A Misstep By the World Health Organization (WHO)

Just what anti-vaccine advocates asked for

When it comes to vaccine advice, we live in a world where every word and every nuance is sure to be made to count. That means that public health agencies have to be especially cautious when they give what might at first glance seem to be common sense, even obvious advice.

         When we looked at the website of the World Health Organization (WHO) on July 5, 2021 here is what we read with regard to vaccinating children against COVID-19:

Vaccines are usually tested in adults first, and only later assessed in children when safety has been proven in adults, because children are still developing and growing. COVID-19 has also been a more serious and dangerous disease among older people. Now that the vaccines have been determined to be safe for adults, they are being studied in children.

WHO’s Strategic Advisory Group of Experts (SAGE) has concluded that the Pfizer/BionTech vaccine is suitable for use by people aged 12 years and above. Children aged between 12 and 15 who are at higher risk of severe COVID-19 may be offered this vaccine alongside other priority groups for vaccination. Vaccine trials for children are ongoing and WHO will update its recommendations when the evidence or epidemiological situation justifies a change in policy.

While the supply of vaccines is limited, the ongoing priority is to vaccinate those most at risk of serious illness who still have not been vaccinated in many parts of the world: older people, those with chronic health conditions, and health workers.

Most children are at low risk of serious disease and vaccinating them is primarily about reducing transmission, which can also be achieved through public health measures, including: physically distancing from others, cleaning hands frequently, sneezing and coughing into their elbow, wearing a mask if age appropriate and avoiding crowded, poorly ventilated spaces.

Now, several ideas here seem like common sense. Of course, we generally test new drugs out in adults before children. Obviously, if there is a short supply of a new drug, we want to give it to the people who need it the most first. But did the WHO anticipate that anti-vaccination advocates would take the advice given in these paragraphs and twist them around to make it seem as if children do not need to be vaccinated against COVID-19? That’s exactly what Critica infodemiologists saw people saying on social media, using the WHO guidance as justification for the misinformation.

The World Health Organization (WHO) guidance on vaccinating children and adolescents against COVID-19 can be easily misinterpreted (source: Shutterstock).

The WHO statement does make clear that the Pfizer/BioNTech mRNA vaccine was tested in children aged 12-15 and found to be both safe and effective. That guidance is much stronger on the website of the U.S. Centers for Disease Control and Prevention (CDC):

  CDC recommends everyone 12 years and older should get a COVID-19 vaccination to help protect against COVID-19. Widespread vaccination is a critical tool to help stop the pandemic. People who are fully vaccinated can resume activities that they did prior to the pandemic. Learn more about what you and your child or teen can do when you have been fully vaccinated. Children 12 years and older are able to get the Pfizer-BioNTech COVID-19 Vaccine.

CDC seems to be recommending that all children twelve years old and older get vaccinated, without exception. The CDC website does mention rare cases of myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the membrane around the heart, that have been linked to the mRNA vaccines (Pfizer/BioNTech and Moderna/NIH), in young adults, noting CDC still recommends the vaccine for all people 12 and over. Finding the association between myocarditis/pericarditis and the vaccines in young people shows us that the surveillance system is working for vaccine adverse events, because this is so uncommon it is like finding a needle in a haystack, and yet the rare adverse event was identified and investigated and now physicians know what to look for in a case of a teenager who exhibits any of the signs or symptoms of myocarditis or pericarditis. The great majority of people who get this recover uneventfully without significant amounts of treatment.

Myocarditis/Pericarditis Noted

We would have expected anti-vaccination advocates to seize upon the myocarditis/pericarditis link and try to make it seem far more common than it is. Hundreds of cases have been reported to the Vaccine Adverse Event Reporting System (VAERS), which only seems like a lot until you consider that millions of doses of vaccine have now been given, making heart inflammation a very rare adverse event that usually resolves without much in the way of medical management. And of course, anti-vaccination advocates did exaggerate the significance of the myocarditis/pericarditis link. But unexpectedly they seized on the WHO guidance to spin a tale that undoubtedly resonated with many parents considering whether to vaccinate their children.

Myocarditis is an inflammation of the heart muscle that has been linked to the mRNA COVID-19 vaccines, especially in young adults. It is, however, rare, and usually resolves without complications (image: Shutterstock)

         We know that there have been widespread inequities in vaccine distribution, with people in low-income countries not getting enough vaccine. We also know that children and adolescents, if they do get infected with the virus that causes COVID-19, tend not to get as sick as older adults. With those two facts in mind, we would also be interested in the idea of moving some vaccine to people at higher risk of severe COVID-19 infection in low-income countries with limited supplies of vaccine. The only problem is that to our knowledge no such program of vaccine redistribution has been seriously considered by any high- or moderate-income country or by any vaccine manufacturer. Rich countries have pledged to help out with the Vaccines Global Access (COVAX) initiative, but that is not the same as designating vaccines that would otherwise have gone to children in rich countries to be sent instead to poor countries and given there to elderly people and people with serious pre-existing medical conditions. If the CDC recommendation to vaccinate children 12 and up is not followed,  we fear that, especially given the challenges of keeping mRNA vaccines frozen during storage, vaccines would simply be wasted.

         So the notion of sending vaccines to more vulnerable individuals in vaccine-deprived countries, however laudable it may sound, was a red herring. No such vaccine redistribution program was ever in the works by WHO or any other international agency.

Good Reasons to Vaccinate Children

         The reasons why it is essential to vaccinate children and adolescents against COVID-19 even though they are less at risk for serious complications were nicely explained by three physicians in a New York Times op ed piece published July 4, 2021 and titled “Covid is a Greater Risk to Young People Than the Vaccines.” The risk of a hospitalization from COVID-19 infection, they point out, is still higher than from a complication from a COVID-19 vaccine. Also, whereas myocarditis/pericarditis almost always goes away by itself, some children who get COVID-19 infection develop complications like Multisystem Inflammatory Syndrome in Children or long-COVID-19 syndrome. “So far,” the three physician authors also note, “326 Americans age 17 and younger have died of Covid-19.”

         There are serious epidemiological reasons for urging parents to get their children vaccinated. COVID-19 shows signs of sticking around. A survey conducted by the journal Nature found that most experts now believe that SARS-CoV-2 (the virus that causes COVID-19) has become an endemic virus, meaning it will persist in the population and continue to infect unvaccinated people. The more unvaccinated people there are, the greater will be the opportunity for the virus to mutate to strains that are resistant to vaccines. If we ever want to bring the pandemic under control, we cannot have a large population of people—in this case many children and adolescents—unvaccinated and serving as a pool of potentially infected hosts. A small number of those children will get very sick and some will even die from COVID-19. Beyond that, the virus will have an opportunity to battle the immune system and learn how to evade it.

         It is easy to see how the WHO guidance misleads people into thinking vaccinating children is unimportant. Epidemiologists, infectious disease experts, and immunologists all want to see everyone vaccinated as soon as possible including children; the WHO is giving advice that seems to undercut that wisdom. We doubt, of course, that experts at the WHO meant their guidance to be misinterpreted this way. Our complaint is that by now public health agencies at local, national, and international levels ought to understand that we are fighting an infodemic in which bad actors will pounce upon any piece of ambiguous advice or guidance they can find to craft misinformation. It is absolutely incumbent upon WHO and all of these agencies to think carefully about how their statements will be interpreted.

What Determines Resilience in the Face of a Crisis?

What the COVID-19 pandemic has taught us.

In the early days of the COVID-19 pandemic, experts warned of a coming surge in mental health issues in the months and years to come. Surely the collective trauma of lives being put on hold, mass job loss, frightening illness and bereavement from losing loved ones to the virus, and almost total social isolation represented a perfect storm for a rapid rise in mental health crises. 

It is still too soon to tell whether this prediction about an overwhelming global mental health crisis will actually come to pass. Experts have noted that during an emergency, people take on a mentality of “just getting through it.” But when the height of the emergency passes and people have room to breathe, they may start processing the mayhem and grief that the emergency has wreaked on their lives and this is when their mental health might suffer. 

