Vaccines and Coincidences

People who oppose vaccinations, including the vaccines against the virus that causes COVID-19, like to cite adverse effects reported to something called the Vaccine Adverse Event Reporting System (VAERS). One that caught our eye recently came from an organization called Children’s Health Defense, which recently stated in its newsletter that as of February 12, 2021 there had been 111 reports of adverse events involving pregnant women who had received COVID-19 vaccines, 31% of which were miscarriages or preterm births.

         Such a claim, taken without any other information, would seem worrisome. The article in the Children’s Health Defense publication goes on to describe several heartrending stories of women who allegedly had been experiencing normal pregnancies, received one or two doses of a COVID-19 vaccine, and lost their pregnancies. It takes issue with any recommendation that pregnant women get the vaccines and highlights the fact that at present we have no safety data from formal clinical trials that included pregnant women.

         It does take some unpacking to understand a story like that, something that people at Children’s Health Defense must be fully capable of doing but avoid in order to make their point. So, we will undertake the task for you in order to illustrate just how easy it is to turn an isolated piece of information about vaccines into a dramatic and frightening tale.

Limitations of VAERS Reports

         First, what is the VAERS? It was created in 1990 by federal law and is run jointly by the U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). VAERS allows—actually encourages—anyone with any knowledge of an adverse event that occurs after any FDA-licensed vaccine is received to make a report. That includes healthcare professionals, drug companies, and members of the general public. CDC and FDA use VAERS reports to identify vaccine adverse side effects that are too rare to be picked up during the clinical trials of a vaccine that typically involve tens of thousands of people. They are looking for “signals” that might indicate a very rare but clinically important problem with a vaccine.

The Vaccine Adverse Events Reporting System (VAERS) allows anyone aware of an adverse event occurring after a vaccination has been received to report it to federal regulatory authorities. These reports do not necessarily mean that the vaccine caused the adverse event (image: Shutterstock).

         It is never certain, however, that a reported adverse event is actually related to the vaccine. We know of a case in which a previously healthy elderly woman died hours before she was scheduled to receive a COVID-19 vaccine. Had she died a few hours after the vaccine, a report could have been made to VAERS identifying the death as vaccine related. In fact, it would have been a coincidence.

         Most VAERS reports turn out to be just that, coincidence. When millions of people receive vaccines, many things that occur naturally will occur after so many people have received a vaccine. If an illness occurs in one in a million unvaccinated people, then one in a million vaccinated people is probably going to get it as well. Again, that’s called coincidence, two events occurring in close proximity to each other without one causing the other.

Miscarriages Are Unfortunately Common Events

         Now, what about the reports of miscarriages after receiving the vaccine? The article by Children’s Health Defense says that 31% of 111 adverse event reports following a COVID-19 vaccine in pregnant women involved miscarriage or preterm birth, so we will assume that is 34 cases. It turns out that between 10 and 20 percent of all pregnancies end in miscarriage. That means that if just 340 pregnant women received vaccine, we would expect that by chance between 34 and 68 of those pregnancies would result in a miscarriage.

         In fact, as of February 3, about 10,000 pregnant women received a COVID-19 vaccine. So, if the vaccine were associated with a higher than expected risk for miscarriage, we would expect to see more than 1000 to 2000 miscarriages to that point. In fact, as Children’s Health Defense notes, only 34 were reported to VAERS.

Miscarriages occur during 10 to 20 percent of pregnancies, so it is inevitable that some will occur by chance after large numbers of pregnant women receive COVID-19 vaccines (image: Shutterstock).

         Like the elderly woman who died hours before getting a shot that we mentioned earlier, there are undoubtedly women who unfortunately suffered miscarriages shortly before a scheduled vaccine and others shortly afterwards. We are dealing with very large numbers here and all kinds of events will happen by chance after someone is vaccinated. The fact that only 34 cases of miscarriage were reported following COVID-19 vaccines actually highlights how random the reporting system really is.

         Our calculations do not prove that COVID-19 vaccines are safe for pregnant women, nor do they prove that vaccines are not involved in miscarriages. They only show that picking out VAERS reports to frighten the public about vaccines is a very misleading business. FDA and CDC will have to explore every case of a miscarriage following vaccination that is reported to VAERS to see if there is any evidence that COVID-19 vaccines elevate risk. It is clear that the numbers alone—and the dramatic stories that anti-vaccination activists concoct about them—do not constitute any danger signal in themselves. Miscarriages are upsetting enough without making women blame themselves for having what is most likely entirely unrelated COVID-19 vaccinations.

         There is a case to be made that pregnant women should be given priority to get COVID-19 vaccines because evidence shows they are at increased risk for severe disease and death if infected. Animal studies did not indicate any increased risks for the Moderna/NIH and Pfizer/BioNTech mRNA vaccines on pregnancy outcomes. That is part of the reason the American College of Obstetrics and Gynecology (ACOG) recommends that COVID-19 vaccines “should not be withheld” from pregnant people. The decision about whether to be vaccinated is essentially left up to the pregnant woman according to the ACOG recommendations, to be made weighing on the one hand the fact that safety data from formal studies in pregnant women is not yet available and on the other the increased risk of severe illness and death from COVID-19 among pregnant women. That’s obviously not an easy choice, but misleading women into fearing the vaccine will cause miscarriage by encouraging misinterpretation of VAERS data is clearly not helpful in making the decision.

         Mining VAERS data is a scare tactic that those opposed to vaccinations will undoubtedly continue to exploit. Doing so enables them to concoct dramatic anecdotes of individuals allegedly harmed by vaccines.  How many stories of vaccinated pregnant women who go on to have healthy babies would it take to counteract them? Or do we need to offer dramatic stories of unvaccinated pregnant women who become seriously ill or even die from COVID-19? Scientists have a natural aversion to arguing their case that way, preferring numbers like those we’ve given to anecdotes. Consequently, we have no such stories to offer in defense of COVID-19 vaccines, but we will continue to address every attempt to use VAERS data to cast doubt on them.

Setting the Record Straight

When Understanding Becomes Misunderstanding

March 2021

Editor’s Note: This is the first in an occasional series in which we will address the many instances in which our attempt to create understanding of a science or health topic results in misunderstanding.

         One of our key missions at Critica is to increase the public’s acceptance of scientific consensus. That means we believe it is always best when people understand the scientific basis for those consensus views. It is a scientific consensus, for example, that available vaccinations prevent serious diseases and have a favorable risk to benefit profile. We would prefer that people not only embrace that statement but understand at least the fundamentals that support it.

         Sometimes, however, misunderstanding is a result of our attempts to create understanding.. We will explore four examples of this and then suggest ways to remedy the risk that understanding will become misunderstanding.

An Army of Antibodies

         Let’s start with the example given above, that vaccines are a safe and effective way to prevent the diseases they are specifically made to target. It seems a good idea that people understand something about how vaccines actually work so that they do not seem so mysterious. After all, it is not obvious how getting a shot today can prevent us from getting a disease later on. So, we try to explain that our immune system works partially by learning how to fight off foreign invaders to which it is exposed. It does this, again in part, by creating a memory system once it has seen a segment of a bacteria or virus. Then, if ever presented with the whole live virus or bacteria again it is ready to produce antibodies that neutralize the pathogens and prevent illness. Vaccines, then, are harmless versions of real viruses and bacteria that train the immune system to remember and produce those antibodies later on if a real infection occurs. Thus, vaccines don’t cure disease, they prevent it. Of course, what happens when we get a vaccine is a lot more complicated than this explanation, but it seems at first glance sufficient to give people some understanding of the basic mechanisms behind vaccination.

         Many people have accepted the idea that vaccines somehow train the immune system to produce antibodies and that antibodies are supposed to attack foreign invaders. Although that is true, it creates the image of armies of tiny soldiers circulating in the bloodstream ready to fight against intruders. We all know that armies make mistakes and sometimes attack the wrong target, so couldn’t that happen with antibodies as well? In fact, there are well known human diseases in which antibodies mistake cells of the body for intruders and attack, causing things like lupus, Crohn’s disease, and rheumatoid arthritis. So, could it be possible that all those antibodies raised by a vaccine could similarly go awry and attack a person’s own tissues and organs?

         The true answer to that question is that such an occurrence is extremely rare with vaccines. Nevertheless, it is not hard to see how someone could examine the protein structure of the part of the virus that causes COVID-19 that vaccines target and then examine the protein structure of different tissues in the body. Doing so led someone to think that the structures—technically known as the amino acid sequences—of the spike protein on the coronavirus and on a protein found on human placentas had some similarity. From that, it was wrongly assumed that the same antibodies that are created by vaccines to attack the viral spike protein might also attack the placentas of pregnant women, therefore making pregnancies impossible to develop and causing infertility.

