Book Review Contributed to Critica by Peter McKenzie-Brown
I bought this book when it first came out but didn’t read it until I found myself in the Coronavirus lockdown, some ten years later. The book is terrific, and I have found out that author Alanna Mitchell later turned it into a one-person play, which she performed across Canada and around the world until, one presumes, the pandemic began.
A Canadian journalist, author, and playwright, Alanna Mitchell says on her website that she is “fascinated with the intersection of science, art and society.”
She titled this book Sea Sick – not “Seasick,” please note. She writes intelligently and passionately, and travelled around the world to do her research. The book is strongly based on science. “The issue is that all over the world,” she writes, “groups of specialists who rarely put their information together, are finding that global climate change and other human actions are beginning to have a measurable effect on the ocean. The vital signs of this critical medium of life are showing clear signs of distress.”
Mitchell writes about a much greater problem than the well-known idea that oceanic fish and other species are in decline. The ocean, she explains in the prologue, contains some 97 percent of Earth’s water, covers more than 70 percent of the planet’s surface, and makes up 99 per cent of our world’s living space. “Even more significant than the ocean’s breadth and width is its depth, or third dimension” she continues. “That total volume, with its immense biological importance, is what I came to think of as the deeps – both the source of life and the future of life on the planet.”
To research this book, she visited the ocean’s threatened areas, where she saw the tragic results of human ignorance and irresponsibility, and talked to scientists who may be able to suggest solutions. Her writing is riveting; her travels, delights; and her findings, intellectually stimulating. Here are a few examples.
Australia’s Great Barrier Reef she calls “The Last Best Place on Earth.” But the corals that made the reef are dying, she says. “The worldwide decay of coral reefs – caused by the pollution from land, too much fishing, nasty practices to capture wild fish for the aquarium trade and waters that are too hot because of global climate change – has already started to take its toll.”
Another example, closer to home. In the Gulf of Mexico, there are enormous “dead zones” – oxygen-free regions where nothing can live because of the toxic chemical runoff into the delta of the Mississippi River system.
In Plymouth, England, she visited a marine laboratory where a precipitous decline in plankton is being studied, a problem she calls “maybe the most important question human beings will ever grapple with.” Plankton forms the bottom layer of the entire oceanic food pyramid, so anything that happens to plankton affects everything that lives in the ocean. Also, it affects land animals whose diet includes seafood – for example, people on every continent including, one assumes, research scientists active in Antarctica.
Her book is not only backed up by travels, but by interviews with researchers, and by reference to their work. For example, she cites a 2006 paper titled “Impacts of Biodiversity Loss on Ocean Ecosystem Services” led by two profs at Canada’s Dalhousie University – Boris Worm and Ransom Myers – that is dreadful in its conclusions. According to these researchers, in the half-century since industrial fishing took hold in the world’s oceans, 90 per cent of all oceanic predatory fishes – cod, tuna, swordfish, sharks – were gone. Today, we are fishing the few remaining percentages. Fish farms are today’s answer to the virtual absence of wild fish in the ocean – an absence brought on by overfishing. More than half of the seafood we and our pets consume today – a decade after Mitchell published her book – is the product of aquaculture. Raising saltwater fish takes place in farms in the ocean itself, with species confined in mesh cages too deep for them to escape, with much of their food being sea creatures that can float or drift on currents through the mesh.
She also went to China, the world’s largest emitter of greenhouse gases, where the waters are polluted – often by the vast pens the Chinese use to raise more farmed fish than any other country. China now provides 62 per cent of the world’s farmed fish.
Mitchell’s final trip is to the Florida Keys, the last research expedition of the book, where she had the opportunity to go to the ocean’s bottom in the submersible vessel Johnson Sea Link. When offered the ride, her immediate reaction was, “Why keep going? Why should another research trip make any difference?”
It did, though. As the submersible sits on the bottom, she had a kind of epiphany. “Shivering in my undersea womb, peering at these wondrous, ancient life forms,” she writes, “it occurs to me that we are in an era that holds out the potential of magnificent regeneration. We could, if we wanted to, form a new relationship with our planet. We could become the gentle symbionts we were meant to be instead of the planetary parasites we have unwittingly become.”
In conclusion, I cannot recommend this book too strongly; it dazzles. Mitchell explains the oceanic problems grippingly. Many of her chapters chronicle adventures in which she accompanies scientists at various research missions around the world. At least as importantly, her writing is engaging and balanced. This book rocks.
By Jack M. Gorman MD, David A. Scales MD PhD, Cody M. Leff, and Sara E. Gorman PhD MPH
July 16, 2020
Misinformation about science and health is rampant on the internet and throughout social media, as attested to by the current WHO-declared coronavirus “infodemic.” Because so many people now seek information and advice about personal health decisions on the internet, such misinformation has the potential to cause significant harm. Parents believing that vaccines cause autism and refusing to immunize their children, or people with cancer shunning traditional treatments like chemotherapy are examples of harm being caused by misinformation promulgated on the internet and social media.
We are Penn undergraduate alumni who formed a non-profit organization called Critica with the goal of improving the public’s acceptance of scientific consensus, counteracting misinformation about science and health, and increasing the use of scientific evidence in public policymaking. Initially, we focused our attention on vaccines, GMOs, nuclear energy, climate change, Lyme disease, and personal gun ownership. More recently, after conversations with the Robert Wood Johnson Foundation, we added the safety of municipal drinking water in the U.S. as an important topic for which the public should be provided scientifically accurate information and given guidance against misleading or incomplete information. Because this was not an area where any of us had significant background, we sought collaboration with The Water Center at Penn.
We quickly learned from our Penn Water Center colleagues that the American public tap water supply is safer than it has ever been and is the safest in the world. We also identified multiple areas in which misleading claims about contamination and toxicity of our drinking water are spread through the internet and social media.
Perhaps the most obvious topic where information regarding tap water is misrepresented is the persistent rumor that fluoridation of water causes a myriad of health problems. There is little scientific debate that fluoride at appropriate concentrations prevents tooth decay in children and adults. In fact, the U.S. Center for Disease Control and Prevention (CDC) declared community water fluoridation one of the ten greatest public health achievements of the 20th century.
Despite endorsements by many scientific and medical organizations, including the American Dental Association and the American Academy of Pediatrics, claims persist that fluoride in drinking water causes medical harm. It is true that at very high levels, fluoride can cause toxicities resulting in abnormalities to skeletal bone, teeth, and the thyroid gland. However, to protect against this, the Environmental Protection Agency (EPA) sets a maximum level of fluoride allowed in drinking water of 4.0 parts per million (ppm) and recommends that fluoride levels be maintained at a minimum of 0.7 ppm to protect dental health. Studies show that in this range, fluoride’s benefits in decreasing tooth decay outweigh any risks of harm. A study in Juneau, Alaska, serves as an example. In 2007 the city voted to stop fluoridating its public water supply, which resulted in a 25.2% increase in tooth decay in children and adolescents.
Most recently, concerns have emerged that children exposed to fluoride in tap water either during prenatal life or infancy can show adverse neurodevelopmental outcomes, particularly lower IQ. These concerns stem from a 2019 draft report from the National Toxicology Program, which concluded that fluoride is “presumed to be a cognitive neurodevelopmental hazard to humans.” While this assertion has been challenged by many experts as well as a report from the National Academies of Science, Engineering, and Medicine, information from the 2019 draft report promoted through social media and internet channels has nonetheless promoted increased debate about the safety of fluoridation of the public water supply.
This situation highlights two common challenges faced by those of us interested in counteracting misinformation about science and health. First, it is understandable that people believe information presented by scientists or scientific organizations without considering the aggregate scientific data, especially when there is some disagreement within the scientific community itself. Hearing that a report from a national scientific agency links fluoride to neurodevelopmental problems is going to make some parents anxious about fluoride’s safety. We need to correct misinformation while at the same time respecting understandable fears and anxieties.
Second, it is frequently difficult to convey risks and benefits to people who do not possess a scientific background. At the levels of fluoride allowed in drinking water, most scientists and health professionals conclude that the benefits far outweigh the risks and that fluoridation is worthwhile to protect the public’s health. But such risk/benefit assessment may not persuade the general public. Studies show that people tend to overestimate very small risks and that some people cannot tolerate any risk. We cannot tell people there is absolutely zero risk that fluoridation will cause harm. We can only say that the benefits of reducing tooth decay and oral infections are far greater than any risk associated with fluoridated drinking water. In explaining this, we need to walk the fine line of acknowledging risk and encouraging rational assessment of that risk.
To counteract misinformation about health and science, we needed to explore the most effective and respectful ways of promoting accurate information about issues like the risks and benefits of drinking water fluoridation. We searched the literature for studies of various methods that have been shown effective in dissuading people from believing misinformation. Most of these studies have been conducted in the laboratory and the majority involve political and public policy statements. Nevertheless, we were able to draft a protocol for counteracting online misinformation in the health and science fields.
Our approach is to enter into a thread of comments on an internet or social media site that begins with some misinformation about drinking water safety. Our CIO, Cody Leff, has developed a method that permits us to pick out stories in traditional media and review them for accuracy. We then use Crowd Tangle software to locate social media sites in which an inaccurate or misleading statement based on the original story is repeated and discussed.