Given the extreme nature of the pandemic, including the degree of negative economic impact and the social isolation that came with it, it might be reasonable to assume that once this “breathing room” sets in, an unusually large portion of the population might experience symptoms of mental illness. On the other hand, it is actually just as reasonable to expect that this kind of surge might not occur and, furthermore, that some people’s mental health may have actually benefited from the experience of enduring the stressors associated with the pandemic. 

Kathy Wu, an assistant professor of psychology at Widener University, has commented that some people may experience a sense of “post-traumatic growth,” in which they gain a deeper appreciation for life and a renewed sense of their own strength and resilience, which can help them more effectively face other challenges in their lives. People who experience this boost in resilience after seeing how they dealt with the pandemic may not maintain this level of resilience in the future, however. Experts note that resilience is not a “fixed factor” but a fluctuating trait that is more present at some junctures in life than at others. While this may sound like a negative, it also means that there is hope for people who appear less resilient in certain situations – since the trait is not “fixed,” there is always a possibility of getting through other challenges with higher levels of resilience. 

Despite the “fluctuating” nature of resilience, there are still factors that make some people more likely to experience it to a greater degree than others. Certain structural factors, such as racial equity, secure housing, and reasonable wages, set the stage for some people to be more resilient than others. To be certain, making changes to these structural factors is never easy, but it could help some people develop higher levels of resilience. At the same time, resilience is definitely something that can be taught and learned. Many of the factors that experts think contribute to a sense of happiness, such as practicing gratitude and mindfulness, nurturing relationships, and focusing on larger goals and intentions, also contribute to resilience. 

So are we on the cusp of a mental health crisis in this country and perhaps globally? While it is a distinct possibility, it is also important to remember that this is not the first collective trauma the world has experienced, and people have a remarkable ability to adapt and cope. While we wait to learn more about the impact of the pandemic on mental health, we should take the time to help ourselves and others strengthen our resilience muscles. The psychological fall-out from this global calamity is not inevitable and we have the power to make a difference now.

Another Vaccine Needs Our Support

The Human Papillomavirus Vaccine (HPV) Will Save Millions of Lives

We are usually in the dark when it comes to knowing what causes specific types of cancer. We may know about risk factors that increase the likelihood of some cancers, like cigarette smoking and lung cancer or alcohol consumption and liver cancer, but exactly how those risk factors work to make cells of a particular organ start to divide uncontrollably, is generally still a mystery.

         An exception to this is the case of cancer of the female cervix. We know the cause of about 90% of cases of cervical cancer—the human papillomavirus (HPV). HPV is actually a group of about 200 viruses, only a few subtypes of which cause cancer. HPV is a sexually transmitted virus and virtually all sexually active people in the U.S. are infected with HPV.

Human Papillomavirus (HPV) is a group of DNA viruses that cause cancer of the cervix and several other human cancers (source: Shutterstock).

HPV infects the cells called squamous cells that line the surface of several organs in the body. The immune system keeps most HPV infections in check, but some long-lived HPV infections have the ability to transform squamous cells into cancerous cells.

HPV Vaccine Prevents Most Cervical Cancer Cases

Vaccinating against HPV consequently prevents almost all cases of cervical cancers and is now recommended for all teenage boys and girls. Imagine that: we can actually tell people that a couple of HPV shots will virtually eliminate the risk of an entire type of cancer. A single HPV vaccine called Gardasil 9 is available in the U.S. The U.S. Centers for Disease Control and Prevention (CDC) recommends that all boys and girls aged 11-12 receive two doses of Gardasil 9, although the vaccine can be given to people up to 45-years-old. The second dose is given 6 to 12 months after the first. A three-dose regimen is recommended for people who get their first dose after age 15.

  The World Health Organization (WHO) announced a program in 2020 that would drastically reduce the incidence of cervical cancer by, among other steps, vaccinating 90% of all girls by age 15. It is estimated that, if successful, such an initiative would prevent 8.7 million cases of cervical cancer among women born between 2005 and 2014. Women in Africa and Asia would realize the greatest benefit.

         It is thus extremely difficult for us to understand why rates of HPV vaccine hesitancy seem to be increasing in the United States. In a study published earlier this year, investigators found that the rate of HPV vaccine hesitancy had risen from 50.4% of parents of vaccine-eligible children in 2012 to 64% in 2018. The authors speculated that misinformation about the HPV vaccine might be responsible for this increase in vaccine hesitancy.

The social media platform Pinterest decided in 2019 to moderate posts about HPV vaccine and a study published last year showed that while this had the effect of decreasing misinformation it also resulted in an overall decrease in posts about the vaccine. Thus, improving the quality of information about HPV vaccine on Pinterest had the unintended consequence of reducing the total amount of information available. All of this comes in the context of a general decrease in support for vaccines among parents in the U.S.

HPV Vaccine is Safe and Effective

         There appear to be unfounded concerns about the safety of the HPV vaccine. A study published in June showed that safety concerns about the HPV vaccine increased substantially between 2008 and 2019. The authors noted that “The COVID-19 pandemic has brought to the forefront the fragility of public confidence in the safety of vaccines,” which raises the possibility that such safety concerns actually increased even more dramatically in the past year.

         The HPV vaccine is clearly safe. Minor adverse reactions like fever or nausea and pain and swelling at the injection site are transient. More serious side effects are extremely rare. Anti-vaccination activists exploit the surveillance system called VAERS that CDC and the U.S. Food and Drug Administration (FDA) use to detect adverse side effects to vaccines. Anyone can report anything that happens after a person receives a vaccination to VAERS and health authorities will investigate. The adverse event is almost always a coincidence, but anti-vaccination activists relish advertising what gets reported to VAERS as if every event is proven vaccine related. It is important to emphasize once again that this is not the case; most things reported to VAERS turn out not to be vaccine related. Gardasil 9 has an excellent safety record. HPV vaccination does not make teenagers become more sexually promiscuous.

         What it does do is prevent people from getting several types of cancer. The incidence of human papillomavirus infections has been reduced dramatically since the introduction of the vaccine. HPV vaccine similarly dramatically reduces the rate of cervical cancer. It also prevents, vulvar, vaginal, anal, penile, and some head and neck cancers. HPV vaccine is also credited with a reduction in premature births.

HPV vaccine is a safe and effective intervention to prevent cervical cancer. It also reduces the risk for vulvar, vaginal, anal, penile, and some head and neck cancers (source: Shutterstock).

         Still, more than a decade after the HPV vaccine was first introduced in 2006, only about half (51.1%) of U.S. adolescent women had completed the HPV vaccine series. By 2019 that number had risen only slightly to 56.8% of girls; the rate for boys was even lower (51.8%). States that mandate HPV vaccine for children not unexpectedly have higher vaccination rates, as do states with higher availability of pediatricians.

         Preventing cancer is very difficult. Usually, to even have a shot at doing so people need to affect difficult changes in behavior, like quitting smoking, reducing alcohol consumption, and getting more exercise. Even doing those things is hardly guaranteed to work.

         Then there is the case of cancer of the cervix. Two shots when a person is 11 or 12 years old reduces the risk to close to zero, and it does so with virtually no risk because in reality adverse side effects are almost all mild and transient.  This seems like something every parent should want for their child.

         We find it shocking, therefore, that only about half of the U.S.’ boys and girls have had the full HPV vaccination series and that hesitancy among parents to get their children vaccinated is growing, mostly because of misplaced safety concerns. What is going on here?

         Insurance, both commercial and public, covers most people for HPV vaccine. Hence, financial access does not seem to be the issue. The finding noted above that vaccination rates are higher in states where there are more pediatricians suggests that there may be an awareness problem. Studies have shown that there are a variety of cost-effective programs like localizing vaccination sites in schools that work to improve HPV vaccine uptake. Renewed efforts to make parents aware of the need to have their children vaccinated against HPV are clearly needed.

