Needle Points | Norman Doidge | EP 222

Hello everyone! I've begun to consider using my YouTube channel and podcast for material generated by people other than myself. I recently put up a lecture by Jonathan Pagiot that was delivered to the Jung Society in Montreal. I thought it was a particularly brilliant discussion of the underlying narrative structure and conceptual structure of Genesis. I added that to the sequence of my videos on Genesis.

My wife is going to be releasing a series of interviews with Jonathan Pagiot as part of her investigation into the nature of the divine feminine, so that's coming up soon. In this instance, I asked my friend and colleague, psychiatrist Dr. Neumann Deutsch, to read an essay he wrote a few weeks ago called "Needlepoints," which is the most penetrating analysis that I've read about the COVID policies that have bedeviled and helped us over the last few years.

Dr. Deutsch is a psychiatrist and a psychoanalyst and a solid scientist renowned for his writing on science and the brain, and in my opinion, Canada's most literate physician writer. He's also a friend and colleague of mine. He wrote the introduction to "12 Rules for Life." His essay, "Needlepoints," which he's reading today, first appeared a few weeks ago in Tablet Magazine, but it's perhaps even more relevant today.

Like me, Dr. Deutsch is vaccinated. He describes the history of vaccines, praises what he calls the kernel insight, and makes a solid and intelligent case for the utility of the technology. Then he details the COVID state of mind, describes the workings and nature of the brain circuits triggered by contagion, and helps explain why the issue of vaccination is tearing families, friendships, professions, and even states apart.

He describes why debates about vaccination and infection policies are always emotionally radioactive on both sides of the debate, showing us why our reason is threatened during contagion, detailing why we are then tempted to treat each other so badly. He explains why those who hesitate in the face of the current policies surrounding vaccination have concerns more justified by history and experience than they are often credited with, particularly when their views are caricatured and demonized.

He makes the case that the best path through the current crisis is not through coercion; that such coercion is, in fact, a reliable indicator of failed government communication and policy. Dr. Deutsch describes the alternative participatory model in which humane physicians speak to patients respectfully and as individuals with their own agency, and explains that those who adopt this approach do much better public health work, as would governments if they wished to enhance instead of degrade trust in public health.

I've now shared this article with conservatives and liberals alike in Canada, and Democrats and Republicans in the U.S. Many of them, all who have received it and read it in this polarized time, have expressed their appreciation for its content and its writer. Dr. Neumann Deutsch did his homework as he always does. He's the author of "The Brain That Changes Itself" and is currently a contributing writer for Tablet Magazine, where this article is published and where all the links to the scientific references he quotes can be found.

He's also the executive director of Health and the Greater Good, a new think tank devoted to finding solutions to health problems that respect civil liberties so that neither health nor civil liberties need needlessly be at the expense of the other. I wanted to bring this article to the broadest public attention possible, given its importance, and felt that having Dr. Deutsch read it so that people could watch it and listen to it on YouTube and in podcasts, assuming that would be the most effective way to disseminate the information.

So, without further ado, Dr. Neumann Deutsch and "Needlepoints."

Needle Points: Why So Many Are Hesitant to Get the COVID Vaccines and What We Can Do About It
By Neumann Deutsch
Read by the author
October 27, 2021

Since my days in medical school, I've had a fascination with the kernel insight behind vaccination— that one could successfully expose a person to an attenuated version of a microbe that would prepare and protect them for a potentially lethal encounter with the actual microbe. I marveled at how it tutors an immune system that, like the brain, has memory and a kind of intelligence and even something akin to foresight. But I loved it for a broader reason too. At times, modern science and modern medicine seem based on a fantasy that imagines the role of medicine is to conquer nature, as though we can wage a war against all microbes with antimicrobials to create a world where we will no longer suffer from infectious disease. Vaccination is not based on that sterile vision but its opposite.

It works with our educable immune system, which evolved millions of years ago to deal with the fact that we must always co-exist with microbes. It helps us to use our own resources to protect ourselves. Doing so is in accord with the essential insight of Hippocrates, who understood that the major part of healing comes from within—that it is best to work with nature and not against it.

Yet, ever since they were made available, vaccines have been controversial, and it has almost always been difficult to have a non-emotionally charged discussion about them. One reason is that in humans and other animals, any infection can trigger an archaic brain circuit in most of us called the behavioral immune system, or BIS. It’s a circuit that’s triggered when we sense we may be near a potential carrier of disease, causing disgust, fear, and avoidance. It’s involuntary and not easy to shut off once it’s been turned on.

The behavioral immune system is best understood in contrast to the regular immune system. The regular immune system consists of antibodies and T cells and so on, and it evolved to protect us once a problematic microbe gets inside us. The BIS is different. It evolved to prevent us from getting infected in the first place by making us hypersensitive to hygiene hints of disease in other people, even signs that they are from another tribe. Since in ancient times, encounters with different tribes could wipe out one's own tribe with an infectious disease they carried, often the foreign tribe had its own long history of exposure to pathogens, some of which it still carried but to which it had developed immunity in some way.

Members of the tribe were themselves healthy but dangerous to others. So we developed a system whereby anything or anyone that seems like it might bear significant illness can trigger an ancient brain circuit of fear, disgust, and avoidance. It can also trigger rage, but rage is complex because it's normally expressed by getting close to the object and attacking it. But with contagion, one fears getting too close. So generally, the anger is expressed by isolating the plague bearer. The BIS is thus an alarm system specific to contagion, and I should add to the fear of being poisoned, which before the development of modern chemistry often came from exposure to living things and their dangerous byproducts, such as venoms.

Thus it can also be triggered by non-animate things, like body fluids of some kinds, surfaces others may have touched, or even more abstract ideas like going to the grocery store during COVID. There is one exception: the BIS doesn't get or stay activated in people who don't feel vulnerable—perhaps because they have good personal protective equipment, or because youth gives them strong innate immunity, or because they know they're already immune, or because they're seriously misled or delusional about the reality of the disease. For everyone else, though, what might trigger the system is rather plastic.

But once triggered, the system is involuntary. The BIS is, I would argue, one of the instinctual reactions that missed appearing in medical textbooks, perhaps because we've not had a pandemic on this scale for a hundred years. Because it focuses on potential bearers of disease, the BIS triggers many false alarms since an infected person may at first show only the mildest and non-specific symptoms, such as a cough or sniffle, before they become deathly ill. That's why even a small exhalation or a surface touched by a stranger could trigger the BIS.

We're at a medical test of danger. We would say the system tends to err on the false positive side. We see it firing every day now when someone drives alone wearing a mask or goes for a walk by themselves in an empty forest masked; or when someone, say, with good health and no previous known adverse reactions to vaccines hears that a vaccine can, in one in 500,000 cases, cause death, but can't take any comfort that they have a 99.999 percent chance of it not happening because it potentially can. Before advanced brain areas are turned on and probabilities are factored in, the BIS is off and running.

One of the reasons our discussions of vaccination are so emotionally radioactive, inconsistent, and harsh is that the BIS is turned on in people on both sides of the debate. Those who favor vaccination are focused on the danger of the virus, and that triggers their system. Those who don't are focused on the fact that vaccines inject into them a virus or a virus surrogate, or even a chemical they think may be poisonous, and that turns on their system. Thus both sides are firing alarms, including many false positive alarms that put them in a state of panic, fear, loathing, and disgust of the other.

And now these two sides of the vaccination debate are tearing America apart at many levels: families, states, and the federal government. It's even affecting the country's ability to deal with the pandemic, splitting hospital staffs and sundering relationships between the scientists studying it. As of this writing, in the United States, about 85 percent of people over 65—the age group most at risk—are fully vaccinated against COVID, more if you include those who had one shot.