Our protocol is based on a psychological intervention called Motivational Interviewing (MI) that was originally developed to help people with substance use and mental health disorders find reasons to pursue treatment. Of particular importance to us is the MI method of establishing common ground with an interlocuter, which is essential for initiating the counteracting protocol. We proceed through the protocol steps including asking the person who has posted the misinformation to explain the scientific basis for their statement; warning or “inoculating” the people joining in on the thread that we will be disputing the misstatement and then later providing actual scientific information; and offering people on the thread the ability to take their own actions to find out what the scientific evidence says rather than passively accepting what they have read from the original poster. Because social reinforcement is an important component to maintaining false health and science beliefs, we also explain that there are social groups that promote the scientific evidence rather than false beliefs.
With a grant from the Robert Wood Johnson Foundation we plan to test our protocol on drinking water safety and to find out if it is effective in persuading people who go online seeking information about the safety of drinking water in their community where there is sufficient useful scientific evidence that can be applied to the topic. We hope to dissuade people from unnecessarily purchasing bottled water or expensive home water filters when the water from their taps is perfectly safe to drink. Once we have learned what parts of our protocol work and what parts need adjustment, we hope to apply it to other health topics, including fears about a hopefully forthcoming coronavirus vaccine.
Jack Gorman is a physician and scientist who majored in English literature at Penn and now works as a behavioral healthcare improvement consultant in addition to serving as president of Critica.
David Scales MD, PhD is the Chief Medical Officer for Critica and an assistant professor of medicine at Weill Cornell Medical College. David is an internist and hospitalist in New York City who did his undergraduate work at Penn and holds a PhD in sociology from Yale.
Cody Leff is a designer and software engineer specializing in user experience and data visualization for the web. Cody received a B.S. in Architectural Design from Stanford University in 2015 and has since worked in a variety of technology-focused roles including product strategy, visual and experience design, software development, and digital marketing. As part of the Critica team, Cody works to promote evidence-based decision-making for health and public policy issues through software and information technology solutions.
Sara Gorman is a public health specialist and author who has written extensively about mental health, global health, and the intersection of public health and psychology, among other topics. Sara’s book, Denying to the Grave: Why We Ignore the Facts That Will Save Us, published by Oxford University Press in 2016, explores the psychology behind irrational health beliefs and decisions. She is currently working on a second edition of the book covering the political war on science in the U.S. and the emergence of misinformation in the face of health crises such as COVID-19. Sara’s work has appeared or been reviewed in TIME, The New Yorker, Science, Psychology Today, The Atlantic, BBC, NPR, and Quartz. Sara majored in English at Penn, holds a PhD from Harvard, and an MPH from Columbia University Mailman School of Public Health.
What we know about misinformation in times of crisis.
It is a common experience to find things on the internet we might not have been expecting. For me, a catnip toy in the shape of Putin that I discovered in the winter of 2017 was certainly a highlight.
But some discoveries are not nearly so pleasant. Lately, in the context of the coronavirus pandemic, there have been many of these not-so-pleasant internet discoveries. Among them were the short film “Plandemic,” a viral video that claimed, among other things, that masks activate the virus and that the coronavirus vaccine will kill millions of people. Then there is the ever-circulating conspiracy theory that Bill Gates created coronavirus so that he could use a vaccine to insert microchips in large portions of the American population that he would use to track people.
While all of these claims are probably more widespread than they should be, there are also a series of other pieces of misinformation about the novel illness that are less extreme. For example, many people still believe that masks are ineffective against the virus and that children are unable to become ill from it. It is understandable why people would believe these misinformed tidbits, especially given statements made by usually reliable sources earlier in the pandemic.
No matter how you look at it, misinformation and conspiracy theories are spreading at alarming rates. This has led the World Health Organization (WHO) to declare an “infodemic.” And indeed, a recent survey of US residents found that 23 percent believed that the virus was created intentionally (only 6 percent subscribed to the belief that it was created accidentally in a laboratory). With misinformation already on the rise and views about coronavirus becoming increasingly politicized, throwing a national election into the mix will likely only exacerbate things, accelerating politicization of false claims about the illness and making it more tempting to believe whatever best aligns with our increasingly passionate political views.
While most of us probably have not seriously engaged with conspiracy theories such as the one about Bill Gates, many, many people are falling victim to false information about the transmission and treatment of the illness that turn out to be extremely dangerous—like believing that silver can cure the illness or that dark skin protects people from becoming infected.
So why is misinformation so appealing during times of crisis? Well, there are at least a few relatively simple explanations. One is that people are abnormally anxious during times of crisis. This is understandably the case. People who suffer from anxiety disorders will tell you that when you are extremely anxious, the desperate search for reassurance can lead you down some strange paths.
This is what is behind the dreaded “internet rabbit hole,” in which a panicked state of mind might lead you to conclude something bizarre based on how your anxiety is guiding your internet search. A lot of this has to do with the fact that the reasoning parts of your brain do not work quite as well when you’re highly anxious so you aren’t able to evaluate information as clearly.
There is also the related issue of distraction. The more distracted we are, the more likely we are to believe false claims. Having a lot of anxiety is like living in a constant state of distraction—it is as though there is a thin veil over everything we see and we can only barely make out what it is.
But this can’t be the whole story, especially with claims that are especially unbelievable, like the idea that saltwater cures coronavirus. This is where we need to understand that people are not only having increased difficulty processing information but they also have a desire to believe something, anything. In order for misinformation to truly work its magic, there has to be a willingness on the part of the recipient (or victim) of misinformation to believe it.
You might be thinking: Why would we want to believe things that aren’t true? Well, extreme circumstances will create an opportunity for us to want this. In the case of something like the coronavirus pandemic, we have few definitive answers to our questions. Why did this happen? How do we stop it? How long will it take to stop it? We do have some answers to these questions but nothing is absolute in such a continuously evolving situation. Human beings are so uncomfortable sitting with this gap in knowledge that they would rather fabricate truth than just live with not knowing.
This is not to say we do this with everything. If there’s a topic I don’t know about, like how to fix a washing machine, but it doesn’t matter that much to me that I don’t know about it, then I am happy to just say “I don’t know.” But if the topic is somehow particularly salient and important and I’m not getting the answers I want from mainstream or typical sources, I will start to perform that panicked late-night internet search that leads me to strange, but oddly passable, explanations.
Given this surge of misinformation, is there anything we can do to lead people to the correct information? It is certainly more complex than simply providing corrective information, but there is a whole literature suggesting various methods to fight misinformation. Here are a few highlights:
Beware the continued influence effect. The continued influence effect refers to a phenomenon in which people hold on to debunked information even after it has been corrected. It is posited that this happens because people build a mental model explaining a particular series of events and it is difficult to disrupt this once it has been formulated. There are a few techniques that have been shown to help overcome this. One is to provide alternative explanations, rather than simply debunking information and saying it is wrong. This helps people build a new mental model. Another potentially effective technique is to warn people about the continued influence effect before you debunk the misinformation. In some cases, this awareness helps people engage more actively in displacing the debunked information.
Use both topic and technique rebuttal. Just as vaccines work by exposing people to small amounts of inactivated virus in order to mount an immune response, it is thought to be the case that a similar type of “inoculation” might work to debunk misinformation. That is, warning people that you are about to debunk incorrect information (topic rebuttal) or that you are about to question the methods by which that incorrect information was created (technique rebuttal) may be more effective in persuading people to believe the correct information than simply providing the corrective information on its own.
Use motivational interviewing techniques. The jury is still mostly out on this technique as a tool to counteract misinformation, but there is reason to believe that engaging people in an empathic dialogue about how they arrived at their views might help them be more open to hearing other sides of the story. This technique requires time and patience, as it may not be effective over the course of a single encounter.
The spread of misinformation surrounding COVID-19 is alarming and dire, but it is also understandable given high levels of stress and uncertainty. All we can do is continue to test new methods of debunking misinformation and continue to suggest techniques for managing anxiety in this highly unusual time.
Making Sense of Treatments Claimed to Prevent or Treat COVID-19
Claims abound throughout traditional and social media about supposed treatments that allegedly can prevent or treat COVID-19. Common sense dictates that not all of these claims are true, but how does one sift through all the drugs, vitamins, minerals, and devices that are said to thwart the virus that causes COVID-19, SARS-CoV-2?
Usually, we await the results of at least one large randomized controlled trial (RCT) (ore on what this is later) before accepting that a new treatment is likely to be safe and effective. For any drug or device that is explicitly aimed at treating a specific disease(s), this is generally what the US Food and Drug Administration (FDA) requires for approval. There are many supplements, medical foods, and “alternative” treatments that do not advertise a benefit for a specific disease but rather claim to improve some aspect of health, like “boosting” the immune system or improving memory. These drugs are not regulated by the FDA, but healthcare professionals and scientists still usually demand that rigorously conducted RCTs be completed before they will recommend them to their patients.
These are, however, not ordinary times. The coronavirus pandemic is a health emergency and it may not be advisable to wait the years it can take for the most definitive studies to be completed for a putative new treatment. As the virus spreads, leaving in its wake death, disability, emotional turmoil, and a ruined economy, we are looking for quick solutions whenever possible. Anything that just might help is going to get attention in the form of press releases from medical schools and pharmaceutical companies, stories in newspapers and broadcast media, and posts on websites and social media. These can sometimes exaggerate the potential benefits of a new treatment or, worse, obscure its potential harms. On the other hand, these communications alert us that something is out there that might work.