         There are two aspects of this problem that we find especially disturbing. We noted above that, as expected, states that have HPV vaccine mandates have higher vaccination rates. Why don’t all states have mandates? Apparently, issues of parents’ rights to refuse and the morality of vaccinating against a sexually transmitted disease come up in state legislatures when HPV vaccine mandates are discussed. While we of course respect everyone’s right to hold personal moral and religious views, there does not seem to be anything ethically appropriate about withholding an intervention with almost no risk that prevents a deadly disease. Should parents have the right to make a decision like that for their children, any more than we give parents the right to decide it is okay for their children to engage in life threatening activities like cigarette smoking and riding in cars without a car seat?

         The second aspect that disturbs us involves the safety concerns. We believe that these are being trumped up by the well-organized anti-vaccination activist lobby and that this poses a direct threat to the public’s health. HPV vaccination saves lives and therefore it is especially morally pernicious to withhold it from someone who lacks legal decision-making capacity—i.e., minor children—and it is unethical to allow misinformation and disinformation about imaginary risks to go unchecked to the point that they influence the decision to vaccinate a child.

We do not believe merely wringing our hands is a sufficient response to low HPV vaccination rates in the U.S. or anywhere in the world. We insist that there is both a medical/scientific and a moral issue here. The medical/scientific issue is that HPV vaccination is a safe and effective method for preventing cervical and several types of cancer. The moral issue is that we are wrong to withhold a potentially lifesaving and nearly risk-free intervention from minor children. Stronger efforts should be made to increase vaccination rates against HPV among children.

A Case of False Hope from FDA

Alzheimer’s disease, the most common form of neurodegenerative disease among the elderly, is a devastating illness with a very poor prognosis. A person diagnosed with Alzheimer’s disease (AD) at age 65 has a median survival expectancy of 8.3 years. More than six million Americans are living with AD now and dementia is the cause of death in about a third of seniors.

         A few drugs have been approved that have very modest effects on slowing the relentless loss of memory and cognitive abilities that AD causes. These drugs, with brand names like Aricept and Namenda, do not cure AD. They may slow cognitive decline, but their positive effects are often so small as to go unnoticed by caretakers. There is a palpable feeling of desperation for an effective treatment that one senses among patients with AD and their loved ones.

         It was that feeling of desperation that may be behind the curious decision of the U.S. Food and Drug Administration (FDA) to approve a new medication, aducanumab (brand name: Aduhelm), for the treatment of AD even though it is entirely unclear it works. Despite an FDA advisory board voting 10 – 0 against approving Aduhelm, physicians can now prescribe monthly intravenous infusions of Aduhelm at a whopping cost of $56,000 a year.

Antibodies Against Plaques

         In fact, aducanumab is an approach to treating AD that has failed on multiple previous attempts at drug development. Alois Alzheimer noted in the seminal paper he presented in 1906 that a patient who had died with “presenile dementia” had two distinctive features in her brain when he performed an autopsy. One of these is called amyloid plaques and the other neurofibrillary tangles, which together remain the hallmarks of the pathological diagnosis of AD to this day. Understandably, scientists have focused a great deal of attention on the plaques and tangles that can be seen with an ordinary light microscope in the brain of someone who has died from AD. The amyloid plaques in particular attracted a great deal of attention. Scientists learned that they are made of a protein called beta-amyloid that in turn comes from the breakdown of another protein, called amyloid precursor protein. Amyloid plaques appear to form early in the course of AD, and it was reasonable to speculate that they could even be the driving force behind the illness.

Deposits between neurons of plaques composed of the toxic protein beta-amyloid are a diagnostic feature of Alzheimer’s disease (source: Shutterstock).

         A novel strategy was devised to try to rid the brain of amyloid plaques: give the patient antibodies manufactured to attack and destroy the protein beta-amyloid. When Critica President Jack Gorman first attended a lecture in which that strategy was described, he was among the first to wonder if the immune system would attack the anti-amyloid antibodies themselves; after all, even though beta-amyloid is a toxic protein it is still a naturally occurring protein made by the patient’s brain, he pointed out at the time, and we don’t usually try to immunize people against their own proteins. Although not much was made of the concern back then, antibodies directed against anti-amyloid antibodies given in an attempt to treat AD have been a significant safety challenge. We’ll come back to this point a bit later.

         It is very hard to study putative drugs for AD because we do not have very good animal models for the disease. No other species besides humans develops AD naturally, although it is possible that this is because no other species lives as long as we do. Dolphins and chimpanzees might get AD-like pathology if they lived long enough. It is possible to insert an abnormal human gene into mice that causes the production of the beta-amyloid protein. These transgenic mice develop memory problems, and it turns out that anti-amyloid antibodies rid the experimental mouse brain of amyloid plaques and restore memory function to them. So that looks like a reasonable animal model to test the hypothesis that giving anti-amyloid antibodies can have a positive impact on the course of Alzheimer’s dementia.

         Except that mice are not humans and the mouse models for AD are all laboratory creations, not examples of a naturally occurring disease process. Drugs that rid the transgenic mouse brain of plaques may even do so in people with Alzheimer’s disease, but that doesn’t mean they will necessarily have a positive impact on the human disease. In fact, every attempt to develop a drug that attacks amyloid plaques until recently has failed. So convincing are these failures, that it has led many scientists who study AD to doubt whether amyloid plaques are as central to the disease as once thought. Rather than causing AD, the plaques may form as a reaction to some other disease process, for example. Amyloid plaques are an attractive subject to study because they are so easily found in the brains of people with AD, but some scientists believe it is time to move on from the beta-amyloid hypothesis for Alzheimer’s diseases.

Intervening Early

         A major advance in studying AD was the introduction of positron emission tomography (PET) brain imaging of amyloid plaques. A radiotracer is injected into the patient and PET scan detectors pick up where it attaches in the brain, thus identifying plaques. Now scientists can identify patients with a significant amount of amyloid plaque burden at very early stages of the illness. They can also see if an anti-amyloid drug actually gets rid of the plaques in the living human subjects.

         This is what researchers studying the drug aducanumab, which is made by the Biogen company, and another anti-amyloid antibody drug for which there was some evidence of efficacy published last may in the New England Journal of Medicine,  donanemab, which is made by the Eli Lilly Company, did. In those studies, patients first underwent beta-amyloid PET scanning to ensure they had a significant accumulation of amyloid plaques, then received the anti-amyloid antibody drugs. For aducanumab (Aduhelm), this is where the controversy begins because in 2019 Biogen and a Japanese pharmaceutical company it is working on Aduhelm with announced that they were stopping two clinical trials because interim analysis of the data that had been so far collected indicated that the drug was not working any better than placebo. Then, in a somewhat startling reversal, the companies later said that on the basis of a new analysis of the data from the stopped clinical trials they had detected an effect of Aduhelm in slowing cognitive decline in patients who received the higher of two doses of the drug compared to placebo. The difference was a 22% reduction in cognitive decline.

         One caution has been raised about abandoning the beta-amyloid hypothesis: plaques probably form very early in the course of the disease, before it is clinically apparent that someone has symptoms. It could be that by that time it is too late to have a meaningful impact on the disease. What would be ideal would be to know that someone has begun to accumulate amyloid plaques before they start to lose memory and other cognitive functions and to be able to intervene at that point.

         FDA usually requires evidence that a new drug is effective in at least two large, also called phase three, clinical trials. Before beginning one of these trials, the sponsor (in this case the drug companies involved) must state their intended main outcome measure. This is done to prevent cherry-picking the data; analyzing data multiple times with multiple different outcome measures can lead, for statistical reasons, to statistically significant findings that are actually flukes. Most experts thought the FDA would require Biogen to perform at least one more phase three clinical trial with the higher dose to prove the drug works better than placebo. The FDA did note that Aduhelm was associated with a decrease in plaques. That is interesting, but it is still unclear if reducing the number of plaques in someone’s brain actually results in an improvement in cognitive function. 

