to assure adequate PPE and N95 masks and give our workers a fighting chance.

Articles

Faced with greater than three times the number of cases as the last surge, along with exponential growth with no end in sight, there is little hope healthcare workers can safely treat patients without a drastic change in policy and a more productive and secure supply line.

Viewpoint: Healthcare Workers Not Being Protected from COVID

The one lesson that the coronavirus disease 2019 (COVID-19) pandemic has taught me is that mankind has not changed that much. My delusions that we evolved into an enlightened society have all but been shattered. We desperately need to join together to fight COVID-19 under a coherent and united federal strategy.

Here is what Dr. Hunter Maguire, president of the American Medical Association, stated: “…that one of the most important questions of the hour was quarantine… A difficulty in dealing with infectious disease in America was the rooted dislike to the curtailment of the personal liberty of the citizens for the benefit of the people at large.” He then called for the federal government to invoke its powers to protect its citizens and aid in repelling the epidemic, similar to an invading army.

There are two profoundly disturbing truths regarding this statement. The first is that this even needs to be stated. We are floundering in hostile waters without a coordinated national response. The second was that this passionate appeal was given in 1893 regarding cholera and yellow fever 

Centuries ago, trephination for headaches, a medieval practice of drilling holes in the skull, was a widely accepted treatment and miraculously had a 90% survival rate. Bloodletting was used to treat a wide variety of maladies by rebalancing body “humours,” a practice which spanned some 2000 years up to the late 19th century. These treatments demonstrate both bias, since once your skull has been drilled without anesthesia you are probably biased against having another procedure; and the placebo effect of bloodletting, a very dramatic procedure which everyone states will help so you believe it does help.

That being said, I still had a hard time imagining how mass hysteria and false beliefs in pseudoscience could overwhelm a culture to the point of widespread acceptance of these practices, until I witnessed the hydroxychloroquine (HCQ) phenomena. This issue should have died long ago but an October 20, 2020 survey by IPSOS found that 28% of the public still believed hydroxychloroquine is 

The passionate and continued obsession we as a society have over HCQ has its roots in the intense fear of a pandemic, misinformation provided by what looks like an organized foreign intelligence 

 and laboratory research which demonstrated this drug literally annihilates the SARS coronavirus. A very toxic mix which has inhibited our public health mix-messaging.

There are now eight prospective randomized controlled trials which have found hydroxychloroquine to be i

. The trials cover the range from prophylaxis (prevention) to mildly and severely sick patients. Hydroxychloroquine was found not to be effective.

Still there are the encouraging laboratory data findings that HCQ blocks the SARS coronavirus in cell cultures. A 2020 highly quoted study demonstrated that 99% of the virus was blocked, a phenomenal 

. Why the contradiction? The answer lies in the extrapolation of results between animals and humans. This phenomenal result was obtained in green monkey kidney culture cells (VERO E6) not human cells.

, demonstrated that HCQ blocks the enzyme needed to permit the virus to enter the monkey cell, but it does not block viral entry into 

. The reason is simple, a different enzyme (TMPRESS2) is responsible for viral entry in humans.

Thus, HCQ appears to work in monkeys, not humans.

What is truly mind boggling is that there is sort of an analogy, a drug approved for another use by the FDA, which blocks the human enzyme. It is nafamostat mesylate (Fusan), which is currently used in the treatment of pancreatitis and as a short-term anticoagulant for 

. This drug is currently in clinical trials to determine if it is efficacious in treating COVID-19.

The cocktails which are promoted combine HCQ with the antibiotic Azithromycin have an additive cardiac toxicity and deadly results can be seen when used in patients with severe COVID-19, many of whom have viral heart damage. I find it hard to believe that anyone would even think of administering these two medications to a patient at the same time.

And this is what is at the root of the current healthcare debacle. Not only are patients who need HCQ having a hard time finding it but those who use it may acquire a false sense of security and not wear masks or socially distance as religiously as they should. The worst-case scenario is that if an effective and safe vaccine is found, a large segment of our population will elect to use HCQ or another ineffective treatment instead, allowing the virus to continue to thrive, and devastate our nation.