57 percent of the overall population is fully vaccinated, but around June the rate of vaccination slowed drastically down to less than 1 million a day from 3.4 million daily in April, even though many more people age 12 and up were now eligible. Five million people who got the first shot had not gone to their follow-up appointment. States started sending vaccines back while some vaccination sites were empty. In response, U.S. public health officials appeared to believe that the number of people who would voluntarily take the vaccine had reached a ceiling.

The change could be seen from the top of the messaging system, with President Joe Biden switching from persuasion to coercion of the armed services, federal employees, and as of September 9th, of everyone working for companies with a hundred employees or more—a category that includes about a hundred million Americans. In a way, this should be the least likely time in history for vaccine hesitancy. For years, vaccinologists explained vaccine skepticism by noticing that few had lived through a large-scale pandemic and because vaccines had already eradicated so many serious diseases that it gave rise to complacency about the threat.

But today's vaccine hesitancy is happening in the midst of a pandemic in which over 700,000 Americans have died, and a recent Rasmussen poll found that a staggering one-third of Americans "quote believe officials are lying about vaccine safety close quote." It seems to me especially vital that we broaden our understanding of the history and current state of vaccines because over the summer many who chose vaccination for themselves concluded that it is acceptable to mandate vaccines for others, including those who are reluctant to get them.

That majority entered a state of crystallization—a term I borrow from the French novelist Anaxagoras, who applied it to the moment when a person falls in love—feelings that may have been fluid become solid, clear, and absolute, leading to all or nothing thinking, such that even the beloved's blemishes become signs of their perfection. Crystallization, as I'm using it here, happens within a group that has been involved in a major dispute for a while. There’s an awareness that some disagreement is in play and people are free to have different opinions, but at a certain point, often hard to predict and impossible to measure, because it is happening in the wider culture and not necessarily at the ballot box, both sides of the dispute become aware that within them this mass of human beings there's now a winner.

One might say that a consensus arises—that there is now a majority consensus, and suddenly certain ideas and actions must be applauded, voiced, obeyed, and acted on, while others are off-limits. One person who understood how this works intuitively was Alexis de Tocqueville. In democracies, as long as there is not yet a majority opinion, a range of views can be expressed and it appears that there is a great "quote liberty of opinion close quote," to use his phrase. But once a majority opinion forms, it acquires a sudden social power and it brings with it pressure to end dissent, a powerful new kind of censorship and coercion.

It begins in everyday life at work, school, choir, church, hospitals, in all institutions as the majority turns on the minority demanding it comply. Tocqueville, like James Madison, was concerned about this tyranny of the majority, which he saw as the Achilles heel of democracy. It isn't only because divisiveness creates a minority faction steeped in lingering resentment, it's also because minorities can sometimes be more right than majorities. Indeed, emerging ideas are by definition minority ideas to start with. The majority overtaking the minority could mean stamping out thoughts and actions that would otherwise generate progress and forward movement.

It's a fascinating moment when this sort of crystallization happens in a mass culture like America's because seemingly overnight even the definition of legitimate speech, or thought, or action changes. Tocqueville observed that quite abruptly a person can no longer express opinions or raise questions that only days before were acceptable, even though no facts of the matter have changed.

At an individual level, people who were within the bounds can be surprised to find themselves "quote tormented by the slights and persecutions of daily obloquy close quote." Once this occurs, he wrote, "quote your fellow creatures will shun you like an impure being, and those who are most persuaded of your innocence will abandon you too, lest they should be shunned in their turn close quote."

In the midst of a pandemic, seeing the unvaccinated as impure is no surprise because, of course, they could carry contagion. But as Tocqueville pointed out, this also occurs when there is no contagion and we begin to experience those who are on the wrong side as impure, as in failing the purity test, and react to them as though they are dangerous.

The fact that we do this even when there is no pandemic suggests that there is, along with the realistic fear of infection, something else going on here: a sense that those with whom we may disagree are impurities in the body politic—bad people who need to be taught a lesson, even punished. A June 2021 Gallup poll found that among the vaccinated, 53 percent now worry most about those choosing not to get vaccinated, "quote surpassing concerns about lack of social distancing in their area, 27 percent, availability of local hospital resources and supplies 11 percent, and availability of coronavirus tests in their area, 5 percent close quote."

True to the behavioral immune system's impulses, this fear is metastasizing into disgust, even hatred of those who, because they believe or act differently, are now perceived as threats. On August 26, in a front-page story in the Toronto Star, my local newspaper, a resident was quoted as saying "quote I have no empathy left for the willfully unvaccinated, let them die close quote."

In the midst of such a death wish for fellow human beings, even the person quoted understood that an important mental capacity has been lost: empathy, or the ability to model other people's minds. When we lose that en masse, the results can be tragic, not least because getting through this must be a group effort.

As I understand it, there are two main approaches to public health in liberal democracies, and both have been tried historically in different places. One begins voluntarily, out of respect for civil liberties, but switches to coercion when some voluntary ceiling deemed insufficient is reached. Ideally, this intervention is based on the principle of least necessary coercion. The benefit of this is that it may work to get more people vaccinated in shorter order, but it also conveys that the government does not trust its citizens to make good decisions on their own—a condescension that in turn, this is human nature 101, eventually generates resentment, even revolt, and the disengagement of significant segments of the population.

The other approach—participatory public health—sees the need for coercion as a sign that something in the public health outreach itself has failed. If a ceiling is reached, society's leaders should not simply resort to force, but rather confront the flaws in their own leadership—that they should double down on their responsibility to generate trust in the public.

The goal of participatory public health is not to crush but to better engage. In that spirit, what follows is an attempt by a physician and neuroscience writer—and someone who got vaccinated early and voluntarily—to understand those who have not made this choice.

This essay is not about COVID deniers or anti-vaxxers who oppose vaccines on ideological grounds, nor is it about the activists or political figures who feed off and benefit from the corrosive discourse around vaccines. It is instead about the vaccine hesitant—those who are concerned and anxious about COVID but also anxious about these new vaccines. These are the people who are not yet vaccinated for reasons that the majority may not understand and which are often more anchored in history and experience than the majority would suspect.

They are the Tocquevillian minority that the majority is threatening with job loss and other restrictions. One needn't agree with the decisions or actions of the vaccine hesitant in order to learn something from them and about them and about society as a whole. They pay attention to and are vigilant about different issues than the vaccinated and have strong feelings about the people and institutions involved in our public health, particularly politicians, the drug regulatory process, and pharmaceutical companies.

For many, vaccine hesitancy is not simply about the vaccines; it's about the absence of faith in the wider systems that brought us the vaccines. "Quote public health moves at the speed of trust close quote," notes physician and author Rishi Manchanda. If we want our public health system to function better, safer, swifter— in ways that more effectively safeguard the lives and livelihoods of all citizens—it must be rooted not in coercion but in confidence and not only among the majority.

Chapter 2: The Kernel Brilliance of Vaccines

The kernel idea of exposing a person to a weakened form of a pathogen or toxin, known colloquially as "like treats like," long preceded modern medicine and came in stages through observation. Paracelsus, who was said to have treated persons during a plague in 1534, noted that "quote what makes a man ill also cures him close quote." During the ancient plague of Athens, 430 to 425 BCE, the historian Thucydides noted that those who, like himself, got the plague and then recovered never got the plague again. Chinese writing alluded to inoculation in the 10th century, and in the 16th century, Brahman Hindus were inoculating people with dried pus from smallpox pustules. Similar practices, which were common in Turkey in the 1700s, were brought to England by the remarkable Lady Montague, the English ambassador's wife.

But when some—such as King George III’s son—died of being inoculated with smallpox, many became reluctant to undergo the procedure. A key advance occurred when farmers in England in the 1700s noticed the dairy maids who milk cows got cowpox on their hands from the udders. Cowpox was a very mild illness compared to smallpox, which had a 30 percent mortality rate by some estimates. It was observed that the maids with cowpox were immune to the dreaded smallpox.