         It turns out that the amino acid sequences of the spike protein and the placental protein are really not similar enough for antibodies to make that mistake and that COVID-19 vaccines do not actually cause infertility. The myth of female infertility grew out of a partial understanding of how vaccines work. Understanding that vaccines stimulate antibodies that recognize protein sequences became the misunderstanding that the COVID-19 vaccine could create antibodies that attack a protein on the human placenta. That myth spread widely on the internet and has been very difficult to dislodge.

Beware the Word “Genetic”

         A second example of understanding turning to misunderstanding involves the concept of DNA damage. It was only in 1953 that scientists first proposed the structure of the genetic molecule, DNA, but today most people know about the double helix in which two strands of DNA twist around each other. People also know that our genes are on these strands of DNA and that these genes code for proteins that do the body’s work. We have also been successful in explaining that mutations in those genes can cause a variety of abnormalities and diseases, like sickle cell anemia, Tay-Sachs disease, and cystic fibrosis.

         People also understand that damage to our DNA can cause disease and that this is the way known carcinogens like tobacco, asbestos, and ultraviolet (UV) radiation from the sun can cause cancer. Unfortunately, this has made the public nervous about anything that has the word “genetic” in it. When people heard that some COVID-19 vaccines are composed of a piece of genetic material from the coronavirus called messenger RNA (mRNA) there arose in some circles the myth that this could alter a vaccine recipient’s DNA and cause disease. Similarly, the fact that foods grown from seeds that have been genetically altered are commonly referred to as genetically modified organisms (GMOs) again makes people think that eating them can somehow damage their own DNA.

         mRNA-based vaccines and GMOs don’t actually alter people’s DNA the way too much sunlight or smoking cigarettes do, but that word “genetic” lingers in the mind. We understand the basics of how genes work and that mutations in them, either inherited or caused by carcinogens, can cause a variety of abnormalities, so it is not hard to see how we might broaden that understanding to the misunderstanding that anything “genetic” must be harmful.

The Flu Shot Actually Works

         Our third example concerns the annual influenza vaccine that everyone (with just a very few exceptions) should have. Every year the CDC urges that everyone over 6 months old get a flu shot. We are also told every year that the flu shot is, depending on the year, anywhere from 10% to 60% effective. That means it is possible to still get the flu even if you’ve had the flu shot.

         Understanding that the flu shot needs to be given every year and that it isn’t 100% effective has led people to the misunderstanding that the flu shot doesn’t work. Although this is a well-known problem, we were somewhat surprised to see the extent of this misunderstanding during a series of online focus groups Critica held earlier this year. A lot of people don’t get the flu shot because they believe it doesn’t work.

By telling people that the flu shot isn’t 100% effective, some people have the misunderstanding that the flu vaccine doesn’t work at all. In fact, people who have the flu shot cut down their chance of getting the flu and also have milder symptoms if they do get the flu (image: Shutterstock).

         It would be hard to argue with that sentiment if it were true—it makes sense to shun an injection of something that doesn’t work. Except that the flu shot does work. In a year when the flu vaccine is, let us say, 50% effective your chance of getting the flu if you get the vaccine is half that if you don’t. Those are actually pretty good odds—in that year getting the flu shot means I have only half the chance of getting an illness that can be quite severe and even require hospitalization. Furthermore, even if I get infected with the virus that causes the flu, if I’ve had the vaccine it is very likely that my illness will be less severe and I won’t develop serious complications like pneumonia or need to be hospitalized. Understanding the limitations of the flu vaccine has led to the misunderstanding that it doesn’t work.

We Don’t Need Vitamin and Mineral Supplements

         A final example involves what we know about vitamins and minerals. We are taught from an early age that we need vitamin D for bone health, for example, and that the best way to get that is to go outside and absorb some (but not too much) sunlight. The need for vitamin C merits drinking some form of citrus juice from time to time, being careful to remember that some drinks with vitamin C in them contain more sugar and calories than is good for us. There is a long list of vitamins and minerals that science has taught us we need to ingest in order to stay healthy.

A multi-billion dollar a year industry provides vitamin and mineral supplements, even though scientists insist these are mostly unnecessary (image: Shutterstock).

         It turns out, of course, that healthy people can acquire all those vitamins and minerals from an ordinary diet and that vitamin and mineral deficiencies are very uncommon in high-income countries like the United States. That has not stopped a huge and extremely lucrative industry from convincing millions of people that they need vitamin and mineral supplements. Americans spend billions of dollars every year on mostly unnecessary vitamins, minerals, and other health supplements. We’ve apparently done a great job at helping the public understand that vitamins and minerals are necessary but a very poor job at counteracting the misunderstanding that in order to get enough of them we have to buy supplements.

         Does this represent the situation Alexander Pope envisioned when he wrote “A little learning is a dangerous thing?” We would answer that question with an emphatic “no” because it assumes (as Pope did) that we should not try to help people understand science if we cannot teach them every complicated detail.

         We do, however, have to anticipate the ways in which helping people’s understanding of a health or science topic can lead to misunderstandings that become dangerous to the public’s health. It doesn’t seem all that difficult to have anticipated the following:

·  Giving people the image of antibodies as attacking armies might lead to the misunderstanding that vaccine-induced armies could make mistakes and attack our own organs

·  Introducing a vaccine with genetic material in them could cause some people to worry about damage to their own genes

·  Telling everyone that the flu vaccine is not 100% effective might lead to people thinking it doesn’t work at all

·  Teaching us that we need vitamins and minerals could be misunderstood to mean that we need to take vitamin and mineral supplements.

Because we did not predict that these misunderstandings could occur, we are now left with the much more difficult task of counteracting them. Studies show that even a single brief exposure to misinformation can lead to its storage in long-term memory, making it difficult to dislodge. We are not talking here about organized efforts to mislead the public as is the case, for example, with a large segment of the anti-vaccination movement. Rather, our concern is focused on understandable ways in which the information we provide can engender misunderstandings. Every time we venture to teach people about a science or health topic it is incumbent that we ask ourselves “how might this information get twisted around to cause a misunderstanding?” It is time to do better at anticipating how our efforts to help people understand science may also engender misunderstandings.

Trust in Your Doctor Put to Better Use

Whom do people trust the most for accurate, up-to-date information about their health? In this age of rapid-fire information technology, one might guess Dr. Google or some other online source. In fact, recent studies show that people mostly trust their own personal physicians for health information. A Pew Research Center report issued last year showed that 74% of us have a positive view of medical doctors and 68% have a “mostly favorable” view of medical research. A 2019 survey reported that 90% of respondents endorsed doctors as the most trusted professionals. In another survey, this high level of trust in doctors was seen in both liberals and conservatives. In Critica’s recent online focus groups in which we asked people where they get their information about vaccines and what sources they trusted the most, participants overwhelmingly named their own doctors. Internet sources were used frequently as well but were not cited as often as doctors. Federal health agencies like CDC and FDA were seen as less trustworthy by many.

         It is probably no surprise that people are more likely to believe and follow information they receive from trusted sources. It may surprise some, however, to see that doctors have held on to this trusted position for decades despite the many changes that have taken place in the American healthcare delivery system. The trusted family physician whom patients know for years and who in turn knows everything about them has largely been replaced by large group practices and specialists. Today, the electronic health record knows everything about us, not our personal physician (if we even have one).

         This situation seems ripe to erode the classic patient-physician relationship and drive people to find other sources of health information. If doctors get all the information they need about us from a computer, why shouldn’t their patients do the same thing and turn to the myriad online sources of medical information available today?

Prevention Not Emphasized

         Yet, despite the insidious commercialization of medical practice, people continue to put a great deal of trust in doctors. The critical question becomes: are we putting that high level of trust to the best use? It is clear that even in an era in which the amount of time doctors get to spend with their patients becomes shorter and shorter, doctors are important influencers. Studies show that people who trust their doctors are most likely to follow the advice they give. Hence, it is reasonable to assume that since most people trust their doctors, physicians are in an excellent position to steer people toward health-enhancing practices and behaviors.

Despite the short time primary care physicians can spend with their patients and the commercialization of medicine, people still say they trust their doctors more than any other professional (image: Shutterstock).

         This is not a topic emphasized in medical training. The science of health has grown to such enormous complexity and depth that medical students have all they can handle learning about basic physiology and biochemistry, a myriad of diseases, and seemingly unending numbers of treatments and interventions. As is often noted, doctors are trained to respond to disease, not to prevent it. And patients generally have the same agenda: we generally go to see a doctor for one of two reasons, either we have a new symptom like pain that demands attention or we need scheduled care for a known, chronic illness. During those visits, our doctors focus attention on our “chief complaint,” the reason we tell them we are there. Appropriate history, physical examination, and tests are considered and we are sent home with instructions on what to do about the problem with which, in medical jargon, we “presented.”