Vitamin D is a good case in point. Vitamin D has been touted as potentially both lowering the risk to be infected with the COVID-19 virus and reducing mortality among those infected. This has led a lot of people to take vitamin D supplements, hoping to prevent being infected with the novel coronavirus. Yet to date there are noD completed, published RCTs demonstrating that vitamin D either lowers the risk of getting infected or improves outcomes if one gets infected. So what is the basis for vitamin D and COVID-19 and how does one decide whether to take extra vitamin D during the pandemic? Let’s review three things: first, what exactly is vitamin D; second, what is the difference between an observational study and a randomized controlled trial; and third, how strong is the evidence that vitamin D plays a role in COVID-19?
Vitamin D Biology
Vitamin D is a fat-soluble vitamin (meaning that unlike water-soluble vitamins, the body can store vitamin D) that was discovered in 1922 by Sir Edward Mellanby in Great Britain. Severe vitamin D deficiency leads to a serious weakening of bones and impaired walking, a condition called rickets. The main source of vitamin D is the sun, although it is also found at fairly low levels in some foods like fortified milk. As ultraviolet radiation from the sun hits the skin it causes a reaction that produces vitamin D. But this molecule must be converted in two steps to be active, first in the liver and then by the kidney. Its most obvious role is to increase the absorption of calcium from the gastrointestinal tract into the bloodstream, thus making calcium available for bone strength and health. Without sufficient vitamin D, there is insufficient calcium and bones get weaker.
In addition to its importance for bone health, vitamin D is also known to modulate immune function and reduce inflammation, and this is the basis for believing it might be involved in COVID-19. Vitamin D has been implicated to play a role in a variety of other conditions, including respiratory diseases, cancer, and diabetes.
It has been remarkably difficult to set upper and lower blood level limits for vitamin D or its active metabolite, in part because there is so much variability between different tests and in part because it has been very hard to figure out exactly what blood level is associated with good health. We know the level below which rickets can occur, but this condition is rare in medium- and high-income countries like the U.S.: most Americans get at least enough vitamin D to prevent rickets. We also have pretty good information about blood levels above which serious adverse outcomes occur, most notably too much calcium in the blood which can clog arteries and cause heart and kidney damage. How much is good for the heart, lungs, immune system, and other organs, however, is in dispute. This means that there are reasonable differences of opinion about how much vitamin D people should get every day, either from sun, foods, supplements or some combination of these. The current recommendation is 600 International Units (IU) for people aged one to 70 and 800 IU for people over 71, but some experts think more is needed for optimal health. The safe upper daily limit for adults is 4,000 IU. That leaves a lot of room between what is generally recommended and what people can tolerate, opening up the question of how much we really need.
The Difference Between Observational and Randomized Controlled Studies
We mentioned above that the gold standard for evaluating the benefits and risks of any new drug or device is the randomized controlled trial (RCT), but this is not the only kind of informative research study. Many important findings emerge from observational studies, which sometimes can be done more quickly than RCTs. In a case like the vitamin D story, an observational study was done by researchers at the University of Chicago in which they looked at medical records of more than 4,300 people who had been tested for COVID-19 and found that of 499 of them who had vitamin D levels recorded before the pandemic, people who were “likely” vitamin D deficient were 77% more likely to get infected with SARS-CoV-2.
This study is called observational because the experimenters did not control any aspect of what happened, they observed how many people got infected and their vitamin D levels and found an association between them. This is very important information, but there are two important things to remember about observational studies. First, because the experimenters don’t control anything, other variables that were unmeasured in the study could also be causing the apparent link between vitamin D and coronavirus infection. For example, perhaps poor people have less access to healthcare and live in more crowded conditions and also have less access to fortified milk. Anyone of those three things (plus many others) could be the reason for the group to have higher rates of infection. The study did not report on income, healthcare access, or living conditions and if any of these were the real reason for the higher risk of getting infected, then giving someone vitamin D would probably not help them.
And second, because of this issue of unmeasured variables, observational studies only indicate associations between two or more things but cannot establish cause and effect. There is an association between height and weight: taller people generally weigh more than shorter people, but one does not cause the other (that is, separate processes determine how tall a person weighs and how tall they are). In other words, the Chicago study does not tell us whether low vitamin D levels actually cause a person to be at higher risk to get COVID, but it does suggest it might be the case.
The only way to be sure that vitamin D actually causes the problem would be to randomly assign people in a study to receive either vitamin D or a placebo and then see how many in each group either get infected or, if already infected, survive. If the group that gets vitamin D does better than the placebo group, we have evidence of a causal relationship. Because in such a randomized study the only difference between groups is who gets vitamin D, we can rule out all other variables as being the cause of risk of infection.
But RCTs have their problems too. First, in order to get people in each group who are the same on everything except whether they get vitamin D, researchers often have to exclude a lot of people who have situations or conditions that might bias the results. Therefore, RCTs are restricted to people who meet study requirements and may not give an accurate portrayal of who actually would benefit from vitamin D, assuming it beats placebo. Because observational studies do not usually exclude anybody from the study, they are more generalizable. Second, RCTs are very expensive and take a long time to complete. In a situation like the pandemic, we really don’t want to wait for a definitive answer if solid observational data suggest something might save lives.
The Vitamin D Story
There are several parts to the story of a possible role for vitamin D in COVID in addition to the University of Chicago study described above. First, it is known that people with dark skin are less able to convert sunlight into vitamin D and it is clear that people of color have higher rates of infection and higher mortality rates when infected than do white people. However, there are of course a host of other reasons why this may be the case, including crowded living conditions, lack of access to healthcare, and higher rates of pre-existing medical conditions.
Second, vitamin D is known, as mentioned earlier, to have a variety of effects on the immune system. One of these is an anti-inflammatory effect, which could conceivably be important in reducing the hyperactive immune response (sometimes referred to as “cytokine storm”) that appears to increase symptom severity in some patients with COVID-19. Thus, there is a plausible biological basis for thinking that vitamin D deficiency may be involved in COVID-19 and that vitamin D treatment might be helpful.
Third, there are other observational studies that link “deficient” levels of vitamin D to risk and mortality associated with COVID-19, although some of them are “pre-prints”—articles that are posted online before they have been peer reviewed for publication in a journal (for example this study).
In the face of this, however, are at least two observational studies that did not find any association between vitamin D deficiency and COVID-19.
If all of this sounds confusing, you can perhaps take some solace in knowing that it is confusing experts in the fields of endocrinology, infectious diseases, and immunology as well. The UK National Institute for Health and Care Excellence (NICE) opined at the end of June that there is insufficient evidence to recommend vitamin D supplementation for any respiratory infection. On the other hand, six medical societies, while again insisting that “The current data do not provide any evidence that vitamin D supplementation will help prevent or treat COVID-19 infection,” still released a statement advocating that people get at least 15 to 30 minutes of sun every day (while taking steps to avoid sunburn) or, if that is not possible because of quarantine, stay-at-home, or other factors, taking vitamin D supplements.
All of these statements make the point that we don’t have definitive clinical trial evidence that vitamin D supplementation will help prevent or treat COVID-19 and we have mixed observational evidence that vitamin D deficiency is involved in increasing risk or severity of illness. We would rather not waitfor big RCTs to be done on the one hand while on the other we don’t want to take things that don’t work and may even be harmful. What can we say about vitamin D, then?
First, almost everyone agrees that people who are really vitamin D deficient should take a supplement, so people at increased risk for COVID-19 or who are already infected might do well at least to have a blood level determined.
Second, there doesn’t seem to be any harm in following the recommendation to get 15 to 30 minutes of sun exposure every day (but be careful not to get sunburned and increase your risk for skin cancer). Remember, however, that this is just our read of the conflicting literature and recommendations; we are not in a position to offer anyone medical advice.
The hardest thing of all is to know what to do about taking a supplement even if you don’t have a clear vitamin D deficiency. If you can’t get outside every day, perhaps the six medical society statement “that most adults 19 years and older obtain between 400-1000 International Units (IUs) of vitamin D daily from food and/or with supplements (ideal intake depends on age and sex)” is a reasonable course. Bear in mind, however, that there are significant adverse consequences of taking too much vitamin D. If you can still get vitamin D supplements, don’t gulp them down indiscriminately.
The vitamin D situation illustrates a problem we all have during a health emergency. Balancing the need to use potentially life-saving interventions as quickly as possible with ensuring that those interventions actually work and cause no harm is not an easy task under ordinary circumstances; it is even harder during a pandemic. The press and social media will pick up on every even remote possibility and often give the impression that things are settled science. Upon further review by scientists, what seems like the latest breakthrough often loses some of its shine. Our job at Critica is to try to help you through these complexities so you at least have a broad enough range of information to be able to make your own, informed decisions.
Editor’s Note: Our esteemed contributor Peter McKenzie-Brown was born in the UK, was raised in the United States, and is now a resident of Calgary, Canada.
I am old enough to remember the assassination of John F. Kennedy on November 22, 1962 – one of only half a dozen dates that are clear in my memory. Glued to the television that night, I saw a nightclub operator named Jack Ruby murder Kennedy assassin Lee Harvey Oswald on live TV – the first murder ever broadcast live. It was a bizarre reality for those of us who lived it.