An English cattle breeder named Benjamin Jeste, who had himself contracted cowpox and was thus immune to smallpox, decided supposedly on the spur of the moment to intentionally inoculate his wife and children with cowpox. They remained immune to smallpox 15 years later. The English physician Edward Jenner, learning of this, began systematically exposing patients to cowpox, including an eight-year-old boy named James Phipps. He exposed James to cowpox and then exposed him to smallpox to see if he'd contract it—an experiment conducted, quite obviously, without informed consent.

The boy survived and was vaccinated 20 times without bad effect, said Jenner, who reported on the benefits of the procedure in warding off smallpox in a series of cases. He was initially ridiculed for this idea but, in the end, prevailed. The phenomenon was soon called vaccination from "vaccinia," the Latin for cowpox virus species "vaca," being cow. Some have even wondered whether the ancient Western symbol for the medical arts and healing still used today, the Rod of Asclepius, a serpent wrapped around his staff, may itself be an allusion to the kernel idea that something dangerous can also protect. According to Greek myth, Asclepius was said to have healed people with snake venom, which can have some medicinal properties that were written about by Nicander.

Interestingly, the same image appears in the Torah in Numbers 21:8, "And the Lord said unto Moses, Make thee a fiery serpent, and set it upon a pole: and it shall come to pass, that every one that is bitten, when he looketh upon it, shall live. And Moses made a serpent of brass, and put it upon a pole: and it came to pass, that if a serpent had bitten any man, when he beheld the serpent of brass, he lived." All of which is to say that the heal-harm paradox is a deep archetype in the human psyche and it came not from big Pharma, but from everyday, often rural, observations about how nature works and how the immune system behaves.

Among the great triumphs of vaccination are the elimination in the United States of the scourge of polio and the eradication of smallpox throughout the world. Indeed, perhaps because of these successes, many of us nostalgically imagine that their development and public acceptance came easily, but the real history shows a more textured picture. A number of polio vaccines had to be tried; the initial vaccine studies had very little oversight, and the first vaccines left some children paralyzed. The first truly effective vaccine, the Salk, had problems too.

In 1955, a bad batch of over 120,000 doses from the Cutter Pharmaceutical Company contained the live poliovirus, causing 40,000 cases of polio and killing 10. The Cutter incident, as the event is now known, revealed the vulnerability of the systems that produce vaccines and remains one of the sources of the nightmare that so haunts the hesitant: getting the dreaded disease from the treatment.

The incident was followed by efforts to improve the regulatory systems so that similar tragedies wouldn't be repeated in the public's mind. Perhaps the greatest triumph of vaccination was the mid-century worldwide eradication of smallpox, a horrifying scourge that was lethal in 30 percent of cases. The history, as it is often told, attributes the victory solely to vaccines, but as British physician Richard Halverson has written, it was not simply the product of a single blockbuster vaccine or campaign, as it is so often described, but rather a regime of multiple public health measures instituted alongside vaccination.

The details here are quite interesting. Beginning in the 17th and 18th centuries, there were a number of mass campaigns of inoculation with smallpox and then vaccination with cowpox that led to a decline in smallpox in the 19th century. By 1948, some physicians in England thought the illness was sufficiently well-managed that mass vaccination of infants, which carried some risks, could wind down, and so mass vaccination was replaced by a new, more individually focused strategy.

If a case was reported, public health officials isolated the person and their contacts, and the contacts were vaccinated. This was called the surveillance-containment strategy. It worked. After the cessation of vaccination in England, a few cases occurred in 1973 and 1978, but both were based on laboratory accidents. According to Halverson, the World Health Organization came to the same conclusion and also adopted the surveillance containment approach. Elsewhere in 1980, the disease was declared eradicated.

But alongside the public health system's triumphant eradication of polio and smallpox from the 1940s through the 1970s, there was a horrifying chapter as well—one that included staggering abuses by public health and medical authorities. The Tuskegee experiment, conducted by the U.S. Public Health Service from 1932 until 1972, sent out representatives to find African-American men with syphilis who were told they would receive treatment for their "quote bad blood close quote." No treatment occurred.

The officials gave these men a placebo instead of penicillin, which would have saved them. This was done so the investigators, by watching the men die slowly, could study the natural course of the devastating disease. During the same period of time, the U.S. public health system oversaw 70,000 sterilizations of "quote mentally deficient close quote" people with learning problems, the blind, and the poor, and also forcibly removed the uteruses of African-American and indigenous women, all as part of an international eugenics movement that swept through public health.

Psychedelics and other drugs were given to people in mental institutions without telling them, often leading to nightmare trips, and dangerous campaigns were undertaken based on only partial knowledge, such as the widespread radiation of healthy children's thymus glands, a key part of one's immune system, which later caused cancers. All of these programs used abstract population-based thinking, dehumanizing people into numbers to be toyed with in the name of science and progress.

None of the public health abuses during this period involved informed patient consent, and yet they were government-sponsored, loaded, and justified in the name of the greater good. It took the revelation of Nazi medical experiments on Jews and others to give rise to a new ethics of consent for research subjects. The Nuremberg Code of Ethics of 1947, along with the 1964 Declaration of Helsinki originally developed by the World Medical Association, required physicians and scientists to obtain the informed consent of all research subjects.

This breakthrough led to the normalization of patient consent not just for research subjects but for those undergoing all medical procedures and became a bedrock of what many of us in the medical field now see as an inviable code of ethics. But in the late 1970s and 1980s, there were new controversies. In 1976, a swine flu outbreak occurred in Fort Dix, New Jersey. Fearing that the country was on the cusp of a pandemic, the U.S. government approved a vaccine and undertook an aggressive rollout that involved 48 million people.

But there were two unforeseen developments. First, the epidemic receded on its own and rather quickly. Second, 450 vaccinated people came down with a neurological disorder called Guillain-Barré syndrome in greater numbers than would be expected during that period. After producing and distributing the vaccine so quickly, the government then reacted with caution, but the idea that a vaccine could cause damage stuck in the public's mind. "Quote this government-led campaign was widely viewed as a debacle and put an irreparable dent in future public health initiatives close quote," wrote Rebecca Crestón in "Discover," "quote as well as negatively influenced the public's perception of both the flu and the flu shot in this country close quote."

That skepticism might have emerged so sharply because the swine flu debacle occurred against the backdrop of another contemporaneous event in the 1970s. A number of parents began arguing that their children were left with serious brain problems and seizures after receiving the diphtheria-pertussis vaccine. Numerous vaccine-related lawsuits followed, and the parents scored many legal victories, costing pharmaceutical companies millions of dollars. It cost 12 cents to make a dose of the DPT vaccine in 1982.

But within a few years, the cost increased 35-fold, thanks to litigation awards, and as a result, companies started leaving the vaccine business. To this day, there's disagreement about the primary cause of the brain problems, with some of the parents insisting it was the vaccine and vaccine advocates arguing that these children actually had a genetic condition called RIVETs syndrome, possibly brought to the surface by the vaccination but which they would have suffered from anyway.

There is little disagreement, though, about what happened next. In 1986, the last pharmaceutical company still making the DPT literally told the government it would stop making the vaccine. Companies making vaccines for other diseases were also being sued and also stopped production. The government grew very concerned, and in 1986, Congress passed the National Childhood Vaccine Injury Act (NCVIA).

The act established a new system for vaccine-related injuries or death linked to childhood vaccinations, wherein companies were indemnified from being sued for safety problems. Soon after, the program was enlarged to include adult vaccination injuries. If anyone believed that a child or person was injured by a vaccine, they could take the complaint to a newly established vaccine court run by the U.S. government and plead their case. If they won, the government would pay them damages from a fund it created out of taxpayer money.

This might have seemed like the best possible solution. The country retained a vaccine supply, and citizens had recourse in the event of harm. But because companies were indemnified from any harm their vaccines might cause, they no longer had a powerful financial incentive to rectify existing safety problems or even improve safety. As time passed, arguably they were financially disincentivized from doing so. The solution shifted liability for the cost of safety problems from the makers onto the taxpayers—the pool that included those who were arguably harmed.