As a nation, we can easily defeat this virus, but it requires us to trust modern science and embrace a national strategy coordinated by public health officials and our federal government. Let’s not embrace attitudes and views of the 1800’s.

The worst-case scenario is that if an effective and safe COVID-19 vaccine is found, a large segment of our population will elect to use hydroxychloroquine or another ineffective treatment instead, allowing the virus to continue to thrive, and devastate our nation.

Viewpoint: Quackery Might Stall Progress Against COVID-19

Coronavirus disease 2019 (COVID-19) is the greatest healthcare challenge our country has faced in over a century. Clifford McDonald, MD, from the US Centers for Disease Control and Prevention (CDC) emphasized at the US Food and Drug Administration’s October 22, 2020 Vaccines and Related Biological Products Advisory Committee meeting that the COVID-19 pandemic is 10 to 15 times more deadly than seasonal influenza. During the FDA’s meeting a number of important areas were discussed:

One of the central strategies of the United States’ response to COVID-19 is vaccine development. Past vaccines have taken years, possibly decades, to develop. The SARS-CoV2 vaccine is being developed at “Warp Speed.” Two strategies have greatly reduced the time of vaccine deployment.

The first was preparation. There had been abundant research regarding vaccine development with SARS (SARS-CoV-1) and other coronaviruses. When the genetic code for SARS-CoV-2 was made available, the viruses’ protein code could be modified to increase immunogenicity and a Phase I trial vaccine trial was rapidly started in 65 days, instead of taking years to develop.

The second was the selection of 6 promising vaccine candidates for at-risk vaccine production, where doses are produced before trials are completed and results are known. There were two candidates in each of the 3 different technologies which were chosen for this program. The technologies and candidates are: Viral mRNA (Moderna, Pfizer-BioNTech), adenovirus vectors (AstraZeneca, Janssen) and recombinant protein plus an adjuvant (Novavax, GSK-SANIOFI). Most of these vaccines require two doses. However, they are not interchangeable. A patient must receive the same vaccine for each dose. As a safeguard, the patient will be given a vaccine informational card to be shown to his provider before receiving his second dose.

Another problem is that the two RNA vaccines which appear to be the furthest along in the development process, require ultra-cold storage {between -70 to -100 degree Fahrenheit} from manufacturer to patient administration. This will be addressed with special shipping containers and probably require dry ice packing.

There is no doubt that initial vaccine design and manufacturing has been greatly accelerated. Guidelines for vaccine approval have been released by the 

. Of concern is the design and duration of Phase II and most critically Phase III Trials. In the past, Phase II and III trials would take on average 30 months 

. The trials have explicit parameters to include individuals who are older than 65 year of age, have comorbidities, and of different races.

The goal appeared to be the awarding of an emergency use authorization (EUA) for vaccine deployment as soon as possible. To meet this goal, preliminary data from Phase III trials can be submitted after an “N” is reached of 3000 

 and with a minimum of 2 months follow-up.

It was asserted that the vast majority of vaccine adverse events occur within the first 6 weeks after the final dose is administered and that a 2 month follow-up would be sufficient for evaluation of safety. However, there will also be extensive post-market surveillance with patients monitored for a minimum of two years.

Post-market surveillance programs will include VAERS along with active surveillance monitoring using the FDA’s BEST system and partnerships with CMS. VAERS is the CDC’s and FDA’s Vaccine Adverse Event Reporting System which is a well-developed and validated system which receives approximately 50,000 reports per year. The BEST system relies on surveying claims data and electronic medical record systems to detect adverse events. There will also be several innovative new systems such as V-Safe which is an interactive text or email messaging check-in system which monitors patients for the first six weeks after receiving a vaccination.

This was very impressive, but of concern. If millions of individuals are given a vaccine in a very short period of time, there is little one may be able to do to prevent harm if post-market surveillance detects a serious problem.