Kennedy’s assassination soon became the subject of widespread debate and spawned numerous conspiracy theories and alternative scenarios. Polls conducted from 1966 to 2004 found that as many as 80 percent of Americans suspected a plot or cover-up. Welcome to the strange world of zombie ideas.
Nobel laureate Paul Krugman defines a zombie idea as “a proposition that has been thoroughly refuted by analysis and evidence and should be dead — but won’t stay dead because it serves a political purpose, appeals to prejudices, or both.” Science notwithstanding, there are those who believe in a flat Earth, a hollow Earth, a geocentric universe or perhaps all three. An entry in the online Skeptic’s Dictionary offers other examples.
Hate speech is a special case in this range of thinking. According to the Cambridge Dictionary, it includes “communications of animosity or disparagement of an individual or a group” because of “group characteristic such as race, colour, national origin, sex, disability, religion, or sexual orientation.” Most liberal democracies – for example, Canada, the UK, France, Germany, The Netherlands, South Africa, Australia, and India – ban hate speech. In many ways, such countries enjoy greater freedom when you weigh the negative liberty to express harmful thoughts against the positive liberty a society enjoys if it disallows the intimidation of minorities.
Some people argue that the purpose of laws that ban hate speech is merely to avoid offending prudes. I cannot think of a single democracy, however, that excises comment from the public square merely because it provokes offense. Rather, hate speech has been so widely proclaimed unlawful because it attacks the dignity of a group.
Among the world’s great democracies, only in the United States is hate speech legal. With few exceptions, America’s Supreme Court has repeatedly ruled that hate speech is constitutionally protected by the first amendment right to free speech. There have been a few exceptions to this. For example, in 1952 the United States Supreme Court upheld an Illinois law making it illegal to publish or exhibit any writing or picture portraying the “depravity, criminality, unchastity, or lack of virtue of a class of citizens of any race, color, creed or religion.” The case provided a legal argument against hate speech by making it possible to sue some offenders for libel. Especially in the world of social media, such a suit would be difficult to apply.
Despite the efforts of Facebook and other well-intentioned sites, hate speech in America now seems to be on the boil. As evidence, Humboldt State University compiled an online visual chart of a series of homophobic, racist, and otherwise prejudiced tweets sent out during an 11-month period; you can take a look at it here. If you are American, it will not make you proud.
Conspiracies: An important offshoot of conspiracy theory is the attempt to explain ordinary events or situations by invoking secret and unseen actions – often politically motivated – of sinister and powerful actors. The term has a pejorative connotation, implying that the appeal to a conspiracy is based on prejudice or insufficient evidence. Conspiracy theories resist falsification and are reinforced by circular reasoning: both evidence against the conspiracy and an absence of evidence for it are re-interpreted as evidence of its truth, whereby the conspiracy becomes a matter of faith rather than something that can be proved or disproved.
Conspiracy theories about moon landings followed conspiracy theories about the assassination of JFK. There were six crewed U.S. landings between 1969 and 1972 – unless you believe the conspiracy theorists who believe the moon landings were hoaxes. The gist of the argument is that the United States lacked the technology to transport humans to the moon and back. They claim that NASA faked the landings in order to make people believe the U.S. had fulfilled President Kennedy’s promise to land a man on the moon before 1970.
What is the evidence? Well, on the lunar landing videos you cannot see stars in the sky. NASA says that’s because the moon’s surface and the astronauts’ suits were so reflective that it was too bright for the camera to pick up the comparatively faint stars. Also, while planting the American flag in lunar soil, the flag appears to wave. With no air in space, how is that possible? NASA says it happened because the astronauts, wanting the flag’s pole to remain upright, moved it back and forth while planting it in the lunar soil. The rotation of the pole caused the flag to move back and forth as if rippling in a non-existent breeze.
Conspiracy theory is essentially the attempt to explain harmful or tragic events by ascribing them to the actions of small, powerful, and secretive groups. One classic example is the one I began this commentary with, the assassination of John F. Kennedy. Such explanations reject the accepted narrative surrounding those events; indeed, the mindset of many theorists is that the official version is further proof of the conspiracy.
Conspiracy theories increase in prevalence in periods of widespread anxiety, uncertainty, or hardship – for example, during wars, economic depressions and in the aftermath of natural disasters like tsunamis, earthquakes, and pandemics. This fact is evidenced by the profusion of conspiracy theories that emerged in the wake of the September 11, 2001 attacks on the United States. Perhaps two thousand volumes on the JFK assassination have been published, many of them purveying conspiracy ideas. Such notions have been spread through countless other media as well.
Perhaps conspiratorial thinking is driven by a strong human desire to make sense of social forces that are self-relevant, important, and threatening. The content of conspiracy theories can be emotionally powerful, and its alleged discovery can be gratifying to those who hold the associated beliefs. Factual support for conspiracy theories is typically weak, and they are usually resistant to falsification. The survivability of conspiracy theories may be aided by psychological biases and by distrust of official sources. Such distrust did not develop in a vacuum. Starting in 1932 and continuing for 40 years, the U.S. Public Health Service working with the Tuskegee Institute studied the effects of syphilis on 399 African American men. The researchers conducting the Tuskegee syphilis study withheld treatment and allowed more than a hundred men to die, despite the discovery of penicillin as a standard cure in 1947.
At the risk of sounding like a conspiracy theorist myself, that does sound like government conspiring against its own citizens.
An extraordinary commentary on these matters can be found in Kurt Andersen’s best-selling history Fantasyland: How American Went Haywire. His take on the past five American centuries involves a series of skillful deconstructions of myths and fantasies that have evolved since the country’s foundation. He dissects such matters as the Salem witch hunts and Scientology. As the story proceeds, he presents a picture of a country in such steep decline that the founding fathers would have wept into their beards.
“By my reckoning,” he writes in his introduction, reality-based people in the US “are a minority – maybe a third of us but almost certainly fewer than half.” Only a third, he claims, “believe with some certainty that CO2 emissions from cars and factories are the main cause of Earth’s warming. Only a third are sure the tale of creation in Genesis is not a literal, factual account. Only a third strongly disbelieve in telepathy and ghosts.”
“A third believe that our earliest ancestors were humans just like humans today,” he says. That percentage also believe that government has, in league with the pharmaceutical industry, hidden evidence of “natural” cancer cures, and that extraterrestrials have recently visited (or now reside on) Earth.
And the beat goes on. Two-thirds of Americans believe that “angels and demons are active in the world,” he writes. At least half are certain Heaven exists, “ruled over by a personal God” – not an abstract force or universal spirit “but a guy.” More than a third of Americans believe global warming is “a hoax perpetrated by a conspiracy of scientists, government, and journalists.”
“A quarter believe vaccines cause autism,” he says. Twenty-five percent believe in witches. No more than a fifth believe the Bible consists mainly of legends and fables, he says – about the same number who believe that “the media or the government adds secret mind-controlling technology to television broadcast signals” and that U.S. officials “were complicit in the 9/11 attacks.”
These myths are contrary to the growth of science, which has accelerated by leaps and bounds over the centuries of America’s settlement and growth. They will not go away, however. What can be best described as a national paranoia within “the land of the free and the home of the brave” is a loss to the country’s dignity, and to the integrity of the democratic alliances that have played such important roles in the world since the end of the Second World War.
 See Gorman SE, Gorman JG: Denying to the Grave: Why We Ignore the Facts that Will Save Us. New York, Oxford University Press, 2016
 Although the number of people who agree that human activities are responsible for the Earth’s warming may be increasing.
Critica Continues the Series About What We Are Vaccinating Against
Part Two: DTaP
With so much news and comment about the hoped-for vaccine against the virus that causes Covid-19, we continue to believe that some general information about vaccines might be helpful. Last month we described the MMR vaccine and the diseases it prevents (measles, mumps, and rubella). This month we tackle another trivalent vaccine—a vaccine that works against three different diseases—the DTaP vaccine. That stands for diphtheria, tetanus, and acellular pertussis (the version for people older than seven years is called TDaP and is sometimes referred to as the booster version).
The DTaP vaccine (which some may remember as the DPT vaccine) is one of the most important standard vaccinations given to children, adolescents and adults. It has saved the lives of countless people around the world because each of the three illnesses the DTaP vaccine prevents is fully capable of causing death.
The CDC recommends that the DTaP vaccine be given to babies in four doses between two and 15-18 months. A fifth dose is recommended between four and six years and a dose for adolescents at 11-12 years. For children who did not receive the vaccine as infants, there is a schedule of recommended catch-up vaccination times in childhood and adolescents. CDC further recommends TDaP as follows:
Pregnant women should get a dose of Tdap during every pregnancy, to protect the newborn from pertussis. Infants are most at risk for severe, life-threatening complications from pertussis.
Adults who have never received Tdap should get a dose of Tdap.
Also, adults should receive a booster dose every 10 years, or earlier in the case of a severe and dirty wound or burn. Booster doses can be either Tdap or Td (a different vaccine that protects against tetanus and diphtheria but not pertussis). However, see later for some other ideas about this.
Like all vaccines, DTAP, TDaP, and Td can cause pain and soreness at the injection site. More serious reactions range from 1 in 10,000 children to the pertussis portion of the vaccine to one in a million children to the tetanus portion. Death associated with DTaP is extremely rare and generally believed by experts to be coincidental rather than caused by the vaccine.