Primary care doctors are in fact urged by every medical society and preventative health association to also think during each of these visits about dozens of other things the patient should do to prevent illness or at least detect it at its earliest and hopefully less ominous stages. The gastroenterologists want the primary care doctor to look up whether the patient is a candidate for a colonoscopy; the psychiatrists want her to inquire about mood and suicidal thoughts; the urologists want men to have a test for prostate cancer (PSA); and everyone expects the doctor to encourage good diets and lots of exercise. More than a decade ago the median amount of a time a primary care physician got to spend with a patient was already only around 15 minutes. Those visits have certainly not gotten any longer and make dealing with all of these demands for preventative care a daunting task.

What Preventative Steps Can We Prioritize?

         Perhaps one thing that would help would be to figure out some priorities for doctors to consider at each visit after they have dealt with the presenting issue. What are, say, three things that a physician can bring up during a routine visit that are both critically important to health and for which there is some evidence that brief discussions on the order of five to 10 minutes can make an actual difference in the patient’s life?

         We decided to first consider the ten leading causes of death in the United States. They are:

  1. heart disease

2. cancer

3. chronic lower respiratory disease (such as emphysema)

4. stroke

5. unintentional injuries

6. Alzheimer’s disease

7. diabetes

8. pneumonia and influenza

9. kidney disease

10. suicide

None of these ten leading causes of death is entirely preventable. The causes of many forms of cancer, including some of the deadliest like pancreatic cancer and the type of brain cancer called glioblastoma, are largely unknown and therefore nearly impossible to prevent. We don’t know what causes Alzheimer’s disease either and therefore prevention is not really possible. As tragic as suicide is, it is not a predictable event and therefore also difficult to prevent.

But there are things we can do to prevent some of these deadly diseases and to at least delay the onset of others. Of these, the one that most stands out is cigarette smoking. Tobacco smoking remains the leading cause of preventable death in the U.S. and around the world. Despite the fact that smoking is difficult to quit, brief screening and counseling about tobacco use by primary care physicians works during routine visits. Doctors often fail to realize that asking people if they smoke and advising them to stop is an effective intervention that increases the chances a smoker will actually quit smoking. Moreover, there are several medications that can be prescribed that also increases the rates of smoking cessation. One clear way to parlay the trust in doctors that pays off, then, is to enquire about tobacco use at every visit.

Although rates of cigarette smoking have dropped dramatically over the last several decades, tobacco use remains the leading cause of preventable death in the U.S. and around the world (image: Shutterstock).

A second effective intervention is to make sure adult patients have had recommended vaccinations. Right now, of course, that conversation is dominated by the need to have everyone vaccinated against the virus that causes COVID-19 as soon as possible. For adults, however, vaccination recommendations also include those for pneumonia, influenza (“the flu”), and herpes zoster (shingles). We and others are developing brief interventions that all healthcare professionals can use to reduce vaccine hesitancy and increase uptake of vaccines that clearly save lives.

Our third recommendation concerns obesity, which is implicated in heart disease, Alzheimer’s disease, some cancers, and adult-onset (or type 2) diabetes. Here it is perhaps less clear that a doctor’s brief intervention meaningfully impacts obese patients’ behavior, but there is some evidence that it does. Given the number of diseases impacted by a person’s weight, we include brief interventions to address overweight and obesity as one of our top three.

An immediate objection to our list is that even addressing these three issues—tobacco use, adult vaccinations, and weight—could together double or even triple the length of an average doctor visit. It is obviously not sufficient to merely ask the patient if they smoke and have all their vaccinations and check if they weigh more than is healthy for them. Each of these conditions demands at least a few minutes of conversation between doctor and patient about the options for improvement. Let us assume for a moment, however, that each patient has a problem with only one of these three problems. Given that brief interventions for each have been shown to be effective, then most visits would be lengthened by only the 5 to 10 minutes it takes to discuss these options and make recommendations.

A healthcare system that cannot extend primary care physicians’ visits by ten minutes in order to address even these three leading risk factors for poor health outcomes is clearly working against itself. Those ten minutes counseling someone about smoking cessation and possibly prescribing a medication to help such as bupropion or varenicline will prevent countless numbers of cases of cancer, terminal respiratory disease, and heart disease. Making sure the patient gets their pneumonia and flu vaccines will help reduce the rate of the eighth leading cause of death. Discussing a diet and exercise plan and referral to a dietician will definitely result in some patients losing weight and averting the early onset of a number of diseases on the list. The savings in human suffering and medical costs would, we are sure, far outweigh the costs of those extra ten minutes.

There are so many other things that doctors could, and probably should, address during each visit, but again we need to remember how short these visits are and think about how we can leverage high levels of trust in doctors to make the greatest impacts on public health. We are not for a moment dismissing all the things doctors must pay attention to that are incidental to what the patient has come in seeking help. Obviously, for example, if a person coming to the doctor because of a cough and runny nose has an elevated blood pressure, the doctor should address the possibility that the patient’s real health problem is not his cold but rather hypertension. We do hope our readers will let us know what they think about our top three and suggest others that are critical to add to the list.

What we are trying to come up with is a workable plan whereby doctors use the trust people still have in them to bring up health issues for which they can have impact in a very short period of time during every visit. We conclude that the three at the top of the list are tobacco smoking, vaccines, and obesity. If at every encounter, regardless of the reason for the visit, doctors ask patients if they smoke, if they have had all their recommended vaccines, and if they are taking steps to keep their weight at appropriate levels, we predict that countless numbers of premature deaths will be averted. We wish we could add more things to this list—there is good evidence for instance that screening by primary care physicians for alcohol use problems and depression can also be effective—but we are cognizant of the realities of modern-day doctor visits. Let’s start with smoking, vaccines, and weight and see if these at least can be accomplished. Otherwise, we stand to waste the most trusted source of health information known.

Debunking A Misinformed Video About Covid-19

Editor’s Note: Critica advisor Carrie Corboy recently came across a four-minute video in which an OB/GYN physician named Christiane Northrup promulgates some misinformation and disinformation about COVID-19 vaccinations. What follows below is Carrie’s wrestling with these false statements and setting the record straight on a number of important scientific points. It is a great exercise in confronting scientific misinformation. Note that we chose not to link to the actual video here because we are loath to be the ones to spread these kinds of inaccuracies and conspiracy theories. We think you will get the gist of what Northrup says from Carrie’s rebuttal. In the interests of transparency, we note that Carrie is a registered pharmacist and senior director at the Janssen division of Johnson and Johnson, a pharmaceutical company that is working to bring a COVID-19 vaccine to market. We do not detect in what follows, however, any trace of bias, just the facts.

Well, I finally worked up the nerve to watch the Northrup video on COVID-19 vaccines and boy it’s a humdinger.  I’ve spent about 4 hours on this, because I wanted to look up everything that is said in the video (and she packs an awful lot into 4 minutes!!)—all such pieces string together bits of truth mixed with opinion or worse.  It’s a lot of work and why we won’t see direct responses to much of this on the internet.

Ultimately, what matters is what you and others think about this and — more importantly — how it affects your decision making.

My goal is for you to take away some things that you can apply going forward because there is a lot out there and it’s up to each of us to decide what we’ll do with the information/who we will listen to.  This is true across all subjects.

Credibility Issues

This woman is an OB/GYN.  Not an infectious disease expert, not a virologist, not an epidemiologist.  She’s not a student or expert in nanotechnology or nano robots.  She doesn’t present any reason that would suggest she has any expertise in 5G.  She nevertheless rehearses the completely false notion that the vaccines have antennae in them that transmit via 5G into the cloud and will be used by Bill Gates and others to mount surveillance of the American public. She doesn’t have the credentials to back up her “expert” opinions.  This happens a lot in medicine.  Physicians are given complete credibility across the entire spectrum of science and medicine.  And, unfortunately, some physicians are happy to cash in on that.  When I have a medical issue, I go to a specialist in the area of my issue.  I don’t even ask an opinion of a non-specialist (other than “do you know an excellent XXX that you would go to for this condition?”).  Even when I did have a specific question for my OB/GYN about a GYN concern, she checked with her surgeon colleagues for their experiences and used that to guide me.  Good health care professionals, good anything, know they don’t know everything.  This woman is claiming to know about an awful lot, none of which lines up with her expertise.

It’s clear this woman makes her money on books, TV, and the like.   These things suggest to me this woman is trying to personally capitalize on sensationalism at the expense of the public.

Lack of Details/Specifics

Which vaccine is she referring to?  There are two now with Emergency Use approvals (Pfizer/BioNTech and Moderna) and others in late stage development (Astra Zeneca, Janssen).  There are over 50 other vaccines in earlier stages of R&D.   This woman makes no claim to a specific vaccine (because then she could be pursued for her lies about a specific product).  So she’s spreading this fear about all COVID vaccines in general.  This is something often seen in unfounded claims.