I found the public comments regarding the COVID-19 vaccination evaluation plan very elucidative, even more so than the formal governmental presentations. Many commenters felt the 2-month EUA follow-up period was too short, since significant complications from vaccines, such as vaccine-associated enhanced disease, as immunity wanes. In addition, 3,000 study participants were by many felt to be too few to detect adverse reactions in racial, pregnant and many high-risk cohorts.
Marcus Schabacker, MD, PhD, CEO of ECRI advised that a minimum trial length should be at least 6 months and consist of data from the full 

Commentators included a BMJ Editor, along with prominent researchers and policymakers from Stanford, ECRI and patient advocacy organizations. A central theme emerged, and many presenters echoed the same points of concern, most surrounded the process of EUA for a COVID-19 vaccine and the implications that EUA would have for patient safety and future vaccine development.

Of utmost concern of many of the commentators was that the primary endpoint for vaccine efficacy was the prevention of COVID-19. This sounds like a valid approach, but any case of COVID-19, even those with just a mild cough would be counted as being prevented. There was not a requirement to prevent hospitalizations, disability, or deaths.

The second concern was that the minimum acceptable vaccine efficacy was set at 50% with a lower error bar set at 

The third concern is that minority populations may be underrepresented. And those who are at high-risk for COVID-19, including children, pregnant women and those immunosuppressed may have exceptionally low or absent representation in the data used for an EUA.

The minimal number of subjects in a trial used for EUA application was set to 3000, and the minimum number of severe COVID-19 cases to have occurred in the control group was set to 5. There were concerns regarding the definition of “severe”. A patient with a SpO2 < 93% could be classified as severe. However, many asymptomatic patients can have this finding. And some felt that 5 severe cases were too few to reliably differentiate a true finding from a chance occurrence, especially in high-risk sub-cohorts. There were concerns regarding the definition of “severe.” A patient with a SpO2 < 93% could be classified as 

. However, many asymptomatic patients can have this finding. And some felt that 5 severe cases were too few to reliably differentiate a true finding from a chance occurrence, especially in high-risk sub-cohorts.

As a side note, not discussed at the meeting, was the issue of challenge trials. This has been extensively covered in the lay press with challenge trials being planned in the 

. In a challenge trial, volunteer subjects would be deliberately given SARS-CoV-2 and monitored for the development of COVID-19. There are significant ethical problems with this approach, since there is no known cure for this disease and many of the promising COVID-19 treatments are performing poorly in 

. But of scientific concern is that by their nature, challenge trials have to be performed in young healthy individuals. SARS-CoV-2 is most lethal in the elderly and those with co-morbidities. Thus, an effective vaccine may be found for the young, but not in the elderly with an aging immune system.

 Once an EUA is granted for a vaccine, several problems arise. First, current clinical trials of the EUA approved and also of other vaccines may have significant subject dropout, as many subjects in blinded studies may choose to obtain the available vaccine. In addition, the approval process would allow for a vaccine with minimal effectiveness in preventing just minor symptoms of COVID-19 to be approved. If this happens, those who have received a minimally effective vaccine may no longer follow public health guidance.

 A recent Harris Poll found that 78% of respondents feared the COVID-19 approval process was influenced more by politics than science. This was bipartisan with 72% of Republicans and 82% of Democrats being 

. And 80% would worry how safe the vaccine was if it was quickly approved. Only 58% of individuals stated they would receive a COVID-19 vaccine as soon as one was 

. Even more concerning was that the acceptance was even lower in Black Americans, a high-risk population for COVID-19. Major patient concerns were:

Distrust of government and government agencies, (such as the CDC who has had changing guidance on masks, testing for asymptomatic carriers and viral aerosolization; and the FDA who has had questionable statements regarding the effectiveness of treatments granted EUAs such as hydroxychloroquine and convalescent serum.)

Respondents wanted recommendations from a well-established reputable organization without ties to government and industry.

Concerns about political and economic influences along with trying to get the vaccine out before the election.

Fear the vaccine will not work. (Similar to the influenza vaccine, different dosages may need to be given to the elderly.)

That the vaccine is being tested on minorities, similar to the Tuskegee Experiments, at the benefit of the sheltered upper class.