This atmosphere of suspicion spread in the 1990s, with even greater explosiveness and toxicity during the vaccine autism debate. The landscape of the vaccine discourse in the United States, never simple or one-dimensional to begin with, was becoming even more complicated and hostile. To understand the polarized psychological reactions to vaccination now, as well as what to do about it, it's essential to disentangle three things. First, there is the kernel idea behind vaccination as a treatment, arguably one of humanity's greatest medical insights. Second, there's the process by which a particular vaccine is produced, tested for safety and efficacy, and regulated—that is, the execution of the core insight, which, as we know, can vary in success from one vaccine to the next or fail completely. We've not yet been able to make an AIDS vaccine, for instance.

Third, there is the way in which those who produce the vaccine and the public health officials in charge of regulating and disseminating it communicate to the public. Only a person who rejects the first kernel idea could sensibly be called an anti-vaxxer. Many people accept the kernel insight and have been vaccinated multiple times in the past, but have come to doubt the execution or necessity of a particular vaccine and hence also come to doubt the claims made in the course of disseminating it. They become hesitant about that particular vaccine and defer or avoid getting it.

One reason hesitancy can take hold in relatively low-trust societies is that reluctant vaccinees typically have no direct relationship with those mandating vaccinations and thus no personal evidence that those people are trustworthy. For a regular medication, a physician needs and has the ability to convince one patient at a time to take a particular drug. This is why pharmaceutical companies have huge marketing budgets to sway individual physicians and patients alike.

In the case of vaccines, companies need to convince only a few key officials in committees who then buy their product and market it for them to an entire population. For companies producing vaccines, mass marketing is replaced almost entirely by political lobbying. A number of events occurred in the 1990s that suggested growing enmeshment between the pharmaceutical industry and scientists involved in drug production and approval decisions, along with the role of profit in the whole arrangement, was becoming an endemic problem.

In 2005, the Associated Press reported that "quote two of the U.S. government's premier infectious disease researchers are collecting royalties on an AIDS treatment they're testing on patients using taxpayer money, but patients weren't told on their consent forms about the financial connection close quote." One of them was helping to develop an interleukin-2 treatment tested around the globe. The problem, as those reports noted, was that "quote hundreds, perhaps thousands, of patients in NIH experiments made decisions to participate in experiments that often carry risks without full knowledge about the researchers' financial interests close quote."

One of the two people running these experiments was a researcher named Dr. Anthony Fauci, who first rose to prominence a decade before in the AIDS crisis. Not only was the assertion about royalties true, it was also perfectly legal. Royalties for public service scientists were first allowed under the Bayh-Dole Act of 1980, which attempted to remedy two related problems: the lack of reimbursement for government-funded research and retaining top scientists who were being lured away from public work by the private sector.

This act and other federal regulations permitted the NIH, for instance, to collect proceeds if its research made money in the private sector and allowed individual government scientists to collect up to $150,000 a year in royalties on treatments they developed. At the time, Fauci said he tried to alert patients to his royalties, but his agency rebuffed him, arguing that he couldn't do so under the law.

The non-disclosure of the researchers' interest was changed after the scandal, but the damage had been done. In the minds of some elements of the public, there was something fishy going on between the government and the pharmaceutical industry, and it had something to do with money and a willingness to disregard or dilute informed consent. These suspicions heightened in the 2000s as key physicians began revealing to the public that Big Pharma had been involved in a number of major abuses of its relationships with government, patients, physicians, and journals.

One of the first to break this story was Marcia Angell, who had been editor of the "New England Journal of Medicine," arguably the most important medical journal in the United States at the time. In her 2004 book, "The Truth about Drug Companies: How They Deceive Us and What to Do About It," she argued that companies spent far more on marketing, administration, public relations, and rebranding than they did on research and that they actually discovered very few new effective drugs. Instead, they used "quote lures, bribes, and kickbacks close quote" to get drugs taken up by physicians.

Angell showed how these companies penetrated medical schools, conventions, and organizations, often passing off marketing as "quote education close quote," which they provided free of charge. More to the point, Angell argued that government agencies were highly compromised. She demonstrated how conflicts of interest permeated the U.S. Food and Drug Administration, which gave expedited reviews and approvals for drugs with major side effects, like heart attacks and stroke, such as Vioxx and Celebrex, and some with no serious benefit.

Angell also revealed that "quote many members of the FDA advisory committees were paid consultants for drug companies, although they were supposed to excuse themselves from decisions when they had a financial connection with the company that makes the drug in question. That rule is regularly waived close quote." She documented multiple instances of committee members discussing decisions on safety violations committed by the very companies that paid them from which they did not recuse themselves.

Angell's book, which was published to great acclaim, was impossible to dismiss as fringe. "Quote Dr. Angell's case is tough, persuasive, and troubling close quote," claimed the New York Times. Publisher's Weekly wrote "quote in what should serve as the 'Fast Food Nation' of the drug industry, Angell presents a searing indictment of Big Pharma as corrupt and corrupting close quote." Over the next few years, the kinds of abuses she documented made it to the courts. As these trials became public, Americans who suffered from serious side effects caused by the drugs involved took notice.

In 2012, physician Ben Goldacre of Oxford University published "Bad Pharma," in which he explored fraud settlements for pharmaceutical companies covering up known adverse events, including lethal ones, and hiding information, including about safety. The book's subtitle, "How Drug Companies Mislead Doctors and Harm Patients," was key. Physicians often didn't know the world was being pulled over their eyes or what had been kept from them. But when the practices of large pharmaceutical companies were examined in the courts with internal documents reviewed, one illegal activity after another was revealed.

Goldacre's list makes one shudder: "quote Pfizer was fined $2.3 billion for promoting the painkiller Bextra, later taken off the market over safety concerns at dangerously high doses, misbranding it with the intent to defraud or mislead close quote," the largest criminal fine ever imposed in the U.S. until it was beaten by GlaxoSmithKline. "In July 2012, GSK received a $3 billion fine for civil and criminal fraud after pleading guilty to a vast range of charges around unlawful promotion of prescription drugs and failure to report safety data close quote." "Quote Abbott was fined $1.5 billion in May 2012 over the illegal promotion of Depakote close quote," "quote Eli Lilly was fined $1.4 billion in 2009 close quote," "quote AstraZeneca was fined $520 million in 2010 close quote," "quote Merck was fined $1 billion in 2011 close quote."

After Goldacre's book was published, the fines kept coming. Johnson & Johnson was made to pay $2.2 billion in 2013, which included, according to the Justice Department, "quote criminal fines close quote" for having "quote jeopardized the health and safety of patients and damaged the public trust close quote." In 2019, the company was fined another $572 million for its role in the opioid epidemic and then fined a whopping $8 billion by a jury in a different case, an amount that will no doubt be reduced, but which signals public outrage at the violations.

These huge fines year after year involve popular drugs taken by tens of millions of patients with negative effects, including death. Stories of devastation have become lore in many families and communities. The circle of concern is even wider if you include those who may not have been personally affected but are aware of this problematic legal history. When you personally take a medication, you tend to notice news about it, especially bad news. Whether or not you've experienced any negative effects yourself, you are naturally alert to their existence. Each time a Big Pharma company is in the courts and in the media because of some problem, the seeds of skepticism are planted in the minds of many Americans, and not just skepticism of the companies themselves.

The transgressions mentioned above were only possible on such a scale because of a textbook case of regulatory capture, consisting of a mixture of perverse incentives and priorities, a tolerance for non-transparency, and in some cases, a culture of collusion. The FDA bills Big Pharma $800 million a year, which in turn helps pay FDA salaries. Regulators also often get jobs in the pharmaceutical industry shortly after leaving the FDA or similar bodies. There is a huge incentive to impress, and certainly not to cross a potential future employer.

