In my last blog piece, I wrote that we have seen a number of diseases that are not endemic to the U.S. pop up and cause outbreaks. Some of these are infections that we have not previously seen people acquire in the continental U.S., but rather were involving international travelers who acquired the infection elsewhere, then traveled to the U.S., became ill, and were diagnosed with the illness here.
Dengue virus is endemic to over 100 countries in the southern hemisphere, predominantly those in tropical and subtropical regions of the world. While we do occasionally see outbreaks of dengue fever in the U.S. territories of American Samoa, Puerto Rico, and the U.S. Virgin Islands, and the freely associated states, including the Federated States of Micronesia, the Republic of Marshall Islands, and the Republic of Palau, cases in the continental U.S. have historically been in international travelers or travelers from these territories.
In 2020, there was an outbreak of locally-acquired dengue fever in Florida (72 cases), which might be less of a concern if it were not for the pattern of emerging outbreaks of other diseases for which we generally have not seen locally acquired infections in the past, but now have resulted in local outbreaks, especially in Florida – e.g., zika, chikungunya prior to the dengue fever outbreak and most recently malaria (while we have historically had local transmission of malaria, we had eliminated malaria from the U.S. back in 1951). It is interesting to note that the common denominator for these four infections is that they are all transmitted through mosquito bites.
Dengue virus is a flavivirus and flaviviruses cause vector-borne diseases in humans. Vector-borne means that the virus is transmitted to humans through the bite of an insect – typically a mosquito, flea or tick. Dengue virus is transmitted by mosquitoes. Other mosquito-transmitted flaviviruses include the yellow fever virus, Japanese encephalitis virus, the West Nile viruses, and Zika virus.
The mosquitoes that are capable of transmitting dengue virus are of the Aedes species. Modelling studies show that Aedes aegypti and Aedes albopictus mosquitoes could potentially extend their natural habitats in the southern hemisphere up to some areas of the U.S., particularly the southeastern parts of the country.
We may miss cases of dengue fever in the U.S., because in some people (estimated to be about 75% of cases), the illness is mild or even asymptomatic. Those with mild symptoms may attribute them to a cold or the flu, or be seen, but not tested for dengue fever given that this is not something most U.S. doctors have seen before.
Dengue fever can manifest as a severe disease, in fact, it is estimated that 22,000 people die from dengue annually across the globe. Classic dengue fever is characterized by high fever and intense muscle, joint and bone aching, and even muscle spasms, giving rise to its colloquial name, “breakbone fever.”
In classic dengue fever, the first phase of the illness lasts 2 – 7 days. In addition to fever and the muscle, joint and bone pain, some patients will complain of headache, nausea and vomiting and some may experience bruising, bloody nose, or bleeding from their gums. On or about the third day of the illness, most people who are symptomatic with dengue will develop a red rash, that may be smooth, may have tiny bumps, or both. In most cases, the rash does not itch. Some patients will get a rash all over their body, while others will have patchy rashes. When the rash is generalized, it generally begins over the tops of the feet and the back of the hands and then spreads to the arms, legs, abdomen and chest. There is much variation in the possible rashes and in some cases, the particular manifestation of rash tells us what the major underlying pathological process is (e.g., immune reaction versus disruption to the proper functioning of the blood and blood clotting system).
While most people recover within about a week, some people do deteriorate and require hospitalization (about 1 out of every 20 cases). Those at highest risk for severe disease are infants, pregnant moms and those with a reinfection of the virus. They can experience profound fluid losses or maldistribution of these bodily fluids, internal bleeding (sometimes called dengue hemorrhagic fever) and potentially can develop shock (sometimes referred to as dengue shock syndrome).
While many lay people are under the false impression that the initial infection of any illness is the worst, and that subsequent infections will always be milder, this is not always the case, and dengue fever is the classic exception. In the case of dengue reinfections, a phenomenon called antibody-dependent enhancement (ADE) can occur. In essence, what takes place is that the initial infection triggers an immune response. Part of that response is the production of antibodies against the virus. When non-neutralizing antibodies are produced (e.g., antibodies that attach or bind to the virus, but do not interfere with or prevent the virus from entering and infecting cells), there are some cases in which these weak antibodies can actually promote the viral cell entry and infection, often also stimulating an intense inflammatory process, a condition we refer to as ADE.
There is no specific treatment available for treating dengue fever. The efforts to develop a vaccine against this infection has been hampered by the potential for ADE. However, there is a vaccine, though it is not licensed in all countries where dengue virus is endemic.
For now, Americans need not take any specific precautions unless you are planning travel to countries where dengue is endemic. However, we need to be mindful of our own changing and evolving public health situation in the U.S.
With climate change, we may see more and more diseases that are not endemic in the U.S. migrating northward. Further, if we continue to exercise a great deal of complacency against other disease outbreaks in the U.S. such as SARS-CoV-2 and monkeypox, we risk allowing these diseases to become endemic, especially, as we allow new variants to emerge and allow infections to transmit among our wildlife and domesticated animals. We often have an opportunity to eliminate infectious diseases, but that window does not stay open for indefinite periods of time. Further concerning is the fact that after going to the efforts to eliminate a number of vaccine-preventable illnesses in the U.S., we have allowed these diseases to reemerge in outbreaks due to the uncontrolled misinformation, disinformation and anti-vax campaigns that are undermining vaccine confidence in the U.S. and globally.
I don’t live my life in fear, but I also don’t subscribe to living my life in blissful ignorance and just accept whatever may come my way, or worse, just throwing caution to the wind. My personal approach is to be aware of the risks to the extent possible and reasonable, and then to make decisions as to the degree of mitigation efforts I am willing to undertake to reduce those risks according to how likely I think the risk is and how bad it would be if the risk materialized.
I write about this approach in detail in Chapter 15 of a book that I co-wrote with Dr. Ted Epperly entitled: “Preparing for the Next Global Outbreak: A Guide to Planning from the Schoolhouse to the White House,” released in April of 2023. https://www.press.jhu.edu/books/browse-all?keyword=Pate.
I want to give credit to Steve Skaggs, an executive who I was privileged to work with while I was President and CEO of St. Luke’s Health System. Steve taught me a lot about enterprise risk management, which has greatly informed and evolved my thinking on this subject.
You likely make these same kinds of decisions all the time and don’t realize the connection. Some of you likely just got your spouse or a child an iPhone or iPad or laptop for Christmas. You were faced with a barrage of decisions as to whether you wanted to purchase an extended warranty, a screen protector, a protection plan in the event something happens that is not covered by the warranty or you need a human being to help you with the technology, a protective case for the device, or an insurance plan that will cover loss of the device or damage so severe that the device cannot be repaired. All of these decisions likely caused you to reflect about the person you were getting the gift for; their prior track record of caring for, dropping or losing things; and how long you thought it likely they would use the device until the next must-have model comes out to then weigh against the cost of whatever protection option you were considering.
The thing is that risk mitigation measures involve trade-offs. If I choose not to get the screen protector, then I need to be extra careful not to drop my device because replacing the glass will be more expensive and more of a hassle. I have never lost or needed to repair my iPhone. If I purchase the insurance for my iPhone, I am out the cost if I never need it, but I have the piece of mind that if something does happen to it, I have made a good bargain by having the insurance. Everyone will weigh these factors, but likely give these factors different weight. I am unlikely to lose my iPhone, so it is more of a difficult decision to purchase the insurance; but for certain other members of my extended family, well, let’s just say it is not a difficult decision at all.
So, my general approach to a known risk is to consider how likely the risk is to materialize and how bad it might be if the risk did materialize. Let’s take influenza. I got influenza back when I was a resident physician assigned to work in a busy, county emergency room. I was young, healthy and probably in the best physical condition (other than for sleep deprivation) of my life at that point in time. However, I was miserable for a good 3 – 4 days, and sick enough that I missed about 5 days of work. If I was going to miss 5 days of work, I would have much preferred to have spent those days on a vacation with my wife, rather than at home in bed with fever, terrible body aching and a bad headache risking exposure of my wife and kids. Thus, my future risk calculations as to whether to get a flu shot and have a sore arm for a day or two, but be able to work, versus avoiding the risk of a sore arm every year, but assuming the risk that an average unvaccinated person will get influenza every 4 or so years was a no-brainer. I have received the influenza vaccine every year since then, and to my knowledge, I have not had another case of influenza.
Sometimes making risk mitigation decisions are fairly straightforward. The risk for influenza presents itself every year, generally over the same time period, and is highest among those with exposure to school-aged children. The risk for severe outcomes is highest among those who are over age 65 or under age 5, those who are pregnant, those who have chronic medical conditions (e.g., asthma, diabetes, heart disease). On the other hand, the flu shot is relatively inexpensive or in many cases free of charge, generally easy to get, and side effects mild.
But, sometimes, making risk mitigation decisions are not so straightforward, and we have seen this play-out with the current pandemic. Risk mitigation measures can be far more difficult when a new risk presents itself as the SARS-CoV-2 virus did, and because the risk is new, we actually don’t know how significant the risks are or how likely they are to occur. Unfortunately, we are, in general, very bad at judging these kinds of risks. The first mistake we often make, is we make an assessment of the risk by simply looking around us to see what seems to be happening. We all recall elected officials who were concluding that this couldn’t be a pandemic because people were not “dying in the streets,” perhaps an ignorant or cynical reference to outbreaks of the plague in pre-modern history. Obviously, if that is going to be the standard by which we judge whether to adopt mitigation measures, we are going to under-respond to infectious diseases and experience more illness and death than is necessary, or I would suggest, is prudent.
Looking around us may include more than just looking for dead bodies in the streets. Many will conclude that the risk can’t be that great because I don’t know anyone who is sick or anyone who has died from the disease. However, when a new pandemic is emerging, especially one that has begun overseas, it may take months before you would have people sick in your social circle. SARS-CoV-2 was first recognized to be causing illness in China in December of 2019, but we didn’t recognize the first case in the U.S. until the third week of January in 2020, and we didn’t identify our first case in Idaho until the second week of March. Obviously, the absence of illness affecting members of our family, friends or co-workers did not mean that the threat was not significant, and waiting to prepare and respond until it does will diminish any chance for containment of the spreading disease. As we write in Chapter 1 of our book, by the time the travel ban was implemented in the U.S., a U.S. citizen had already returned from China infected.
Unfortunately, there are many viruses that can cause serious disease and can be circulating around you, but you would not know it based on what I will call anecdotal observations, such as making an assessment solely on whether are any family members, co-workers or friends are sick. That is because, like SARS-CoV-2, oftentimes many of the people a virus infects may have no symptoms (asymptomatic) or may have mild and few, non-specific symptoms (pauci-symptomatic) that does not raise suspicion of the potentially serious virus causing the infection, but rather might be ascribed to having overdone things, being sleep deprived, or perhaps having “allergies.” A notorious example of this is poliovirus. When poliovirus circulates in a population, most parents of children will not know it. Their children may seem fine or may have symptoms that they would ascribe to just having a “stomach flu.” That is because, depending on the strain of poliovirus, only 1 child in 200 or more infected will develop the fully manifest and dreaded poliomyelitis. Going back to our risk framework, one might reasonably assess the risk of contracting poliomyelitis as being low (but increasing given vaccine hesitancy and global travel), but would reasonably have to assess the risk if their child was to get poliomyelitis as quite high since the health outcomes can be quite severe and life-long, including premature death. Then, these risks would be weighed against the cost, hassle and effectiveness of the mitigation measures – a series of 4 shots that every child can receive for free, are widely available in doctor’s offices and public health clinics and are extremely effective providing life-long protection against poliomyelitis.
The other problem with our risk assessments with new infectious diseases like COVID-19 is a focus on what we doctors would refer to as acute disease outcomes – what happens to the patient during the initial illness – the severity and length of the initial illness, whether the illness is likely to require a trip to the doctor or the emergency room, whether hospitalization is frequently necessary, and whether there is a significant risk of dying from the infection. This is where the media, press and public focused their attention during COVID-19. And, of course, as we saw in this pandemic, there will be those who will actually promote people getting infected as being good for their own health and leading to a state of so-called “herd immunity” (Dr. Epperly and I devote nearly all of chapter 12 of our book to explaining this flawed theory), if they consider the case fatality rate to be acceptably low.
However, as physicians we know (or should know) that there are plenty of viruses that don’t kill their hosts at the time of initial infection, but can cause serious health problems and even death months to years later (e.g., hepatitis C virus, Epstein Barr virus, measles virus, mumps virus, and human papilloma virus just to name a few). That doesn’t mean that all new pandemic viruses will cause long-term health consequences, but when we have high, sustained transmission rates to the extent that the majority of the population is becoming infected, and in many cases reinfected, prudence would call for adopting the “precautionary principle.”
The precautionary principle is often employed when the future risks are unknown, but there is some basis for anticipating that those risks may be significant and potentially serious in the future and the only known way to avoid those potential long term health consequences is to prevent infection until more time can pass to study whether health consequences occur and what they are. In this case, we knew from the original SARS coronavirus outbreak in 2002 – 2003 that even though most common coronaviruses did not cause significant disease burden, this coronavirus caused significant mortality and, in some individuals, long-term health consequences similar to what we began to see with SARS-CoV-2 in late 2020 and early 2021.
In fact, I commonly have heard some commenters recently say that infection is not the same thing as disease. I certainly believed that was likely to be the case in 2020, but I am far less persuaded of our ability to distinguish between the two since 2020, as we have seen increasing evidence of long-term health consequences, even in people who had asymptomatic or pauci-symptomatic infections. Now let me be clear, I am certainly not suggesting that everyone who is infected will develop long-term health consequences. What I am suggesting is that I don’t know who will develop long-term sequelae from infection (let alone multiple reinfections, which as I have pointed out in earlier blog posts do increase the risk of long-term health sequelae), and neither do those who are making that statement. It is not so much that the statement is technically wrong, as it is that I believe that statements like that suggest that we can distinguish at the time of infection those who will develop disease versus those who will not, which clearly is not true and I believe contributes to the public not making accurate risk assessments as they consider what is right for their selves and their families.
I mentioned above two important concepts. First, is that anecdotal observations are inherently biased and prone to misjudging risks. Second, is the precautionary principle when dealing with a novel virus for which there is wide-spread and sustained spread and no long-term follow-up. So, how do we make an accurate assessment of risk? We obtain data and until that point, we exercise the precautionary principle.
Let’s look at just a few examples of data and how they are showing that the conventional wisdom and anecdotal observations during this pandemic were wrong. [Let me just insert here that I have certainly not been right in every instance as I tried to anticipate and predict what would happen with this virus. However, through a combination of the precautionary principle, risk assessment and a healthy dose of good luck, neither my wife nor I, nor another family I regularly advise, have ever (to the best of our knowledge) been infected with SARS-CoV-2 or developed COVID-19. My interest in writing this blog post is not to suggest that I have always been right or that others were wrong. This is not a competition. This is about what can we learn from what we did right and what we did wrong, so hopefully, we can prepare for and manage through the next (and there will be a next) pandemic with better success, less illness and fewer deaths.]