The overall cost for society is far too high for a flawed and relaxed vaccine approval process. If the vaccine has low effectivity and primarily prevents mild disease, it will offer little protection to society and may cause inconceivable harm. To paraphrase Peter Luri, MD, MPH, from the Center for Science in Public Interest—The benefits of a minimally effective vaccine can be negated if the public relaxes wearing masks and social distancing. But even worse, if the vaccine is ineffective, it will further fuel the antivaccine movement for decades to come.

By their nature, challenge trials have to be performed in young healthy individuals. SARS-CoV-2 is most lethal in the elderly and those with co-morbidities. Thus, an effective vaccine may be found for the young, but not in the elderly with an aging immune system.

FDA Panel Reviews Many Challenges Facing a COVID Vaccine

Recently, an international group of scientists signed a declaration advocating for achieving herd immunity from coronavirus disease 2019 (COVID-19) by opening communities and business, while protecting the vulnerable with “focused protection.”  The Declaration states: “A comprehensive and detailed list of measures, including approaches to multi-generational households, can be implemented, and is well within the scope and capability of public health professionals.” But to be honest, I’m not sure how this can be done.

Currently, the United States is undergoing a third peak of infections on our first wave and the metrics, of cases and test positivity rates are increasing. Hospitalizations are also increasing in a number of states. Nationally, deaths, a lagging indicator, are holding steady but these are expected to rise in the weeks ahead. Hopefully, recent advances in medical treatments will mitigate this occurrence.

For infection preventionists and frontline healthcare workers, the Great Barrington Declaration places their lives and livelihood at risk. A field hospital has been activated in 

 and the state is at risk of running out of hospital beds and trained staff. Similar concerns exist in 

.Many other states are also seeing surging of COVID-19 as cold weather approaches.

All agree, that if the healthcare system is overrun, necessitating the use of field hospitals and inexperienced staff, the case fatality rate will soar.

 reported that two of the signatures including one of the primary authors have “proposed that societies may achieve herd immunity when 10 to 20 percent of their populations have been infected with 

However, most epidemiologists agree that the percentage of the population needed for herd immunity is much higher SARS-CoV-2 has an unmitigated 

.Meaning, on average, one infected patient will spread the disease to 5.7 other individuals. This rate of infection would require 80% of the population to become infected before herd immunity would even start to have an effect.

For those who do not believe that SARS-CoV-2 is that infectious, just look at the recent superspreader event at the White House’s Rose Garden. Everyone was tested, but one test was probably a false positive and an infected asymptomatic individual attended the event. The event was held outside but without masks or social distancing.There were just over 200 people at the event. At least three White House 

 have infections linked to the event. This virus is highly infectious.

And there are other major problems with the false narrative of herd immunity:

First, lasting immunity is in doubt. There have been at least four studies to date which have found neutralizing antibodies to be of short duration in SARS-CoV-2 patients. The most recent, was published in 

 and reported similar results to previous studies, with 58% of individuals with antibodies at baseline becoming seronegative at 

Second, the virus is constantly mutating. The website

shows the mutations of the SARS-CoV-2 virus. There are hundreds and unfortunately some of them may involve the virus’s spike protein which is the basis for the effectiveness of our immunity, vaccines, and monoclonal antibody therapies. Researchers from Peking University Health Science Center have identified viruses with increased infectivity and 10 strains which were “remarkably resistant to some” 

Reinfections are starting to be reported, but thankfully still appear to be a rare 

.In two of the documented cases, viral RNA was available from both the first and second infection, proving the reinfection. Of concern, is that the patient’s second infection was worse than the first, giving rise to the possibility of immunological enhancement of the disease. This could of course complicate vaccine development. The exact incidence of reinfections is unknown. What is known is that it can occur.