The truth about the patent (which I find interesting she calls out the 060606 portion of the full patent number—trying to conjure a subconscious  connection to Satan?). It’s an outright lie that the patent refers to anything injectable/internal to the body.  Furthermore, the vaccines are not the product of some secret form of nanotechnology. People are understandably confused about what the “nano” means when it is used in reference to some of the vaccines. In fact, genetic material in some of the vaccines is surrounded by lipid (i.e. fat) nanoparticles. That means that the lipid particles are nanometer in size (a nanometer is one-billionth of a meter). No nanotechnology and no antennae.

Toxic metals in vaccines?  Why do I have to go digging to try and figure out what she’s talking about?  I’m *assuming*  she’s referring to aluminum that can be used as an adjuvant (something in a vaccine in addition to the protein we need the immune system to identify, that increases the immune response) By the way, this reduces the number of vaccines needed (e.g., one shot or multiple shots) and ensures longer immunity.  How would she know if (any of) these vaccines (and again, which is she talking about??)  include aluminum (this is not public information yet)?  She’s happy to state this as if it’s fact.  . 

Also, aluminum is pervasive in our environment, foods and medicines.  

She’d have some credibility if she compared the amount of aluminum in vaccines to something we are already exposed to (like infant formula or breast milk or antacids)…but this would not serve the message she’s delivering because we’d quickly see that if aluminum is a problem, avoiding vaccines is not going to fix that problem at all.

Luciferase does not work by shining a light on it…outright lie .  But boy is it powerful to say another word that conjures the devil or Satan.

Non-human DNA…what is this referring to?  Again, how does she know/have access to such proprietary information?  And which vaccine is she talking about?  She doesn’t even know which non-human DNA might be in the vaccine – she just names different animals. Which animal is it, if it’s true?  Again, by not naming a vaccine, she can’t be countered.  In fact, the two currently available vaccines have mRNA from the virus and not DNA. We are unaware of any non-human DNA being a part of any vaccines for COVID-19.  It would be a longer story to explain that, even if there were, it wouldn’t make vaccines unsafe and that DNA from another species does not alter the genetics of humans.

The word is chimera (not “chimer” as she says) and chimera exist naturally and not infrequently—further details here (rather interesting). At first I thought this was an illustration of her lack of expertise in this area, but when I read the reference I had an even more critical impression: she knows what a chimera is and that it occurs frequently in nature, because she’s an OB/GYN and this can often occur during pregnancy and persist in the mother long after she has given birth.  When people talk blindly on topics they are not expert in, that’s one thing (because we can quickly assess expertise).  When someone uses information they are familiar with to mislead, on the other hand, that can cause great harm and to millions of people.

mRNA in the vaccine (and not all candidates are mRNA vaccines) are from the virus (not from another animal) and only a small snippet that creates the protein that we all see as a ’spike’ on the corona-virus pictures/emojis.  This ’spike’ is what the immune system responds to.  So the mRNA makes the spike (and only the spike, none of the material that allows replication of the mRNA is included) and the body develops an immune response without having to get an infection.

The 99.9% recovery claim. What/who is the source for this recovery rate from COVID-19?  What does ‘recovery’ mean?  I have to assume by “recovery” she means “didn’t die from the acute COVID infection.”  She doesn’t define it, so here again, I have to draw assumptions.  Let’s say my assumption is correct.  It’s interesting that she posits a ‘recovery rate’ and not a ‘death rate.’  99.9% sounds so good, so harmless.  Due to the long period of contagiousness before feeling any illness (and those that never feel ill enough to stay home) spreading is fast and extensive.  If you will allow me the assumption that no one (without having been vaccinated, or without permanent social distancing and masking) will avoid COVID-19, then consider that 0.1% of 330 million people (US population) is 330,000 people.  Is it okay with her that 330,000 people in the US (and 7 million worldwide) die that did not need to?  And it’s not going to go away, so that 0.1% deaths will continue forever without a vaccine.  She purposefully spins what is a grim number to sound like no big deal.  

Let me also point out something you well know–a significant factor in ‘recovery’ (again, here I am using the “not dying from acute COVID-19” definition) is access to enough high-quality health care.  So, imagine the scenario where you do not vaccinate because you decide the risk for you dying from COVID-19 is low, yet you travel and in another part of the US, or world, you become ill.  What you may have recovered from here at home, you may not in another location due to different health care capabilities or resources.  In this country, we see that the vast healthcare disparities have made Black, Latinx, and Native American people more vulnerable to acquiring the virus and developing severe illness from it than white people. Then there’s the ethical issue of what you bring with you to other areas that are less equipped to handle the disease.  Again, you may be fine, but quite literally kill others.  That’s a very personal assessment.

Finally, if you want to look around at data, try this site (which has been online and public since the start of the pandemic). If you go to the tab at the bottom of the map called ‘case-fatality ratio’ (note: it is not called a “death” or a “recovery rate”) and click on any of the dots in the screen you can see the case-fatality specifics for that area.  Clearly, if we just look at positive tests and deaths due to COVID, plenty of areas see differences.  You can quickly compare by the size of the dots the differences among countries and states.  For example, in Florida, the case-fatality ratio is 1.83%—quite a bit more than the 0.1% the doctor in this piece is trying to comfort us with.

Biostatistics take effort to learn—people earn bachelors, masters, and PhDs in it–and it’s not possible for people like you and me to be experts.  It is reasonable for anyone using such numbers to explain what is assumed/what is meant by them.  This woman does none of that.  She leaves us to our own interpretations.  What people should minimally do is select scientific sources of information (or several) that are trustworthy due to the expertise.  Here is a source to explain the recovery rates.

I will leave you with another bit of information that this doctor did not mention: just because people do not die after COVID-19 infection does not mean they have resumed pre-COVID-19 life or health.  This is where the importance of defining ‘recovery’ becomes clear. Cancer patients are told that life will be a new normal.  As a cancer survivor, I will tell you it is drastically different, and nothing about it is normal.  And I’m fortunate with not a lot of limitations.  I don’t have a rate for this “no longer infected but still suffering” group of people but if I could protect anyone from this ’new normal life’ with little to no risk to myself, then I’m going to do it.  This article is coverage of an NIH meeting on this topic.  The CDC also has an informative page on long term effects of COVID-19. 

And if the ethical, moral angle on this doesn’t resonate, maybe the economics does.  The people most at risk are the ones we depend on the most in this world, the people with minimum wage jobs or contractors in the gig economy that run the operations as well as the professionals and laborers that staff our hospitals.  You may express concern about locking things down and the economic consequences, and I agree they are real and devastating.  I am convinced, however, that staying open and letting everyone get sick (and die, or not quite recover) is going to be just as devastating to the economy.  There are certainly small countries that have tried this model and they are not faring well economically, either.

In 4 minutes this person spouts a bunch of conflated bits of information, infers that she is qualified to speak of this.  It takes someone a lot of time to unwind, verify and correct what has been said.  No one makes money doing this, so these dangerous bits float about our environment, unchecked.

At the end of the day, vaccination will be a choice.  The non-vaccinated may have consequences to their choices, the most drastic of which is dying from COVID-19 themselves or infecting a loved one who then dies or who is permanently affected and they must care for.

This woman is putting her own fame and financial gain ahead of the health of anyone within earshot.

Do Race or Ethnicity Have Biological Meaning in Medical Practice?

A medical student with white skin is about to describe a patient newly admitted to the hospital to her attending physician. She will start by giving the patient’s age and sex (“A 58-year-old man was admitted to the hospital last night after presenting to the emergency department with slurred speech and weakness in his left arm and leg”). Should she also mention in this opening statement that the patient is a “58-year-old Black man?”

         To think she should would be to assume that race is a fundamentally biological trait that is embedded in a person’s genetic makeup (the genome) and inherited from the previous generation. Here we see a complicated apparent paradox.

         One the one hand, scientists tell us, based on substantial research, that race is really a social construct and has very little if any biological meaning.  On the other hand, there is serious interest lately in the notion that ethnic minorities should be included in higher proportions in research studies because we should not assume that Black, Latinx, and white people will all respond similarly to different medical interventions. That sounds as if there must be a biology somewhere involved in race. How we work out this apparent paradox is critical if we are to begin to undo centuries of healthcare discrimination and abuse of ethnic and racial minorities in the United States.

The Case for Race as a Social Construct

Why do anthropologists tell us that race is not a function of biology? This is because while conventionally assigned  race may be associated with some diseases (e.g. white people are more likely to have cystic fibrosis and Black people more likely to have sickle cell anemia), in these cases race  itself is still only an association (Black people can also have cystic fibrosis and white people also have sickle cell anemia).  If you sequenced the genome of any individual and got their complete genetic code, nucleoside by nucleoside, you would not be able to determine from this information whether they are white, Black, Asian, Latinx, or Native American (although according to some you may be able to determine what geographic region of the world their ancestors came from). Two people with dark skin may identify themselves as Black and two people with light skin call themselves white, but the two Black people and two white people are likely to be more genetically different from each other than either white person is with either Black person. That is, there is often more genetic diversity between two people of the same race than there is between two people of different races.