Alzheimer’s disease is a devastating neurodegenerative illness for which there is no cure. It robs its victims of their memory and other cognitive functions; available drugs offer very modest slowing of cognitive decline (image: Shutterstock).

         But it didn’t. Despite the overwhelmingly negative opinion of its own external advisors, FDA granted approval for Aduhelm even though there is very little reason to be confident at this point it actually works. We have one study in which a reanalysis of the data suggests it might be effective and another study in which it did not separate from placebo. That is very thin evidence upon which to hang a new drug approval.

One might say, as the FDA probably considered, that anything that might have the slightest chance of working in a disease for which the outcome is always devastating and there is no cure should be made available to patients. But there are at least three objections to that argument. First, as has been the case with all the attempts at designing anti-amyloid antibody drugs to date, Aduhelm has adverse side effects that are probably at least in part due to anti-drug antibodies mentioned earlier that the brain itself produces. About one-third of patients in the clinical trials developed brain swelling and between 17 and 19% had small brain bleeds. 

Second, as mentioned earlier, the drug is extremely expensive. Because most people with Alzheimer’s disease are over age 65, Medicare will be asked to pay for Aduhelm, thus adding another significant financial burden to taxpayer supported healthcare.

Third, the argument that a lesser standard of evidence can be used for a drug that attempts to treat a very serious illness for which there are very limited existing treatment options may seem humane, but it actually undercuts our entire system of rational drug development. Not only should a drug work in order to garner FDA approval, its benefits should outweigh risks. In the case of Aduhelm we have the barest evidence of benefit and significant evidence of risk. Three members of the advisory board that voted against approval of Aduhelm have resigned their positions in protest.

         Our system of drug approvals has worked remarkably well. It is rare that the FDA approves a drug that subsequently proved harmful; instances in which that has happened, like Vioxx, come to mind so quickly because they are unusual. Patient advocacy groups and pharmaceutical companies complain all the time that the drug approval process is too slow and thus deprives people of the chance to take advantage of treatment breakthroughs, but it simply takes a long time to put together enough evidence to convince experts that a new drug is both safe and effective. As the editor of the Washington Post recently wrote in its discussion of Aduhelm “In the U.S. health-care system, patients’ interests chronically come behind the interests of big business.”

         It is a fine thing to want to give hope to people suffering with Alzheimer’s disease and to their caregivers. What we don’t want to do, however, is undermine our regulatory procedures and give people false hope. The FDA is requiring that Biogen perform another large-scale study of Aduhelm and perhaps that will yield the so far elusive evidence that the drug works. As things stand now, however, we believe the FDA acted impulsively and unscientifically to approve a drug for which there is minimal evidence of benefit and significant evidence of risk. Healthcare dollars are precious and should never be wasted on ineffective treatments.

When Drugs of Abuse Become Psychiatric Medications

What we know and don’t know about a new category of psychiatric medications

Medications used for the treatment of psychiatric illnesses like depressionbipolar disorder, and schizophrenia have been proven to work in countless randomized controlled studies and should be considered for the treatment of any of these conditions. Yet it is also clear that they are only partially effective for many patients and totally ineffective for others. Scientists, therefore, continue to search for medications for illnesses like major depression and posttraumatic stress disorder that will be more effective than currently available agents and that will work for more people who suffer from these conditions.

Microgen/Shutterstock
Source: Microgen/Shutterstock

Curiously, some of the greatest excitement in psychopharmacology circles right now comes from drugs that have long been considered drugs of abuse. Specifically, a version of ketamine is already approved for the treatment of depression. Both MDMA, also known as ecstasy, and psilocybin, aka magic mushrooms, are being developed for mood and anxiety disorders. Not so long ago it would have been unthinkable to consider these agents as candidates for licensed psychopharmacological agents. Why are they now being studied so intensively and greeted with such excitement?

Which Drugs Are Being Studied?

Ketamine is now given as the FDA-approved inhaled agent esketamine to people suffering from a major depressive episode. Some centers also administer ketamine intravenously for depressed patients. Its benefit compared to traditionally available antidepressants like the SSRIs is that ketamine works almost immediately—some patients feel better within minutes of receiving a first ketamine dose and stay well for as long as two weeks. It is also effective for patients who have not responded to other treatments for depression.

On the street, however, ketamine is known as “Special K.” Ketamine has dissociative properties that can cause an “out of body” experience that some people find pleasurable. Hence, long before ketamine was ever used to treat depression it was an abused drug.

Ecstasy, sometimes called “Molly,” is the street name of a drug that also causes a dissociative experience, sometimes accompanied by hallucinations and other distortions of reality. Right now, it is an illegal drug, but in a landmark paper published in the prestigious journal Nature Medicine earlier this year, it was shown to be an effective treatment for post-traumatic stress disorder (PTSD) when accompanied by manualized psychotherapy. In that study, 90 patients with PTSD were randomized to receive either psychotherapy plus MDMA or psychotherapy plus placebo. Active MDMA was associated with robust improvement in PTSD compared to placebo and the investigators reported few adverse side effects from MDMA.

A psychedelic drug now under study for the treatment of a psychiatric disorder is psilocybin, the active ingredient in “magic mushrooms.” With effects similar to LSD, magic mushrooms have long been used to induce a “trip” that includes hallucinations and euphoria. Nevertheless, last April investigators reported in the New England Journal of Medicine on a study that compared psilocybin to the SSRI antidepressant escitalopram (brand name: Lexapro) for the treatment of major depression. In that study, 59 patients with depression were randomized to receive either psilocybin or escitalopram and all also received “psychological support.” There was no measurable difference in outcome between psilocybin and escitalopram, but psilocybin was superior to the SSRI on several secondary measures such as the percentage of patients who were judged to have improved and the speed at which that improvement took place. There were no statistically significant differences in adverse side effects.

Is It Okay to Repurpose Drugs of Abuse?

Ketamine, MDMA, and psilocybin are thus now being looked upon as psychiatric medications capable of improving depression, PTSD, and other disorders. Some commentators have been nearly breathless in describing these drugs as breakthroughs for the treatment of psychiatric illness, suggesting we’re on the cusp of a new era in psychopharmacology.

It would be helpful if we could say that these drugs are addressing some underlying abnormalities in conditions like depression and PTSD. We do have information about the biological mechanisms of action of all three of them. Ketamine works mainly through an interaction with the brain’s glutamate neurotransmission system and also has effects on opioid receptors. Both MDMA and psilocybin work mainly through the enhancement of the brain’s serotonin receptor system, the same system that is affected by SSRI-type antidepressants like Prozac and Lexapro.

Unfortunately, however, we still have no firm idea if derangements in any of these neurotransmitter systems are actually the cause of any mood or anxiety disorder. There are many theories linking abnormal glutamate neurotransmission to depression, for example, and some solid data from animal studies suggesting such a link, but no definitive proof that any abnormality in glutamate neurotransmission is part of depression yet exists. We cannot say that any of these drugs work by remediating a known abnormality in the brains of people with psychiatric illnesses any more than we can say that about any of the traditional psychiatric medications.

One thing we can say is that most of the currently approved medications for depression and PTSD are usually not abused, sold on the street, or addictive. There is no evidence that Prozac, Lexapro, or Zoloft are abusable drugs. By contrast, ketamine, psilocybin, and MDMA all have long histories as street drugs and can be addictive for some people. The questions raised by this simple fact are as philosophical as they are scientific. Clinical trials will tell us whether or not drugs like ketamine, psilocybin, and MDMA work to relieve conditions like depression and PTSD: as noted, some studies already exist. Are we ready, then, to have such drugs go into wide use for the treatment of psychiatric illness? What does it mean that drugs once considered dangerous and addictive are now being looked upon as potentially effective treatments for mental health disorders?

Some people find that drinking alcohol improves their mood, and it is possible that a clinical trial could show that alcohol works better than a placebo in making people with depression feel better. Of course, no one would ever suggest that we consider alcohol as a treatment for any psychiatric illness. The adverse side effects of alcohol would be considered too serious to warrant its use as an antidepressant or anti-anxiety agent. After all, alcohol is a potentially addictive substance that some people abuse.