It's useful to see how this works by examining a case that became famous as a tale of epic greed and corruption, and which patients and physicians were misled and deceived. Only after patients, families, activists, and even whole communities yelled themselves hoarse about it for years, in 1995 the FDA approved OxyContin for short-term serious pain, like terminal cancer or post-operative pain. This approval was based on legitimate scientific studies related to these narrow experiences. The FDA then made it available for minor pains with around-the-clock daily usage in 2001.

That approval for long-term use was not based on any studies. According to a 60 Minutes report in 2019, "quote equally suspicious but legal was the large number of key FDA regulators who went through the revolving door to jobs with drug manufacturers close quote." The opioid epidemic has to date left half a million Americans dead. This same compromised regulatory system allows Big Pharma to pay for and play a key role in performing the very studies that lead to the authorization of its own products.

For decades it was not just common for authors of studies to receive payments from the very companies making the medicines being tested, it was also systematically hidden. Drug companies secretly ghost-wrote studies of their own drugs. Goldacre shows how they conscripted academics to pretend they had authored them. The papers were then submitted to mainstream journals whose imprimatur would give the study’s credibility, allowing these drugs to become "quote the standard of practice."

16 of the 20 papers reporting on the clinical trials conducted on Vioxx, the anti-inflammatory and pain medication that got FDA approval in 1999, then was taken off the market in 2004 for causing heart attacks and strokes, were ghostwritten by Merck employees, then signed by respected scientists. Merck ultimately agreed to pay out $4.9 billion in Vioxx lawsuits. The academics who lent their names to the studies could then stuff their CVs with these articles, receive promotions, hire salaries within academia, and ultimately get more consulting fees from pharmaceutical companies, at which point they are seen as "quote experts close quote" by a trusting public.

In the current regulatory environment, companies run the studies of their own products. A Danish study found that 75% of drug company self-studies assessed were ghostwritten. A leading U.S. editor of a specialist journal estimated that 33 percent of articles submitted to his journal were ghostwritten by drug companies. These imposters don't get adequately investigated by Congress because the pharmaceutical and health industries are now the highest paying lobby in the country, having doled out at least $4.5 billion in the last two decades to politicians of both parties.

"Quote Pfizer's PAC has been the most active close quote," Stat reporter Lev Fetyur writes, "quote sending 548 checks to various lawmakers and other industry groups, more checks than the actual number of elected officials in the House and Senate close quote."

While Goldacre’s book shows the many ways that drug studies have been rigged to deliver certain outcomes, one doesn’t always have to rig a study to get the same result. Among the most common techniques is to delay the reporting of medication side effects until after the patent runs out, and then use the bad publicity to sell a new replacement medication, which is still on patent. Polls repeatedly show that the chief concern among the vaccine hesitant is about side effects or at least effects that don’t show up right away.

The latest edition of the standard textbook in the field, Plotkin’s Vaccine, has an excellent chapter on vaccine safety, which notes, "quote because reactions that are rare, delayed, or which occur in only certain subpopulations may not be detected before vaccines are licensed, post-licensure evaluation of vaccine safety is critical close quote." Post-licensure first requires FDA approval, so for most vaccines that means more follow-up after the typical two-year approval process—at least several years of it.

In 2018, the New York Times's pro-vaccine science writer Melinda Wenner Moyer noted with shock that she learned it was not uncommon among vaccine researchers to take the attitude that censoring bad news about their research was necessary, and that some who didn’t were ostracized by their peers. "Quote As a science journalist I've written several articles to quell vaccine angst and encourage immunization, but lately I've noticed that the cloud of fear surrounding vaccines is having another nefarious effect: it is eroding the integrity of vaccine science," she wrote. "In February, I was awarded a fellowship by the non-partisan Alicia Patterson Foundation to report on vaccines. Soon after, I found myself hitting a wall when I tried to report on unexpected or controversial aspects of vaccine efficacy or safety. Scientists often didn't want to talk with me. When I did get them on the phone, a worrying theme emerged: scientists are so terrified of the public's vaccine hesitancy that they are censoring themselves, playing down undesirable findings, and perhaps even avoiding undertaking studies that could show unwanted effects. Those who break these unwritten rules are criticized close quote."

Moyer went on to quote authorities who argue that smaller studies and even inconclusive ones often give us the first glimpse of an insight or problem, and this is to say nothing of the wider issue. If scientists play down their undesirable findings in potentially mandated medicines, as Moyer found them to be doing, they are not just missing opportunities for good science; they are potentially generating anti-scientific misinformation. "Quote Vaccine scientists will earn a lot more public trust and overcome a lot more unfounded fear if they choose transparency over censorship close quote," she wrote.

By the time Moyer published her article in 2018, many Americans were already long in the habit of questioning certain elements of their public health— in part because of this hornet's nest of corruption and regulatory capture. But this habit could also be explained in part by the general trend in medicine over the past two decades towards recognizing the superiority of individually tailored interventions, or personalized medicine, which acknowledges that different people have different risk factors, genetics, medical histories, and reactions to medical products.

It is now commonplace for people to take responsibility for their own health because this is precisely what we have been telling them to do, encouraging them to get to know their own unique risk factors for disease based on their own individual histories and genetics. Vaccines, in contrast, are a one-size-fits-all intervention administered en masse by those who know nothing specific about the vaccinees or their children. And when political and medical authorities change policies from day to day and public health recommendations in one jurisdiction or country differ from those in others, questions will be asked.

The public has been assured that we in healthcare recognize that the era of medical authoritarianism and the ugly practices that led us to require informed consent are behind us. This means that whenever there is a treatment on hand, the burden of proof to demonstrate that it is safe and effective must fall on those who offer it. It means we must never stifle questions or shame people for being anxious. I am a psychiatrist and a psychoanalyst, and I deal with people's anxieties and their paranoia too. Too many people think the anxious are necessarily weak. One medical colleague calls the vaccine hesitant "wimps."

But this is, if not entirely wrong, a superficial way of understanding anxiety. Anxiety is a signal. It evolved to get us to pay attention to something—not always an external threat and sometimes an internal one, such as an ignored feeling or forbidden thought threatening to emerge from within. Anxiety can be neurotic; it can even be psychotic. It can also save your life because dangers do exist. When people don't experience enough anxiety, we say they're in denial. Thus, in some situations, the capacity to feel anxiety can be an advantage, which is likely why it's preserved in evolution in so many animals.

Aristotle understood this very point long ago, as he noted that the courageous person, say a soldier, can and should feel anxious—he is facing danger after all, and his wisdom tells him there is risk. What distinguishes the courageous person from the coward is not that they don’t worry or fear, but they can still manage to move forward into the dangerous situation they cannot avoid facing. All of which is to say that the presence of anxiety alone is not dispositive of sanity or insanity. It alone does not tell you whether the anxiety is well or ill-founded. The same goes with distrust; sometimes distrust is paranoia, and sometimes it's healthy skepticism.

As of a September 2019 Gallup poll, only a few months before the COVID-19 pandemic, Big Pharma was the least trusted of America's top 25 industry sectors—number 25 of 25. In the eyes of ordinary Americans, it had both the highest negatives and the lowest positives of all industries. At number 24 was the federal government, and at number 23 was the healthcare industry. These three industries form a neat troika, though at number 22 was the advertising and public relations industry, which facilitates the work of the other three.

Those inside the troika often characterize the vaccine hesitant as broadly fringe and paranoid, but there are plenty of industries and sectors that Americans do trust. Of the top 25 industry sectors, 21 enjoy net positive views from American voters; only Pharma, government, healthcare, and PR are seen as net negative—precisely the sectors involved in the rollout of the COVID vaccines. This set the conditions in a way for a perfect storm.