These three people appear to be members of different racial groups, but there may be nothing in their genes that distinguish one from the other. This is the reason that race is often called a social rather than a biological construct (image: Shutterstock).

         If, then, race has little biological significance it would seem irrelevant for the medical student to mention it when presenting the new case to her professor. Race has been used as an excuse to discriminate against people and to create huge inequalities and inequities among racial groups, so perhaps pointing out that someone is Black in the course of giving a medical report would only serve to perpetuate bias. An oft-noted example is that for the same level of pain, Black patients are systematically prescribed less and lower doses of pain medication than white patients. What if the attending physician harbors latent racist views and is prone to take the complaints of Black people less seriously than those of white people? Isn’t it better to think about the patient’s problems blinded to his race in order to ensure an objective assessment and equitable treatment plan?

         The answer to the above question is probably yes and until medical students and attendings go to see the patient at the bedside to gather more information and perform a physical examination, there is probably no reason to identify the patient as belonging to any one of the conventional racial groups.

In Some Cases There are Biological Considerations

         Yet in other contexts within medicine, we are actually encouraged to consider the possibility that race does entail differences that are biologically meaningful. Recently during clinical trials of vaccines against the virus that causes COVID-19 the concern was raised that research participants should represent the same racial mix as they are in the general population. About one-third of Americans are identified as Black, Latinx or another group other than white and the question raised here is whether we would know if a vaccine worked in Black or Latinx people if they weren’t included in representative numbers in the research studies. But if race is not biological and if two white people are likely to be more genetically dissimilar than a Black and a white person,  why should the racial make-up of a clinical trial make any difference?

         One reason is because some studies have shown that different racial groups, on average, respond to certain medications differently or have different risks for acquiring some illnesses. For example, a category of medications called ACE inhibitors used to treat some cardiovascular problems seem to work less well in Black patients than in white patients. A difference in the genes for an enzyme that metabolizes drugs in the liver between Asians and whites makes the former group more sensitive to antipsychotic medication, therefore making it best for Asians to take lower doses. Black people have a higher rate of venous thromboembolism than people of other racial groups and also have a higher risk for developing systemic lupus erythematosus

         Of course, because of genetic differences within groups, not all Blacks, whites, or Asians will manifest these or any other differences in a given drug’s effectiveness or risk for a specific illness. Furthermore, whether or not a drug works in any individual also depends on many non-biological factors, like whether or not a person can afford to buy the drug in the first place. Nevertheless, race does seem to make a difference in some ways that are biologically meaningful in medical practice.

The Importance of Social Determinants

         Returning to our medical student’s patient, he turned out to have suffered a non-fatal stroke on the right side of his brain. He also had a history of poorly controlled high blood pressure (hypertension), a known risk factor for stroke and heart disease. Now Black people have higher rates of hypertension than whites. Does knowing that this patient is Black make any difference? Probably not much in making a diagnosis and deciding on treatment. The signs and symptoms of stroke are identical across all racial groups and the treatments the same. Perhaps this patient will not be prescribed an ACE inhibitor to treat his hypertension, but there are many other choices that work equally well in Blacks and whites.  The patient’s race may, however, have a profound influence on how he is treated. This would not be because of biology in this case but rather because of prejudice and non-biological factors. 

         Some have stated that ethnicity may be more useful than race in making medical decisions. Our stroke patient appears to be Black to our medical student and attending physician, but his background is complicated. His father emigrated to the United States from Brazil, identifies as  Black, and speaks Portuguese. His mother was born in the United States of parents of Italian ancestry. Our patient speaks a little Portuguese, likes to eat Italian food and practices the Catholic religion. His African ancestry is therefore more remote than his Brazilian and Italian backgrounds. Ethnicity takes into account all of these factors of origin, religion, language, and behavior in addition to skin color. In this context it is very likely that our patient would even have a good response to an ACE inhibitor. Illnesses that are often thought of as occurring in only one racial group, can actually occur in many. Sickle cell disease, for example, while most common among people of African ancestry, also occurs in people of European, Middle Eastern, and Asian ancestry.

         Why do Black people have higher rates of hypertension than white people? Interestingly, black people living in the United States have higher rates than black people living in Africa, so ancestry does not seem the key factor here. Rather, socioeconomic factors are most likely key to understand the differences in rates of hypertension. Living in a low-income neighborhood is associated with hypertension. There is less access to medical care and less money to afford healthy food and medications. The chronic stress of living in an economically deprived neighborhood and of facing racism and racial discrimination is also linked to hypertension. A study showed that when residents of racially segregated neighborhoods move to less segregated communities they experience a decrease in blood pressure. Thus, one’s race profoundly determines the socioeconomic factors that affect one’s health and the healthcare received.

Factors like those depicted here and directed against people of color have more of an impact on health outcomes than do any racial biological factors (image: Shutterstock).

         In coming up with a comprehensive treatment plan for our stroke patient, knowing his skin color is less important than understanding the socioeconomic factors that may influence his rehabilitation, recovery, and avoidance of future strokes. Does he have social support? Is he someone who is usually adherent to prescribed medications? Can he follow a healthy diet and get exercise? Can he afford quality medical care? Is quality medical care even available where he lives?

         These factors, often called the social determinants of health, turn out to be far more important than race in determining medical outcomes. In fact, about 80% of health outcomes is said to be a function of social determinants of health. They are, unfortunately, too often not felt to be part of a physician’s purview, although that is changing rapidly.

         The history of racial discrimination, racism, and inequities has had a profound effect on healthcare in the United States. People of color receive less quality care and have higher rates of morbidity and mortality for many conditions than white people. Because of persistent structural racism, it is definitely important to ensure that racial and ethnic minorities are included in numbers that at least mirror their population representations for things like clinical trials. It is absolutely possible that some Black people, for instance, might react differently to a COVID-19 vaccine than some white people and therefore having them in these studies is critical. Similarly, we should not ignore race as we strive to overcome inequities and inequalities in the provision of healthcare, improvement of health outcomes, and the distribution of healthcare professionals.

         Still, for any individual patient it would seem that neither race nor ethnicity is going to make a major difference in making a diagnosis or selecting interventions. Rather, we need to boost our attention to the underlying factors that create differences in health outcomes among races—the social determinants of health. Our stroke patient turns out to have a loving, supportive family and adequate resources to obtain medical care. He is generally adherent to medical recommendations and prefers to see Black physicians. Factors like these are highly important in determining how well this patient will do. Another patient without social support or adequate resources will not do as well unless these factors are attended to.

When thinking about race, then, it is true that healthcare providers need to bear in mind that there are some instances in which biology may properly influence decision-making. But it is more important for them to understand how decision-making is all too often influenced by irrational attitudes about race of which they may be unaware. These attitudes have led to massive health disparities that it is every healthcare professional’s duty to help remedy. 

Air Pollution and PM2.5: The Deadly Result of Burning Things

There are many well-known health consequences of the climate crisis we are facing. These come from excessive heat and heat waves, drought, and natural disasters like floods and hurricanes. There is one consequence of burning fossil fuels, however, that is killing people right now on a daily basis. That is a type of air pollution called fine particulate matter or PM2.5.

         Many types of particles constitute air pollution, but perhaps the nefarious are the microscopic particles called fine particulate matter or PM2.5. The number 2.5 comes from the fact that these particles are 2.5 microns or smaller in diameter. To put that in perspective, a human hair is about 70 microns in diameter (a micron is one millionth of a meter or about one twenty-five thousandth of an inch). PM2.5 is released into the air when we burn things—it comes from car exhausts, power plants, indoor cooking, smokestacks, fires, the use of certain types of fertilizers in agriculture, and a variety of other sources. Living near a highway confers long-term exposure to PM2.5and may account for higher premature mortality rates among people who live in areas near heavily trafficked roads.

PM2.5 Is a Serious Health Risk

         PM2.5 is the sixth leading cause of death in the world, responsible for about four million deaths every year. Not surprisingly, it causes or worsens lung and cardiovascular disease because it gets deep into lungs and into the circulating blood. In the respiratory system, it is a cause of and worsens asthma, chronic obstructive pulmonary disease (COPD), and possibly cancer.  Studies show it is associated with a wide variety of cardiovascular disorders including hypertension, arrhythmias, heart attacks, and stroke. It also plays a role in neurodegenerative diseases like Alzheimer’s disease and Parkinson’s disease. PM2.5 easily slips across the blood-brain barrier, the physical system that protects the brain from toxic substances floating in the bloodstream, and therefore increases the risk for a variety of neurological diseases.

Smoke from burning fossils fuels causes air pollution, including a type called fine particulate matter of PM2.5. PM2.5 has been shown to be a serious health risk and to cause premature death (image: Shutterstock).