The first example has been the common refrain that COVID just hospitalizes and kills those elderly folks who were going to die anyway. I have been persistent in trying to dissuade people of this notion on the weekly radio show (The Doctors Roundtable segment of Idaho Matters) I appear on (Boise State Public Radio on Wednesdays at 12 noon MT with host Gemma Gaudette). There has been data over the past couple of years that refutes that statement, but let’s look at a recent analysis and study published by the University of Oxford Assessment of COVID-19 as the Underlying Cause of Death Among Children and Young People Aged 0 to 19 Years in the US | Public Health | JAMA Network Open | JAMA Network.
The University’s Department of Computer Science found that during the time period August 1, 2021 through July 31, 2022, COVID-19 was the eighth leading cause of death in children and young people in the U.S. Keep in mind that the prevailing public view and that promoted by a number of physicians who engaged in disinformation campaigns was that children don’t get seriously ill from COVID, COVID is nothing more than a cold in children, and children don’t die from COVID. Further, young, healthy adults at their prime, were also led to believe that COVID, and even repeated COVID infections need not be a concern to them. By the end of this study period, large gatherings had become common-place again, masking seemed to be ever increasingly rare, there was far less interest in testing or receiving antiviral treatment when people became ill, few people were quarantining any longer following exposure to a known case of COVID, and many employers were no longer even requiring infected individuals to isolate. Schools seemed to have little interest in enhancing their air handling and filtration and eventually, to my shock, hospitals began to abandon masking even in cancer treatment areas and in neonatal and pediatric units.
What specifically did this analysis find:
Among children and young people aged 0 – 19 years in the U.S., COVID-19 ranked eighth among all causes of death; fifth among all disease-related causes of death (i.e., excluding things like accidents); and first in deaths caused by infectious or respiratory diseases.
By age group, COVID-19 ranked seventh (infants), seventh (1–4-year-olds), sixth (5–9-year-olds), sixth (10–14-year-olds), and fifth (15–19-year-olds).
COVID-19 was the underlying cause for 2% of deaths in children and young people (800 out of 43,000), with an overall death rate of 1.0 per 100,000 of the population aged 0–19. The leading cause of death (perinatal conditions) had an overall death rate of 12.7 per 100,000; COVID-19 ranked ahead of influenza and pneumonia, which together had a death rate of 0.6 per 100,000.
Like many diseases, COVID-19 death rates followed a U-shaped pattern across this age-range. COVID-19 death rates were highest in infants aged less than one year (4.3 per 100,000), second highest in those aged 15–19 years (1.8 per 100,000), and lowest in children aged 5 –9 years (0.4 per 100,000).
Overall, deaths in children and young people were higher during the Delta and Omicron waves compared to previous waves (pre-July 2021), likely reflecting the higher numbers infected during these periods. Nevertheless, in the pre-Delta period of the pandemic, COVID-19 still ranked as the ninth leading cause of death overall.
The month with the highest number of COVID-19 related deaths in 0 – 19-year-olds was January 2022 at 160.
Keep in mind that these statistics are only for those deaths that were reported as having been caused directly by COVID-19. Deaths where COVID-19 might have been a contributing cause to the death, but not the primary cause, were not included. Had the researchers included this group, the numbers would have been considerably higher.
Some have argued once confronted with data like this that the children who were hospitalized and died were those with serious underlying health conditions. However, another study showed that more than half of the children who developed severe disease were otherwise healthy and could not have been predicted to have developed severe disease.
Despite this data, the general public still is under the belief that COVID in children is no worse than a cold, and this, together with the vaccine hesitancy resulting from wide-spread, coordinated anti-vax and vaccine disinformation campaigns, likely accounts for the very low percentage of children, especially the youngest children being vaccinated with the COVID-19 vaccines.
Obviously, the absolute numbers of deaths in children from COVID-19 are low in comparison to older adults, but relative to other things that kill children, COVID-19 was significant.
The low absolute numbers caused some physicians to argue against COVID-19 boosters for children. Of course, some of these physicians were the same ones who spread vaccine disinformation and argued against anyone getting the COVID vaccines. Nevertheless, I was appalled to hear even a few reputable doctors argued against the COVID-19 boosters for children due to the low risk of serious illness or death. That has never been the sole or even major criteria for developing and administering children’s vaccines. It was yet another message to the public that we need not be concerned about long-term health impacts to children from repeated SARS-CoV-2 infections. Frankly, the truth is that we are only now beginning to comprehend the long-term health consequences of the initial infection, let alone from repeated infection, and none of these physicians can guarantee that children will not suffer long-term consequences. If the vaccine was not proven safe and effective in the general pediatric population, then withholding boosters might be a valid consideration. But, if some arbitrary hospitalization or mortality rate threshold is now going to be the criteria for childhood vaccines, there are going to be a lot of vaccines falling off the recommended childhood vaccination list. That would be a tragic mistake.
Why would I even think that long-term health consequences could be possible in children? Well, first of all, we see many signals for long-term health consequences in adults, and I have previously written a number of blog posts on that subject.
Nevertheless, I learned in medical school that children are not little adults. That means that we cannot necessarily assume that children will be affected by infection in the same manner as adults. Further, even disease in very young children can be different than in older children.
Because of the widespread misinformation that COVID-19 was not dangerous for kids and for young adults, we saw that pregnant women were often not aware of the increased risk to their unborn children from COVID-19, sometimes with disasterous outcomes. I also was appalled that some hospitals were not requiring masking in their pediatric and neonatal intensive care units. In addition, I worried for the young infants that I saw parents carrying into large gatherings, stores and restaurants.
Here are two recent studies that should cause all of us pause:
First is a prospective, multicenter trial that was conducted during the first two years of the pandemic. It was published in The Journal of Pediatrics on December 20, 2023. https://doi.org/10.1016/j.jpeds.2023.113876. Three groups were compared: (1) 152 infants hospitalized for treatment of COVID-19; (2) 79 infants who were hospitalized for acute infections other than COVID-19; and 71 healthy controls who were not hospitalized or ill.
The study was designed to merely measure the levels of high sensitivity troponin, a blood marker for heart cell (myocyte) injury. If you have presented to the emergency room with chest pain, there is a good chance that you had a blood test for this marker, which in adults we use as one of the potential indicators of heart attack. High sensitivity troponin can be elevated with any cause of myocardial (heart muscle) injury, including myocarditis.
Those children hospitalized with COVID-19 were significantly more likely to have elevated high sensitivity troponin levels than either the healthy infants or the infants with other non-COVID infections, and those infants less than 3 months of age were especially more likely to have an elevation of troponin levels with infection.
The good news is that the troponin levels gradually returned to normal and the children showed no clinical evidence of heart disease at one year of follow-up. On the other hand, it remains unclear whether there are any long-term consequences until these children can be followed further out. [You might be asking yourself why the need to follow these children out further if everything looked okay 1 year later. That is because the immune systems of infants less than 6 months of age is immature and not fully developed. We are still learning about the immune response in adults to SARS-CoV-2 and we know almost nothing about the immune response in infants this young. We do see evidence of viral persistence in some adults and so a reasonable question would be whether these children clear the virus from their system.]
The other study was published in March of 2023. https://jamanetwork.com/journals/jamanetworkopen/ fullarticle/2802745. The researchers looked at the neurodevelopmental outcomes of infants born to mothers who had COVID-19 during their pregnancy compared to infants born to mothers with no known COVID-19 during their pregnancies. This was a cohort study of 18,355 infants delivered after February of 2020. After controlling for other risk factors such as premature delivery, the researchers found that male, but not female, infants born to mothers who had COVID-19 during their pregnancy were more likely to receive a neurodevelopmental diagnosis in the first year of life.
I have not provided an exhaustive review of studies looking at outcomes of infection in infants, but rather, I am just trying to make a point. I don’t know whether any of the infants with elevated troponin levels or any of the infants with neurodevelopmental delays will have long-term consequences from their exposure to the SARS-CoV-2 virus, but, neither does anyone else. I think if you asked any pediatrician, would you want your child or grandchild to be born with elevated troponin levels or to be diagnosed with a neurodevelopmental delay, they would respond that they would prefer they not be. The problem is that we won’t know whether there are long-term health consequences for years. I pray that there will not be. To me, it just seems prudent to exercise the precautionary principle until we know.
I have used infants as an example to make a point. We know the least about them, and they have no way to protect themselves. However, there are far more studies and reason for concern about the long-term health consequences in adults. I am surprised that employers are not exploring options to help protect their employees because if I am correct, even if they were to only act in their self-interests, not protecting their employees will impact their health plan costs, disability insurance costs, employee productivity, profitability, and recruitment costs.
In part 2 of this blog series, I will explain how we are being too complacent in our planning (or lack thereof) for the next pandemic.
It is estimated that 18.2% of adults over the age of 18 have had the updated COVID-19 vaccine booster as of the first week of this month. That same percentage for children ages 6 months – 17 years is only 7.8%. No doubt there is greater vaccine hesitancy due to rampant vaccine disinformation and anti-vax campaigns. The intended audience for this blog post is not this group, but rather those who have not received the updated booster because they were not aware one was available or because they did not believe it was needed due to prior vaccination or infection.
A recent study (BNT162b2 XBB1.5-adapted Vaccine and COVID-19 Hospital Admissions and Ambulatory Visits in US Adults | medRxiv) looked at the efficacy of the updated XBB.1.5 Pfizer-BioNTech COVID-19 vaccine booster (2023-2024 formulation) in preventing the need for medically-attended care (office visit, urgent care visit, emergency room visit or hospitalization) for COVID-19 among adults a median of 30 days post-booster compared to a group that did not receive any updated booster regardless of prior infection or vaccination history. The median age of the study participants was 54 years. The study was conducted on patients cared for by a health system in California (Kaiser Permanente Southern California) between October 11 and December 10 of this year.
The adjusted odds ratios for the reduction in need for medically-attended care in the updated booster group were 0.37 for hospitalization and 0.42 for all other sites of care.
The most shocking finding was reported by the authors of this study in this statement: “Compared to the unvaccinated, those who had received only older versions of COVID-19 vaccines did not show significantly reduced risk of COVID-19 outcomes, including hospital admission.”
What does all this mean in plain English (at least as plain as I can make it)?
Prior vaccination and/or infection does provide some degree of immunity for a period of time, but that protection wanes over time and is not durable (in other words, does not last for years). Thus, until new vaccines are available (there are some very promising ones undergoing clinical trials now), maintaining immune protection from moderate to severe disease will require updated boosters or alternatively repeated reinfections (however, my last blog piece and other prior ones have indicated why this is a foolish and dangerous approach).
Because of rampant transmission among large populations of people across the world, including immunocompromised individuals, the SARS-CoV-2 virus is evolving through recombination (the swapping of genetic material between two or more SARS-CoV-2 viruses with different sequences in the same person) and mutations (changes that add to or subtract from the genetic sequence of the virus during the process of copying the genetic code in making new viruses in infected cells). Some of these genetic changes have resulted in newer forms of the SARS-CoV-2 virus being more immune evasive (i.e., being able to get around some of the body’s immune defenses, including antibodies). [I should note that SARS-CoV-2 is behaving in a way that is unprecedented. We have never had a virus be able to circulate in the general population infecting persons of all ages throughout the year for this many years, causing so many reinfections through immune evasion and evolve to the point that recombinant viruses have now been driving the pandemic for two years now. In view of this and other aspects of this virus that I have written about throughout the pandemic, I believe that the public’s confidence that repeated infections are of no significant concern to long-term health could very well end up being unjustified.]
Because a higher proportion of the population received earlier vaccination, it would seem that some of the fall-off in booster uptake is not vaccine hesitancy, but rather a mistaken notion that boosters are not needed because of their prior vaccination and possibly because of the commonly- held notion that so-called “hybrid immunity” (the immunity resulting from a combination of prior vaccination and infection) is the ultimate immunity against reinfection.
There is also a commonly-held belief that reinfections are always milder and/or the virus is evolving to become milder thus contributing to a sense of complacency about the need for subsequent boosters.
While no doubt, there has been some degree of population immunity that has heretofore protected us from the high levels of deaths and hospitalizations that we previously saw in the Delta (fall 2021) and early Omicron (winter 2022) waves, this study is a warning, as well as what we are currently seeing in a number of countries recently with significant rises in hospitalizations and deaths, that the virus is evolving enough and our prior immunity is waning enough that relying on prior vaccinations and remote infections may no longer be sufficient protection against moderate and severe disease, and we could potentially see higher rates of disease and severe illness in the near future.
The good news is that the newly updated booster is effective in significantly reducing the risk for moderate and severe COVID-19. The bad news is that a very small percentage of the population has received the new booster.
My fear is that a lot of people travelled and gathered with others for the holidays believing that they had a lot more immune protection from moderate and severe disease than they really did. If so, we could see a significant rise in urgent care visits, emergency room visits, hospitalizations, and God-forbid, deaths over the next two to three weeks.
If you have not received the newly updated COVID-19 booster and have not had COVID-19 in the past couple of months, it is not too late to get boosted. I would get it tomorrow, if I were you. And, the good news is that if you have concerns about the mRNA vaccines, you can get the Novavax booster, which is a rather “old-fashioned” type of vaccine that we have used for many years prior to this pandemic.
A growing body of research is all coming to the same conclusion: SARS-CoV-2 reinfections are cumulatively increasing the risks for long-term health consequences. A recently published study from Canada (Experiences of Canadians with long-term symptoms following COVID-19 (statcan.gc.ca) is one of the more recent studies on this subject.
In a survey of Canadians, as of June of this year, approximately 2/3 of those surveyed reported a confirmed or suspected case of COVID-19 since the beginning of the pandemic, and many of this group reported reinfections, as well.
Approximately 3.5 million Canadian adults reported Long COVID symptoms at any point of the pandemic (occurring in about 16% of all adults previously infected), and as of June, 2.1 million were reporting persistence of their symptoms. Roughly half reported no improvement in their symptoms since their onset. [Note: I have discussed what Long COVID is, the nature of the symptoms, the suspected pathophysiology of the disease, and other long-term health consequences of COVID-19 extensively in prior blog posts if you need a refresher.]
Of note, while most countries use one- or two-month’s duration of symptoms in their case definition of Long COVID [The World Health Organization uses two months in its case definition]; Canada has a more restrictive case definition requiring at least 3 months for the duration of symptoms before calling it Long COVID.
People of the world are at risk for reinfections due to:
The waning of both vaccine-induced and infection-induced immunity;
The low percentage of children that have been vaccinated;
The low uptake of annual COVID-19 boosters;
The low rate of antiviral treatment of early COVID-19 to minimize the chances for serious illness and Long COVID.
The high percentage of persons who are asymptomatic or pauci-symptomatic (few symptoms often mistaken for allergies or a “cold”) but nevertheless capable of transmitting the virus to others.