We will now review each of the three illnesses this vaccination prevents.
Tetanus is sometimes referred to as “lockjaw” because it usually involves the tightening of the jaw and month due to severe, involuntary muscle contraction. Muscle spasms then spread through the body, which can cause fractures and tendon injuries. People with tetanus can get pneumonia, blood clots in the lungs, nerve injuries, and several other complications and can lapse into a coma. Although most people survive tetanus, recovery can take several months and the mortality rate from severe tetanus is about 50%.
Tetanus usually begins with a wound, often an innocuous one like a simple cut or puncture wound. Most times, the individual does not even feel the need to seek medical treatment. But the bacteria that causes tetanus, clostridium tetani, lurks everywhere and can enter the wound, take hold, and release two powerful toxins that cause the disease. These bacteria are an example of what are called anerobic bacteria, meaning that they live without oxygen and therefore can survive underneath the skin or deep in tissues.
In the U.S. today, most cases of tetanus and most deaths from tetanus occur in people who have never been vaccinated. The vaccine has dramatically decreased the incidence of tetanus in the developed world, but it still kills many people worldwide in places where vaccination rates are low.
Because the bacteria that cause tetanus do their damage via the toxins they secrete, the tetanus vaccine is designed to stimulate immunity against the toxin itself. This involves taking the toxin and chemically inactivating it to a form that cannot cause illness. An inactivated toxin is called a “toxoid.” When the tetanus toxoid is injected, the immune system recognizes it as a foreign invader and develops immune memory so that if the vaccinated person is later actually infected with the tetanus bacteria, antibodies will immediately be produced to destroy the toxin and prevent disease.
This might be a good opportunity to reiterate that despite the fact that children now receive many vaccines according to the recommended CDC schedule, they do not “overwhelm” the immune system and render it unable to fight other diseases. The immune system operates by developing cells and antibodies that are highly specific to each individual disease-causing agent. The antibodies against tetanus toxins involve a miniscule portion of the human immune response capacity and have no implications for the ability to fight other diseases.
Diphtheria is one of those diseases that is so rare today because of vaccination that some people may think it doesn’t exist any longer. Unfortunately, the bacteria that causes diphtheria, Corynebacterium diphtheriae, does still exist and without vaccination, diphtheria cases will return. Jack remembers an unvaccinated child with diphtheria in the pediatric intensive care unit when he was a pediatric intern in the 1970s. The child developed a dread heart complication and died.
Diphtheria starts with what seems like a fairly ordinary upper respiratory infection but can quickly progress to difficulty swallowing and obstruction that causes difficulty breathing. As with tetanus, these complications are caused by a toxin released by the bacteria (actually by a virus that infects the bacteria). If that bacteria enters the blood circulation, it can cause a type of heart muscle damage called myocarditis and also nerve damage. About 5-10% of people with diphtheria die, a figure that rises to 20% among children under five and adults over 40.
Please remember those statistics. One in five children under five will die if they get diphtheria; the vaccine extremely rarely if ever causes death and the serious complications that can occur in about 1 in 10,000 children who get the whole DTaP vaccination are mostly temporary.
Again like tetanus, the vaccine against diphtheria is aimed against the toxin that causes the illness. A chemically inactivated version of the toxin, called the diphtheria toxoid, is injected and this stimulates memory in the immune system, making it prepared to fight an actual infection if that ever happens. Complications from diphtheria toxoid itself are mild, such as pain at the injection site and occasionally low-grade fever.
Pertussis (Whooping Cough)
Although once again the incidence of pertussis, or whooping cough, has dramatically decreased since vaccine introduction, it is still a cause of infant death around the world and cases have been increasing steadily in the U.S. since the 1980’s. Half of babies who develop pertussis require care in the hospital and 1-3% under three months die. It is spread in much the same way as the virus that causes COVID-19—by droplets from coughing and sneezing. But unlike COVID-19, a person exposed to pertussis bacteria is virtually guaranteed (80-90%) to get the illness. Also, unlike COVID-19, pertussis is caused by bacteria, called Bordetella pertussis, and not a virus.
There are three stages of pertussis infection, each lasting up to six weeks. The first signs that an infant, child, or adult has contracted pertussis is usually a seemingly ordinary upper respiratory infection with stuffy, runny nose and sneezing. This is the catarrhal phase. Next comes the much more serious paroxysmal phase in which a severe cough lasting several minutes develops. The cough is often followed in babies over 6 months by a loud whooping sound. During these episodes of coughing, a baby can be unable to breath and become exhausted. Broken ribs and burst blood vessels in the eyes have occurred because of the paroxysmal coughing. Pneumonia can develop. This is the phase in which deaths can occur. It is clearly not an ordinary cold or even the flu, but a life-threatening event that is painful to watch.
For survivors of the paroxysmal stage there is the convalescent stage, with cough lasting for weeks.
Once again, the culprit in pertussis is not the bacteria themselves but five toxins they produce. The vaccine, therefore, is aimed at producing immunity against the toxins. The newest version of the pertussis vaccine was introduced in 1996 and is called the acellular vaccine. The older version contained killed whole virus and caused a significant number of adverse side effects, including seizures with high fever in one in 1,750 doses. The newer version does not contain whole killed virus but rather only some inactivated bacterial proteins and has a much lower rate of complications (about 1 in 10,000 serious complications, including high fever, seizures, inconsolable crying, and a syndrome in which the child becomes listless and lethargic with poor muscle tone for several hours). But immunity from the acellular vaccine may wane over time. Just as it is currently recommended that adults get tetanus and diphtheria boosters (called Td vaccine) every 10 years, some experts now recommend that pertussis vaccine be added to those boosters in the form of the TDaP vaccine.
Our hope in bringing you this series to you is that it will remind all of us that vaccine-preventable diseases are rarely seen today only because the vaccines against them are so effective. They are by no means eradicated and unless most members of a community are vaccinated, epidemics of them will certainly return. You will hear people tell stories about horrid complications from vaccines and make claims that they harm the immune system and can even be lethal. We do not deny the fact that in extremely rare cases vaccines may cause serious complications and we have been careful to outline them here.
For every story you hear about a child who has allegedly been harmed by a vaccination (and we say allegedly because many of them turn out to be coincidences), we could tell you a million stories of children who have no serious complications and because of vaccines can live lives free of some of the most horrible disease known.
What will happen to our trust in science as a result of crisis mismanagement?
In times of crisis and stress, we can find some emotional relief by clinging to long-trusted anchors. Sometimes these are individuals in our lives whom we count on for wisdom and good advice. An emotional anchor can also be an institution to which we are attached, like a religious congregation or advocacy group. It can even be a more remote agency that we have always trusted to come through for us when an emergency looms.
In the case of the novel coronavirus pandemic, many people look to the U.S. Centers for Disease Control and Prevention (CDC) for expert guidance and action. After all, ever since its founding in the 1940s to deal with malaria in the Southeastern part of the country, the CDC has always seemed to rise to the occasion every time an infectious disease threatened us. CDC was there to help eliminate malaria, yellow fever, and typhoid from the U.S., get control over tuberculosis, prevent swine flu outbreaks in the 1970s, and figure out what is behind Legionnaires disease. In the 1980s when the first mysterious cases of a disease that wiped out part of the human immune system arose, CDC’s work to identify the ways the AIDS virus (HIV) was spread was truly impressive and lifesaving.
That is only a partial list of the many accomplishments that made CDC the world’s leading public health agency, the agency to which Americans and people all over the world turned to keep us safe from emerging pathogens. We felt certain that the CDC operated primarily on the basis of science, with a minimal political agenda.
Blunders and Missteps
That is what makes the recent blunders and missteps by CDC so threatening. An agency with veritable “parent figure” status is letting us down. According to a 2018 article in The Atlantic, the trouble began several years before COVID-19. That year, the Trump-appointed CDC director, Brenda Fitzgerald, turned out to have “eyebrow-raising investments in companies directly related to” her work at CDC, including in four of the five biggest tobacco companies in the world. The Atlantic article pointed out that “One of the centers’ chief public-health objectives is to end smoking. In fact, the only real public-health position on tobacco usage is that it should be eliminated entirely … the CDC’s chief holding even a penny of tobacco stock, let alone a portfolio that includes almost all the major companies, runs counter to that goal.”
The article then goes on to recount threats of cuts to the CDC budget that have rendered the agency “defensive” and compromised its ability to meet international threats like Ebola and Zika. Every year, in fact, the Trump administration has proposed cuts in the CDC budget. These never actually occur because Congress pays no attention, but it cannot help CDC morale to know that the chief executive wants the agency to shrink.
Perhaps this is at least partially responsible for the problems CDC has had in responding to the COVID-19 pandemic. It has been noticed, for example, that its current director and other leaders have been absent from the forefront of press conferences about COVID-19 held by the administration. Isn’t the CDC the one institution above all others we want to hear from when an epidemic sweeps the country?