         In one interesting recent study, investigators used positron emission tomography (PET) scanning to measure the amount of a protein that is found in increased amounts in people with Alzheimer’s disease. The protein, called amyloid, forms plaques in affected individuals’ brains. All of the participants already had evidence of cognitive impairment at the time of the scans. The amount of PM2.5 in the patients’ home neighborhoods was taken from existing databases both for 2002-2003 and 2015-2016. They found that higher levels of PM2.5 exposure both thirteen years before the scans and more recently was associated with the presence of brain amyloid plaques. This finding confirmed a number of other epidemiological and animal studies showing a link between dementia and PM2.5 pollution.

         Most recently, PM2.5 exposure has been linked to increased death rates for patients with COVID-19. After adjusting for 20 possible confounders, authors of one study concluded that “A small increase in long-term exposure to PM2.5 leads to a large increase in the COVID-19 death rate.” This is one of the many ways that the current pandemic is linked to the ongoing climate crisis caused by burning fossil fuels like release carbon dioxide and to agricultural practices that release nitrous oxide into the atmosphere.

         The issue of setting appropriate air pollution standards is clearly one of environmental justice. People of color are exposed to significantly more air pollution than white Americans and this may partially account for higher rates of respiratory and cardiovascular disease and shorter lifespan. A Brookings report noted that a new administration could help address the “persistent inequity of air pollution exposure in low income neighborhoods and communities of color.”

PM2.5 particles present in air pollution cause adverse health effects involving many organs of the body including lungs, heart, blood vessels, and brain (image: Shutterstock).

EPA Refuses to Budge

         The U.S. Environmental Protection Agency (EPA) monitors PM2.5 levels throughout the country and sets a maximum concentration for average annual PM2.5 at 12.0 µg/m3 (that’s 12 micrometers per cubic meter). On December 7, 2020 the EPA disappointed many scientists and environmental activists by announcing its final rule against lowering that standard. EPA had convened one of its Clean Air Scientific Advisory Committees (CASAC) in 2015 to study the current standards for PM2.5 and make recommendations for revisions. This CASAC was composed of 20 experts from a variety of relevant scientific fields. But in 2018 EPA Administrator Andrew Wheeler dismissed the PM2.5 CASAC. The committee met on its own anyway  in 2019. Its members reviewed the literature on air pollution’s health effects and concluded that concentrations lower than the current standard of 12.0 µg/m3 should be instituted to between 8 and 10 µg/m3. It was clear from their review of the available science that lower concentrations of PM2.5 still have an adverse effect on lung and cardiovascular disease. EPA ignored that recommendation in its decision last month.

         Scientists, both in and out of EPA, have consistently pointed to solid research showing that much lower concentrations of PM2.5 are responsible for adverse health effects, including higher rates of COVID-19 mortality. These are especially prevalent among communities of color and low-income neighborhoods, places where decades of structural racism have resulted in the disproportionate placement of factories, highways, and warehouses with idling trucks. We can only hope that under a new administration this matter will get swift attention and the recommendation to lower the PM2.5 standard be addressed.

         Ultimately, it is up to our society to do what is really needed to eliminate the PM2.5 health risk: eliminate the production of greenhouse gasses like carbon dioxide, methane, and nitrous oxide. Climate change is already killing people in many ways—it is not just a concern for the future. Air pollution is one of those ways. It is time to face it.

Is There Any Amount of Alcohol That Is Good for You?

Many reports and studies tell us that Americans have been drinking more alcohol since the start of the coronavirus pandemic. As restrictions have been placed on bars and restaurants, online sales of alcoholic beverages have soared. Presumably, people are drinking more to blunt the stress and strain of the pandemic and its attendant social isolation and economic woes. Is this increase in drinking alcohol  harmful?

         Of course, no one disputes that excessive drinking to the point of meeting criteria for an alcohol use disorder is harmful. There are differences of opinion, however, about the health effects of more moderate alcohol consumption. Some studies have shown that moderate drinking, usually defined as one to two drinks a day for men and one drink a day for women, has beneficial effects on heart health. One potential reason for this is that alcohol raises the level of so-called “good” or HDL cholesterol. It also has an anticoagulant effect, which decreases blood clotting and therefore potentially reduces clot formation in the coronary arteries.

         It is important to remember, however, that although studies do suggest fewer cardiovascular deaths in people who drink moderate amounts of alcohol, no study has ever shown for sure that this is a cause-and-effect relationship. It could be that people who drink a bit of red wine every day have other lifestyle advantages over those who do not, like better access to healthcare or more exercise. Furthermore, there are other ways to achieve similar benefits on cholesterol levels, including exercise and possibly consuming foods that contain the same antioxidant as red wine– resveratrol. Such foods include grapes and blueberries.

         At the other end of the spectrum, more than moderate levels of alcohol consumption are likely to harm the heart. One study, for example, showed that several biomarkers in the blood of heavy drinkers were elevated compared to non-drinkers, indicating a pathological effect on the cardiovascular system. Somewhere in the transition from moderate to heavy drinking alcohol loses its potential cardioprotective effect and becomes a cardiovascular toxin, capable of increasing the risk for high blood pressure, heart attack, and stroke.

Alcohol Increases Cancer Risk

         So far, this seems to make the decision to drink fairly straightforward—one drink a day is okay, more than that may not be. But that is only considering alcohol’s effects on the cardiovascular system. Less well-known perhaps is the fact that some metabolites of alcohol are carcinogens, including acetaldehyde. Last year, the American Cancer Society, in its Guideline for Diet and Physical Activity for Cancer Prevention, said “it is best not to drink alcohol.”

         That statement does not mean it is okay to drink moderately, but rather you should not drink at all (the guidelines do say that if you are going to drink, drink moderately). The message here is that alcohol consumption is associated with increased risk for a number of different kinds of cancer, including head and neck cancer, esophageal cancer, liver cancer, breast cancer, and colorectal cancer. A recent epidemiological survey looked at the number of cancer cases and cancer deaths attributable to alcohol consumption. The numbers varied widely by state, but senior author Farhad Islami concluded from the work that “”In the United States, on average, alcohol consumption accounts for 4.8% of cancer cases and 3.2% of cancer deaths.” In some instances, the influence of alcohol was even greater, accounting for 12.1% of cases of breast cancer in women and more than a quarter of cases of throat cancer.

         When dealing with carcinogens, it can be hard to put upper and lower limits on how much is safe and how much is likely to cause cancer. Smoking one cigarette a month is not as great a risk for lung cancer as smoking two packs a day. How much alcohol over a lifetime increases the risk for any of the alcohol-associated cancers is still unclear, which is why the American Cancer Society makes its blanket recommendation that “it is best not to drink alcohol” rather than telling us how much alcohol is likely to be unsafe.

         All of this makes the increases in alcohol sales and consumption during this last year of the pandemic especially alarming. Perhaps if the pandemic ends soon we will see a drop in drinking, but there is no guarantee that that will happen; many of the people who started drinking or increased their drinking since March 2020 are likely to continue doing so even when the pandemic finally ends. If they drink at moderate levels—one to two drinks a day for men and one drink a day for women–they may actually reduce their risk for heart disease but at the same time increase their risk for cancer. If they drink heavily then both heart disease and cancer risks go up. Increased alcohol consumption could turn out to be one of the biggest long-term health risks of the pandemic. Public prevention efforts are urgently needed. At the same time, healthcare providers should make a special effort to inquire about patients’ drinking habits and warn them of the risks.

Some Mistakes Are Just Mistakes, Some Deliberate

Most of the incorrect information we encounter about things like the COVID-19 vaccines represent fear based on understandable misinterpretation of data and statements by scientists. Sometimes, however, spreading misinformation appears to be a deliberate attempt to distort evidence and advance an anti-science agenda. In the latter case, we call it disinformation. It is important to be able to recognize the difference between mistakes and disinformation.

Our colleague Kathleen Hall Jamieson, head of the Annenberg Public Policy Center at the University of Pennsylvania, recently called our attention to a posting by the extreme right-wing site Infowars that made two claims about vaccines for COVID-19 (Note: we’ve included the link but in no way agree with anything you will find there). The first is that the vaccines will ultimately be deadly because of something called “vaccine-enhanced disease” and the second is that the vaccines will prevent women from becoming pregnant.

We’ve seen both of these claims expressed by people who have picked up on information circulating around various media sites. What they have seen is indeed frightening and their own posts reflect both understandable fear and misunderstanding. Let’s look at both claims in more detail and see how Infowars uses them to deliberately turn people away from getting vaccinated against COVID-19. As we will see, Infowars’ claims are exaggerated and filled with untruths: vaccine-enhanced disease and infertility are both very unlikely outcomes of COVID-19 vaccines.