Lack of media attention and/or misunderstanding of what the end of a public health emergency means and what it doesn’t mean;
The significant transmission levels of SARS-CoV-2 across the world and the infection of immunocompromised persons, both of which are driving the evolution of increasingly immune evasive variants;
The abandonment of most non-pharmaceutical measures to reduce infections in communities;
The resistance to adopting enhanced ventilation and air filtration in schools and other public buildings;
The significant transmission of infection in health care facilities;
The general public’s lack of understanding of the long-term health risks from COVID-19;
Disinformation campaigns that promote infection as a way to boost immunity or to achieve herd immunity (both of these assertions have been disproven);
The misinformation campaign of “vax and relax”;
The lack of reporting of cases and community transmission levels;
The marked reduction in testing;
Confusing guidance on isolation and quarantine that was also often not evidence-based; and
The well-documented fact that many employees are not staying home when ill, sometimes due to the lack of sick-time or paid time off.
The surveys revealed that the risk for long-term symptoms increased with each infection:
14.6% of those surveyed reported long-term symptoms following their first infection. That percentage increased to 25.4% with two infections and to 37.9% with 3 or more infections. In other words, this study (and others) suggests that the risk for long-term symptoms and Long COVID is cumulative.
I should also point out that there may be other long-term health consequences from COVID-19 that do not cause symptoms and there are other conditions, as have occurred following some other viral infections, that may not become manifest for years or decades.
There has also been little public discussion as to the economic implications of Long COVID – worker productivity, increases to employer health plan costs, rising insurance premiums, loss of employment, disability rates, and increases in life insurance pay-outs, among others.
In this study, of those that developed Long COVID, 22.3% were impacted to the extent that they missed time from school or work – on average 24 days. Given the large numbers of Canadians afflicted, the researchers estimated a total loss of about 14.5 million days of work and school among all Canadian adults. [Note that the population of the US is roughly 10 times that of Canada.] Approximately 5.3% of Canadian workers sought disability or worker’s compensation for Long COVID, and 93.8% of these applicants were approved. Of note, some of the most common occupations involved those with serious shortages in the U.S., e.g., healthcare, social services and education.
I fear that the majority of the population in the U.S. have become far too misinformed and complacent about COVID-19 and the risks for long-term health consequences. Unfortunately, I also fear that we will only come to appreciate these years from now, with profound regret, as we see the true impact of this disease and multiple reinfections, and God-forbid, not only in adults, but sadly our children.
Many Americans will travel either domestically or internationally during the upcoming holiday season, either for business, vacation or to visit family and friends. Unfortunately, in my experience, most people do not consider the potential for getting ill while away from home, where they would go for health care if they became ill especially on a holiday, how they would communicate their health history and medications to health care providers who may not speak English if travelling abroad, and how they would pay to be medically transported to another hospital if they or a family member was seriously ill and hospitalized, but wanted or needed care at a more advanced or specialized hospital or one closer to home. Often, international travelers are not aware of health threats that they may encounter in countries they plan to visit that are different than those we face in the U.S.
Just as you would plan the itinerary for your travels, one should plan ahead for the unexpected, especially, if you will be traveling with young children or persons who are at high risk for health problems. Most calls I receive for help when people are away from home are actually cases in which no one imagined the family member would suffer a serious illness and is now hospitalized in another country, where the hospital is demanding cash payments, the family member is having to pay for their own extended lodging, and no one understands what is wrong with their family member. These are heart-breaking situations.
Additionally, people who might decide that under normal circumstances that their health is excellent and therefore they would pass on certain vaccines such as influenza or COVID-19 (not something I would advise, yet I understand that many people do think like this) should reconsider when travel is involved. First, it is always disappointing when you have looked forward to a trip, visiting family or a vacation, and likely spent a lot of money arranging it, to then get sick. That disappointment can turn to fear when the illness is severe enough that medical attention is needed and you are away from home and uncertain as to where to turn.
Second, if you are visiting friends and family, even if you do not become severely ill, you now may be the source for infecting a young child or an elderly person who very well might become severely ill. I have read heart-wrenching stories of people who did not take precautions, became ill and may have merely experienced a cold-like illness, but realize they likely infected a parent or grandparent or other family member who developed severe illness, required hospitalization, and in some cases died.
Finally, it can certainly be a desperate situation to be trying to find health care for a child or other family member at night, on a weekend or on a holiday even in the U.S., not to mention when you are away from home and not familiar with the health care system in the city you are visiting and, in the case of international travel, don’t speak their native language.
Here are my tips and recommendations:
Domestic Travel within the U.S.
Check with your doctor’s office to make sure you and all the family members who will be traveling with you are up-to-date with all your immunizations. In addition to the regularly scheduled immunizations:
Most everyone over 6 months of age should get the influenza vaccine. Those who are 65 years and older should get the high-dose flu vaccine.
Everyone over 6 months of age should also consider getting a COVID-19 updated booster shot (or your first, if you have never received one).
If you are traveling with a child under the age of 1 or if any travelers are over the age of 60, be sure to check with their doctors as to whether they should get the RSV vaccine.
If you want to check your immunizations for yourself, if you have received them all from a single health care provider, they may be listed on that provider’s patient portal if they have one (e.g., myChart if the provider is on the Epic electronic health record system). But, if you received some of these vaccines from a pharmacy or if you have received them from a number of providers who are not all on Epic, you can get a complete list of the vaccines you have received and the dates you received them by downloading the free app Docket https://docket.care/, as long as the providers who gave you the vaccines participate in and report to the Idaho Immunization Reminder Information System (IRIS). That app will also indicate if you are due for certain vaccines.
If any of the travelers have multiple medical conditions, an unusual medical condition and/or take medications on a regular basis, consider printing out a list of those medical conditions and medications.
You might be surprised to know how many patients I have seen who tell me, “I take a small white pill for my blood pressure, and a big yellow pill for ….” First of all, these descriptions don’t narrow down the range of possibilities of medications much and rarely will a description like that inform us as to the dosage of the medication. Further, patients might often call a capsule a pill, when a doctor or pharmacist would not. So, be sure to list the name of the medication (if you have the generic and the brand name, provide both, but either one will be fine if you don’t), the dosage and the unit (e.g., most pills you take probably are measured in milligrams, referred to as “mg” following the number, but children often take solutions of medications and they are sometimes labeled with the dose (e.g., 250 mg), but other times with the volume (e.g., my youngest grandson spent the night with me this week and I had to give him his medication and the direction was to give 1.88 cc or ml).
It is fine if you don’t know what the abbreviation on the bottle stands for because the doctors and pharmacists will, but in some cases the dose and the volume can be the same or close numbers, therefore, we want to make sure we know what abbreviation follows the number because that will tell us whether we are looking at the dose or the volume to be administered). Finally, be sure to write down how often you are taking the medication– e.g., twice daily, at bedtime, with meals, or as needed.
If you are high risk for severe disease with COVID-19 (see https://www.cdc.gov/coronavirus/2019-ncov/your-health/risks-getting-very-sick.html for factors that increase your risk for severe disease) or traveling with someone who is, now that Paxlovid is approved by the FDA, you may wish to discuss with your physician whether you are a candidate for Paxlovid (anti-viral medication) if you get infected while away from home, and if so, whether your physician will prescribe it so that you can take the medication with you. Given the need to start Paxlovid soon after detection of infection, and the challenges you may face while out of town in getting a medical evaluation and a prescription for the medication in a timely manner over the holidays, and if out of the country, the fact that Paxlovid may not be available, having the medication to take with you may come in handy. However, do not take the medication unless and until you have a positive test for COVID-19.
Consider whether you should purchase a family medical evacuation/air transport plan. (see below under international travel). While you may think this would only be needed for international travel, consider what you would do if you were out of state and a family member became very ill and required a prolonged hospitalization.
I recommend that you carry medication in your carry-on bag rather than your luggage. First, probably everyone who is reading this has had the experience of lost luggage. Therefore, if you are not going to take all of your medication in your carry-on, at least carry an extra day or two of medication in the event your luggage is delayed. Further, some medications can be temperature sensitive and lose effectiveness if exposed to extremes of temperature for an extended period of time. Cargo bay temperatures can get as low as 45 degrees Fahrenheit. If you do plan to pack medications in your luggage, be sure to check with your pharmacist whether that might create any problems.
I also recommend packing a few days of extra medication just in case your plans change or there are unforeseen weather events or other circumstances that would delay your return home.
It may be prudent to take an adequate supply of at-home COVID tests with you that would allow you to test each person who is traveling with you. There are still significant transmission levels of the SARS-CoV-2 virus, and transmission levels may be higher during the holidays.
Every household still has the opportunity to order 4 free at-home rapid antigen tests (2 boxes each containing 2 tests) if you have not already ordered them in the past two months. You can order these free tests at https://special.usps.com/testkits while supplies last. I am not sure you will receive yours in time for your holiday travel, but it is worth a try, and even if not, these can be used to replenish your current supply.
If you already have a supply of tests, check the expiration dates to make sure that the tests are current. However, the FDA has recently extended the expiration dates for a number of home tests based on more testing since the agency issued their authorization for the tests. So, before tossing any of your current tests in the trash, check the FDA’s website at https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list to see if your test’s expiration date has been extended.
If you are out of tests and don’t receive your free tests in the mail in time, you can find tests at most pharmacies and many grocery stores. You may be glad you traveled with some tests if there is significant transmission wherever it is you are traveling to, as pharmacy inventory can quickly be exhausted when there is sudden demand. Plus, it is not fun to have to be contacting multiple stores to find out which has tests when you are not feeling well.
Many of the COVID-19 tests are also sensitive to temperature extremes, so I also recommend that you place these in your carry-on luggage rather than your checked bags. Keep in mind that the most important thing in in relying on the result of an at-home COVID-19 is the control line (often indicated by a “C” on the test strip where the line should appear) showing up. If it does not show up, discard the test and get another one.
It also may be advisable to take a supply of over-the-counter fever-reducing medicines, cold-symptom relieving medicines, and high-quality masks with you. Be aware that there have been shortages in many parts of the country of children’s over-the-counter medicines from time-to-time, and this will be worse if there are significant levels of COVID-19, RSV, influenza and other respiratory viruses circulating. Also keep in mind that some pharmacies and grocery stores may have reduced business hours on the holidays.
You would be well advised to wear a high-quality mask in airports and at least while boarding the aircraft and deplaning. While airplanes generally do have good ventilation and filtration of air, we have a number of well-documented transmissions of SARS-CoV-2 on flights, even to passengers who are not seated close to the index case. Further, keep in mind that ventilation is poor prior to the captain turning the engines on and they are frequently off during boarding. In addition, sometimes the captain will turn the engines off on the tarmac if there is going to be a significant delay in order to conserve fuel. It only takes seconds for the virus to transmit to a passenger when another passenger walks by who is infected, and the passenger may not even be aware that he or she is infected.
Make a plan. Check with your doctor and your children’s doctors’ offices about (1) what their holiday hours will be and (2) whether someone will be available to help you if you or your child gets sick when the office is closed and you are out of town. However, you also need to plan ahead for emergency rooms and hospitals in the area where you will be staying in case the medical issue cannot be handled over the phone and requires urgent attention.
Beware that some urgent care clinics may not be open on holidays or may have limited hours. Also beware that emergency rooms are often extremely busy during the height of respiratory virus season (including during the holidays) and may also have reduced staff on the holidays. Therefore, there may be significant delays. Remember that many of the people in the emergency room are likely there for respiratory infections, so you will be wise to wear a high-quality mask at all times other than when the physician is examining your nose or throat, when they are obtaining a sample from you for testing or in the event that they need to place oxygen on you. Since waits can sometimes be many hours, you may want to take your next dose of medications with you.
Know where to go for medical attention. Identify one or more urgent care centers near where you will be visiting. Check their website to verify days and hours of operation and check to see if they have reduced hours of operation on the holidays. If yours or your child’s illness does not seem to be severe, urgent care centers will likely be your best bet in that wait times are generally shorter and co-pays through your insurance are likely to be less than for an emergency room visit.
Have a plan in the event of an emergency. In some parts of the country, the high volumes of illness, the increase in injuries that we see this time of year, and the reduced staffing due to illness and holiday scheduling will lead to the overwhelming of ERs and to delays in EMS response times. Therefore, know where the nearest hospital is, and if you have small children, where the nearest pediatric hospital is.
If there is more than one hospital near where you will be visiting for the holidays, you can check with your doctor to see if he or she is familiar with them and can make a recommendation. If not, there is no single best source to identify the highest quality hospitals in your area, so I use a couple of websites.
The first is the LeapFrog Hospital Safety Grades https://www.hospitalsafetygrade.org/search?findBy=state&zip_code=&city=&state_prov=ID&hospital=, which I use to get a sense of the hospital’s commitment and efforts towards ensuring patient safety. You can search hospitals by state to allow you to compare. I strongly prefer hospitals with an “A” grade for patient safety, but there may not be one near where you will be staying.
I then look at quality scores and awards, and I like the HealthGrades website for this: https://www.healthgrades.com/find-a-hospital. When you go to this webpage, type in hospitals and the city and state you will be visiting. The hospitals in that area should pop up in descending order of overall quality. When you click on the hospital, you will see recent quality awards, if any. Then, given that you most likely would need a hospital for a respiratory illness, you can click under the areas of pulmonary (lung diseases) and critical care (how well the hospital, its doctors, nurses and therapists perform in caring for patients in the intensive care unit) to see how that hospital’s quality outcomes are.
Another indicator of the best hospitals that I use is Magnet status – a very difficult to achieve status, and even more difficult to maintain, for excellence in nursing that has been correlated with quality of care. You can go to https://www.nursingworld.org/organizational-programs/magnet/find-a-magnet-organization/ and scroll down to select the state you are visiting, and the list of Magnet designated hospitals and the years in which they have been redesignated, if applicable, will appear.
Of course, if you did not plan your choice of hospital in advance and you have an emergency, just go quickly to your nearest hospital.
Plan for an extended wait time in the ER and the potential that you or your child might have to be admitted to the hospital. Given the back-up in hospitals and the extraordinary time that you may have to spend in the ER with your child or family member even if they are not admitted, plan for who will care for your other children on short notice while you are at the hospital, especially if you or a family member must be admitted as an inpatient?
Who will care for any pets you traveled with if you are tied up in the ER or hospital for more than a day?
In the event of the need for hospitalization, if the hospitalized family member is a child and you are far from home, you can check to see if there is a local Ronald McDonald House that can provide your family members with lodging while your child is hospitalized https://rmhc.org/our-core-programs?c_src=paid&c_src2=23AOPMsearch_google&&msclkid=36e13d7f148b123697ad5828dc8971a6&gclid=36e13d7f148b123697ad5828dc8971a6&gclsrc=3p.ds. If the hospitalized family member is an adult, you can check with the hospital to see if there is any subsidized lodging or financial assistance for lodging. Alternatively, many hospitals have arrangements with local hotels that will provide discounts or reduced rates to out-of-town family members of patients.
International Travel
Check with your doctor’s office to make sure you and all the family members who will be traveling with you are up-to-date with all your immunizations. In addition to the regularly scheduled immunizations:
Everyone over 6 months of age should get their influenza vaccine. Those who are 65 years and older should get the high-dose flu vaccine. There won’t be significant influenza activity in the southern hemisphere during our upcoming holiday if that is your destination, however, you will face exposure risks while at airports and on airplanes on the way.