Right from the start of the pandemic, instead of taking the lead and using its powerful blend of scientific talent and cutting-edge laboratories, CDC seems to have dropped the ball. It is reported to have delayed testing the first individual in California who developed non-travel-related COVID-19 in February. This delayed recognition that community spread of the virus was already occurring in the U.S. Then, CDC sent out test kits for the virus that turned out to be flawed and yielded spurious results. According to The Washington Post, the problem arose because of contamination of the test kits in the CDC laboratory manufacturing them. At first, CDC refused to acknowledge the problem and it took a recommendation from the Food and Drug Administration (FDA) to convince CDC to stop the process and correct the problem. Waiting for an accurate viral test further delayed our getting on top of the pandemic.article continues after advertisement
Now that accurate tests are available for the virus that causes COVID-19 (called SARS-CoV-2), we should be able to estimate the rate of infection in the U.S. by knowing how many people are currently infected (the numerator) and how many people have been tested (the denominator). Once again, however, CDC has blurred the issue by making an obvious mistake: conflating two tests that give different information about SARS-CoV-2 infection. The test for the current viral infection is the one usually done by swabbing the nose with a special six-inch probe. The sample is then sent to a laboratory where a type of laboratory process called PCR is done to detect the presence of the virus. If it is positive, the person tested is currently infected with SARS-CoV-2. This test seems to be relatively accurate at this point.
The other test detects antibodies to the virus in people who have previously been infected. At the time of writing this commentary, the antibody, or serology, test, is still of questionable accuracy and it is not entirely clear what the presence of antibodies means. In order to be useful in preventing future infection in someone who has already had COVID-19, antibodies must be able to neutralize the virus and must be able to do so over a relatively long period of time, for 2-3 years for example. Even when the accuracy of the serology (antibody) test is optimized and if the detected antibodies do indeed confer long-term protection against reinfection, the test gives very different information than the direct viral test using the swab. One tells you if you are infected now, the other if you were previously infected. Conflating the two tests, as CDC did, inflates the number of tests for infection that are actually being done and produces misleading information. Exactly how the CDC could have made such a basic error is unclear, as is the slow pace they seemed to have taken to correct it.
CDC issued guidelines for reopening some businesses and other gathering places during the last week of May that are strict but well-informed and reasonable. The White House, however, apparently disagreed with the CDC guidance on reopening houses of worship. Recommendations to limit choir activities were quietly removed from the CDC guidelines and references put in about preserving First Amendment rights. Surely, singing in a choir has got to be one of the ripest places to spread viral infections, with people crowded together forcefully emitting breaths into the ambient air. There doesn’t seem to be any First Amendment issue with recommending that for now places of worship refrain from that part of their worship service—after all, they had been mostly worshiping via teleconference without anyone gathering for several months to this point. Here we see again how politics seems to invade the CDC’s work and overwhelm its dedication to science.
One of us (Jack) was funded by the National Institutes of Health to conduct research on the AIDS virus shortly after that epidemic began in the 1980s. He remembers how he and his colleagues were dazzled by the speed with which the CDC figured out how HIV is transmitted. Years before the first antiretroviral drug to control HIV infection was introduced, CDC epidemiologists saved countless lives by notifying the public that sharing bodily fluids, intravenous drug administration, and infected blood transfusions were the modes of HIV transmission.article continues after advertisement
We need a strong CDC that is devoted to science to resume its lead role in controlling emerging infectious diseases. Without that, one major source of comfort and reassurance during a crisis is severely compromised. We cannot afford to be bereft of our emotional anchors at a time like this.
The Public is Unaware of the Problems that Plague Filling a Prescription
This commentary was suggested to us by Critica advisor Carrie Corboy. Carrie is a pharmacist and Senior Director at Janssen Research and Development, a division of Johnson and Johnson. She focuses on medication adherence, policy, and development and helped us prepare this commentary.
Once upon a time getting a prescription medication was fairly easy. Your doctor or other qualified healthcare provider wrote you a prescription on a prescription pad, you took it to your local pharmacy, and later picked up your medication. Your pharmacist was usually relaxed and had time to answer questions you might have about how to take the medication and any adverse side effects. Maybe it never really was that easy; it certainly isn’t today.
We have written before about the problems we have getting facts about our healthcare system in order to make rational decisions to reform it. Here, we address four areas that concern getting medication from a pharmacy: electronic prescribing, prior approval, overworked pharmacists, and prescription benefit managers.
Electronic Prescribing is Mostly a Benefit
Doctors in most cases no longer “write” prescriptions on those little prescription pads but send them directly to the pharmacy via an electronic prescribing system. Electronic prescribing, or e-prescribing, has many advantages over written prescription. Foremost among them is increased safety: pharmacists no longer have to try to interpret physicians’ illegible handwriting, which cuts down on errors. E-prescribing also reduces the number of phone calls needed between pharmacist and prescriber, thus saving valuable professional time, and allows for efficient recording of each patient’s medication history (although this may only apply to the pharmacy chain where a prescription is filled).It also reduces the problem of stolen prescription pads and forged prescriptions.
But there are also problems with e-prescribing. Prescribers may feel that the available fields on the e-prescribing page do not adequately convey exactly what they want their patients to take and how it is to be taken. To overcome this, the prescriber can write comments in a notes section, but these not infrequently contradict the instructions in the drop-down menu field. Resolving the problem takes up pharmacist time. Electronic prescribing also makes it easy for chain pharmacies to message doctors repeatedly to refill prescriptions; sometimes this is helpful but, as we have been told, other times it involves medications the doctor and patient have decided to discontinue, and the repeated reminders clog up the physician’s inbox and degrade the physician-pharmacist relationship.
Another problem we have heard is that e-prescribing makes it easier for doctors to refill prescriptions multiple times without seeing the patient in person; it is generally recommended that patients be reevaluated at some reasonable intervals while taking medications for prolonged periods of time. Finally, electronic prescribing software can stop working because of problems with the e-prescriber vendor’s computer system; doctors and patients must wait while those computer problems get fixed.
Overall, the benefits of e-prescribing seem to clearly outweigh the downsides and we certainly do not advocate a return to written prescriptions. But now that big businesses have taken over the entire prescribing industry, including e-prescribing vendors and chain pharmacies, there is clearly the need for a number of improvements, some of which may have to be legislated.
The Bane of Prior Authorization
A more pressing problem arises when that prescription hits the pharmacy and a red flag goes up: your insurance company won’t cover the medication unless the doctor who prescribed it gets in touch with the insurer and justifies the prescription. This process is called “prior authorization” (also known as prior approval and pre-certification). Perhaps it was once a good idea. For example, insurance companies are absolutely right to balk at paying for a brand name medication when a cheaper generic version is available. Asking the doctor to justify why he thinks a brand name drug is necessary is reasonable under those circumstances. In fact, some states have laws that require the dispensing of the equivalent generic product, when one is available, unless the doctor specifies on the prescription “dispense as written” or “brand medically necessary” or the patient demands the brand name medicine.
But the prior authorization procedure has clearly gotten out of hand. Although health insurance companies claim it is a method to improve patient outcomes by ensuring that only safe and necessary medications are prescribed, physicians believe that prior authorization is merely a tool health insurers use to lower their costs. There has been a steady increase in prior authorization requests, placing an ever-increasing burden on physicians to spend lengthy amounts of time on the phone with insurance company employees. A survey by the American Medical Association (AMA) found that medical practices spend an average of two business days per physician on prior authorization requests.
Prior authorization requests areassociated with delaying care and harming patients. Prescribers are also frustrated, according to the AMA survey, because many of the drugs for which prior authorization is required are “neither new nor costly.” One physician we know, for example, was asked to do a prior authorization for an antidepressant that has been available as a cheap generic for decades. She was given a list of medications she must give the patient first before the requested antidepressant; none of the drugs on the list were antidepressants and some were drugs for cancer and hypertension.
As another example, let’s take someone suffering with depression for whom a psychiatrist has prescribed the antidepressant bupropion. One insurer may cover the cost of generic bupropion, another might insist that only the brand name drug, Wellbutrin, will be covered, while a third may insist that a totally different antidepressant be tried first. Since there is little evidence that there is much difference among antidepressants in terms of their effectiveness and that what might be more important in antidepressant selection is the patient’s other circumstances (other diseases and medications that might make one antidepressant better than another), this prior authorization is unlikely to have anything to do with what is best for the patient. Nor is it clear that it is related to cost, since three different insurers seem to have a different price for the same drug.
Worst of all, neither prescriber or patient in this case can predict which version applies to the patient’s own specific insurer, something that will likely not be revealed until either the physician gets a note on her electronic prescribing application that prior authorization is needed or when the patient shows up at the pharmacy and is told the medication cannot be filled. This process clearly needs increased transparency and possible regulatory relief. It should only be used when there is a legitimate potential for improving patient care or lowering costs without harming care. Right now, it seems a tool perversely designed to harass healthcare professionals and subject patients to needless delays for their medicines.
The Pharmacists’ Plight
Let’s say your doctor has successfully e-prescribed your medication and succeeded in a prior authorization process to get your insurer to cover its cost (minus co-pays, co-insurance, or what’s remaining of your deductible, of course). If you’ve decided not to have your prescription delivered to your home, you are now ready to go to the drugstore to pick it up. Your local pharmacy is likely to be part of a huge national chain, like CVS, Rite-Aid, and Walgreens. As you approach the pharmacy of the larger retail store you likely can hear things like “one pharmacy call” repeating over and over and the phone ringing and you can see the car waiting at the drive up window. Behind the pharmacy counter you will still find someone who has undergone rigorous training to become a pharmacist—in fact, they hold a doctorate in pharmacy– and an expert on the risks and benefits of a wide range of drugs. But that pharmacist is also working under tremendous corporate pressure.