Vaccine-enhanced Disease

Vaccine-enhanced disease is a real thing and a definite concern any time a new vaccine is developed. It occurs when a vaccinated person is exposed to the pathogen (e.g. a virus or bacteria) that causes the disease the vaccine targets. Instead of neutralizing the pathogen, the antibodies raised by the vaccine (and possibly other elements of the immune system) actually assist the pathogen to infect cells and cause even worse disease than seen in unvaccinated people. This is called antibody-enhanced disease or ADE.

The classic case of ADE involves Dengue fever, a viral illness that usually causes mild, influenza-like symptoms. But scientists noted that two populations of people—infants whose mothers had Dengue fever and children who themselves had had a mild case—developed a more severe form of the illness called Dengue hemorrhagic fever if they were exposed to the virus. It is believed in this case that the antibodies either passively transmitted to the newborn or raised during mild symptomatic infection with Dengue fever do not neutralize the virus upon new infection but instead assist viral entry into cells.

Anti-vaccination proponents have claimed that COVID-19 vaccines will make the illness worse through a mechanism called vaccine-enhanced disease (image: Shutterstock).

ADE caused by vaccines are rare. The two best described instances of vaccine-enhanced disease occurred with a vaccine for respiratory syncytial virus (RSV) and an early form of measles vaccine. A vaccine against RSV, which is a common cause of pneumonia in children, was tested in clinical trials, but vaccinated children experienced worse pneumonia after being exposed to the virus in the community than unvaccinated children and the clinical trials were halted, and the vaccine never released to the public. Scientists are still working to develop a vaccine against RSV for children that will not cause vaccine-enhanced disease.

An early form of the measles vaccine in which the virus was inactivated by formaldehyde also caused more severe illness in vaccinated children when exposed to the measles virus and was withdrawn. The currently used measles vaccine does not cause vaccine-enhanced disease. Nor do any of the other vaccines now given to people.

What we can understand from this is that vaccine-enhanced disease is indeed a real phenomenon and something that must concern scientists developing new vaccines. Because vaccine-induced disease shows up when a vaccinated person is then exposed to the pathogen the vaccine targets, it may not be picked up immediately after a vaccine enters clinical trials, especially when the trial is placebo-controlled and before the blind is broken when no one knows who actually received the active vaccine rather than a placebo. So, it is understandable that if people hear something about vaccine-enhanced disease they will wonder if this could happen with COVID-19 vaccines.

Several lines of evidence make such an occurrence less likely. First, animal studies have so far failed to show any evidence for vaccine-enhanced disease with the COVID-19 vaccines. Second, antibody-dependent enhancement as is seen with Dengue Fever involves a different viral receptor (Fc) than the one used by the COVID-19 virus (ACE2). Finally, no cases of vaccine-enhanced disease have yet been detected among the hundreds of thousands of people who have already received a COVID-19 vaccine. In evaluating the possibility that the COVID-19 virus (SARS-CoV-2) could be involved in vaccine-enhanced disease, a commentator in the journal Science Translational Medicine concluded that “So far, that looks like too narrow a path for the virus to stumble through.”

No one can ever offer an absolute, 100% guarantee that a new medication won’t have some totally unforeseen, serious adverse side effects long after it is thoroughly studied in clinical trials. Our conclusion is that it is unlikely that the COVID-19 vaccines will cause vaccine-enhanced disease. This will of course be monitored, but it should not dissuade anyone from getting vaccinated.

Unfortunately, Infowars represents vaccine-enhanced disease as a major threat and warns people that there is a good chance the vaccines will kill people. You can read the specifics of their claims if you wish—we won’t repeat them here—but it is clear they are massively exaggerated, fear-mongering attempts to convince people not to be vaccinated. While people hearing about vaccine-enhanced disease may reasonably ask if this is a concern for the COVID-19 vaccines, what Infowars does clearly goes beyond anything reasonable. It crosses the line between misinformation and disinformation.

COVID-19 Vaccines and Fertility

The second worry we have frequently encountered is that the vaccines will disrupt female fertility. Here’s the science behind this concern.

There is a protein on the placenta of pregnant women called syncytin-1 that is necessary for a pregnancy to proceed successfully. The claim is that the mRNA in the Pfizer/BioNtech and Moderna/NIH vaccines not only codes for the intended target, coronavirus spike protein, but also for syncytin-1. This would lead the same antibodies that the vaccine induces to attack the virus to also target syncytin-1, thus making it unlikely that a pregnancy could proceed. Once again, we can certainly see how someone reading about this would form a legitimate concern about whether being vaccinated against COVID-19 would compromise fertility.

There is no evidence to suggest that COVID-19 vaccines will adversely affect fertility (image: Shutterstock).

As in the vaccine-enhanced disease situation, Infowars makes the infertility claim seem like a major, known threat and states that “if it [the vaccine] starts attacking placentas, no one will be able to get pregnant.” Infowars also says that “the syncytin resembles the Spike protein so much.”

There are two things that can be said about these dramatic statements. First, in fact the coronavirus spike protein and the placental syncytin-1 protein are almost completely different. The two proteins share only a few short amino acid (the building blocks of proteins) sequences and therefore it is highly unlikely that antibodies against the virus would be able to target syncytin-1. Second, women enrolled in the vaccine clinical trials did in fact become pregnant. In the Pfizer/BioNtech trials, the only pregnancy with problems occurred in a woman who received placebo.

It is important to acknowledge once again that no one can ever guarantee with absolute certainty that some totally unexpected side effect will occur, even after all the clinical trials are completed for a new drug and many people have taken it without incident. And for now, because of a lack of sufficient data, FDA recommends against pregnant and lactating women receiving the vaccine. That may change once clinical trial data are accumulated with pregnant women receiving the vaccine and for now is a pretty standard FDA decision following the introduction of a new drug. It absolutely does not mean that there is any evidence right now that COVID-19 vaccines will adversely affect fertility.

We see again how Infowars and its like exploit reasonable fears and questions people may have about a health topic by taking things out of context, piling on warnings that have little basis, and exaggerating potential risks. Infowars could just as easily have checked out the vaccine-enhanced disease and fertility claims as we did in writing this commentary. Although sometimes the science can be complex, there are plenty of user-friendly explanations about both things from reliable sources that mitigate fear and worry.

Why would anyone go so far beyond expressing reasonable concerns to the point of active deception? Different disinformation organizations likely have their own reasons, but deliberately spreading incorrect or misleading information jeopardizes the health of individuals and communities. It’s worth fighting hard against.

Mental Health and School Re-Entry

What does the evidence show?

It is an unfortunate and sometimes downright upsetting phenomenon to see mental health used as a scapegoat to divert attention from other topics. Many will likely be able to report seeing this happen in the wake of mass shootings. In those instances, some people who wish to divert the conversation away from a focus on gun control may say something like “this isn’t about gun control, this is about mental health.” They tend to claim that untreated mental illness is the real culprit behind the tragedy and often propose solutions such as registries of people with mental health diagnoses that can be used in gun purchases. While mental health can and certainly often is a factor here—and we personally are always in favor of conversations that might shine a light on the often-overlooked problem of untreated mental illness in this country—the motivation behind this attention is likely simply to turn attention away from another urgently important but less politically desirable topic. 

This kind of diversion tactic unfolded again last spring and summer with calls for schools to reopen amid the COVID-19 pandemic. Then-President Donald Trump, many of his supporters, and others claimed that keeping schools closed was very threatening to mental health and that the mental health-related risks of not reopening posed a greater threat than the COVID-related risks of reopening.

It goes without saying that school and socialization are positive drivers of youth mental health. But is it really fair to say that keeping schools closed poses a dire threat to mental health? More dire than the threat of serious outbreaks of a highly contagious and potentially deadly disease? It is here that we must better understand what the evidence we have actually says. 

In general, and perhaps not surprisingly, school attendance is associated with better mental health and emotional well-being. Being in school can lead to a greater sense of connectedness, social support, and, more practically, better access to services. The benefit is often more pronounced for students with special needs and those who have behavioral or emotional issues and thus for whom extensive use of technology as part of virtual schooling might be difficult.

Indeed, any population that is already vulnerable will struggle more with school closure. For all students, schools are central to general development (especially for young children), building social and emotional skills, food security (which has an impact on mental health), and addressing social and racial inequity (which also has an impact on mental health). 

Source: Halfpoint/Shutterstock

Source: Halfpoint/Shutterstock

Given the mental health benefits of being in school, does it necessarily follow that we need to rush our children back into these potentially unsafe conditions in the midst of a pandemic that threatens all of us? Ultimately the question comes down to one of weighing risks. And to be able to weigh risks, we have to have a clear understanding of what has happened to mental health (and what is likely to happen to mental health) as a result of the pandemic and associated school closures and general lockdowns.

There is some reason to believe that the pandemic is already taking a toll on mental health, especially among teens. One study out of Italy and Spain found that 85 percent of parents perceived changes in their children’s emotional state during quarantine. High school and college students are clued into the possibility of the pandemic’s negative effects on their mental health, with more than half in a recent survey expressing concern about their own mental health as a result of the COVID pandemic. Professionals in California have also reported an uptick in depression and anxiety in the teen population since COVID began. 