Proponents of the use of drugs like ketamine, psilocybin, and MDMA would vehemently reject the analogy with alcohol. In the clinical trials done so far with these agents, adverse side effects seem to be minimal and, in the doses and manner in which they are given, addiction unlikely. Furthermore, some widely used, FDA-approved psychiatric drugs can be misused. The anti-anxiety agents called benzodiazepines, like Valium, Xanax, and Klonopin, for instance, can be abused, as can the psychostimulant medications used to treat Attention Deficit Hyperactivity Disorder (ADHD), such as Ritalin and Vyvanse. There is precedent, therefore, for our use of potentially abused drugs as treatments for psychiatric illnesses.

Is psychiatry going in the direction of approving the use of “mind-altering” street drugs as medications? Or are we simply following solid science in recognizing that once tainted drugs indeed have useful properties to help people suffering from severe illnesses get better? These are questions with which we will have to wrestle, even as clinical trials examining the utility of medications once considered drugs of abuse continue to show their effectiveness for psychiatric disorders.

Does it Matter Where the Coronavirus Came From: Yes and No

The big flap that erupted in May surrounding the exact origins of the virus that causes COVID-19 (called SARS-CoV-2) demonstrates what happens when politics intrudes too forcefully into science. Until then, the viral origin story was presented to us in both mainstream media and scientific communications as settled on a “natural origin” theme that involves bat coronavirus strains mutating until they achieved the potential to infect and harm humans. The “lab leak” theory—that the virus is the result of an accident at a virology laboratory in Wuhan, China—has been emphatically seen by those sources as a false conspiracy theory manufactured for purely political reasons.

         Then, of course, some things changed. A vague report of three laboratory workers at the Wuhan lab requiring hospitalization in November 2019 for an illness that is reminiscent of COVID-19 surfaced. Few details are available, and the Chinese government is apparently not being particularly cooperative with scientists investigating the virus’ origins, but the workers’ illnesses make the lab leak theory seem more credible. President Biden ordered intelligence agencies to investigate the origins of SARS-CoV-2 further and Facebook stopped censoring posts that discuss the lab leak theory.

         In a penetrating article in Columbia Journalism Review, Jon Allsop notes that many journalists simply assumed that because the Chinese lab leak theory was promulgated by former President Trump and seemed to serve a political purpose relevant to his campaign for a second term, then it must be false. Now that the lab leak theory seems to have gained credibility, that assumption is being called into question. Allsop wrote:

To my mind, staking out the proper boundary between science and politics has been the defining journalistic challenge of the pandemic; it might well be impossible to pinpoint, though we could, collectively, have been more thoughtful about looking, and the errors around the lab-leak reflect that failure.

         Scientists will now pursue the origins of the coronavirus in more detail and perhaps at some point the question of where the virus came from will be resolved. It is reasonable to ask the question, however, what difference it will make. In one very important way the origins of the virus make absolutely no difference: the need to vaccinate as many people as quickly as possible. From that public health vantage point, the controversy about whether the COVID-19 pathogen has a natural or laboratory origin is a distraction. The virus is very much with us, we know its genetic structure, we are tracking its mutations, and we have vaccines that offer protective immunity.

Key To Preventing Future Coronavirus Pandemics

         There are at least two reasons, however, why the origin controversy does make a difference, first because it is important in any effort to prevent future coronavirus pandemics and second because it can tell us something about the way science news is reported. Let’s take these two in turn.

         We are now familiar with the concept that viruses change their basic genetic structure at an alarmingly rapid rate, albeit faster for some viruses than others. Every time a copy of a viral RNA or DNA molecule is made there is a chance that some errors in laying down the base pairs will occur. Most of these have no effect on the virus’ actual characteristics, called its phenotype, whereas some are lethal to the virus and prevent further replication. Still others make the virus more “fit,” more able, that is, to infect its host. Bats have seemingly developed immunological mechanisms that permit them to coexist with the kind of coronavirus that causes COVID-19, but over time and with increasing contact with humans, bat viruses can mutate to forms that will infect humans, replicate efficiently in human cells, and cause disease. This natural origin theory is still the prevailing view among many scientists.

Until recently, scientific consensus seemed to hold that the coronavirus that causes COVID-19 originated in bats (image: Shutterstock).

         Knowing the details of how the virus managed to mutate to a form capable of harming people would obviously be important information in any effort to thwart future pandemics. In fact, that is exactly the work of the Wuhan Institute of Virology. Scientists there study strains of coronavirus to see which are likely to become infectious and which carry the potential to produce serious human illness. It is that work that is currently at the heart of the controversy. In one scenario, Wuhan virologists created SARS-CoV-2 as part of their efforts to understand how these viruses mutate and how they can infect human cells. One strategy for doing this is to induce what is called a “gain of function” mutation. Instead of waiting for nature to produce a mutation that makes a virus more infectious, scientists can induce the mutation in the laboratory and see how the protein products of the gene bearing the mutation work. In a gain of function scenario, the artificially induced mutation allows the virus to do something it couldn’t originally do.

         While gain of function research provides a pathway to inferring important insights into viral pathology, it is also controversial for obvious reasons: do we really want scientists making more dangerous viruses in their laboratories? For that reason, the U.S. federal government put a moratorium on gain of function research during the Obama administration, but it was revived in 2017. The National Institute of Allergy and Infectious Diseases (NIAID) funds research at the Wuhan Institute of Virology, but NAIAD director Anthony Fauci stated emphatically at a Senate hearing that it has never funded gain of function mutation research there. One scenario of the lab leak hypothesis is that SARS-CoV-2 was created when scientists induced a gain of function mutation in the virus and then the virus was accidentally released from the lab.[1]

The lab leak theory for COVID-19 posits that the causative virus was created in a laboratory in Wuhan, China and released accidentally (image: Shutterstock).

         Some scientists believe that careful examination of the virus’ genetic sequence suggests a natural origin. If the Chinese government were to cooperate with scientists investigating the origins of the virus, it could make public all the sequences of coronavirus that the Wuhan laboratory has created, and these could then be compared to the genetic sequence of SARS-C0V-2. Although the lab has published some such sequences—and none so far match—it is believed that the lab has not released sequences for all the viruses on which it has worked.

         We can only hope that Chinese scientists are permitted to disclose exactly what manipulations they did perform of coronaviruses and also which strains infected the three lab workers in November 2019. Without that information, it will be tough for scientists to definitively rule out the lab leak theory. That puts us at a disadvantage in any battle to suppress future coronavirus outbreaks.

Leap To a Conclusion

         Our second reason for believing the origins of the COVID-19 virus are an important scientific topic is that they tell us some profound things about the way journalists are approaching science these days. In this case, journalists seem to have leapt to the conclusion that the lab leak theory is incorrect because they were suspicious of one of its promoters—the Trump administration. While we categorically reject the hypothesis that SARS-CoV-2 is really a bioweapon, it is important to acknowledge that we do not have evidence that permits us to rule out the accidental lab leak theory. And, as the well-known saying goes, absence of evidence is not evidence of absence. Some journalists and perhaps many scientists in this case rejected the lab leak theory because they didn’t like the politics with which it was associated. That’s a breakdown of both good journalistic procedure and of science. The lab leak theory appears to be tenable, even if it provides fuel to some ugly conspiracy theories. China is not helping by doing everything it can to thwart a proper inquiry. We need to do what we can, though, to complete as thorough an investigation as possible into the origins of SARS-CoV-2.


[1] We are aware that some have insisted the release was deliberate, but that idea does strike us as part of an elaborate and fanciful conspiracy theory that lacks credibility.

What Determines Parental COVID-19 Vaccine Hesitancy?

What we know and don’t know about uptake of the COVID-19 vaccine among children.