According to a recent New York Times report pharmacists said “they struggled to keep up with an increasing number of tasks—filling prescriptions, giving flu shots, answering phones and tending the drive-through, to name a few—while racing to meet corporate performance metrics they characterized as excessive and unsafe.” These corporate metrics, like answering the phone within three rings, are generally unrelated to patient care quality and create an environment of constant multitasking and interruption. This has led to concerns that pharmacists will make more errors filling prescriptions. Writing on behalf of the Pharmacist Moms Group, pharmacist Suzanne Solimanasked that:
..chain pharmacies to publish all of their metrics for calculating pharmacist and technician hours and ultimately error rates. We also encourage pharmacies to publish how many prescriptions are filled each month and how much staff they have so that patients can make an informed decision as to which pharmacies provide adequate staffing to suit their needs.
In addition to causing practical problems like increasing the prescription fill error rate and taking up valuable pharmacists’ time, corporate demands on pharmacists pose a moral dilemma for them. A recent ethical analysis of pharmacy practice argues that pharmacists work under ethically challenging circumstances, provoking a “moral crisis” in addition to the practical one. We believe that the former is as important as the latter in causing pharmacist distress.
American corporations are, of course, permitted to keep their corporate secrets. We don’t require that General Motors tell the public what new car designs they are working on or department stores to reveal their number of employees. But if overworked pharmacists are in jeopardy of making errors and becoming burnt out, it becomes a public health issue that the public is entitled to fully understand. Soliman’s plea for more transparency from the chain pharmacies seems urgently needed both to protect the health and safety of pharmacists and of their patients. We may not be able to return all the way to the days of the friendly neighborhood pharmacy, but we have a right to demand that pharmacists have working conditions that do not jeopardize our safety.
At this point, you hopefully have a bottle of the medication your doctor wants you to have in hand and you may even have been able to ask the pharmacist to clarify the instructions on the bottle and explain the drug’s adverse side effects to you. It is now time to pay for the medication, and you hold your breath wondering how much it will be. You’ve been taking this medicine for a long time and you know it is a generic version, but its price seems to change from month to month and from pharmacy to pharmacy. You wish that you could just look up the price of 30 pills of this medicine on the internet. It’s not like buying a car, after all. Shouldn’t somebody be able to just tell you how much it costs?
In fact, how much drugs cost in the U.S. is a mystery to most of us and a large part of that stems from something called pharmacy benefit managers (PBMs). You may not have known that you have your very own PBM. If someone is covering the cost of your prescription medication, you probably do have a PBM. It is not there to help you get your medication. Rather, a PBM is a corporation that serves as a middle person between insurers and other prescription medication payers on the one hand and drug companies on the other. The insurers essentially hire a PBM to manage the pharmacy benefit portion of your health insurance or Medicare Part D plan. The less the PBM actually spends buying drugs from drug companies, the more money they get to keep. More than 90% of the $450 billion we spend annually on medication is processed by PBMs.
PBMs are supposed to lower the cost of drugs by using their purchasing power to negotiate better prices from drug companies and by keeping lists called formularies of medications they will cover. Putting only the cheapest versions of drugs on the formulary is another way that PBMs try to hold down costs. Ideally, these savings would be passed on to consumers.
But PBMs operate largely in secret and it increasingly turns out that they are maximizing their own profits but not necessarily saving consumers money. One suspect PBM practice is to receive so-called rebates from drug companies. Rebates are funds returned by drug manufacturers to PBMs to make it more attractive for the PBM to list the drug company’s more expensive drugs on their formularies. The PBM shares a portion of the rebate with the health insurer and retains the rest. Ideally, this would create an incentive for the insurer to lower premiums, but it also creates a clear incentive for PBMs to put high cost drugs on the formularies and this translates into higher costs for patients. Interestingly, until very recently, pharmacists were forbidden from telling their patients that they could pay less for a prescription by paying for it outside of their insurance coverage.
Rebates are big business: the amount of money rebated by pharmaceutical companies to PBMs increased from $39.7 billion in 2012 to $89.5 billion in 2016. The amount of rebate for each drug, however, is usually a corporate secret and can change annually as PBMs negotiate new prices with manufacturers. This means that consumers and the employers providing health insurance are largely kept in the dark about how much a drug actually costs and often cannot find out what they will pay until they are at the pharmacy counter with a credit card in hand.
Last, and possibly worst, the prices of medicines that are made available to the public—called average wholesale price or list price–are quite high because they are the starting point to which the rebates are applied. However, for people with no medication insurance, this is exactly the price that they pay for medicines. Therefore, the most vulnerable people are charged the most. It thus becomes clear why many patients simply do not fill the prescriptions that they need to survive–they cannot afford them..
Physician Guy Culpepper wrote on LinkedIn recently that CVS Caremark, the PBM of the CVS Health corporation, was “only covering the Brand name version of some prescription drugs. So if I prescribe the generic, in an effort to save my patient money, CVS Caremark will refuse to cover it.” Even though the real price of the generic drug is less than its equivalent brand name version, in this case the PBM gets a bigger rebate for covering only the brand name version. That rebate, however, is not always passed onto the customer but instead can result in a higher price and more out-of-pocket cost. Culpepper called rebates “kickbacks” and went on to state that “PBMs will pretend these ‘rebates’ will mean lower costs for the payers. But if that were true, PBMs would support transparency to show us just how much money they save us.”
If rebates save money, that is of course not obvious to consumers, who face ever-increasing prices for medications and higher out-pocket-costs. An analysis of the effects of rebates on the cost of drugs for seniors covered by Medicare Part D showed that they increased both out-of-pocket costs and Medicare drug spending. Once again, the place to start fixing this problem is with greater transparency. Regulators should demand that rebates be publicly disclosed, if not eliminated altogether. Corporate secrets do not seem justified in managing our very expensive healthcare system. We desperately need to reduce healthcare costs so we can extend quality coverage to more people. Rebates turn out to be a very poor method of controlling drug costs and more likely to improve corporate profits instead.
As we have noted before, Americans spend much more for healthcare than citizens of other high-income countries and get the poorest outcomes in terms of lifespan. Medication spending is one factor that is increasing our exorbitant healthcare cost outlay and several of the elements we have discussed here also have the potential for jeopardizing patient well-being. Our concerns about electronic prescribing do not undermine its many benefits, but prior authorization, overworked pharmacists, and rebates to prescription benefit managers are all detrimental in their present form to the public’s health, create dissatisfied healthcare professionals, and function poorly to control costs.
In all of these cases, the minimum step to improvement would appear to be legislating increased transparency. We need to know how insurers and their PBMs determine what prescriptions require prior authorization and reform that process so it truly saves money without tying up doctors with endless phone calls and delaying treatment; we need chain pharmacies to publish their work flow metrics and make it clear that driving pharmacists to the point where mistakes are unavoidable is unacceptable; and we need drug companies and PBMs to reveal the complex tangle of drug rebates and, if necessary, regulate this process so that it truly serves to reduce costs instead of forcing people to accept more expensive drugs and higher out-of-pocket costs. Making medication unaffordable to some people is obviously not in the service of improving healthcare.
A person who needs to fill a medication prescription is likely suffering from a medical problem that is at very least distressing and uncomfortable and at worst painful and even life-threatening. Getting the prescription filled should not add to the patient’s woes, nor should it drive healthcare professionals to distraction or unnecessarily drive up healthcare costs. It is time we examine carefully the whole system by which we get our medication and intervene when necessary at every step of this complex and often mystifying process.
 Disclosure, a Critica team member, Jack Gorman, owns a small amount of stock in the Rite Aid Corporation.
Critica Begins a New Series About What We Are Vaccinating Against
Part One: MMR
Although a large majority of Americans believe that vaccines are safe and effective, a sizable minority are “vaccine hesitant” and worry about the safety of childhood vaccinations. One reason often cited for vaccine hesitancy is that many of the diseases we vaccinate against are rare in the U.S. today, so new parents have never seen them. Without a mental image of what a vaccine-preventable disease looks like and does, people may have trouble appreciating the risk it poses. If the risk of the disease seems, mistakenly as we will see, negligible, then any alleged risk of the vaccine against it becomes more believable.
Simply telling people that the risk of a serious reaction to a vaccine is one in several thousand does not have the weight of a single anecdote of a child who has suffered from one of the rare serious adverse side effects. Similarly, just telling people that a vaccine-preventable disease causes “X” number of serious complications may not be convincing. But seeing children with these conditions is highly persuasive.
One member of the Critica team began his medical career in pediatrics and is old enough to have seen cases of measles, mumps, rubella, and diphtheria. For him, the idea that anyone would hesitate to vaccinate against these diseases is hard to grasp. Recently, he was describing how serious the complications of measles can be to a young parent who had never seen a case. She seemed surprised that measles can be, and still is, sometimes fatal. “I don’t think people my age have any clue what the diseases we vaccinate our children against can actually do,” she said.
And so we decided to begin a series of articles describing some of the vaccine-preventable diseases, starting here with measles, mumps, and rubella, the targets of the MMR vaccine. That’s the one, of course, that was once accused of causing autism, a thoroughly false claim that we won’t bother getting into here. Nor can we counter vivid anecdotes of serious vaccine reactions with vivid anecdotes about children with these illnesses because we have none: despite the recent and alarming increases in measles cases in the U.S., it is still uncommon and most pediatricians will go through an entire career without ever seeing a single case of measles, mumps, or rubella.