Despite these reports, it is difficult to know the ultimate impact of COVID-19 and associated quarantine on mental health. It may take years before we understand the relationship and even then, it will be hard to isolate COVID-19 as the cause, especially since mental health issues are already on the rise among teens and young adults.

In cases such as these, we would normally advocate carefully and scientifically weighing the risks against one another to reach a decision about when to keep schools open and when to shut them down. But there is simply too much uncertainty here to be able to do that. We don’t fully understand how contagious the virus is specifically among young people, we don’t know what the role of school opening is in the perpetuation of large outbreaks, and we also don’t know how long the pandemic will even last.

In our view, it is not acceptable at this stage to keep schools open or reopen schools on account of mental health when COVID cases are extremely high. It is likely that many factors are involved in whether or not opening schools in specific communities is a major driver of increased viral transmission. We simply don’t know enough about the relationship between quarantine and mental health to be able to say that the risks of keeping children out of school outweigh the risks of COVID-19 spreading widely in a community. In the end, we need to do everything we can to protect both the physical and mental health of as many people as possible. 

The Long and Short of Long-Term Side Effects

Although most Americans say they will have a COVID-19 vaccine as soon as it is made available to them, a substantial minority—especially among Black and Latinx people—are hesitant to be vaccinated. One of the most common reasons for this reluctance is concern about “long-term side effects.” Many people hesitant to be vaccinated against COVID-19 say they want to wait and see what happens to the people who do get vaccinated before they agree to have one themselves. We’ve heard some say that the wait-and-see period will be as long as five years.

         These concerns perplexed us at first. After all, 30,000 people were enrolled in the Moderna/NIH vaccine trial and over 40,000 in the Pfizer/BioNTech trial. Since those vaccines received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA), millions of people have received the vaccines. Adverse side effects have been very rare, so don’t we already have enough data?

         What we realized in listening to those who worry about “long-term side effects” from the vaccines is that they seem to be conflating three phenomena. The first are adverse side effects (AEs) that arise many months or even years after someone took a medication. The second are AEs that turn up only after individuals take a medication regularly for a long period of time. The third are AEs that occur soon after someone has taken a new drug or vaccine but only show up for the first time after the clinical trials have been completed and many thousands or millions of people have received them.

Adverse Events That Show Up Years Later Don’t Occur with Vaccines

AEs of the first type occurring many months or years after a vaccine is taken are almost unheard of. In fact, we could not find a single instance in the literature of an AE occurring to someone years after being vaccinated with any of the currently available vaccines. Critica’s vaccinology consultant Dr. B. K. Titanji of Emory University told us that “To my knowledge there are no human vaccines in use which have long-term effects in the order of years post-immunization. The majority of adverse events really occur in the short-term post immunization in the order of weeks to months.” 

Vaccines do not cause adverse side effects that only appear many months or years after receiving the vaccine (source: Shutterstock).

The only example that even comes close to this type of AE detection is the tragic outcome of clinical trials for a vaccine against respiratory syncytial virus (RSV). RSV is a common cause of severe respiratory infection and pneumonia in children. A vaccine against RSV was tested in 1966. Children who received it and then contracted RSV infection in the community turned out to get worse respiratory illness than unvaccinated children and two toddlers who received the vaccine in a clinical trial died. We now know that this occurred because of something called vaccine-enhanced disease, a phenomenon that will not occur with the COVID-19 vaccines we now have. The 1966 RSV vaccine was of course never approved by the FDA and was not given to anyone after the clinical trials.

At the time of this writing, more than 20 million people in the US have received at least one dose of a COVID-19 vaccine. We thus already have a lot of data on short-term AEs from the vaccines, which are mostly mild and resolve in hours to a few days.  Based on decades of experience with vaccines and what we have observed so far with COVID-19 vaccines, it seems that waiting to see if someone who received a vaccine will develop a serious AE in a year or more is almost certainly misguided. During that year of waiting to be vaccinated the chances of getting infected with the virus that causes COVID-19 are much higher than any AEs from the vaccine.

Adverse Events That Occur After a Drug Has Been Taken Regularly for a Long Time

         The second type of AEs—those that occur only after people have taken a medication regularly for a long period of time—doesn’t really apply to vaccines, which are given only a few times. Newly observed AEs do occur once people start taking a medication on a regular basis for longer periods of time than clinical trials last. This happened, for instance, with an antipsychotic drug called olanzapine that caused only a few pounds of weight gain in eight-week clinical trials but turns out to be capable of causing much more significant weight gain and even diabetes once someone has taken it daily for months. Again, that sort of “long-term side effect” just doesn’t apply to a vaccine that is given in just two doses.

Adverse Events That Only Show Up Once Huge Numbers of People Have Received a Vaccine

         The third type of long-term AE is one that only shows up once large numbers of people have taken a drug. A clinical trial might only involve hundreds to tens of thousands of people, so they can only pick up on AES that range in that frequency. An AE to a drug that only occurs at a lower frequency than can be detected in a clinical trial might emerge as more and more people receive the drug. There is an example of this in the history of vaccines. In 1998 a vaccine for rotavirus was approved by the FDA. Rotavirus causes severe gastrointestinal illness in children. The 1998 vaccine turned out to increase the risk in infants for something called intussusception, a condition in which the infant’s small intestine telescopes onto itself, causing a small intestinal blockage that is a medical emergency.

In the clinical trials that led to this first rotavirus vaccine approval, there were five cases of something called intussusception among 10,054 infants who received the vaccine and one case among 4,633 infants who received a placebo. This difference of risk between 0.05% and 0.02% is not statistically significant, meaning it could have been just a chance occurrence. Given those data, the FDA approved the rotavirus vaccine. However, once the vaccine was administered to more children after it was approved, more cases of intussusception shortly after vaccination were reported, leading the vaccine to be withdrawn. Thus, it was not until more children received the vaccine than had in the initial clinical trials that a rare but serious AE was detected. Subsequently approved vaccines for rotavirus have a much lower risk for intussusception (somewhere between 1 in 20,000 and 1 in 100,000 infants).

Could something like this happen with the COVID-19 vaccines? We cannot guarantee that it won’t, but remember that millions of people have received one of the two vaccines already available. That means that AEs picked up after the clinical trials of the Moderna/NIH and Pfizer/BioNTech vaccines must, by definition, be extremely rare. For example, much has been made of severe allergic reactions—or anaphylaxis—to the two vaccines, but right now the rate of those is approximately 11 per one million people. Headlines also blared about the death of a previously healthy Florida doctor a few weeks after he received the Pfizer/BioNTech vaccine. Once, again, even if that death was caused by the vaccine, which is still under investigation, that would put the risk of death from the vaccine at somewhere around 1 in several million. The risk of death from COVID-19 for a 45-year-old person is about 1 in 1000 and for a 65-year-old person is about 1 in 100.

The risk of serious illness or death is far, far lower from a COVID-19 vaccine than it is with COVID-19 itself (source: Shutterstock).

Yes, there will be all kinds of illnesses and even deaths in people who receive COVID-19 vaccines, but the vast majority of these will be what we call incidental deaths. We have seen many people claiming that vaccines, including COVID-19 vaccines, cause a number of different serious AEs such as Bell’s palsy and Guillain-Barre syndrome. Writing in STAT News, Helen Branswell points out that “On an average day, 110 people in this country may develop Bell’s palsy, a temporary facial paralysis, and another 274 will develop Guillain-Barré syndrome, a form of paralysis that usually resolves over time.” With so many millions of people receiving the vaccines, it is inevitable that by coincidence there will be cases of people who develop one of these after getting vaccinated. As Branswell further points out, heart attacks are most likely to occur in the morning, but we don’t blame having breakfast for heart attacks.

There are several surveillance systems in place to monitor for new AEs from vaccines, including the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD). Using these, both FDA and the Centers for Disease Control and Prevention (CDC) continuously gather information on all possible vaccine-related AEs. Looking back at 20 years of post-marketing vaccine safety information updates, a recent study concluded that vaccines “…were found to be remarkably safe.” The study supported the robustness of the surveillance systems now in place.

As we have often stated, no one can guarantee anything in health and science with 100% surety, including the risk that unforeseen adverse side effects will emerge for COVID-19 vaccines as more and more people get them. But there is so much information suggesting that won’t happen: it almost never has happened with vaccines in the past and nothing much has emerged yet after millions of people have already been vaccinated. Waiting to be vaccinated to see if some rare AE turns up is just not worth the gamble according to the odds. The chances of getting infected with the COVID-19 virus, of developing serious illness from it, and even of dying from it remain many orders of magnitude greater than of developing anything more than mild and transient AEs from the vaccines.