For anyone who studies vaccine hesitancy, the introduction of the COVID-19 vaccines seemed like a perfect storm. These were vaccines developed on a quick timetable with heavy government involvement in response to an urgent need against a disease about which we certainly know far from everything.

At first, vaccine hesitancy was significant. According to a Kaiser Family Foundation poll in December of 2020, only 34 percent of respondents indicated plans to get vaccinated as soon as possible. At that time, 39 percent of respondents said they would wait and see, 9 percent said they would only get the vaccine if required, and 15 percent said, “definitely not.” Yet by March 2021, rates of hesitancy were down considerably. At this point, 32 percent reported having already gotten the vaccine and 30 percent indicated intent to get it as soon as possible, leaving only 30 percent with more hesitant attitudes (as opposed to 63 percent in December).

fotodrobik/Shutterstock
Source: fotodrobik/Shutterstock

While it is not entirely clear what helped tip the balances here, perhaps seeing other people get vaccinated and enjoy new freedoms was helpful to many Americans who were simply afraid of the unknown. This change is of course good news, but now we face a new, potentially more difficult challenge: As the vaccine becomes available to children ages 15 and younger, parental hesitancy about getting their children vaccinated has emerged as a potential roadblock to widespread vaccination. Even among parents who have received the vaccine without much thought or hesitation themselves, significant reservations about the safety of the vaccine for children may exist.

In a recent survey of 1,258 parents, the majority (53 percent) did report that they intended to vaccinate their children eventually but only 26 percent said they would do so right away. Moreover, a full third of parents surveyed said they did not plan to get their kids vaccinated at all. While it is of course possible that parents will become less hesitant as they see more and more of their peers vaccinating their children, these numbers are concerning. We do not have a wealth of information on the reasons behind these concerns, but a few bear mentioning as strong possibilities.

Parents erroneously believe that COVID-19 is not a threat to children. Anecdotally, parents have reported that they feel confident that they can protect their kids from COVID without a vaccine using masking and social distancing measures and that even if their kids get COVID, it will not be serious. They, therefore, weigh the risk of receiving the vaccine, which they perceive to have unknown long-term effects, as greater than the risk of their children getting COVID.

This is a dangerous misperception. While it is true that severe illness is less likely in children than adults, any individual child could experience a severe case that could result in hospitalization, death, or long-term health impacts. Given that there is currently no evidence that the vaccine is unsafe, parents should recognize that putting their children at risk of contracting COVID is much more dangerous and certainly unnecessary. In addition, children can be vectors of the disease and a failure to vaccinate them might result in a general inability to reach community (also known as “herd”) immunity.

Parents may also irrationally believe that adverse effects from vaccines are more likely to occur in children than in adults. Most parents have been confronted with some kind of messaging about vaccines causing disabilities in young children. The most well-known example of this is the myth that the MMR vaccine causes autism. Myths of this sort do not circulate to the same degree about adult vaccinations, which may lead parents to the misperception that vaccines are somehow more dangerous for youth than for adults.

Parents also tend to view their children as particularly vulnerable already, and thus may feel the need to “know more” about the vaccine before they will allow their child to get it. Their standard of safety evidence is thus higher for their children than for themselves. While the desire to protect children is obviously in many ways a good instinct, this particular line of thinking is based in pseudoscience that can lead parents to fail to vaccinate their children against dangerous illnesses. In fact, children do not necessarily experience more adverse side effects to medications than do adults. Vaccines are thoroughly tested in each age group before being authorized for use in that age group.

As COVID vaccines begin to receive approval for younger and younger children, it is imperative that the CDC and other local and federal health agencies and authorities thoroughly understand the nature of vaccine hesitancy among parents and that they communicate effectively to ensure that more parents get their children vaccinated. We should not be waiting until the vaccines are all approved and available to start this campaign. We already know that parents are hesitant, and we should be communicating with them early and often. Without vaccinating children, it is unlikely this pandemic will ever recede and allow us to return to complete normalcy. Public health agencies and professionals must do everything they can to ensure that parents understand that it is in everyone’s best interest to get their children vaccinated. Putting their children and those around them at risk of serious illness should not be an option when safe and effective preventive measures are available.

Why Are Gun Sales Going Up During the Pandemic?

We recently noted that alcohol sales increased significantly during the pandemic and also reminded our readers that the climate crisis is still there even as our attention has been waylaid by COVID-19. Now we feel it important to identify another pandemic casualty—the marked increase in gun sales and gun ownership. Overall background checks for guns increased by 69 percent between 2020 and 2019. As Allie Volpe noted last April in Rolling Stone, one consequence of the coronavirus pandemic is that more people will own guns once it is over than did before it began.

         It seems that legislation is always being introduced at state and federal levels in an attempt to control the sale of guns and the country’s biggest gun advocate organization, the National Rifle Association, is almost always in the news as well. That makes the subject of gun ownership a political one. Although Critica as an organization tries to stay apart from partisan politics, one of our readers recently pointed out that he thought it was fairly obvious how we feel about guns. Does that mean that politics is seeping through our commitment to scientific evidence?

The Second Amendment to the U.S. Constitution has been interpreted by federal courts to give Americans the right to own a gun. Critica asks the question, however, why would someone choose to own one (image: Shutterstock).

         We acknowledge, of course, that the Second Amendment of the U.S. Constitution has been interpreted to mean that Americans have a right to bear arms. Whether that interpretation is correct or not is best left to legal scholars. All too often those who defend ad libitum gun ownership see any advocacy for gun control legislation as an attempt to overturn the Second Amendment. Let’s stipulate for a moment that the Second Amendment does really offer the right to own a gun. Critica has a different point to make than the constitutional one.

But the Data Say They Don’t Offer Protection

Tucked in at the very end of the recent Pew Report “Key facts about American  and guns” is the finding that “personal protection tops the list of reasons why gun owners say they own a firearm.” A Gallup poll is cited in the report that showed that “Roughly six-in-ten (63%) said this in an open-ended question,” a rate much higher than those who said they owned a gun or guns for hunting (40%). This raises an obvious empirical question: is an individual American indeed safer owning a gun?

         We reviewed the data on this question at some length in our book Denying To the Grave and concluded that owning a gun does not make you safer. In fact, there is no evidence that an increase in gun ownership is associated with a decrease in crime. An excellent article by Melinda Wenner Moyer in Scientific American from 2017 makes the point that most of the research looking at the relationship between personal gun ownership and crime “punctures the idea that guns stop crime.” Writing in Nature, Joseph M. Pierre concluded that:

…more than 30 years of public health research supports thinking of guns as statistically more of a personal hazard than a benefit. Case-control studies have repeatedly found that gun ownership is associated with an increased risk of gun-related homicide or suicide occurring in the home…

The data on guns and safety are somewhat limited because of something called the Dickey Amendment, which limits the amount of federal money than can be used for firearm research. We also don’t have a neat randomized control trial (RCT) in which one group of people are given guns and another, matched carefully for numerous demographic factors, are not given them and then both groups followed for several years to get a picture of gun violence patterns. Such a study would be unethical if even possible. Yet the data we do have are, as Pierre notes, remarkably consistent: people rarely successfully use guns to defend themselves whereas owning a gun increases the risk a person will be shot with it. Owning a gun then, in general, makes a person less safe.

So Why Buy One Then?

The question from a Critica point of view, then, is not whether an individual has the right to own a gun but rather why anyone would want to own one. The data seem to indicate a clear decision path: given the choice, do the safe thing and shun buying a gun. In this formulation, the choice is left totally up to the individual, but the right decision is clear.

The data are fairly consistent that owning a gun increases risk for being injured or killed by a firearm and does not offer personal protection (image: Shutterstock).

That does not mean that we are necessarily agnostic about gun control legislation. In addition to jeopardizing personal safety, guns are a threat to the public’s health. That means, of course, that just as laws are accepted that prevent children from smoking tobacco or drinking alcohol and that mandate we wear seat belts in cars and don’t smoke in public places, laws to protect the public from gun violence are fair game. It is just that in this line of thought, we are asking why any individual would, given the evidence, make the decision to buy a gun.