Chapter 3: A New Plague Descends

In February and March 2020, it became clear that the disaster that had swept through Wuhan was becoming catastrophic in Bergamo, as frontline healthcare workers were dying. In both China and Italy, the virus had also spread throughout Western Europe and arrived in North America. Early reports of the case fatality rate reached over 14.5 percent in Italy in the spring, and in Spain, Sweden, and other hot spots it was over 11 percent, devouring the elderly in every affected country. PPE often didn’t exist for frontline healthcare workers; bodies were stored in refrigerated trucks.

Citizens were told masks would not protect them and that there were no known outpatient treatments. While hospitals could provide oxygen, this was often insufficient, and so victims were put on ventilators, which may have made some cases worse and was a horrible way to die. While much of the United States was terrified, there was some light. Dr. Anthony Fauci, the physician-scientist now running the country's pandemic defense, seemed able to answer most press questions, projected an affable, avuncular persona, and spoke in ways people could understand—which is what the nation required.

Even skeptics had hopes; Fauci seemed steady when events took unexpected turns, explaining that we were learning as we went along. He said the lockdown would be for 15 days to flatten the curve. When that didn't work, he explained why, argued that it should be extended, and much of the nation went along.

In the United States, exhausted by its hyperpolarized political scene, here was someone who had worked with both parties advising every president since Ronald Reagan. For those on the right, he could be seen as an employee of and messenger for President Donald Trump; for those on the left, he was a long-time public servant who had headed the same institution, the National Institute of Allergy and Infectious Disease (NIAID), since 1984 and played vital roles in the fights against AIDS and Ebola.

There was a widespread sense that Fauci was the right man at the right time. But then there were flip-flops on masks. After claiming the science showed that masks were unnecessary, Fauci later said they were absolutely necessary but wouldn't be for the vaccinated, until eventually they were. There were also disputes about lockdowns. Initially introduced as temporary to flatten the curve, they were later extended to become a new way of life in order to save lives.

But then some states like Florida, which didn’t impose long and severe lockdowns, had lower age-adjusted mortality than states like New York, which did. Then another issue emerged that was not simply scientific but also political. Since the earliest days of the pandemic, many regular people struggled to make sense of its origins. The Chinese Communist Party had claimed the virus emerged from a wet market while denying any connection to virology labs located nearby.

There was obviously a cover-up unfolding in China, with arrests of citizen journalists and detentions and disappearances of Wuhan physicians who witnessed the first cases and who would have had ideas about where it started. Various observers argued that there was reason to consider that COVID may have leaked from the Wuhan Institute of Virology and perhaps even may have been engineered by gain-of-function (GOF) research, in which a natural virus is made more contagious and lethal, ostensibly to see if the scientists can get ahead of nature and to study it—how it operates, in order to make new vaccines or medications or for biological warfare.

GOF is so controversial that in 2014, President Barack Obama put a moratorium on it. In 2017, Drs. Fauci and Francis Collins, then Director of the NIH, who had opposed the moratorium, succeeded in having it lifted. But Fauci asserted that the scientists who were in a position to judge the COVID situation concluded its origin was natural. The media followed suit and called those who thought otherwise conspiracy theorists.

The New York Times, the Washington Post, and others called the possibility of a lab leak a conspiracy theory that had been debunked. In the meantime, a master narrative began to emerge: once upon a time, life was relatively normal and safe, and then the pandemic came and life as we knew it suddenly changed in awful ways. The only way out—the only path back to a world without COVID—would be to make a vaccine as quickly as possible.

Until then, everyone would have to do their part to stop the spread, which meant that basic social functions would have to cease, including school for millions of children. Thousands of small businesses would have to close and civil liberties rolled back. It would be a difficult time, but eventually, we would have the vaccine, and COVID would be over, as long as everyone got it. Of course, but then who wouldn’t want to?

On this point, Bill Gates of GAVI, the Vaccine Alliance, and the largest private contributor to the WHO, was very direct: "quote The ultimate solution, the only thing that really lets us go back completely to normal and feel good is to create a vaccine close quote," he said. If you asked researchers or most physicians in the spring of 2020 how long it normally takes to produce a vaccine safe enough to administer to patients, many would have pointed out that the average fast vaccine takes seven to ten years and that the first vaccine might just be one of several required to end a given crisis because often the first is not the best.

This seemed too long. Gates predicted that there would be problems moving quickly because companies would have to produce a one-size-fits-all vaccine that could have different effects on different groups, including pregnant women, the undernourished, and people with existing comorbidities. "Quote People like myself and Fauci," Gates said, "are saying 18 months to make the vaccine if everything went perfectly. There will be a trade-off; we'll have less safety testing than we typically would have. We just don't have the time to do what we normally do close quote. The solution, he noted, was that "quote governments will have to be involved because there will be some risk and indemnification needed close quote."

In August, that solution was reached. As "The Intercept" reported on August 28th, "quote an amendment to the PREP Act stipulates that companies 'quote cannot be sued for money damages in court close quote over injuries caused by medical countermeasures for COVID. Such countermeasures include vaccines, therapeutics, and respiratory devices close quote." The only exception to this immunity would be if death or serious physical injury is caused by willful misconduct.

Indemnification for vaccines was, as discussed above, not unique. What was new was that the companies producing them were indemnified before the vaccine was even made and fully assessed, knowing it would all be done faster than ever before. As the nation agonized over mounting deaths, the race for a vaccine was moving quickly, if too opaquely for some.

In September 2020, a number of scientists began openly worrying about the non-transparency of the vaccine trials and whether this could wind up affecting vaccine hesitancy. The New York Times ran several articles on this, reporting that AstraZeneca, Pfizer, and Moderna had each withheld their study protocols from outside scientists and the public. Withholding protocols guarantees that outside researchers can't know how participants are selected or monitored and how effectiveness or safety are defined—so that they can't really know what exactly is being studied.

Pharma companies have traditionally argued that not only the trial patients but the clinical trial data belong to them, that it's proprietary, even though the study's results impact millions. This is part of a kind of traditional secrecy in the field. Delaying protocol release conveniently means that it is a company's press releases—not the verified science—that dominate the public's all-important initial impression of its product.

That the government regulatory agencies go along with all this—indeed, it is, in fact, standard practice—doesn't assuage the public. For many, it makes the whole process appear corrupt, and it doesn't help that according to the conflict of interest disclosures of the authors of the Pfizer and Moderna vaccine clinical trials, some of the authors are employed by these companies and often have stock options. The essence of the scientific method is conducting experiments that everyone can objectively see and verify. Transparency is the bedrock of experimental science and the means to ultimately dispel doubt.

Moreover, in terms of the scale of public involvement, the experience of the summer and fall of 2020 was unlike any other in the history of medicine. Never before had studies of this size and consequence been run so quickly or a medicine produced so quickly to be given to hundreds of millions of people. These studies were called phase 3 clinical trials, and if they had positive results, then the vaccine could be given to hundreds of millions of people on the basis of an FDA emergency use authorization.

But how long were the patients followed in these two studies after their second dose to assess safety and efficacy? Two months. On that basis, the vaccines were given to over a hundred million people. One must not confuse the perhaps immaterial fact that the vaccines were made quickly with the arguably more important fact that they were tested on people for only a short time. These vaccines were developed so quickly in part because the new mRNA technology allows quicker production and because parts of the production lines that in the past were staged out over time were in this case set up simultaneously with the help of huge cash infusions.

All else being equal, there's a serious argument that it might be hugely advantageous to be able to produce new vaccines so quickly. "Quote If you can intervene with, let's say, a forty percent effective vaccine four months before you can intervene with an eighty percent effective vaccine, you save more lives with the forty percent effective vaccine that's delivered four months earlier close quote," Barney Graham of the National Institutes of Health pointed out. "Quote Being fast in an outbreak setting, in some ways, is more important than being perfect close quote."

Still, it was obvious as early as the fall that some testing steps would be skipped. "Quote we'll have less safety testing than we typically would have close quote," Gates noted, "quote we just don't have the time close quote. Must that be a problem? Why, especially during a pandemic, wouldn't we want to quickly distribute any vaccine that appears to work, even somewhat effectively, to those who are willing to take on any potential risks that may go with less safety testing?