Everyone over 6 months of age should also consider getting a COVID-19 updated booster shot (or your first, if you have never received one). There are some countries that are having significant surges in COVID-19 at the present time, (e.g., Australia, Germany and Sweden), but like the U.S., most countries are no longer reporting their cases. Consider that the country you are traveling to may have higher transmission rates than the U.S. at the time you travel, so take steps to protect yourself.
If you are traveling with a child under the age of 1 or if any travelers are over the age of 60, be sure to check with their doctors as to whether they should get the RSV vaccine.
If you want to check your immunizations for yourself, if you have received them all from a single health care provider, they may be listed on that provider’s patient portal if they have one (e.g., myChart if the provider is on the Epic electronic health record system). But, if you received some of these vaccines from a pharmacy or if you have received them from a number of providers who are not all on Epic, you can get a complete list of the vaccines you have received and the dates by downloading the free app Docket https://docket.care/, as long as the provider who gave you the vaccine participates in and reports to the Idaho Immunization Reminder Information System (IRIS). That app will indicate if you are due for a vaccine and list the vaccines that you have already received and the date received.
Travel Agent – optional
If you are using a travel agent to plan international travel, ask for any information they can provide you as to vaccines you will need, documentation of vaccines any of the countries you are traveling to might require, restrictions on medications you can take with you to those countries (see below), as well as medical care resources in the cities you will be visiting.
Travel Medicine Clinic – optional At least 6 weeks prior to travel
You can do the necessary research for yourself (see below), but I personally like the ease of going to a travel medicine clinic (the one my family uses is https://www.stlukesonline.org/communities-and-locations/facilities/clinics/st-lukes-clinic–travel-medicine-and-immunizations, but you can research other options in your area. Saint Alphonsus also has a travel medicine clinic https://www.saintalphonsus.org/specialty/travel-medicine/). During your travel medicine consultation, they will identify all the vaccines you might need for the countries you are traveling to, administer those vaccines and give you vaccine certificates for any countries that require them. Travel medicine clinics may be an especially good option if the people traveling are at high medical risk or if you need a vaccine that is not commonly available in most doctor’s offices or pharmacies, such as yellow fever vaccine. In addition, they can identify health threats in those countries such as infections transmitted by mosquitos, ticks or fleas and provide you with information as to how to avoid or minimize those exposures.
You also can consider public health departments that offer travel medicine services, however, many don’t and some have discontinued these services with the onset of the COVID-19 pandemic, so be sure to check their websites (e.g., Central District Health no longer offers this service) to see if they do offer the service and to schedule an appointment.
If you are uninsured or may experience high out of pocket expenses for vaccines, many public health departments will have immunization hotlines (e.g., in Ada and Boise Counties 208-327-7400, Valley County 208-634-7194, and Elmore County 208-587-4407) that you can call to get information as to the immunizations they offer (they may also list these on their websites, e.g., you can go to https://cdh.idaho.gov/hl-immunizations-adults.php for the list of vaccines offered through Central District Health) and schedule an appointment to receive your necessary vaccinations.
There are programs available to cover the cost of many vaccines (but not those that would not be routine vaccines in the U.S.) for those who are uninsured or for those with insurance plans that are not ACA-qualified plans for which the insured is required to make an out-of-pocket payment. For example, the Vaccines for Children program https://www.cdc.gov/vaccines/programs/vfc/index.html will cover the cost of all routine vaccines for children who are uninsured, including the COVID-19 vaccines, and the Bridge Access Program will cover the costs for COVID-19 vaccines for uninsured adults.
Go to the CDC’s travel website and enter the name of the country or countries that you will be visiting. https://wwwnc.cdc.gov/travel/destinations/list. This will provide you with any travel health notices, including particular health risks in those countries and alerts relating to disease outbreaks. That site will also list recommended and required vaccinations for travelers to those countries. While most countries are no longer requiring COVID tests, immunization records of COVID-19 vaccines or quarantine for travelers, foreign countries can often make changes very quickly in response to outbreaks in their own countries, and so it is best to check to be sure there is no requirement that might catch you by surprise, and depending on the country you are traveling to, there might be requirements related to other diseases.
Pay particular attention to the section entitled “Healthy Travel Packing List,” especially if you plan to travel with medications and/or medical supplies. Some countries require medications to be in their original, labelled prescription bottles rather than in a pill box organizer. There are some over-the-counter and prescription medications that are perfectly fine to travel with inside the U.S., but are outlawed in certain other countries, and could even land you in prison. People are often surprised that certain cold medicines and over-the-counter medications to treat diarrhea are outlawed in certain countries. Be sure to check with the U.S. Embassy website https://www.usembassy.gov/ for each country you will be visiting to ensure that you are permitted to travel with the medications you plan to take with you, as well as any restrictions regarding syringes needed to administer those medications or any other medical supplies you plan to take to ensure they are permitted and that you have any required medical documentation. Also, be mindful of dosage limits. For example, diphenhydramine (commonly sold under the brand Benadryl) is available in the U.S. in 25 mg tablets and capsules. However, at least one country makes it illegal to have this medication in more than 10 mg formulations.
There are currently 31 countries that have circulating poliovirus (see https://wwwnc.cdc.gov/travel/notices/level2/global-polio for a complete list). Be sure that you have been fully vaccinated, and keep in mind that if you are traveling with a young child under the age of 6, that child may not yet be fully vaccinated against polio under the current schedule of vaccines. Therefore, check the immunization records yourself for IPV or inactivated polio vaccine to be sure your child has had a total of four shots. If not, check with your pediatrician’s or family medicine physician’s office as to the risks for the child or if the child is old enough to receive the 4th shot before you depart. If adults will be traveling to one of the 31 countries listed above, check with your physician or travel medicine clinic to determine whether you should receive a one-time IPV booster prior to your travel.
There are currently 39 countries that have been experiencing outbreaks of measles. You can check the current list of those countries at https://wwwnc.cdc.gov/travel/notices/level1/measles-globe. Measles is the most contagious virus that we know of, and exposure can occur more than an hour after the infected person leaves a room and a susceptible person enters.
If an adult becomes infected with the rubeola (measles) virus who has not had measles and has not been vaccinated against measles, there is a significant chance for severe illness that would require hospitalization. I promise you that you do not want to be hospitalized overseas, and obviously, this situation will be worse if you are the only adult traveling with a young child without someone to care for the child if you need to be hospitalized. Further, if the child you are traveling with is under the age of 6, he or she may not yet have been fully vaccinated against measles. Therefore, be sure to check the vaccination record for the child or talk to the child’s physician to determine whether the child is fully vaccinated, and if not, whether the child is old enough to be given the second dose of vaccine (called MMR for measles, mumps and rubella) at least two weeks prior to your departure.
If any of the travelers have multiple medical conditions, an unusual medical condition and/or take medications on a regular basis, consider printing out a list of those medical conditions and medications. You might be surprised to know how many patients I have seen who tell me, “I take a small white pill for my blood pressure, and a big yellow pill for ….” First of all, these descriptions don’t narrow down the range of possibility of medications much. Further, patients might often call a capsule a pill, when a doctor or pharmacist would not.
Be sure to list the name of the medication (if you have the generic and the brand name, provide both, but of the two, the generic name is likely to be most helpful to health care professionals in another country), the dosage and the unit (e.g., most pills you take probably are measured in milligrams, referred to as “mg” after the number, but children often take solutions of medications and they are sometimes labeled with the dose (e.g., 250 mg), but other times with the volume (e.g., my youngest grandson spent the night with me this week and I had to give him his medication and the direction was to give 1.88 cc or ml). It is fine if you don’t know what the abbreviation on the bottle stands for because the doctors and pharmacists will, but in some cases the dose and the volume can be the same or close numbers and we want to make sure we know what abbreviation follows the number because that will tell us whether we are getting the dose or the volume to be administered. Be sure to write down how often you are taking the medication– e.g, twice daily, at bedtime, with meals, or as needed.
If you are not traveling to an English-speaking country, be sure to have a copy of the list of medical problems and medications that is translated into the native language for that particular country. Google and Adobe can both be used to translate your document into the language(s) of the country(ies) you are visiting. However, medical jargon is not always accurately translated, so it can be helpful to ask someone who speaks that language to review the translated version to make sure it accurately reflects what you meant to write. There are also some professional services that offer this service that you can find online. It also may be that the translation services department of your local hospital would be willing to review the document for you.
Finally, keep in mind that not all medications you are taking may be available in that country, and even if they are, they may go by a different name. So, when traveling to a non-English speaking country, add what you take the medication for to the list since they may need to change you to a medication that is available in their country.
It also may be advisable to take a supply of over-the-counter fever-reducing medicines, cold-symptom relieving medicines, and high-quality masks with you. You are unlikely to be familiar with the over-the-counter medications in other countries, and if it is a non-English speaking country, you may have difficulty reading the labels and understanding the instruction for use and dosing of the medications.
If you are high risk for severe disease with COVID-19 (see https://www.cdc.gov/coronavirus/2019-ncov/your-health/risks-getting-very-sick.html for factors that increase your risk for severe disease) or traveling with someone who is, now that Paxlovid is approved by the FDA, you may wish to discuss with your physician whether you are a candidate for Paxlovid (anti-viral medication) if you get infected while away from home, and if so, whether your physician will prescribe it so that you can take the medication with you. Given the need to start Paxlovid soon after detection of infection, and the challenges you may face while out of town in getting a medical evaluation and a prescription for the medication in a timely manner over the holidays, and if out of the country, the fact that Paxlovid may not be available, having the medication to take with you may come in handy. However, do not take the medication unless and until you have a positive test for COVID-19.
When traveling to a non-English speaking country, strongly consider identifying a website or app (e.g., Google translate) on your iPhone that you can use to translate to and from that country’s native language, or you can certainly purchase hand-held devices that will translate speech as well. This can be important if you need to request medical services and need directions or help, and this can be invaluable if you are in an urgent care clinic or emergency room and need to communicate to the health care providers and no translator is available.
If you need to travel with medical devices (e.g., a CPAP machine, a nebulizer, etc.) that require electrical power, be sure that the country you are traveling to uses the same kind of plugs and outlets as the U.S. (many don’t), or you may need to take a converter with you. Here is a website you can use to determine the different electrical standards countries use https://www.worldstandards.eu/electricity/plug-voltage-by-country/ and I found a helpful picture guide to the different types of plugs here https://www.skyscanner.net/news/international-travel-plug-adapter-guide. You likely can find converters at stores like Walmart or quite a number of options online. Keep in mind that if you are taking a cruise, the plug outlets are likely to be the ones used by the country of origin of the ship rather than the country you are traveling to. Be sure to check with the cruise line or your travel agent.
Consider whether you should purchase a family medical evacuation/air transport plan. I have unfortunately been called a few times over my career by a distressed family member, most often a spouse of someone who very unexpectedly became severely ill and required a prolonged hospitalization. While insurance may cover part or all of the hospitalization abroad, unlike in the U.S. where hospitals accept most insurance plans and don’s submit bills until after discharge from the hospital, foreign hospitals often require cash payments on a daily or weekly basis. Further, not that American doctors aways do a good job of explaining what is wrong with the family member, but I am often told that family members abroad don’t get to talk to the doctor regularly or don’t understand what the doctor is saying. For these, and other reasons, these family members are often desperate to have the patient transported home to a local hospital or at least to a different hospital in an English-speaking country or one with greater capabilities to treat their loved one.
Unfortunately, when patients are very ill, they need to be transported with a medical team that can care for the patient in air and handle any emergencies that might occur en route. Travel more than 150 miles requires a jet. These transports are very expensive (in my experience, even relatively short transports are in excess of $10,000.00. Overseas transports will obviously be far more expensive.
Most often, your medical insurance will only cover air transport if it is not possible for your family member to get the needed care at the hospital where they are. Issues with communication or the hospital requiring cash up front would generally not qualify for coverage under many insurance policies, nor would a request to transport the patient so that you can be closer to home, where there is more family support and doctors who have previously cared for the patient.
Therefore, you may wish to purchase a medical evacuation/transport plan. I have a plan that costs less than $400 per year to cover all members of my household. If you wish to purchase a plan, it is important to understand that not all of these plans are the same, and there are some important questions you should ask prior to purchasing your plan.
Most plans that I reviewed will only provide transportation to the nearest suitable U.S. hospital. For example, if your family member was hospitalized in Mexico, you would most likely be transported to a hospital in South Texas or Southern California, which may feel like a big improvement, but may still be far from home, may cause difficulties for your children who need to get back to school, and is almost certain to be far away from other family and friend support, all while incurring ongoing lodging costs for yourself away from home. There are plans that will cover transportation back to Boise or whatever your nearest local hospital that has the capacity and capability to care for your family member is located.
Another factor in your choice of plan would be whether they will guarantee your ability to fly back with your family member. Many plans will indicate that they may accommodate a family member with a patient, but don’t guarantee it. Obviously, it can be distressing for both family members to be separated from each other, and it is always more difficult for the receiving hospital and doctors when there is no family member available to provide information. Similarly, not all plans will ensure that your luggage will be accommodated on the flight. That may seem like a minor detail, but there are a lot of headaches and expense when you have to arrange for your luggage to be flown to the city you are being transported to and then from that airport to wherever you will be staying, all while you are worried about the welfare of your family member.
Finally, another thing that I like about my plan is that even if my wife and I are travelling domestically, if we were out of state and I wanted to get her back to Boise or she wanted to transport me, this plan would cover that transport.
You would be well advised to wear a high-quality mask in airports and at least while boarding and deplaning. While airplanes generally do have good ventilation and filtration of air, we have a number of well-documented transmissions of SARS-CoV-2 on flights, even to passengers who are not seated close to the index case. Further, keep in mind that ventilation is poor prior to the captain turning the engines on, and often the engines are not on during boarding. Sometimes the captain turns the engines off on the tarmac if there is going to be a significant delay in order to conserve fuel. It only takes seconds for the virus to transmit to a passenger when another passenger walks by who is infected, and that passenger may not even be aware that he or she is infected.
If hospitalization becomes necessary, and the hospitalized family member is a child and you are far from home in another country, you can check to see if there is a local Ronald McDonald House that can provide your family members with lodging while your child is hospitalized https://rmhc.org/our-core-programs?c_src=paid&c_src2=23AOPMsearch_google&&msclkid=36e13d7f148b123697ad5828dc8971a6&gclid=36e13d7f148b123697ad5828dc8971a6&gclsrc=3p.ds. If the hospitalized family member is an adult, you can check with the hospital to see if there is any subsidized lodging or financial assistance for lodging. Alternatively, many hospitals have arrangements with local hotels that will provide discounts or reduced rates to out-of-town family members of patients.