The Pew report we mentioned earlier also tells us that Democrats are more likely to favor restrictive gun legislation than Republicans. It is easy to see how our reading of the scientific record might seem to be the same as taking a political position on gun ownership, but we want to be clear that if the data indicated gun ownership offered real protection, we would advocate for it. That just isn’t the case.

Why then, do people choose to ignore the evidence we have and insist that owning a gun is the safe decision to make? There are likely many reasons, but here is an area where better funding for firearms research would be incredibly helpful. We need a great deal more information on what motivates people to buy guns in the face of clear evidence that doing so is anti-protective. And why are gun sales going up during the pandemic? One hypothesis advanced last year by two Oregon State University professors is that owning a gun is linked to expressions of personal freedom. Everyone on some level must feel a constriction of their usual freedoms by the pandemic. Some have taken this to an extreme by declaring wearing face masks to be an impingement on personal freedom rather than a necessary public health maneuver. Perhaps buying a gun helps overcome that feeling of restricted personal freedom for some. 

Another possible reason comes from the observation that people who have bought guns during the pandemic tend to be more suicidal than other gun owners. However, although many studies have hinted at an increase in mental health problems due to the pandemic, there is no evidence that the suicide rate, including the firearm suicide rate, increased in the last year in the U.S.

Although we don’t have enough data yet to understand why gun ownership is soaring during the pandemic, we do see in it one phenomenon that has plagued overall reaction to COVID-19—the difficulty we have accurately judging risk. As Michael F. Dahlstrom notes in his recent PNAS paper, narrative stories are far more convincing than data recitations. We can give you all the numbers demonstrating that COVID-19 vaccines are safe, but a single story of an unusual adverse side effect carries more weight. Similarly, all the data in the world showing that gun ownership does not convey protection are inadequate in the face of a single news story—or perhaps even one television or Hollywood depiction—of a citizen defending himself with a gun.

Every day, someone somewhere in the U.S. who has never owned a gun before will make a decision about whether or not to buy a gun to keep in the house. How do we drive home the point to him (most guns in the U.S. are owned by men) that doing so will not make him or his family any safer but actually the opposite? Do we need to offer graphic stories about people who have shot themselves with the very gun they once bought to protect themselves? Should we be telling the sad stories of men who shoot their wives or girlfriends in the midst of an argument with the very gun they purchased to make the family safer? There are far more stories of that kind than there are of people fending off home invaders by waving the gun in the night table at them.

A Breakdown in Public Health Communication

The Flu Message Is Not Getting Through

Back in December 2020 we posted a commentary about seasonal influenza, explaining how the flu vaccine works and why everyone should get it. That’s the same advice public health experts, like those at the U.S. Centers for Disease Control and Prevention (CDC), give us every year. We wondered what people really think about the flu and the flu vaccine and undertook a study to find out. The results of our inquiry, which we’ll describe below, are perhaps not surprising but they are certainly disheartening: people in our sample largely think the flu is a minor illness and that the flu shot either doesn’t work or actually gives people the flu. Almost no one seemed inclined to get the flu shot this year or any year.

Influenza— “the flu”—is a serious infectious disease that sends hundreds of thousands of people to the hospital in most years, especially young children and the elderly (image: Shutterstock).

What Critica Did

         Funded by a grant from the Robert Wood Johnson Foundation, Critica commissioned a firm called Fluent to conduct focus groups about attitudes toward flu and COVID-19 vaccines in three geographic areas, Newark NJ, Chicago Il, and central Texas. The pandemic prevented holding in person focus groups, so Fluent advised shifting to an online method called bulletin boards. As Fluent describes them, bulletin boards are asynchronous discussions involving greater numbers of individuals than typical focus groups, and over an extended period of time. Participants log into a password-protected site to answer questions that are posted and monitored by a moderator, who can also follow-up on responses for clarifications or elaboration. We conducted our bulletin board discussions about attitudes to vaccines between January 12 and January 28, 2021.

         A total of 94 people participated in this research, nearly evenly divided among the three regions. Fifty-four of the 94 participants were women. Forty-three identified themselves as white, 23 as African American/Black, 12 as Hispanic/Latinx, and 10 as Asian American/Pacific Islander. The participants had a range of education and household income levels. These volunteer participants were not selected to be a representative sample of the U.S. population, but they do represent a reasonable mix of sex, age, race, and socioeconomic status. This makes their near unanimity of opinion about the flu and the flu vaccine arresting.

What People Told Us About the Flu

         In general, respondents to our bulletin boards seemed unconcerned about the flu. They expressed the opinion that the flu is generally a mild illness, easy to get over with perhaps the assistance of readily obtainable over-the-counter medications. While public health officials stress that the flu kills thousands of Americans every year, including young children, the consensus of people we spoke with seemed to be that the flu is no big deal. That in turn meant that few people felt any great motivation to get the flu vaccine.

         Although many of our participants are aware that their own doctors, whom they generally trust, recommend an annual flu shot, they breezily reject their doctors’ advice, often in favor of “natural” or “holistic” treatments. People believe they can boost their immune systems and prevent getting the flu by taking a variety of supplements, eating a healthy diet, and getting exercise. Vaccines, like the flu shot, were seen as “unnatural” and akin to injecting “foreign substances” into their bodies.

         There was also an often-expressed belief that the flu shot either doesn’t work or can in fact cause the flu. A typical sentiment is reflected by one participant from Texas who said “I stopped taking any flu vaccine in the 1990s after one administered made me become very ill. It actually game me the full-blown flu.” We and many others explain repeatedly that it is impossible to get the flu from the flu shot. The vaccine does not contain live virus and cannot make anyone sick. Rather, it is possible to get the flu in spite of the flu vaccine because the influenza virus mutates rapidly and comes in multiple strains. Each season’s vaccine inevitably fails to cover all versions of the virus and therefore seasonal flu vaccines vary in effectiveness.

         That of course doesn’t mean they are ineffective but rather they are not 100% effective. Getting vaccinated lowers any individual’s chances of getting the flu and, if infected, usually decreases illness severity. That message does not seem to be getting through, however, as witnessed by comments like these from one of our study participants: “I don’t believe that the science behind the flu vaccines is as expert as the field makes it out to be since they are typically developing vaccines for the strain of flu the ‘think’ will be here in a given year.”

Influenza vaccination—“the flu shot”—significantly lowers the chance of getting the flu and, if infected, usually reduces illness severity (image: Shutterstock).

         Over and over again, participants related stories about people they know who got sick after receiving the flu shot. These stories clearly have more salience than anything people hear from experts. “I have heard,” one respondent told us, “that vaccines protect you from getting sick and keep you healthy. I heard this from my doctor or the news. I don’t believe it is true and I am not persuaded by the arguments…My mom got the flu vaccine and still got the flu.” Overall, 50 of the 94 people in our sample felt flu vaccine may be unsafe or believe it causes the flu.

Public Health Messaging Has Failed

         As we pointed out in December, according to the CDC, in most years millions of people contract the flu in the U.S., hundreds of thousands of them require hospitalization, and tens of thousands die. So there is obviously a huge gap between what public health authorities like the CDC tell us about the flu and what people believe. Moreover, it seems the CDC has been reassuring people for decades that the flu shot doesn’t cause the flu, but our observations indicate that the message is going unheard. People who trust their personal physicians and even value the information provided by federal health institutions like the CDC are nevertheless more often persuaded by their own personal experiences and by stories they have heard about the flu.

         To us, this suggests a nearly complete failure of public health messaging. It is not just that the flu is a serious illness and that its incidence can be substantially decreased by vaccination. It is that CDC, health departments, and doctors persistently tell us those things, but somehow no one believes them. The immediacy bias seems to reign here—if I never had a bad case of the flu, then it must mean that the flu isn’t serious; if I know someone who got a viral illness after getting the flu shot, then it is clear to me that the flu shot caused them to actually get the flu.