Some people might even decide for themselves that a raging pandemic is a dangerous enough threat to outweigh every other possible concern. But what we shouldn't do, if we want to maintain public trust and cohesion, is act as though there is no chance that any legitimate concern could ever possibly emerge or that we know more than we really do after only two months of study with complex biological systems. We simply can't presume that just because we have a fantastic idea for a treatment, the safety we hope for and see at the start will necessarily hold over time.

Take the classic example of thalidomide. It was originally a sedative used for anxiety and later tried for nausea. It worked, leading some to theorize that it could prevent nausea in pregnant mothers. In practice, once on the market, it did. But it also caused serious birth defects in children. It took longer than nine months and enough cases to realize that these side effects came from the drug and even more time to overcome the drug companies' opposition to the facts.

The same applies to any of the major drugs pulled off the market for causing cancer, heart attacks, and diabetes; they don't always cause dire consequences immediately or in everyone. Sometimes these drugs set a process in motion immediately, but it takes scientists a year or many years to pick up the trend in the population at large. Working from first scientific principles, and based on what we already know, we can often develop a neat theory about what might work. But because we don't know what we don't know, it often doesn't turn out as we expect. That is why empirical science developed as a way to test our theories; empirical science is always, by definition, science after the fact.

This is especially important given the specific kind of vaccine that was being approved in the United States, the mRNA vaccine—which was a first of its kind. Instead of exposing a person to the virus itself in attenuated live form, like the MMR or killed form like the polio shot or flu shot— which is how many of the other vaccines we've come to know work—in the mRNA vaccine, a person is exposed to an artificially made genetic messenger mRNA that goes into their cells and directs them to make part of the virus, which then triggers antibodies.

Early on in the rollout, both the pharma PR industry and the press emphasized how novel these vaccines were and how this unique technique would produce a vaccine so quickly. But when some side effects started to emerge and people got nervous, officials and the company’s own PR teams changed their message. These techniques were now presented as not new at all but as having been around a long time. The hesitant notice flip-flops in communication like this.

At best, it makes them wonder about the lasting veracity of public health messages. At worst, it makes them deeply suspicious. Over the course of the summer of 2020, while the clinical trials were ongoing, outside scientists still had no access to what exactly was being measured and hence studied, so there was no external check on or observation of the process, despite much of the research having been funded by government.

Marketing and distribution would be done by the government. The government would be providing the customers, and the government would even pay for the consequences of safety problems that might arise. Withholding protocols rather than disseminating them as widely as possible was, under such circumstances, a sign of outlandishness, and the governmental agencies that are supposed to advocate for the public—in this case, the FDA, CDC, and NIH—countenanced it.

In September 2020, one bit of secrecy was lifted. It turned out that AstraZeneca had stopped its clinical trial twice. The first pause was not even announced; the second one was, but neither the UK public nor the FDA nor scientists were immediately told why. Before they ever found out, however, AstraZeneca CEO Pasqual Soriat did privately disclose the reason—two cases of serious neurological damage—to the J.P. Morgan investment bank.

To some, this said much about who exactly this process was designed to benefit. "Quote The communication has been horrible and unacceptable close quote," vaccine advocate virologist Peter Hotez said. "Quote This is not how the American people should be hearing about this close quote." Scientists started to demand to see the protocols. Hotez and others "quote criticized obtuse statements released by government officials, including UK regulators, who he said failed to supply a rationale for resuming their trials close quote."

Government officials and the regulators who most citizens assume are there to keep the process honest seemed instead to be partners in the obfuscation. In November 2020, the exciting news arrived—we had vaccine liftoff! Phase 3 trials of the Pfizer and Moderna vaccines were said to be 95 and 94.5 percent efficacious, as Fauci and the company press releases announced, and the emergency use authorization was granted on the basis of these two-month studies, allowing distribution of the vaccines to millions.

"Efficacious" is the term used to describe how effective a treatment is in the artificial situation of a clinical trial with volunteer patients—a group not always representative of the wider population. "Effective" is the term used to describe how a treatment works in the real world. The media quickly assumed the two were the same. To them, hearing that a vaccine was 95% efficacious meant it was practically perfect, which the press repeated over and over. But what exactly were the vaccines efficacious at doing? Stopping viral transmission? Preventing severe illness? Or reducing hospitalization or ICU admissions? Preventing death? Efficacious for how long? And efficacious in whom? In the elderly, who were most vulnerable to death?

Without clear definitions and answers to these questions typical of much of the coverage, Americans only had a limited idea, really, of what these vaccines had been shown to do in the narrow universe of clinical trials—let alone what they do when given to the public. In fact, they didn’t receive answers to a single one of these questions. Moreover, there was still a cloud of mystery surrounding the trials.

After pressure mounted in the wake of the AstraZeneca revelation in September, the four major Western vaccine manufacturers finally released their protocols—each over a hundred pages long. After the protocols were released, Peter Doshi, an associate editor at the British Medical Journal, who does research into drug approval processes and how results are communicated to the public, tried to sound an alarm: "Quote None of the trials currently underway are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths close quote," he said.

Only one of the studies of the Oxford AstraZeneca looked at whether vaccinated individuals were less likely to transmit the virus by doing weekly PCR swabbing. Vaccinated people had lower viral loads, were less likely to have a positive COVID test, and were positive for shorter durations—very good news indeed, though not automatically applicable to the other mRNA vaccine studies.

So what were these clinical trial studies that showed 95% and 94.5% efficacy looking at if not saving lives and viral transmission? Consider that researchers can set up a study to examine whether a vaccine prevents a person from experiencing any or all of the following events, sometimes called endpoints: an asymptomatic infection—the patient is carrying the virus but the case is so mild that they don’t know it, even though it is shown to be present by a positive virus test; a clinically symptomatic infection that is mild and might be confused with a common cold; a clinically symptomatic infection that is moderate; a clinically symptomatic infection that requires hospital admission; a clinically symptomatic severe infection requiring ICU admission; and even a ventilator; a clinically symptomatic severe infection that ends in death.

What were the events, or the endpoints, that the Phase 3 Moderna and Pfizer studies claimed to be examining? They said they looked at any clinically significant infection "quote of essentially any severity close quote" as the primary endpoint, but therein lies the rub. As Doshi explained, "quote severe illness requiring hospital admission, which happens in only a small fraction of symptomatic COVID-19 cases, would be unlikely to occur in significant numbers in trials because most people with symptomatic COVID-19 experience only mild symptoms close quote."

How few serious cases in terms of deaths were there in the Pfizer trial? Not a single person died of COVID-19 in either the vaccine or the placebo group. The report that Moderna gave to the FDA on December 17, 2020, specifically said it considered death "quote a secondary endpoint close quote," and added that "quote there were no deaths due to COVID-19 at the time of the interim analysis to enable an assessment of vaccine efficacy against death due to COVID-19 close quote." By publication date, one person had died in the placebo group.

Go over that again! In the study period for the two new mRNA vaccines, only one person out of seventy thousand died a COVID death. Now, ask yourself, without knowing the demographic markers of the trial participants but knowing for a fact that hundreds of thousands of people were dying from the virus, does this seem to you like an appropriate way to study severe illness? Moderna told the British Medical Journal in August 2020, "quote you would need a trial that is either five or ten times larger or you'd need a trial that is five to ten times longer to collect those events close quote."

In a talk based on her Lancet article given to the British Medical Journal's COVID-19 known unknowns vaccines webinar in February 2021, Dr. Suzanne Hodgson, National Institute for Health Research academic lecturer in infectious diseases at the University of Oxford, stated, "quote The current RCTs, randomized control trials, that are ongoing are not powered to assess efficacy against hospital admission and death close quote."