We do hope, however, that these short descriptions of vaccine-preventable diseases will serve as a reminder that there is a very good reason we vaccine against them: at very least they make young children thoroughly miserable for a week or more and at worst they cause severe and sometimes fatal complications.
Measles Still Kills
Measles, also known as rubeola, is caused by a remarkable virus. Remember that all the cells in the human body have genes composed of a molecule called DNA and that DNA is transcribed to RNA, which then begins the process of engineering protein production. The measles virus, on the other hand, has no DNA. It contains only RNA and is therefore called an RNA-virus. The same thing is true of the virus that causes AIDS, HIV. That makes it easier for the virus to incorporate itself into an infected person’s own cells and redirect what they do.
And just like HIV, the measles virus has the uncommon ability to suppress an infected person’s immune system for months and sometimes longer.
That makes people who get measles susceptible to getting infected with other viruses and bacteria, increasing the risk of serious complications.
The measles virus lives in an infected child’s nose and throat and is spread to others by coughing and sneezing. It can actually live in the air of a room where someone coughed for as long as two hours. An infected child can spread measles to other people from four days before a rash appears to four days after it appears. Because measles often starts with symptoms that are similar to the common cold, like coughing, runny nose (coryza), fatigue and loss of appetite, a person can spread it before even knowing they have measles. And spreading it is easy; measles is one of the most contagious viruses known. As many as 90% of people who come in contact with someone with measles will get it.
The rash is what gives away the diagnosis of measles. Shown in the illustration below, It often starts with little white spots, called Koplik spots, inside the cheeks. A day or two later the characteristic red, bumpy, blotchy, and somewhat itchy rash starts on the face and neck and spreads throughout the rest of the body, all the way to the feet. During this week to ten days of unfolding symptoms, a child with measles feels awful. While it is true that you can only get measles once, that one time is memorable for the patient, who spends the time with watery eyes, coughing, sneezing, feeling very weak, and itchy all over. High fever makes it impossible for the child to do much and kills his or her appetite. If you are a parent with a child who has measles, you are likely to say to yourself “even though I know this is going to go away, I wish my child didn’t have to suffer like this.”
Unfortunately, measles doesn’t always “just go away.” While most children recover completely, others have serious complications. Before the measles vaccine became available, measles killed more than 2 million children every year. That number has been drastically reduced since the measles vaccine was introduced, but unvaccinated children can still succumb to measles. In 2018 there were about 140,000 measles deaths around the world, mostly in children under five years old. For every 1000 children who contract measles, two die. Most of those occur when the measles virus infects the lungs, causing pneumonia, or the brain, causing encephalitis. Measles can be especially devastating for children with suppressed immune systems, including children with cancer. Infants who have not yet been vaccinated against measles are also particularly vulnerable to the serious complications of measles infection.
Against all of this, it seems clear that vaccinating children to protect them from measles is a very good idea. The measles vaccine is a “live attenuated virus” vaccine, meaning that the naturally occurring measles virus is changed by growing it in cell cultures to a form that is incapable of causing measles but still able to stimulate the immune system to make antibodies against it. If at any point a vaccinated person is exposed to the real measles virus, the immune system will then immediately attack the virus and prevent the vaccinated person from getting sick
The leading cause of death from measles is pneumonia. The measles virus can infect the lung, as seen in this illustration where the white patch in the right lung represents the infection (source: Shutterstock).
As we mentioned earlier, we are not going to debunk here the completely erroneous claims that the MMR vaccine causes autism or any other damage to the brain or immune system. It is true that there are people who have allergies to all kinds of things and that includes the MMR vaccine. But just keep this in mind: fewer than one in one million people have a serious allergic reaction to MMR vaccine; two out of every 1000 children will die from measles. Consider those odds.
Mumps: A Silly Name for a Serious Disease
The word “mumps” sounds a bit silly and perhaps encourages people to think of the illness as something that is not very serious. That is, of course, a mistake. The mumps virus belongs to the same family of viruses as the measles virus (the paramyxoviruses) and, like measles, it first infects the nose and throat and is spread mainly by coughing and sneezing. Also like measles, mumps is highly contagious.
Although rarely fatal, mumps infection can cause serious and sometimes permanent damage. The hallmark of the illness is swelling of the salivary glands, especially the parotid gland. This is very uncomfortable and often painful, but almost always resolves in about a week without complications. More serious is infection by the mumps virus of the testicles, a condition called orchitis. About 10 to 20% of post pubertal boys and men get orchitis with mumps. In about half of those cases, there is permanent damage to some of the internal structures of the testicles, resulting in permanent reductions in sperm count and impaired fertility.
Swollen testicles, impaired fertility, brain infection, and deafness, then, are all some of the potential complications of having mumps. Doesn’t sound as if most parents would want to take the risk of withholding the vaccine, does it?
Rubella: the German measles
It is true that rubella (the “R” in MMR) is usually a very mild illness. So mild, in fact that many people don’t realize they have it or think it’s just a routine viral infection. And that is the problem, because the serious threat from rubella infection (also known as “German measles”) occurs when it strikes a pregnant woman. Because rubella can be so subtle and because people who have it are contagious for a week before the typical rash appears, it is not possible to simply try and keep pregnant women away from someone with rubella. The damage can be done by someone who doesn’t know they have it or to a woman who doesn’t yet know she is pregnant.
The rubella virus belongs to a different family of viruses that measles and mumps (togavirus), but like them is an RNA-virus. Children with rubella may have fever, runny nose, swollen glands, red eyes, and a pinkish rash. It’s also spread by coughing and sneezing. It goes away by itself in a few days and rarely causes any further complications or damage. So why bother with a vaccine?
The answer is that rubella infection in a pregnant woman, especially if she is in the first trimester, causes the congenital rubella syndrome. The baby whose mother was infected is born with cataracts, deafness, and heart defects. There may also be problems with other organs, growth retardation, and intellectual disabilities. That is, of course, if a baby is born: rubella infection can also cause miscarriage and stillbirth.
When the same member of the Critica team who started his medical training in pediatrics was in college in 1973 he got rubella. He didn’t feel that sick, but he had a rash all over his body and went to the student health service. He remembers the doctor there saying, “I’ve seen deaf babies because of German measles, you are going into isolation in the hospital.” One interesting thing about this case is that he was told as a child that a viral illness he had was German measles, but that could not have been possible because you cannot get it twice. Rubella infection was confirmed by a blood test when he got it in college and that means what he had as a child had to have been something else. That’s how easy it is to mistake rubella for a different viral infection and hence to unwittingly spread it to a pregnant woman.
It is true that if you don’t vaccinate your child against rubella, someone else will suffer the consequences: the newborn of an unvaccinated pregnant woman whom that child infects. It would seem to take a very high degree of self-centeredness and cynicism to use that as the excuse for not administering a completely safe vaccine against rubella to every child.
We will do this reminder about what the diseases do that we don’t see much of anymore because vaccines prevent them again soon. Next up will be the diseases prevented by the DPT vaccine (diphtheria, pertussis, and tetanus). It will be more harrowing stories of children dying or being born with terrible congenital abnormalities. Next time someone tries to tell you that vaccines hurt children, you might show them this commentary and correct that impression: it is the diseases that vaccines prevent that hurt children.
To the extent that we scientists humanize our work, science can take us a bit of the way in helping solve the very long-standing lack of racial justice in the United States. Epidemiology tells us, for instance, that black Americans are disproportionately affected by COVID-19, climate change, and air pollution. Economics research shows how vast income inequality among the races in the U.S. is.. Research in neuroscience, psychology, and sociology help us understand how racial bias forms and the strategies for overcoming it.
If our work at Critica teaches us anything, however, it is that science is never value neutral. Physical laws and chemical processes may be value neutral, but the human beings who study, experiment, and interpret them are never without impact on the work of science.
That is why it is imperative that Critica affirm its commitment to the deeper humanization of society in the face of an overwhelming moral wrong. Our Board and Officers are united in condemning what we are learning is widespread police misconduct, something we should have known long before the tragic death of George Floyd. We applaud those who have joined the international protest movement against racial injustice and add our voice to its principles and demands. We pledge to do more within our own organization and ourselves to overcome the crippling biases to which we are all subject, however aware or unaware of them we may be.
It is of vital importance to us that whenever we are wrong, we acknowledge our mistake and fix it. That policy usually applies to a scientific belief; if we ever back something that is incorrect, we hope we will be ready and willing to correct our error when the evidence steers us in that direction. Overcoming racial prejudice is more difficult because no matter how well-meaning we are, no person is immune to it. Our Board and Officers are entirely composed of white people; we recognize the critical need to be diverse. We commit to understanding how we created a monoracial institution, developing greater awareness of ourselves as racial beings, and becoming a place that is authentically welcoming to people of color who are interested in Critica’s mission and vision.
This organization is founded upon the principles of a book called Denying to the Grave.It is no small irony that this could describe so much of white America’s response to racism. It offers the tools to help people use science in their best interest and for society’s greater good. Our skill set is designed to help us overcome specious, unconscious beliefs such as implicit racial bias. Our moral and scientific lives require that we use them now.