I recommend that you carry medication in your carry-on bag rather than your luggage. First, probably everyone who is reading this has had the experience of lost luggage. Therefore, if you are not going to take all of your medication in your carry-on, at least carry an extra day or two of medication in the event your luggage is delayed. Further, some medications can be temperature sensitive and lose effectiveness if exposed to extremes of temperature for an extended period of time. Cargo bay temperatures can get as low as 45 degrees Fahrenheit. If you do plan to pack medications in your luggage, be sure to check with your pharmacist whether that might create any problems.
I also recommend packing at least a few days of extra medication just in case your plans change or there are unforeseen weather events or other circumstances that would delay your return home.
It may be prudent to take an adequate supply of at-home COVID tests with you that would allow you to test each person who is traveling with you. There are still significant transmission levels of the SARS-CoV-2 virus, and transmission levels may be higher during the holidays.
Every household still has the opportunity to order 4 free at-home rapid antigen tests (2 boxes each containing 2 tests) if you have not already ordered them in the past two months. You can order these free tests at https://special.usps.com/testkits while supplies last. I am not sure you will receive yours in time for your holiday travel, but it is worth a try, and even if not, these can be used to replenish your supply.
If you already have a supply of tests, check the expiration dates to make sure that the tests are current. However, the FDA has recently extended the expiration dates for a number of home tests based on more testing since the agency issued their authorization for the tests. So, before tossing any of your current tests in the trash, check the FDA’s website at https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests#list to see if your test’s expiration date has been extended.
If you are out of tests and don’t receive your free tests in the mail in time, you can find tests at most pharmacies and many grocery stores, and may be better off purchasing them prior to departure rather than searching for them in another country. Moreover, you may be glad you traveled with some tests if there is significant transmission wherever it is you are traveling to, as pharmacy inventory can quickly be exhausted when there is sudden demand. Plus, it is not fun to have to be contacting multiple stores to find out which has tests when you are not feeling well.
Many of the COVID-19 tests are also sensitive to temperature extremes, so I also recommend that you place these in your carry-on luggage rather than your checked bags.
What causes syphilis and how is the infection transmitted?
Syphilis is a disease that results from infection with a bacterium called Treponema Pallidum. Most often, transmission of this infection occurs with sexual activity, regardless of whether homosexual or heterosexual in nature. Generally, transmission results from direct contact with a chancre, which is a syphilitic sore oftentimes resembling a superficial ulcer. The chancre is typically painless; however, exceptions occur such as when the chancre is located on the anus.
Chancres typically appear on the penis, vagina, anus, rectum, lips or mouth. However, the person who is the source of the infection is not always aware that they have a chancre, and the person who becomes infected may not notice the chancre, especially when it is located inside the sex partner’s mouth, vagina or rectum. Thus, transmission most often occurs during oral sex, vaginal intercourse or anal-receptive sex and the chancre develops at the site where the bacteria (often referred to as spirochetes because of their corkscrew-like appearance under the microscope) are inoculated – i.e, on the lips or in the mouth with oral sex, on the penis with intercourse, on the labia or in the vagina with vaginal intercourse, and on the anus or in the rectum with anal-receptive sex. Of great concern is the potential for a pregnant mother to infect their unborn fetus through placental transfer of the bacteria (see below).
Syphilis can be successfully treated with antibiotics.
What is the natural course of infection if left untreated?
After exposure to Treponema Pallidum from sexual contact with someone who is infected, the incubation period (the time period between exposure and subsequent infection until the disease becomes manifest) can range from 10 days to 3 months, but on average is 3 weeks. The resulting disease is referred to as primary syphilis and is generally recognizable by the development of one or more chancres (multiple chancres are more common in HIV-positive individuals). At this point, the patient is contagious and may remain infectious to others for up to a year if untreated. The patient may have enlarged lymph nodes (which most often are not tender) in the area near the chancre. If a woman becomes infected and is not treated, she can transmit the infection to her unborn baby if she becomes pregnant up to four years later.
Even without treatment, the chancre tends to resolve on its own over the course of 3 – 6 weeks, with or without leaving a small scar behind. However, when the patient is not treated for syphilis, the disease most often progresses to secondary syphilis.
Secondary syphilis occurs between 4 and 10 weeks after the initial chancre of primary syphilis. It is difficult to identify secondary syphilis other than by performing a screening blood test based on the patient being at risk due to unknown or multiple sexual partners or suspicion when a wide range of possible rashes appear.
The classic rash of secondary syphilis is one that does not cause itching and appears on the palms of both hands. The other place I always check is the bottom of the feet. The rash can be very faint, so one has to look closely. Secondary syphilis is the great masquerader and may present with rash over the back, areas of hair loss, a patch on the tongue, or condylomas (wart-like skin lesions) over the genital areas (though they can occur in the mouth) that are typically white or gray in color. These rashes can easily be confused with other diseases and conditions.
Some patients will have symptoms during secondary syphilis, such as fever, headache, muscle aches, fatigue, and even weight loss. However, many patients do not report symptoms. The symptoms will resolve with or without treatment. However, if not treated, the disease will most often then progress to latent syphilis, and in some cases, to tertiary syphilis.
Latent syphilis can only be detected with a blood test. There are no rashes or symptoms to suggest that infection is present. The latent stage can last many years.
The dreaded consequences of untreated syphilis are the potential for transmission to an unborn child and the development of the next phase of syphilis called tertiary syphilis. Tertiary syphilis can affect the brain (severe headaches, confusion, dementia, weakness, paralysis), nerves (numbness and loss of sensation), eyes (pain, redness, blurred vision or even loss of vision), heart, blood vessels, liver, bones and/or joints. It also can be fatal.
What is congenital syphilis?
An infected pregnant mother can transmit the infection to the developing fetus with potentially severe consequences to the baby. Therefore, testing for syphilis is recommended in all pregnant moms at their first prenatal visit, especially since physical signs of syphilis are often not evident. If the mom has risk factors for acquiring syphilis (drug use, sex worker, multiple sex partners, homelessness, incarceration or sexual partner has been incarcerated), then repeat testing in the third trimester is indicated.
Untreated syphilis during pregnancy sadly can cause the baby to be stillborn (often after 20 weeks) or tragically, to die shortly after birth in as much as 40 percent of pregnancies.
Babies who survive to be delivered can appear to be normal, but then deteriorate several weeks later. Even if the baby survives, developmental delays and seizures may result. Babies can also have wide-ranging signs of congenital syphilis including rashes, bleeding from the nose, anemia, liver enlargement or jaundice, lung and/or kidney problems, among others. These problems tend to manifest within the first two years of life, whereas toddlers with congenital syphilis can develop a number of deformities and loss of hearing after the age of 2 years.
Unfortunately, more than 3,700 babies were born with congenital syphilis in 2022, more than 10 times the number just a decade ago. It is estimated that 90 percent of these cases could have been avoided with early and proper prenatal care and prompt treatment.
If you have unknown or multiple sex partners, please get testing on a regular basis. If you are concerned about anonymity, contact your local health department for confidential STI (sexually transmitted infections) screenings and testing. Keep in mind, you can have more than one STI. My personal record as a physician is diagnosing a patient with 5 STIs at the same time.
If you become pregnant, be sure to get prenatal care right away and on a regular basis.
For some time now, I have raised the potential for liability against employers in lawsuits brought by their employees for failing to provide certain basic protections against infection with the SARS-CoV-2 virus, especially in the case of health care employers. In the specific case of hospitals and nursing homes, we have already seen a number of lawsuits brought by patients or their survivors when the patient was infected by staff or other patients following their admission to the hospital or nursing home.
It is not surprising that we have not yet seen more lawsuits filed due to the fact that there have been immunity protections offered to hospitals and health care providers by a number of states and, to some extent under federal law, during the early years of the pandemic.
Some of the state legislatures extending limited immunity have allowed those laws to expire, other laws were only in effect during the time the Governor had declared a state of emergency, and in the case of at least one state, the legislature has repealed the immunity provision.
Further, there is some confusion among the courts as to whether federal law (Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 – the “PREP Act”) would extend liability protection to health care providers even in situations where the providers failed to implement or use the countermeasures covered by this law (see below). Much of this law remains in effect under declaration by the Secretary of Health & Human Services; the latest declaration will expire at the end of 2024.
The law does not offer immunity from liability under all situations. For example, an exception stated in the law is death or serious physical injury caused by willful misconduct. (Note that it is the misconduct that must be willful; not that there was intent to cause death or serious injury.) A case involving this situation must be brought in the federal court in Washington D.C.
The act also contemplates that health care providers will make a reasoned decision as to how to deploy covered countermeasures. It appears that even HHS agrees that if a provider fails to act purposefully or fails to make a decision or policy as to how the covered countermeasures are to be deployed, the protections under the act likely do not apply. Further, the defined covered countermeasures in the statute include a number of things, but as to respiratory protection, only respiratory protective devices that are approved by the National Institute for Occupational Safety and Health (“NIOSH”) are covered. By now, all of us have seen many hospital personnel unmasked or merely wearing procedure masks. NIOSH only approves respiratory protective devices (masks and respirators) that are N-95 or greater in quality, thus the use of procedure or surgical masks would not qualify as a covered countermeasure.
Many of the lawsuits brought by patients or their estates allege that the patient contracted COVID-19 because the facility failed to provide its staff with personal protective equipment (“PPE”), failed to teach the staff how to properly use that equipment, or failed to ensure that its staff used the PPE that it had been given. The PREP Act extends its protections to “injuries directly caused by the administration or use of a covered countermeasure[.]” 42 U.S.C. § 247d-6e(a). Thus, the failure to administer or use a covered countermeasure would seem to fall outside of the protections of the statute.
Defendants (health care providers) often seek to remove these cases from state court to federal court in order to avoid state law claims of medical malpractice, ordinary negligence and corporate negligence (which can lead to much larger awards from a jury) by asserting that the immunity provisions of the PREP Act apply and that federal courts have the sole jurisdiction over these cases. In the majority of decisions I can find, plaintiffs have been successful in remanding these cases back to state court under a variety of arguments, including that the PREP Act does not provide for a cause of action (in other words, a basis for bringing a lawsuit) other than the very narrow circumstances of death or serious physical injury resulting from willful misconduct or that the PREP Act does not even apply to the circumstances of the lawsuit.
In a case involving the death of a patient due to COVID-19 while being cared for at a rehab and nursing care facility (Mitchell v. Advanced HCS), the federal district court for the Northern District of Texas remanded the case (i.e., sent it back to state court from federal court) for trial, in large part finding that the PREP Act is an immunity statute, not a statute providing a cause of action (i.e., a basis for a lawsuit) absent the narrow exception stated above. Thus, the state law claims of medical negligence, ordinary negligence and corporate negligence can proceed, and to the extent that the immunity provided under the PREP Act applies, defendants can offer that as a potential defense.
In the case of Grohmann v. HCP Prairie Village, the plaintiff resided in an assisted living facility in order to ensure his safety and care. He contracted COVID-19 while at the facility and it was alleged in the lawsuit that the staff did not seek prompt medical care for his condition contributing to his death two days later. It was further alleged that the employer allowed its employees to work while sick with symptoms of COVID-19 and that the facility failed to train and monitor its staff’s use of PPE to ensure that the virus was not spread among the residents of the facility. It was further alleged that the facility undertook no efforts to isolate those residents with symptoms consistent with COVID-19 and failed to implement an infection control plan to prevent an outbreak of COVID-19 within the facility.
The plaintiff (the estate of Mr. Grohmann) filed their case in state court asserting state law claims of wrongful death, loss of chance of survival, and negligence. The defendant (assisted living facility) sought removal to federal court and the dismissal of all the state law claims based on their claim that the PREP Act was intended by Congress to preempt state law claims.
In deciding these jurisdictional and procedural questions, the federal district court in Kansas first decided that the narrow circumstance that would provide for exclusive federal jurisdiction of death or injury caused by willful misconduct does not apply because the plaintiff did not allege this in his lawsuit. The court then turned to the language in the statue that defines its scope as applying to “injuries directly caused by the administration or use of a covered countermeasure.” The court points out that the phrase “administration or use” is not defined in the statute. So, the court then turns to the Declaration of the Secretary of HHS which gives effect to provisions of the statute noting that it defines “Administration of the Covered Countermeasure means [1] physical provision of the countermeasures to recipients, or [2] activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures.” 85 Fed. Reg. at 79,197.
The court then looks to prior decisions of cases involving the PREP Act decided by the federal district court of Kansas. “In eleven related cases, our court held that the PREP Act was ‘inapplicable’ to plaintiffs’ negligence claims where plaintiff’s ‘case is premised on inaction’ and there was ‘no clear allegation that any injury or claim of loss was caused by the administration or use of any covered countermeasure, let alone that the loss arose out of, related to, or resulted from the same.’” Eaton, 2020 WL 4815085, at *1 n.1, *6–7. The court went on to write, “Eaton reasoned that ‘the PREP Act addresses the administration or use of covered countermeasures. There is simply no room to read it as equally applicable to the non-administration or non-use of covered countermeasures.’” Id. at *8.
The court then went on to cite other federal district courts (including Florida and California) and even state courts (e.g., New York) that have come to the same conclusion.
Acknowledging that the failure to administer or use a countermeasure could still be protected by the PREP Act in the limited circumstance of allocating scarce resources, for example, early in the pandemic when the availability of countermeasures was in short supply and decisions had to be made as to which patients such countermeasures would be offered. In contrast to these rationing kinds of decisions, nonfeasance of simply not using countermeasures that were available would not provide the health care provider with the immunity provided under the statute.
In examining the facts of the present case, the court noted that the “plaintiff alleges that … failures to act directly and proximately caused the alleged harms. As inEaton, plaintiff here alleges that defendants failed to take various preventive measures to stop the entry, spread, and consequences of COVID-19 within the facility and that defendants’ failure to take those precautions led decedent to contract, develop, and die of COVID-19.”
Defendants try to bring the plaintiff’s claims under the reach of the PREP Act by pointing out some of the countermeasures employed by the facility, such as testing and the use of some PPE. However, the court points out that to bring the plaintiff’s claims under the PREP Act, the defendants would have to show that the “decedent’s death was causally connected to the administration or use of any drug, biological product, or device (i.e. a covered countermeasure).” The court goes on to explain, “The claims here are ‘precisely the opposite: that inaction rather than action caused the death.’”
The court then remanded the case to state court finding that the plaintiff’s claims do not fall within the scope of the PREP Act.
Having failed to successfully remove cases to federal court and dismiss state law causes of actions, defendants in cases in which a patient was infected while in their care, but defendants failed to use measures to contain the spread of COVID-19 in their institutions, face the potential for significant liability if plaintiffs can prove their cases in court.
I have not yet seen reported decisions of these kinds of cases in state court. My suspicion is that defendants, recognizing the potential liability they are facing, are settling these cases out of court. On the other hand, I am certain there are some cases proceeding to trial for which discovery and identification of expert witnesses has been underway. I’ll update you as I find reports of the outcomes of these cases.