Isolation of Those At a Significant Risk is Not Possible

: The 1918 flu pandemic took over two years and four waves for it to completely 

, a similar time frame may well occur with SARS-CoV-2. How does one protect those at risk for that long of a time? Especially when the at risk comprises about half of the United States 

.This includes those who are over the age of 65, or who have obesity, type 2 diabetes mellitus, cancer, COPD, chronic kidney disease or 

.Obesity alone is found in over 40% of our adult 

.But even those between the ages of 20 and 44 have a 20% risk of 

Emphasis on Mortality as the Only Concern of SARS-CoV-2 Virus

: One of the Declaration’s goals is to “minimize mortality.”As knowledge of how to treat advanced disease increases, mortality has decreased. But similar to other fatal illnesses, survival is often associated with lasting disability. Unlike the flu, SARS-C0V-2 affects every organ of the body. During hospitalization there is a 20% chance of 

.Even in asymptomatic young athletes, MRI scans have been positive in approximately 15% of screened athletes with a positive SARS-CoV-2 test, including those who are asymptomatic or 

Symptoms can persist for a long time and may be permanent. A study published in 

performed a two month follow up of adults with non-critical COVID-19. At 6 months, 30% still had shortness of breath, 40% had fatigue and 23% had disturbances in smell or taste. The symptoms were most prevalent in those patients 40 to 60 years of age. Younger patients may be less likely to have symptoms, but these may develop decades later when their pulmonary and cardiac reserves decrease. There have also been reports of a growing number of long-haulers who experience a myriad of persistent symptoms with chronic fatigue being the most prevalent.

Thus, it is not just death, but the concern for long-term or delayed heart and lung disease which has kept professional athletes from competing.

: The calls to return to the “old” normal disregards the transformation which has occurred both in education and industry. Many companies, the latest being Microsoft, are planning to offer work from home options and 

.Worker production and satisfaction is up and company costs are down.The same is also true for online shopping and delivery. Shoppers had been rapidly switching to online prior to the pandemic, both for convenience and reduced costs. COVID-19 accelerated this trend, which is unlikely to be reversed. Returning to school can be done safer with social distancing, masks, viral testing and attention to air quality and sanitization. But at-home online education may be incorporated into the curriculum to encourage independent learning and staggered in-school attendance would allow for smaller class sizes and more individual teacher attention.

Misinformation regarding this virus abounds. Cornell University estimates that 38% of media stories have misinformation which has its roots in the 

.Carnegie Mellon University has found much of the misinformation on twitter can be traced back to bots which are similar to the playbooks of Chinese and Russian 

.There is even rumors that those who are asymptomatic are not able to spread the virus and that PCR tests are overdiagnosing SARS-CoV-2. Nothing could be further from the truth. Just look at the White House’s Rose Garden event which was a super-spreader event apparently caused by an asymptomatic individual who had a false negative result on a pre-event rapid test. Thus, there was under, not overdiagnosis of an asymptomatic spreader.

There is growing consensus in the United States regarding the recommendation of not going into another lockdown. South Korea did not close their economy, instead their strategy was wearing masks, social distancing, hand hygiene along with abundant testing and contact tracing. This public health strategy was widely accepted by their populous and they stopped the spread of the virus. If the United States followed South Korea’s example, a country of 51.6 million people, we would have lost under 3000 souls.

, one can assert that as of August 1, 2020, over 200,000 lives have been needlessly lost, since promising therapies are just around the corner.

In all likelihood, this virus will become endemic and we will have to adjust our lives to live with it as safely as we can. Some who are deeply religious, feel this is Mother Nature’s way of protecting the Earth from the abuses of mankind. I am not sure about that, but I am sure we all need to start sacrificing for each other; looking out for each other by following sound public health advice of wearing masks, social distancing and hand hygiene. If we do this, SARS-CoV-2 can be controlled, possibly defeated; if we do not, we will inflict upon ourselves needless fatalities and long-term disabilities which we will have to endure for generations.

For infection preventionists and frontline healthcare workers, the Great Barrington Declaration places their lives and livelihood at risk. A field hospital has been activated in Wisconsin and the state is at risk of running out of hospital beds and trained staff. 

Kevin Kavanagh, MD

Articles

Viewpoint: Healthcare Workers Not Being Protected from COVID

Viewpoint: Quackery Might Stall Progress Against COVID-19

FDA Panel Reviews Many Challenges Facing a COVID Vaccine

Viewpoint: The “Not So” Great Barrington Declaration