In the same seminar, Doshi presented on the transparency issue, having read the protocols and then the Phase III trial studies of the Pfizer, Moderna, AstraZeneca, and Sputnik Russian vaccines. He wanted to check the raw data from the studies in order to verify it. That is, he wanted to see not just the final charts, tables, averages, percentages and conclusions, but to look over the individual cases. Most of the studies had a line in them that claimed such data was available upon request.

According to Doshi, he wrote to the drug companies that had authored the studies and asked to see it, but he wasn't permitted. "Quote each time a trial is published, there is this data sharing statement, and everything sounds good until you read the fine print close quote," he said. "Quote Pfizer, for example, says that it is sharing data upon request. I asked the same for Moderna, the same for Oxford AstraZeneca, and the Russian vaccine. They all said they will be sharing the data—just not yet—and most are tying the data release to the end of the trials. So we have a situation where the vaccines are being administered to the masses but the data isn't being shared because the sponsors say the trials are ongoing close quote."

Pfizer data, he learned, might arrive in January 2025. Moderna said it may be available once the trial is complete—sometime in 2022. Other companies were similarly vague. To date, approximately 4 billion people have already gotten these vaccines—many receiving a first-of-its-kind mRNA genetic formulation—without outside sources reviewing the raw study data. Given that the companies won't release this data in a timely manner, it is reasonable to assume that public health officials in different countries that approved the vaccines have not seen the raw data either or run verification checks.

Given all this, it is difficult to assuage those who distrust the systems that delivered the vaccines. At least one of these vaccines, the Moderna, was supported by the NIH and NIAID, which may have joint ownership in intellectual property that undergirds the vaccine. That means their budgets stand to benefit from sales, and individual government employees may get royalties for them. Though it would fall to the FDA to officially approve the vaccines, the advice to enact vaccine mandates would come from a small network and would be based on studies that were authored, in some instances, by people who are employees of the companies themselves and which were testing their own products.

And when a remarkably trusting public and a few scientists requested to look at the raw data, they got stiffed. One can only imagine how enriched our knowledge would be if it were otherwise. If, to take just one example, the raw data were available and verified by the hive mind of world scientists who drilled down could see for whom the vaccine was most effective and who was most at risk of serious side effects in order to follow them longer than two months and to protect those groups of people in the future, the confidence this would have inspired in a vaccine produced so quickly might have been astonishing—a miracle not only of human scientific advancement but of the human capacity for persuasive communication and the social progress it can generate.

Alas, that's not what we got. The train was already barreling out of the station when the first vaccines were rolled out in December 2020. Fauci received his Moderna shot, announcing that he wanted to get publicly vaccinated as a symbol "quote for everyone in the country." "Quote I feel extreme confidence in the safety and the efficacy of this vaccine close quote," he said.

As to the question of how sick the patients in the study were, he said with regard to Pfizer, it was 95 percent efficacious not only against disease that is just clinically recognizable but severe disease close quote. And he said much the same was found for the Moderna vaccine. By the spring of 2020, the master narrative—the necessity of using one main tool, the vaccine, to vanquish the enemy—was working brilliantly. Government data from Israel and the UK showed that the vaccines weren’t just efficacious in clinical trials but also effective in the real world.

An April 28th article in the Harvard Gazette was titled "Vaccines Can Get Us to Herd Immunity," despite the variants. Dr. Uğur Şahin, the chief executive of BioNTech, which developed the mRNA vaccine for Pfizer, was quoted, saying that Europe would reach herd immunity in July or August. The virus would no longer be able to spread in the UK, "freedom day" was set for June 21st, later changed to July 19th, and the return to normal in other vaccinated countries seemed not far behind.

On April 22, Israel, considered the world’s most vaccinated country, except for some tinier nations, for the first time recorded no daily COVID deaths. Pfizer's CEO, who called Israel "quote the world's lab close quote” not only because it was highly vaccinated but because it was vaccinated early—giving the world a glimpse of its future—announced in February that the experiment was going marvelously, saying, "quote the current data shows that after six months the projection is robust close quote" and "quote there are a lot of indicators right now that are telling us there is a protection against the transmission of the disease close quote."

The UK, the second-most vaccinated large nation, had a terrible death count in January, but on May 10th, there was not a single COVID death in all of England, Northern Ireland, and Scotland. President Biden assured the American people confidently, "quote if you're vaccinated, you're protected; if you're unvaccinated, you're not close quote," reiterating that being vaccinated "quote is a patriotic thing to do close quote." This was a riff on CDC Director Rochelle Walensky's statement, "quote if you have two doses of the vaccine of the mRNA vaccines, you're protected. You don't need to wait for a booster; you're protected close quote."

Over the spring, Walensky became an increasingly prominent face in the months since Biden was inaugurated. A slew of officials who had advised the Trump administration were out of the picture: Dr. Robert Redfield as head of the CDC, Dr. Deborah Birx, and Dr. Scott Atlas, and a new cohort was ushered in. More and more, Walensky became a visible voice of public health.

In April, during a White House press briefing, barely four months after distribution of the first vaccine doses began, Walensky announced that the "quote CDC recommends that pregnant people receive the COVID-19 vaccine close quote." But if you checked the CDC website that day, as many pregnant women and their physicians, of course, did, you would have found something different: "quote If you are pregnant, you may choose to receive a COVID-19 vaccine, but quote there are currently limited data on the safety of COVID-19 vaccines in pregnant people close quote."

In the press briefing, Walensky had cited a study from the "New England Journal of Medicine," about which she said, "quote no safety concerns were observed for people vaccinated in the third trimester or safety concerns for their babies close quote." The study did claim that there was no increased incidence of fetal death or neonatal death, which was very reassuring, but it was unable to answer one of the main questions many pregnant women are concerned about: "Will these new vaccines have adverse effects on my baby's development after birth?"

The study's authors made clear that they didn't have enough longitudinal data on women in the first or second trimester of pregnancy to draw conclusions about women vaccinated in those two trimesters when different organ systems develop, and that their study was therefore "quote preliminary." "Preliminary findings did not show obvious safety signals among pregnant persons who received RNA COVID-19 vaccines; however, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes."

Recall that the vaccine rollout began in December 2020. For older people, this study only looked at safety data on women in various stages of pregnancy from December 14, 2020, to February 28, 2021—a two-and-a-half-month period. Many women become more vigilant in pregnancy about what they eat and what they put into their bodies, so it should come as no surprise that more than one woman who was either pregnant or trying to conceive began wondering about a question that one of my colleagues asked me: "If at the time of the study the vaccine had only been available for two and a half months, wouldn't that mean if it's still true that human gestation is approximately nine months, that literally no one who had been vaccinated early in pregnancy had yet followed through to a full-term pregnancy?"

None of this is to insinuate an opinion about the use of vaccines in pregnancy. We are here discussing how simplifications of what scientific studies actually show at a particular moment, even when they turn out ultimately to be right, can generate distrust. I would venture that what young families wanted to hear was something both reassuring and reflective of whatever trustworthy data was available to date, like "We are working on a longer study and feel hopeful about it, but for now we at least know if vaccinated in the third trimester there is little chance the vaccine will lead to a death."

That, I believe, would have quelled anxiety. But the government and its messaging partners chose a different posture—one that suggested certainty when important data was still yet to come. A lesson in human nature: when public health officials distrust the public, the public will come to distrust them.

Take, for example, an article by Kimberly Atkins Stowe, Senior Opinion Writer and columnist for the Boston Globe, who got the Johnson & Johnson vaccine in April, a week before the FDA put a pause on it because of blood clot complications. As Atkins indicates, the FDA admitting that there might be a problem, as opposed to hiding it, made her more—not less—likely to believe that the institution is on top of monitoring the vaccines. "Quote I want others to view this pause not as a reason to doubt the drug but a reason to believe in it close quote," she writes.

The mainstream media in the United States also often downplayed potential problems and even demonized those who took them seriously, portraying white, Christian Republicans as the