Meanwhile, there is a related case, but with very different facts and issues presented, that was decided by the U.S. Court of Appeals for the Ninth Circuit (this is the court that handles appeals for federal courts in Idaho) earlier this year. The underlying case is one brought by the family of a deceased San Quentin Prison guard (Gilbert Palanco) against the San Quentin Prison, the state of California, the California Department of Corrections and Rehabilitation and certain specific prison officials, including health care providers, after prison guard Palanco was infected with the SARS-CoV-2 virus while on duty and subsequently died from COVID-19 complications. The defendants had asserted limited immunity under California state law, but the district court denied the grant of immunity. Defendants then appealed this decision to the Ninth Circuit Court of Appeals.
Early in the pandemic, prison officials ordered the transfer of 122 prisoners who were determined to be at high risk due to underlying medical conditions from one prison where there was an outbreak of COVID-19 to San Quentin State Prison where there were no known cases of COVID-19. Not surprisingly, this resulted in an outbreak at the San Quentin facility that killed guard Palanco and more than 25 inmates.
According to the panel of judges hearing the case on appeal, “Plaintiffs sufficiently alleged a violation of Polanco’s substantive due process right to be free from a state-created danger, under which state actors may be liable for their roles in creating or exposing individuals to danger they otherwise would not have faced.”
On appeal, the court does not decide the facts of the case, nor does it render a decision as to the underlying lawsuit. Rather, the court assumes that what plaintiffs allege is true for purposes of determining whether in that case, the defendants would be entitled to the immunity provided under law. In so doing, the panel of judges noted that, “the failure to adequately test or screen inmates prior to the transfer, the transfer itself, and the decision to house the inmates in open-aired cells upon arriving at San Quentin, among other things, placed Polanco in a much more dangerous position than he was in before, the danger was particularized and sufficiently severe to raise constitutional concerns, and defendants were aware of the danger that transferring potentially COVID-positive inmates to San Quentin would pose to employees.”
Harmful to their defense was the fact that prior to this event, California Correctional Health Care Services adopted a policy opposing the transfer of inmates between prisons, reasoning that transfers would “carr[y] [a] significant risk of spreading transmission of the disease between institutions.” Further, there was evidence that all of these prison officials and health care providers had been briefed about the dangers of COVID-19, the highly transmissible nature of the virus, and the necessity of taking precautions (such as social distancing, mask-wearing, and testing) to prevent its spread. Defendants were also aware that containing an outbreak at San Quentin would be particularly difficult due to its tight quarters, antiquated design, and poor ventilation.
Adding to the bad facts of the case, most of the 122 transferred inmates had not been tested for COVID-19 in more than three weeks despite the outbreak existing at the time of transfer, none had been screened based upon a review of symptoms, and the inmates were packed onto buses in numbers exceeding the guidelines set out by the Department of Corrections for inmate safety. Inmates who were showing signs of possible infection upon arrival at the San Quentin State Prison were not quarantined. Two days later, when the county public health officer learned of the transfer, prison officials were advised to immediately sequester the transferees, that mixing of the prison populations be restricted to impede spread of disease and that exposed staff and prisoners be required to mask. Unfortunately, prison officials did not heed this advice and asserted that the public health official had no authority over a state-run prison.
Over the ensuing three weeks, San Quentin State Prison went from no cases of COVID-19 to nearly 500. Medical experts issued a report raising concern of a “full-blown local epidemic and health care crisis in the prison and surrounding communities” if not contained. The Prison’s response was also criticized for the failure of staff and prisoners to be provided with PPE even though it was readily available on site. When staff were provided with masks, due to poor training, many wore the masks improperly. The report also cited unacceptable delays associated with testing. Again, prison officials declined to implement any of the recommendations made in the report and declined testing offered for free by one laboratory.
Not surprisingly, the outbreak continued unabated. By July, more than 1,300 inmates and 184 staff had tested positive. Two months later, those numbers had ballooned to more than 2,100 inmates and 270 staff. As of early September, approximately twenty-six inmates and one guard had died of COVID-19.
Guard Palanco was 55 years old and at high risk due to his underlying medical conditions. Part of Palanco’s responsibilities was to transport ill inmates to health care facilities. Despite these risks, he was not provided with PPE.
In reviewing this case on appeal, the panel of judges took all of the facts of the case to be true for determining whether defendants were entitled to immunity under California law. In doing so, the panel held that plaintiffs sufficiently alleged a violation of Polanco’s due process right to be free from a state-created danger. The Fourteenth Amendment of the U.S. Constitution mandates that “[n]o State shall . . . deprive any person of life, liberty, or property, without due process of law.” The court pointed out that under the state-created-danger doctrine, state actors may be liable “for their roles in creating or exposing individuals to danger they otherwise would not have faced.” Liability ensues when state employers affirmatively, and with deliberate indifference, create or expose their employees to a dangerous work environment.
Interestingly, the defendants in this case also argued for immunity under the PREP Act, however, the district court denied the request finding that the PREP Act did not apply.
The court of appeals affirmed the holding of the district court, meaning that the case will now be returned to the district court for trial and the defendants will not be able to assert statutory immunity as a defense.
I have been quite shocked by the lack of infection control measures undertaken by hospitals, as well as their lack of transparency. I don’t know whether this results from poor leadership or disregard for patients under the mistaken assumption that they will have immunity from legal responsibility. However, I encourage health care leaders and boards to consider the court decisions to date to reassess their policies and procedures. Consider carefully cases of high-risk patients that are now at higher risk in a hospital, where they come to for treatment and healing and rely on care from health care professionals, than they would have been at home.
When I was CEO of a hospital and later, a health system, I placed patient and employee safety at the forefront of all my decisions. While I wished we lived in a world where all health care leaders did the right thing because it was the right thing, the realities are far more complex. However, the risk calculations are shifting with these court decisions to date, and I urge boards and leaders to at least proceed with open eyes, being aware of the risks of what I think will soon be a large number of trials and settlements, and all the associated costs, not to mention reputational damage and loss of the public’s trust.
When a novel virus (novel means a new virus or new strain of virus to which the population would not be expected to have preexisting immunity, and little, if any, cross-immunity [i.e., immunity to other strains of viruses that might be similar enough to provide some protection against the new strain based upon prior infection or immunization against the prior strain]) emerges in a human population and is sufficiently virulent so as to make individuals uncomfortably sick or severely ill, patients will present to emergency rooms and some will be admitted to the hospital, oftentimes, hours or days before the infecting pathogen is identified.
If the virus is efficiently transmissible and health care workers and organizations have not taken appropriate steps (personal protective equipment [PPE] and air handling), those health care workers, staff, patients and visitors within sufficient proximity to the infected patient may be infected. This is a common problem in third-world countries when outbreaks first occur, and unfortunately, it is not unusual for some nurses and doctors to become severely ill or even die.
In 2014, a patient presented to a Dallas emergency room following international travel with a disease we fortunately do not see in the U.S., except in international travelers, almost always those arriving from an African country. Unfortunately, this patient had an infection with Ebola virus that more often than not results in death. Fortunately, it is not among the most transmissible of viruses that we deal with.
Nevertheless, to understand the potential public health threat of this one patient becoming ill in the U.S., 48 individuals had close contact with him after he became ill, but before he presented to the hospital, and another 76 hospital workers cared for him after he presented to the hospital. Two nurses ended up becoming infected, and of course, there were many health care workers who then were required to care for these two new patients. Thus, one can see how a single infected person could expose hundreds of people directly, and then this can be amplified through other people who have subsequently been infected. This is one way in which disease outbreaks can occur, and, under the right circumstances, an outbreak could lead to an epidemic, or rarely, even a pandemic.
The patient with Ebola unfortunately died from his disease. Fortunately, both nurses recovered.
In Wuhan, China, patients began to be admitted to the hospital in December 2019 with an illness that resembled severe acute respiratory syndrome (SARS), which had created an epidemic in 2002 – 2003, but not with the same virus that had caused these new cases of disease. It would subsequently be determined in early January that this new disease outbreak was being caused by a novel coronavirus, which would subsequently be named SARS-C0V-2 to distinguish it from the SARS-CoV that had caused the 2002 – 2003 disease outbreak. Unfortunately, 3,387 health care workers in China had been infected as of February 24, 2020. Many of them no doubt were infected in caring for patients, however, some number of them likely were infected by colleagues or even outside of the hospital with the emergence of community spread of disease. In the U.S., as well, even with our advance notice of this emerging novel viral pandemic, many health care workers were infected while caring for patients, in some cases due to shortages of PPE, but also from family members, children and other close contacts.
In many ways, we have been fortunate that, in the case of the Ebola exposure in Texas, most of those who were exposed did not become infected, and that in the case of SARS-CoV-2, the case fatality rate was not higher. Nevertheless, both examples demonstrate how quickly a novel virus could spread if highly transmissible, given the number of contacts a sick patient is likely to have, and the multiplier effect that would occur if the infectivity (the proportion of those exposed who will develop infection) was very high.
We know that hospital-based spread of infection was an important factor in both prior novel coronavirus disease outbreaks – SARS-CoV in 2003 (Cooper, B. S. et al. Transmission of SARS in three Chinese hospitals. Trop. Med. Int. Health14, 71–78 (2009)) and Middle East Respiratory Syndrome coronavirus – MERS-CoV in 2012 (Cowling, B. J. et al. Preliminary epidemiological assessment of MERS-CoV outbreak in South Korea, May to June 2015. Euro Surveill.20, 7–13 (2015). In the case of SARS, the study of three Chinese hospitals demonstrated that transmission rates were higher within hospitals than within communities. In the case of MERS, in a Korean outbreak of the disease, 75 – 89% of infections could be traced to three nosocomial (within hospital) super-spreading events.
A study published last month (The burden and dynamics of hospital-acquired SARS-CoV-2 in England | Nature) attempted to study the burden (amount of disease) and transmission dynamics (how the virus spread) of SARS-CoV-2 within a hospital in England. They examined data from 356 hospitals (excluding children’s hospitals). The differentiation between patients who were infected in the community versus those who acquired the infection following hospitalization was determined on the basis of the interval from the time of hospital admission to confirmed PCR testing for SARS-CoV-2 infection. Community-onset infections were defined as those with an interval of 2 d or less; an interval of 3–7 d led to a classification of indeterminate healthcare-associated; those with intervals of 8–14 d were classified as probable healthcare-associated; and those with intervals of 15 d or more were classified as definite healthcare-associated.
This is not merely an issue of academic interest. Widespread transmission of a virus within hospital can impact the public’s health in many ways. The most obvious is that when health care workers are exposed, they may need to be removed from the workforce temporarily in quarantine, even if not ill. Obviously, if those health care workers become ill, they need to be in isolation and also are unavailable to care for patients, at a time when we already have many shortages of health care workers.
Health care workers in quarantine or isolation may, in turn, inadvertently infect household members or close contacts, which can further contribute to spread of the virus in the community and burden hospitals with more infected patients.
Shortages of health care workers then mean increased expenses for hospitals to pay over-time and, if the shortages are severe enough, significant increased costs to hire temporary replacement staff. Overtime work, temporary staff who are working in a hospital that they are new to and perhaps in an area of care that they are less experienced can result in quality-of-care issues. Further concerns for patient safety and quality of care occur when health care shortages are severe enough or the number of patients being admitted are so high as to result in staff being pulled to care for patients from areas where they don’t deal with these kinds of patients on a regular basis or when patients must be overflowed into areas where these types of patients are not normally cared for.
Further, because patients admitted to the hospital for reasons other than the disease outbreak tend to be very young or elderly and/or immunocompromised, patients who become infected while in the hospital (nosocomial infections) tend to have much higher rates of serious disease and mortality than seen in the general population.
The researchers in the study referenced above estimated that between June 2020 and March 2021 between 95,000 and 167,000 inpatients acquired SARS-CoV-2 in hospitals (definite or probable) in England (1% to 2% of all hospital admissions in this period). Further, the evidence demonstrated that patients who themselves acquired SARS-CoV-2 infection in hospital were the main sources of transmission to other patients. Health care workers, on the other hand, were as likely to be infected by fellow health care workers as patients. Once vaccinated, the rate of infection among health care workers dramatically reduced.
All of this demonstrates the importance of early identification and prompt initiation of infection control measures for patients with new hospital-acquired infections and for other patients they may have infected. Further, these studies reinforce the need for measures that reduce transmission from patients with asymptomatic infection in non-COVID-19 hospital areas, including improved ventilation, use of face coverings by patients and staff, increased distancing between beds, minimizing patient movements within and between patient care units and promotion of hand hygiene. The findings also support efforts to prioritize health care workers (HCWs) for COVID-19 vaccination both due to direct protection to HCWs and due to indirect protection offered to patients. Finally, the findings highlight the need to prioritize research into effective methods of reducing hospital transmission of airborne pathogens for which evidence is currently mounting, including patient care unit design and air filtration systems.
In May of 2020 at the World Health Assembly, a resolution was passed recognizing that managing mis-and disinformation would be critical to managing the COVID-19 pandemic, and then on September 23, 2020, the World Health Organization (“WHO”) declared an “infodemic” in a joint statement by the WHO and United Nations with respect to the COVID-19 pandemic in which “false or misleading information in digital and physical environments during a disease outbreak” had become excessive. The organizations pointed out that COVID-19 is the first pandemic in history in which technology and social media was used to further the public health aims of containing and controlling the pandemic, but also in “amplifying an infodemic that continues to undermine the global response and jeopardizes measures to control the pandemic.” They also pointed out that “Mis- and disinformation can be harmful to people’s physical and mental health; increase stigmatization; threaten precious health gains; and lead to poor observance of public health measures, thus reducing their effectiveness and endangering countries’ ability to stop the pandemic.”
The WHO pointed out that false and misleading information “causes confusion and risk-taking behaviours that can harm health. It also leads to mistrust in health authorities and undermines the public health response. An infodemic can intensify or lengthen outbreaks when people are unsure about what they need to do to protect their health and the health of people around them. With growing digitalization – an expansion of social media and internet use – information can spread more rapidly.”
On July 14, 2021, the U.S. Surgeon General issued an advisory entitled: “Confronting Health Misinformation.” In it, Surgeon General Vivek Murthy stated: “Health misinformation is a serious threat to public health. It can cause confusion, sow mistrust, harm people’s health, and undermine public health efforts. Limiting the spread of health misinformation is a moral and civic imperative that will require a whole-of-society effort.”
The report goes on to state: “Misinformation can sometimes be spread intentionally to serve a malicious purpose, such as to trick people into believing something for financial gain or political advantage. This is usually called ‘disinformation.’”
On July 29, 2021, The Federation of State Medical Boards (“FSMB”) issued a public statement entitled: “Spreading COVID-19 Vaccine Misinformation May Put Medical License at Risk” to address what it reported as a “dramatic increase in the dissemination of COVID-19 vaccine misinformation by physicians and other health care professionals on social media platforms, online and in the media.” The statement reads as follows:
Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license. Due to their specialized knowledge and training, licensed physicians possess a high degree of public trust and therefore have a powerful platform in society, whether they recognize it or not. They also have an ethical and professional responsibility to practice medicine in the best interests of their patients and must share information that is factual, scientifically grounded and consensus-driven for the betterment of public health. Spreading inaccurate COVID-19 vaccine information contradicts that responsibility, threatens to further erode public trust in the medical profession and puts all patients at risk.”