         The flu will be back next season, when it is likely that fewer people will be wearing facemasks or practicing social distancing. That makes the potential for more widespread flu outbreaks next year than last year a season a definite possibility. Next season’s flu might be milder than in past years because with fewer cases the virus itself has had less time to mutate to more serious strains. On the other hand, it could be more severe; people usually develop some at least partial immunity to the flu every season, but that will not happen this year because of the flu’s low prevalence rates. It will also be more difficult for scientists to decide which strains of the flu next year’s vaccine should target, something they do in part by observing the strains that are prevalent the previous year and on the Southern Hemisphere’s flu variants the preceding July and August. For 2021-22 there will be little to go on in order to make that determination.

         We need a new national strategy to educate people about the flu’s seriousness and motivate the public to get vaccinated. Since it appears, at least from our small sample, that personal experience and stories mean the most to people, perhaps that strategy needs to include advertising the stories of individuals who have developed serious cases of the flu and even telling stories about people who have died. This of course must be done only after research indicates it will be effective; telling the stories of children who die from the flu could backfire and make people even less likely to accept vaccination.

         Clearly, however, CDC and other public health experts need to dramatically rethink how they convey the flu story to the public. No matter how many advances molecular biologists and virologists make in developing more effective flu vaccinations, they are useless if people don’t believe in them.

On Flip-Flopping

Or How Does Science Make Up Its Mind

No one likes a “flip-flopper” it seems. We want public figures to stick to one clear message, be they politicians running for office, scientists announcing their latest findings, or public health authorities telling us what we need to do to avoid becoming ill. A change in that message, what we call flip-flopping, is seen at best as a sign of weakness and at worst evidence of lying and corruption.

         Let’s take the recommendation to wear face masks during the COVID-19 pandemic. It is true that at first, even the trusted Anthony Fauci seemed to be saying that only healthcare workers needed to wear them. The rest of us, experts recommended, didn’t need them.

         Several months later, however, Fauci, the U.S. Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and a host of other experts seemed to change their minds; wearing face masks, we were then told, is a vital part of the public health strategy to prevent the spread of the novel coronavirus that causes COVID-19. Most people have complied with that recommendation and wear face masks while in public gatherings, but a constant stream of dissenters insist this change in recommendation means the authorities don’t know what they are talking about in the first place, were lying to us, and were acting out of some bizarrely concocted conspiracy to control people’s lives.

Science Marches On

         We think that what really happened is that scientists made some new discoveries about face masks that altered best practice recommendations. At the beginning of the epidemic we did not have a lot of data about face masks or about how SARS-CoV-2, the virus that causes COVID-19, is spread. In just a few months after the pandemic began in the U.S., however, data emerged on three fronts. First, studies using laboratory animals demonstrated that masks prevent the spread of SARS-CoV-2. Second, epidemiological data began to show that instances in which people wore face masks were associated with lower rates of infection. Third, scientists confirmed that SARS-CoV-2 can be aerosolized and spread through the air over long distances, meaning that face masks that prevent aerosolized particles emitted by coughs, sneezes, and talking can be an important tool in preventing viral spread.

Some people mistakenly believe that the change to recommending we wear face masks while in public represents a nefarious “flip-flop” and evidence of scientific corruption. In fact, it came about because of the gathering of new scientific evidence (image: Shutterstock).

         Those insights gleaned from laboratory and epidemiological studies changed thinking about face masks and led to all of those experts changing their minds and their recommendations. Were they wrong at first to recommend against face masks? A better way to think of it is that they made recommendations based on what was known about them at the time. Was Ptolemy wrong to say during the days of the Roman empire that the sun revolves around the earth? Of course, but it turns out that the idea was based on the best available scientific observations of the time and not on stupidity or an ulterior motive. When Copernicus, Galileo and other later scientists provided new data that proved the earth revolves around the sun, science “changed its mind.” It was very hard in the fifteenth century for many people—including many astronomers at the time–to go along with that kind of momentous change in scientific thinking and it is still hard for us to do so today. We don’t love change, not about which heavenly bodies circle each other nor about whether we should wear face masks to prevent disease spread. Yet we must be able to adjust our thinking to accept new scientific consensus when it emerges. To try to dismiss new scientific consensus by accusing the scientists behind it of lying or dark conspiratorial motives is a defense mechanism against accepting the normal way that science develops.

Science Inevitably Involves Change

         It is the nature and indeed the virtue of science that it is built to provide new insights that change current dogma. We may be about to see a radical change in physics because new experiments show that a subatomic particle called the muon has a stronger magnetic spin than current theory predicts. Physicists seem mostly excited by the prospect of developing a new theoretical understanding of how forces work in nature, even though if that turns out to be the case a lot of textbooks will have to be rewritten. The public seems interested but not particularly upset with this prospect because few of us understand the complex mathematics behind the current physics, so changing it perhaps won’t matter much to most of us. Still, at least one educated person we know queried whether his computer will still work if physics changes its theories.

The nature of scientific consensus is to be established via twists, turns, and roundabouts in the collection of scientific evidence. Change is both common and desirable (image: Shutterstock).

         When it comes to things that affect our daily lives, like how much sugar is safe to consume, whether we need to scrub every surface we come in contact with to prevent getting COVID-19, or whether we should take vitamin D supplements, we want there to be a strong and unshakeable scientific consensus. Sometimes, however, the consensus isn’t unshakeable, as we know with the dietary recommendations for sugar and fat consumption. Sometimes the consensus isn’t strong: experts and guidelines tend to suggest that only people who are clearly vitamin D deficient need take supplements, but what exactly constitutes “deficient” in this case is difficult to define and much debated among experts. That amount of change or uncertainty is unsettling and we tend to default to conspiracy theories rather than accept that change and uncertainty are vital parts of the scientific enterprise.

What Scientists Can Do

         There is an important thing that scientists can do to help people accept that change and uncertainty are natural parts of the scientific process. Scientists need to state much more forcefully when they speak to the media or the public in general that things are uncertain or incompletely known. There is a growing tendency among publicity departments at research universities and medical centers to “sell” the work of their faculties as representing major discoveries and “breakthroughs” when in fact much of what is being promoted is really just a small part of a larger, ongoing scientific process. Press releases from universities, medical schools, and teaching hospitals have become part of an attempt to increase market share rather than to carefully inform journalists and the public about how science works.

         For example, many medical and scientific authorities whom we trust initially spoke about face masks as if there was settled science proving their inability to help block transmission of COVID-19. In fact, they should have said that at that early point in the pandemic there was insufficient information to indicate their usefulness and that further scientific inquiry might alter the recommendation not to use face masks, which in fact happened. That way, the public would not have felt so misled when new data came in suggesting that face masks are indeed a very important part of the effort to contain the pandemic.

         Just as fundamentally important as having the scientific community adopt a humbler attitude about what science in fact “knows,” is the critical need to improve science education so that people are not so shocked by inevitable twists and turns in scientific consensus and public health recommendations. If we persist in teaching children and young adults science by forcing them to memorize “facts” we will continue to create the misimpression that science is set in stone. For those of us who have done experimental work, it is absolutely no surprise that outcomes of even the most rigorously designed studies often fail to support initial hypotheses, that some findings are not replicable by further experimentation, and that there is a continuous need to update what we think we know. Science is our best route to establishing true insights into the way the natural world works, but that route is nevertheless filled with twists and turns and roundabouts. We need to teach people that this is how science really works.

         We should not automatically and derisively call a change in knowledge or recommendation or even political opinion a “flip-flop.” Rather, we should welcome an open-minded approach to science and to politics in which new scientific evidence is accepted and incorporated into existing theories, even if on occasion it means that an entire theory needs to be dramatically revised. No one was lying when they advised that face masks were unnecessary to control the raging novel coronavirus. Admittedly, they were a bit too sure of themselves in saying that, but we should be relieved that scientists were willing to look foolish and change their guidance about face masks as new facts emerged from scientific inquiry. Let’s be a little kinder about the next “flip flop.”