On September 9, 2021, the American Board of Family Medicine, the American Board of Internal Medicine, and the American Board of Pediatrics issued a “Joint Statement on Dissemination of Misinformation” expressing support for the FSMB’s statement above, but going further and stating the following:
“We also want all physicians certified by our boards to know that such unethical or unprofessional conduct may prompt their respective board to take action that could put their certification at risk.
Expertise matters, and board certified physicians have demonstrated that they have stayed current in their field. Spreading misinformation or falsehoods to the public during a time of a public health emergency goes against everything our boards and our community of board certified physicians stand for. The evidence that we have safe, effective and widely available vaccines against COVID-19 is overwhelming. We are particularly concerned about physicians who use their authority to denigrate vaccination at a time when vaccines continue to demonstrate excellent effectiveness against severe hospitalization and death.”
On May 23, 2023, the U.S. Surgeon General issued a new advisory entitled: “Confronting Health Misinformation.” In the advisory, Surgeon General Murthy states: “Health misinformation is a serious threat to public health. It can cause confusion, sow distrust, harm people’s health, and undermine public health efforts.” A critical point, in my opinion, is the statement: “Limiting misinformation helps us make more educated decisions for ourselves, our loved ones, and our communities.” In the report, misinformation is defined as: “information that is false, inaccurate, or misleading according to the best available evidence at the time.”
The Surgeon General’s advisory also calls out the harmful effects of misinformation during the COVID-19 pandemic: “During the pandemic, health misinformation has led people to decline vaccines, reject public health measures, and use unproven treatments. Health misinformation has also led to harassment and violence against health workers, airline staff, and other frontline workers tasked with communicating evolving public health measures.”
On August 15, 2023, a study entitled Communication of COVID-19 Misinformation on Social Media by Physicians in the U.S. was published in the Journal of the American Medical Association Network Open (https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2808358). The authors point out that approximately 1/3 of the >1.1 million confirmed COVID-19-related deaths in the U.S. as of January 18, 2023, “were considered preventable if public health recommendations had been followed.”
The authors of this study examined a time period beginning just after COVID-19 vaccines became available to the public (January 2021) through the end of the following year (December 2022). They identified 52 physicians in 28 different specialties across all regions of the United States who repeatedly spread COVID-19 misinformation using social media. They found that nearly one-third of these physicians were affiliated with groups with a history of spreading medical disinformation, such as America’s Frontline Doctors.
Several books are planned for publication later this year and early next year examining the coordinated efforts by some of these physicians and organizations sponsoring them, as well as some of the money fueling these efforts. The challenge is that while there appears to be very well-funded and coordinated disinformation campaigns, the medical organizations that could respond to protect the public were very uncoordinated, and often stood on the sidelines not knowing how to respond or simply choosing not to.
Hospitals and physicians witnessed first-hand the harm of disinformation causing deceived individuals to show up in their emergency rooms and intensive care units still refusing to believe that they had COVID-19 or surprised that the ivermectin or hydroxychloroquine or other concoction of vitamins and supplements did not prevent their severe disease, while public health individuals watched in frustration as these physicians (including two physicians from America’s Frontline Doctors who served in one case as a state surgeon general and in the other a member of a public health board) undermined public health measures and thwarted efforts to protect the public.
What I present here is basically a strategic plan for the Federation of State Medical Boards; state medical licensing boards; specialty boards that certify physicians; national, state, and county medical professional associations and societies; specialty organizations; and hospitals to respond to the disinformation campaigns that will undoubtedly be repeated during future pandemics. It has commonly been said that “nature abhors a vacuum,” but it can just as well be stated that truth abhors a vacuum. That is because disinformation campaigns are enabled when true experts and authoritative organizations remain silent.
The Problem to be Addressed
This proposed national response is very focused and directed at:
Physicians who represent themselves as physicians and who promote their education, training, medical licensure, board certification, and/or knowledge and experience in order to gain the trust of their audience in an effort to influence the public about measures that should be taken or avoided regarding prevention, diagnosis and treatment of a disease;
Who utilize social media or other press, media and public forums;
To disseminate medical information that the physician knows to be false, should know is false or with reckless disregard as to whether the information is true or false;
With such information being harmful to, or having the potential to harm, the public if followed; and
Who continue to spread the medical information after the WHO, FDA, CDC, FSMB, state licensing boards, specialty certifying boards, and/or national professional associations have issued public statements or posted statements to their websites that indicate the information is false, incorrect, or inconsistent with the scientific evidence.
In other words, physicians who are touting their credentials to gain the public’s trust, while disseminating medical information that they know to be false or should know that is false repeatedly and over an extended period of time, and continue to do so after public statements by authoritative professional bodies or warnings (see below).
The reasons for this very limited and targeted focus include:
This provides the best opportunity to defeat legal challenges of adverse actions (see below for a discussion of these legal issues).
Science, medicine and technology evolve. With that evolution, we learn new things, we develop fuller understandings of things we previously have studied, and sometimes we learn that what was previously known is no longer true or is no longer completely true. With this evolution in our knowledge and technology, the way we evaluate, diagnose and treat conditions also evolves and new best practices emerge. The statements and practices of physicians should only be judged based upon the evidence, the consensus of experts and the prevailing practices at the time of the statements.
We do not want to penalize physicians who are trying to help the public and their patients during a time of uncertainty for simply being mistaken or not being aware of a recent new study. Rather, these efforts are focused on those physicians who are acting irresponsibly, in an ongoing fashion even after being put on notice or forewarned, promoting information that is contrary to the weight of the evidence or public guidance by professional and expert organizations without acknowledgement of that fact.
The Harms or Potential Harms that Need to be Addressed
Medicine has become a more complicated and expansive field given the explosive growth of knowledge in the field related to scientific discovery; new scientific methods; and advances in our studies and understanding of the fields of genetics, immunology, molecular and cell biology, virology, imaging techniques, genomics, vaccinology, proteomics, precision medicine, among others. Because of this complexity, rapid rate of new developments, and confusing messaging from advertisements for medications, supplements, treatments and non-traditional therapies, the public often relies on advice from physicians, whether during a visit with their own doctor, or from listening or reading the advice of doctors who provide guidance to the public on television and radio, in articles or on social media platforms.
Physicians are trusted sources for information by the public because of their extensive education, training, experience, expertise, ethical principles guiding the profession, and oversight and regulation. The public is generally unaware that there is little oversight and regulation of physicians providing guidance to the public, nor that some physicians may be violating their professional and ethical norms due to ideology, political aspirations and financial conflicts that place their own self-interests over the interests of the public.
An ethical and legal foundational duty imposed upon physicians in the practice of medicine is that of informed consent. Informed consent requires that we explain the medical condition to the patient or their legal decision-maker as accurately as we can as well as the treatment options, including the risks and benefits of each, as well as the risks and benefits of not undertaking any treatment. It is an abuse of the informed consent process to be untruthful or to manipulate patients to undergo treatment that is ill-advised or that places the physician’s interests over those of the patient. Doing so not only has the potential to harm patients, but undermines the public trust in the medical profession.
There is no doubt that an unscrupulous physician can harm many patients in their medical practice. But, the potential number of patients harmed will be constrained by the physical limitations of how many patients a busy physician can see and provide dangerous advice to. On the other hand, social media has enabled unscrupulous physicians to reach a much wider and broader audience, and those readers or listeners have the opportunity to further amplify these messages among those in their social networks, potentially harming far greater numbers of people.
As the article I cited above indicates, “approximately one-third of the more than 1,100,000 confirmed COVID-19-related deaths as of January 18, 2023, [in the U.S.] were considered preventable if public health recommendations had been followed.” Of course, a main focus of disinformation purveyors was sowing doubt and distrust of the COVID-19 vaccines, while not communicating any of the benefits. “As of December 2022, estimated death rates for unvaccinated persons in the US were 271 per 100,000 compared with 82 per 100,000 for those fully vaccinated, yet only 69.2% of eligible people had received the full primary vaccine series, and 15.5% had received the bivalent booster.”
Informed consent cannot be attained when physicians present a medication or treatment as perfectly safe without acknowledging potential side effects and adverse effects, nor when a medication or treatment is promoted as wholly ineffective or dangerous without acknowledging the potential benefits, nor when a medication is promoted as effective when the weight of the evidence fails to establish benefit and the FDA and the pharmaceutical company that produce and distribute the medication release public statements discouraging the use of the medication due to lack of effectiveness. In cases where a medication or treatment has benefits that outweigh the risks at the population level, a physician who knowingly promotes those medications or treatments to the public as dangerous and of no benefit is using their medical degree, license, education and training, board certification and/or expertise to manipulate people’s medical decisions at the best and harm people at the worst, in a manner that is always immoral, unethical and unprofessional. I have never read a medical practice act that didn’t prohibit these behaviors.
This focus on excess deaths in the above article resulting, in part, from disinformation campaigns, fails to capture the full breadth of harm from COVID-19 disinformation. We now know that these reported deaths undercounted the total deaths, because deaths as a consequence of COVID-19 are increased in at least the 12 months that follow recovery from the acute infection, but are often not attributed to COVID-19 in death certificates when the death occurs more than 30 days following the acute illness. Further, deaths, in of themselves, fail to capture the full impact of the harms – the consequences of the loss of a spouse to the remaining spouse, especially when the spouse who died was the main financial support for the family and source for health insurance, nor the impact on children when the death is that of a sibling or one or both parents or their caregiver. Further, death counts fail to measure the financial impact to families when the family member required a prolonged hospitalization or required prolonged follow-up medical services, when the affected family member develops Long COVID and no longer can work or must reduce the amount they work, and other consequences of COVID-19 short of dying. There are other long-term potential health consequences of SARS-CoV-2 infection that we don’t yet fully recognize or understand and that have not yet been quantified.
The Legal Issues
There are several potential legal barriers that must be overcome, but they are not insurmountable.
First Amendment protections for speech.
The First Amendment provides for the protection of some, but not all speech. The intents of promoting the marketplace of ideas and debate, especially debate of a political nature, are cherished rights of a free nation and democracy. While the jurisprudence around the First Amendment is not complete (e.g., there remains little guidance around the category of what is commonly referred to as professional speech), nor even always consistent, it is clear that not all speech is entitled to the same degree of protection, and some speech is not protected at all (e.g., obscenity, child pornography, and certain hate speech). Furthermore, even some protected speech can be regulated if there is a compelling government interest and the restriction is narrowly tailored to satisfy that interest.
Examples of where restrictions on free speech have been permitted include speech in courtrooms (one cannot successfully defend a charge of lying under oath (perjury) with a First Amendment defense, nor would the First Amendment allow a defendant to speak over a judge or a witness in a proceeding), false advertising, mislabeling of medications, defamation (slander and libel), impersonating a police officer, and making terroristic threats.
One can see a recurring pattern that tends to characterize speech for which restrictions are constitutional – those areas of speech that cause or may cause harm to others:
perjury – harm to the effective administration of justice, including the potential for wrongful convictions and imprisonment of defendants;
false advertising – financial harm to purchasers;
mislabeling of medications – physical harm to those who take those medications;
defamation – harm to another’s reputation and potential financial harm to a business;
impersonating an officer – potential physical harm to someone wrongfully detained; and
terroristic threats – harm to someone’s security and rights to be left alone.
Also, notice most of the above examples also involve false speech. In those instances, false speech that harms has no value under the First Amendment and is entitled to no protection. Supreme Court holdings in the ‘70s and ‘80s included such statements as “[u]ntruthful speech, commercial or otherwise, has never been protected for its own right,” false statements “are not protected by the First Amendment in the same manner as truthful statements,” and [f]alse statements of fact are particularly valueless [because] they interfere with the truth-seeking function of the marketplace of ideas.”
However, the Supreme Court has not gone so far as to hold that all false speech is valueless or beyond the protection of the First Amendment. Although it is not explicitly clear where the Supreme Court will draw the line, we can get a pretty good idea from at least two decided cases. In one, the Court wrote that “the knowingly false statement and the false statement made with reckless disregard of the truth, do not enjoy constitutional protection.” Garrison v. Louisiana, 379 U.S. 64, 75 (1964). This holding gives us the perspective of the Court that knowingly false statements (disinformation as opposed to misinformation) could be subject to discipline without violating the physician’s First Amendment rights to free speech. Moreover, a more recent case gives us an additional insight that ties back to the examples of prohibited speech listed above. In United States v. Alvarez, 567 U.S. 709 (2012), the plurality stated: “even where the utterance is false, the great principles of the Constitution which secure freedom of expression … preclude attaching adverse consequences to any except the knowing or reckless falsehood. Although the plurality struck down the statute in question on First Amendment grounds as being overly broad in its proscription, in a separate concurring opinion by Justice Breyer and joined by Justice Kagan, these justices suggested that a similar statute, more narrowly tailored to avoid situations where a specific harm is likely to occur, could survive a legal challenge on the basis of the First Amendment. In fact, Congress amended that statute to require proof of fraud, and so far, that statute has not been successfully challenged.
In summary, the cumulative jurisprudence on the First Amendment’s right to freedom of expression would seem to allow government regulations and actions against physicians for disinformation when the following can be shown:
the statements are knowingly false or the false statements were made with reckless disregard of the truth;
the statements have caused or are likely to cause harm; and
the prohibition is narrowly tailored to prevent the speech that is causing or likely to cause harm.
Issues relating to State Medical Board jurisdiction
As I stated above, I haven’t seen a medical practice act that doesn’t proscribe unethical or unprofessional conduct. Nevertheless, various excuses have been offered by medical boards that have declined to institute investigations into complaints about licensees spreading disinformation to the public. I will list some of these excuses and explain why they fail to be barriers to investigations and discipline.
Excuse #1 – Offering medical advice to the public is not the practice of medicine. Of course, medical licensing boards do regulate more than “the practice of medicine,” including such things as false or misleading advertising or even taking action against licenses of physicians convicted of felonies not involving the practice of medicine. The practice of medicine is defined in each state’s medical practice act. Many statutes may need to be updated to reflect the changing nature of medical practice. Today, the practice of medicine has expanded to virtual care and telehealth services that were not technologically possible in decades past, and when available more recently, were not particularly common until the COVID-19 pandemic. If the state legislature is inclined to revise and update the medical practice act, consideration should be given to expanding the definition of the practice of medicine to encompass situations where the physician is holding themselves out to be physicians in providing medical advice to the public, including when that advice is to refrain from receiving a treatment or medication that is ordered or prescribed by a physician.
Excuse #2 – The state board cannot investigate or discipline a physician for conduct outside of the physician-patient relationship, and in providing medical advice on television, the internet or social media, there is no physician-patient relationship. However, state boards do this all the time. If a physician is determined to have submitted false information to the board upon which the board relied in granting the physician a license, the board can act, even if the physician has seen no patients yet. There are many cases of persons holding themselves out as physicians who are not, and the boards regularly submit cease and desist orders. Obviously, if they are not physicians, they cannot have physician-patient relationships. Further, there are instances in which physicians and charged with or convicted of crimes that have no direct connection to a physician-patient relationship (e.g., murder, child pornography or sexual assaults) in which cases the state board may discipline or suspend a physician’s license even though no physician-patient relationship was at issue.
The Plan
State licensing boards
Examine your medical practice act to determine whether the board would have the authority to investigate and discipline a physician for disinformation under current provisions, such as unprofessional conduct.
If not, consider whether your legislature would be willing to consider an amendment to the medical practice act to expand the board’s authority. The key guiding principle is that the licensing boards should protect the public from unscrupulous physicians knowingly presenting disinformation holding themselves out to be licensed physicians or experts in the matters that are the subject of their false statements.
Strongly consider posting notices to your public website and in the board’s physician newsletters that put physicians on notice that certain medical guidance being promoted to the public is false, incorrect, misleading or unsupported by the weight of current evidence. A physician’s ongoing spread of disinformation after such notice should help demonstrate the intent necessary to support disciplinary action and overcome a First Amendment challenge.
An even stronger support for disciplinary action can be made by sending a physician who continues to spread disinformation notice and a demand to disclose their basis for continuing to publicly promote false statements and then issuing the physician a warning if that basis is inadequate to support those false statements.
If the licensing board’s general counsel still feels uncomfortable in pursuing these cases of public disinformation due to the absence of a physician-patient relationship, then the publicly promoted false statements should be sufficient basis to investigate the physician’s medical practice to determine whether the physician is advising and treating patients in accordance with their incorrect advice to the public, and if so, this would form the basis for discipline without any First Amendment challenge having a chance of being successful.
The Federation of State Medical Boards (FSMB)
The FSMB should assemble expert panels to review the evidence related to the medical disinformation physicians are providing to the public and provide the basis and the studies that support the falsity of the disinformation.
The expert panels should provide a review of the evidence in a report that can be posted to their website and distributed to the state licensing boards.
The report should also identify the current or potential harms to the public that can result from the public following the disinformation advice that physicians are presenting to the public so that state licensing boards can prove that the physician knew or should have known that the statements they were providing to the public were false, but also demonstrate the harm or potential harm that could result from the public following the misguided advice. Together, this evidence should help a state licensing board to be able to overcome a First Amendment challenge in the discipline of a physician.
WHO and CDC
The CDC and WHO must remain above the political fray and remain objective without compromising their positions to outside pressure from non-experts with political or ideological agendas.
It is essential that the WHO and CDC present clear, easy-to-find information on their websites that reviews and synthesizes the accumulated knowledge from epidemiological data and scientific studies along with references.
Ideally, reviews of our accumulated knowledge would be presented concisely and without scientific and medical jargon for the public and in a more detailed and scientific manner for health care professionals. This information should be updated regularly, with a clear indication as to the date of the update, and in the review for health care professionals, there should also be an extensive list of references from which the best evidence is derived.
There should also be a site on both organizations’ websites where commonly spread disinformation is refuted in a clear and convincing manner. Not only must we refute this disinformation to the public, but we must provide journalists and reporters with the information needed to avoid inadvertently further spreading that disinformation and to refute disinformation and to challenge those physicians spreading the disinformation.
Specialty certifying boards
Clear statements should be made public and disseminated to all their diplomates by all specialty boards similar in nature to the joint statement by the American Boards of Internal Medicine, Family Medicine and Pediatrics provided in the introduction above.
Drawing from the reports recommended to be issued by the WHO, CDC, FSMB, and state licensing boards, specialty boards should convene expert panels to review the best evidence to date and publish consensus statements as to the best evidence in their fields.
These reports should be regularly updated, fully referenced and a clear date indicated as to when the report was last updated.
So too, reports should be posted as to disinformation being propagated by physicians and a clear analysis as to why it is false and/or misleading. This information should be provided on the website and in the professional publications of the board in order to place physicians spreading disinformation to the public on notice that the information they are purveying is contrary to the weight of the current evidence.
Specialty boards are private organizations and thus not subject to the First Amendment free speech obligations in the way governmental agencies are. Too often, specialty boards have deferred discipline to state licensing boards, which are more limited in the actions they can take than are specialty boards. Further, lack of action on the part of specialty boards may ultimately become an existential threat. Physicians seek board certification for a number of reasons. One is the mark of distinction it has represented that a physician has mastered and is current in their knowledge and skills of the specialty. Obviously, allowing board-certified physicians who knowingly convey false medical information to the public and continue to do so even after notice that their statements are not supported by the weight of the current evidence undermine the publics and the profession’s confidence that board certification is a meaningful distinction of current knowledge and expertise in the field. Another reason for board certification is to satisfy the credentialing requirements for medical staff membership or for participation in an insurance network of providers. However, the failure to discipline diplomates, including revoking board certification, will not only undermine the credibility of board certification, but also make these requirements for board certification less legally defensible, and in the end, likely result in fewer physicians seeking board certification or recertification, fewer hospitals giving weight to board certification in their credentialing process, and fewer managed care networks using board certification as a factor for the participation in their networks.
Professional associations and medical societies
Professional organizations and medical societies should also undertake efforts to disseminate to their memberships updates as to the best evidence on emerging health issues that are receiving interest by the public in the media, press and on social media.
Similarly, they should be proactive in attacking disinformation head on and providing the evidence as to the falsity of that information.
Professional associations, and perhaps to a lesser extent, medical societies, are highly dependent upon their reputations because membership is seldom required for physician employment, medical staff membership or insurance plan participation. Therefore, professional associations and medical societies should protect those reputations and censure those among their membership who persist in spreading disinformation publicly, including revoking designations of advanced standing such as fellow or master designations.
Hospitals
Hospitals are also negatively impacted by the spread of medical disinformation. Disinformation may undermine efforts to protect their own staff, decrease the willingness of staff to employ protective measures, and result in increased absenteeism, staffing shortages, increased employee health care costs, and decreased worker productivity. Hospitals are also often one of the most trusted and valued voices in their communities. They, especially non-profit, tax-exempt hospitals, must be sources of truth and must educate their communities so that those who want to protect themselves will have the best available information to do so.
Hospitals should consider revising their medical staff bylaws to make clear that the role of the hospital and its medical staff is to serve the needs of their communities. Those needs can only be served when people are provided with truthful and accurate information that allows them to make an educated decision based on the risks and the benefits, as well as their own personal values in deciding the best course of action for themselves and their minor children. Health care professionals should never coerce or manipulate people’s health care decisions. Doing so can negatively impact the hospital’s reputation, harm people and is inconsistent with the mission and values of the hospital. For these reasons, ongoing spread of disinformation to the public when the physician knows or should know the statements to be false, and when those statements, if followed by the public, causes or can cause harm, should be a basis to deny medical staff membership or to discipline current members of the medical staff. Providing medical staff members who are spreading disinformation with a notice of concern and allowing them an opportunity to present their evidence to support their misstatements prior to taking adverse action will provide an opportunity for the physician to be educated and, if the physician persists in their misinformation campaign, will help satisfy due process requirements.
If specialty boards do not also take actionable steps to put their diplomates on notice and discipline those who continue to spread disinformation, hospitals and insurance companies should consider lessening or eliminating considerations regarding board certification for medical staff membership.
Conclusion
The popular quote, “The only thing necessary for the triumph of evil is for good men to do nothing,” is apropos to the crisis of disinformation.
There is mounting evidence and a growing consensus that health disinformation spread by physicians touting their medical credentials and expertise is harmful to the public, undermines public health efforts during public health threats, and adversely impacts trust in science, public health and medicine. This conduct on the part of physicians is also contrary to the professional and ethical guidelines of our profession.
Disinformation campaigns have benefitted from significant funding and coordination. Efforts to combat disinformation will not succeed with individual scientists and physicians carrying the responsibility on their shoulders. It is critical that the WHO, CDC, FSMB, state medical licensing boards, national specialty boards, professional associations and medical societies, and hospitals all step up and reinforce each other’s efforts to report and update the weight of the current evidence, to call out disinformation and to take action against those physicians who continue to repeatedly spread disinformation to the public on television, radio, cable networks, the internet and social media.
Concerns about legal challenges can be overcome in a number of ways as presented above. The keys to success are that these organizations must be clear about the weight of the evidence; update that evidence; refute misinformation and disinformation; place physicians on notice about their spread of disinformation; offer those physicians an opportunity to provide the evidence to support their positions, but if not persuasive and the spread of disinformation continues, then all of these organizations should take the relevant action against these physicians without deferring to other organizations to do so. The keys to successful actions are demonstrating that (1) the physician knew or should have known that their statements were false, inaccurate or misleading, or that the physician acted with reckless disregard as to the truth or falsity of their statements; and (2) that the statements harmed or had the potential to harm members of the public who followed the advice provided by the physician.
This proposed response to disinformation does not deprive physicians of their ability to challenge the medical consensus or to raise concerns. For example, one physician repeatedly reported to the public that he had seen a marked uptick in the number of cancers in his practice following the availability of COVID-19 vaccines. The proper venue to disclose his findings would be to the FDA, the CDC, or his professional organizations or to organize a clinical study to investigate the issue. It is not responsible behavior to use this assertion that was unverified and unvalidated to scare the public, when that physician would not have a basis for establishing COVID-19 vaccinations as the cause as opposed to SARS-CoV-2 infections themselves or other potential causes, was promoting other false information, a similar increase in cancer rates had not been identified anywhere else in the world despite the world-wide distribution of these vaccines, and the fact that this physician was later alleged to have made cancer misdiagnoses. Physicians remain free to express concerns or fears to the public, however, they need to be clearly identified as such, rather than represented as fact.
I have been asked many times in the last few weeks, especially now that we are having signs of a new surge (as a reminder – when I use the word surge, I mean a significant and sustained increase in COVID-19 cases; I am not using it as an indicator of magnitude, i.e., that the number of cases, or hospitalizations, or whatever indicator one might wish to use, has or will hit some arbitrary threshold) – whether one should get a bivalent booster now (if they never received a bivalent booster or if they qualify for two and got the first, but not the second) or wait for the new monovalent boosters that are planned for this fall.
The FDA has indicated that they advised vaccine manufacturing companies of their intention to move to an annual COVID-19 vaccine update. In June of this year, the FDA provided guidance to these companies that the fall booster should be a monovalent vaccine (meaning the spike protein from on variant, as opposed to last year’s booster, which was a bivalent vaccine comprised of two spike proteins – one from the original form of the virus and the other from the BA.4/BA.5 variant) derived from the XBB.1.5 variant.
At that time, vaccine companies indicated that new vaccines could be ready in August, and perhaps even in late July. While the FDA has to approve the new vaccines, the CDC issues the specific guidance as to who is eligible for the booster, timing of vaccines and whether it is safe and effective to administer the COVID vaccines together with other vaccines.
We have a new CDC director who I have been very hopeful would be committed to more timely and more clear communication than what we got with the previous director. So far, I am disappointed. She has stated that the vaccines will likely be available to the public in October, though more recently, she has indicated that it might be as early as late September. Regardless, she has not (to my knowledge) explained to the public why the delay. Pfizer has indicated that they already have the vaccines prepared and have already submitted their paperwork for FDA approval. Novavax (currently approved only for those ages 12 years and older that is a more traditional type of vaccine as opposed to the mRNA vaccines produced by Pfizer and Moderna), has indicated that it will be filing for approval of its updated vaccine this month. So far, no explanation as to why it would take another 6 – 8 weeks to get these vaccines out to the public.
Until the CDC’s vaccine committee meets and recommends guidance and the CDC director signs off on those recommendations, the vaccines will not be made available to the public and we won’t know the answers as to who can get the vaccines, the timing of vaccines relative to prior vaccination or infection, and whether these COVID vaccines maintain their safety and effectiveness if administered with other vaccines, such as the newly approved RSV vaccines for persons over age 60 and the influenza vaccine that will be offered this fall.
So, now back to the question. Should a person who has not received the bivalent booster get boosted now, or alternatively, a high-risk patient who received one bivalent booster shot, but not the second, get a bivalent booster now or wait for the new monovalent vaccines anticipated to be available in October?
Although it is frustrating that we don’t yet have guidance from the CDC about timing for the new monovalent booster, my guess is that they are going to advise that the new booster not be administered within 4 months of a prior COVID bivalent booster shot (and I anticipate they will state 2 months for immunocompromised persons). This recommendation would be based on recent data as to the optimal spacing of boosters to generate the maximal immunological response and would be consistent with the guidelines issued last year for the bivalent vaccine booster administration. That data is not crystal clear, but seems to suggest that you want at least 2 months between boosters and that 4 months is better than 2, with some remaining question as to whether 6 months might be even slightly better than 4.
Now to answer the question. This would be how I would analyze and answer this question from a patient or their physician:
Is the patient significantly immunocompromised? If yes, go to Question 1; if no, go to Question 2.
If you are significantly immunocompromised and it has been 2 or more months since your last booster, ask your physician about getting another bivalent vaccine now. It will be nearly two months until the new boosters are available, and I would doubt that ACIP will recommend and the CDC director would adopt a requirement for you to wait four months from your last vaccination to get the new vaccine.
When was your last COVID vaccine dose? If < 3 months, wait for new vaccine. If > 4 months, go to Question 3.
(If the answer is > 3 months ago, but < 12 months, we can be fairly confident that the person has little protection against getting infected, but likely strong protection against severe disease or death, unless they have an immune deficiency or significant immunocompromising condition.)
3. Can you limit your exposures until you can be vaccinated in October (work remotely, avoid large groups of people, wear well-fitting N95 masks when around others outside your family, household family members similarly able to limit exposures, etc.)? If so, wait for new booster. If not, go to question 4.
Is the patient at high risk for severe disease – age > 65 years and/or significant underlying health conditions that would place the patient at increased risk? If no, go to Question 4; if yes, go to Question 5.
4. Do you have to or plan to engage in situations that will create high risk of exposures between now and October (for example, international travel, health care worker, school teacher in a school that is not taking precautions, daycare worker, etc.) and you did not receive the bivalent booster within the past 12 months? Consider getting bivalent vaccine booster now and then getting new monovalent vaccine as soon as you qualify (my guess is it would be 4 months after your bivalent booster dose, but in any event, wait at least 2 months before getting the new booster). If the patient has had 1 dose of the bivalent booster, wait for new monovalent booster, but add mitigation measures.
5. Do you have to or plan to engage in situations that will create high risk of exposures between now and October (for example, international travel, health care worker, school teacher in a school that is not taking precautions, daycare worker, etc.), but you have received one dose of the bivalent booster within the past 12 months? If the bivalent vaccine dose was received in the past 3 months, wait for the new monovalent vaccine booster, but add mitigation measures and consider postponing your international travel until at least several weeks after being boosted with the new booster shot. If your dose of bivalent vaccine was received more than 4 months ago, and especially if it was 6 or more months ago, consider getting a second bivalent vaccine booster shot now and then getting the new monovalent vaccine as soon as you qualify (my guess is it would be 4 months after your bivalent booster dose, but in any event, wait at least 2 months before getting another booster).
Dr. Pate's blog 