"Fluvoxamine is a “repurposed drug,” and comes from what might seem like a most unlikely source – psychiatry. It is an antidepressant used most commonly to treat obsessive-compulsive disorder. The drug has had two randomized control trials, or RCTs (the highest level of evidence) and four observational studies showing it keeps people with COVID out of hospital, from requiring intubation, and helps prevent death. The discovery of its anti-COVID properties came after impressive sleuthing in France and the United States. Then a partnership co-led by a team of Canadians conducted the large randomized trial that proved what it could do...
Consider how things appeared in April, 2020, when Bill Gates, whose foundation is the largest private contributor to the World Health Organization, said: “The ultimate solution, the only thing that really lets us go back completely to normal and feel good … is to create a vaccine.” His “only” meant, that in practice, our chief hope and focus – in research, policy, in the media, and even emotionally, for many – became the vaccines. Mr. Gates articulated what became our master narrative: Public health would stop the spread with extemporizing measures such as lockdowns, discouraging social functions and travel, and closing schools and businesses until the vaccines arrived, all of which would protect us until we achieved vaccine-induced herd immunity everywhere, which, we were told, would eliminate the virus. We put our faith in the vaccines, while other approaches – such as drugs for early treatment, or a role for our natural immunity, or lowering our personal risk factors, for instance – got comparatively less attention.
Key individuals predicted – half promised, really – we’d be done with COVID, at least in the West, by the summer of 2021. In February, 2021, Pfizer’s CEO, Albert Bourla, said the vaccine was still offering strong protection at the six-month mark and “indicators right now … are telling us that there is a protection against the transmission of the disease.” That April, Dr. Ugur Sahin, the CEO of BioNTech (which developed the vaccine for Pfizer), told reporters, “Europe will reach herd immunity in July, latest by August.” It wasn’t a tough sell. Who would not want it to be true? Having no pandemic experience, we took them at their word. Politicians fostered the idea that our proper aim for handling COVID would be to “eliminate it everywhere,” as Prime Minister Justin Trudeau said. Early treatment doesn’t promise that, though it might lower death rates. Eradication had more psychological appeal: let’s get it out of our lives forever.
Yet, in dismal December, 2021, two years in, with cases soon to reach record highs, and another lockdown looming and vaccines waning, it wasn’t working out that way. Perhaps if we hadn’t been so focused on one tool things might have gone differently. And perhaps if certain voices hadn’t been silenced, and others handed a megaphone, our pandemic tool kit, and mindset, would have been different too.
Early in the pandemic, at the Sainte-Anne site of the Parisian mental hospital, Psychiatrie & Neurosciences, something mysterious occurred. The staff started contracting COVID in high numbers, but their patients, gravely mentally ill, did not. Three staff got COVID for every patient, despite the patients having more risk factors, such as being overweight, or having cardiovascular disease.
Someone wondered, could it be that the patients’ psychiatric medications were protecting them?...
Repurposed drugs have a track record, and thus often a safety advantage. And the generic ones are cheap. Fluvoxamine costs about $15 for a course of treatment. Repurposed drugs are used by poorer countries that can’t afford vaccines or expensive early treatment drugs such as Paxlovid ($500) or Molnupiravir (US$700 and not yet approved in Canada).
So why hasn’t treatment focused more on repurposed drugs?
First, because the master narrative, once it took hold, directed our attention away from this possibility. Second, in North America, the first repurposed drug that came to public attention was hydroxychloroquine. When it was endorsed by then-president Donald Trump it became highly politicized. People’s opinions about it often had more to do with their political affiliation than whether they had read any of the (now) 303 studies. Third, agencies that regulate drugs, such as the U.S. Food and Drug Administration and Health Canada, mandate that any drug they evaluate have a sponsor, usually a drug company agreeing to assume liabilities for the drug. It’s an extremely expensive process. If an old, cheap generic drug shows promise for repurposing, it still needs independent studies before a health body will recommend it for that. Drug companies have no financial incentive to apply for a formal approval for a new use and the drugs may languish.
Of all the reasons that we didn’t focus on repurposed drugs, I would argue, the master narrative was the most important, because of the way it organized so many people’s thoughts, attention and emotions.
The narrative would not have been nearly as problematic had it not been so tied into something else: the military metaphor that has defined our COVID experience from the beginning. This master narrative was our battle plan and this was a “war” to eradicate the enemy virus.
This military metaphor seems second nature in medicine. We are always in a “war against cancer,” or “combatting” heart disease, Alzheimer’s, and AIDS. But this way of thinking only became common in medicine several hundred years ago, after the philosopher Francis Bacon argued the goal of science should change from what it had been – “the study of nature” – to the very practical “conquest of nature.” Soon physicians were speaking of “conquering” disease, with “magic bullets.” We increasingly left behind the original Hippocratic mindset of medicine as an extension of nature, which involved working with it, as an ally, wherever possible – not to conquer, but to heal, often with the help of the patient’s own healing capacities...
Reappraisal of any prevailing narrative requires taking in new insights, which, by definition, arise from a minority viewpoint. When a military metaphor sweeps through a society or a bureaucracy beset by fear, all-or-nothing, you-are-with-us-or-against-us thinking follows. We become more prone to see someone who doesn’t go along with the majority view – including scientists who spot problems with the reigning narrative – as putting the rest of us at risk, and a “traitor,” rather than as someone doing their job. They are attacked, censored or self-censor to survive. In war, you shut up and follow orders, or get court-martialed.
We are especially suspicious of other people during contagion, because our brains are fired up by a primitive circuit that protects us by making us obsessively preoccupied with the purity of those around us. Will this person get me sick? It even fires if we think their actions, or even policy proposals might be risky. The circuit, called the behavioural immune response, causes us to fear, loathe and feel rage toward the “impure” germ bearer. It results in many false alarms (think of someone driving alone with a mask on). It’s one reason debates about vaccines are emotionally radioactive. Some vaccinated people feel all the unvaccinated bear germs, while some unvaccinated people feel vaccine may put germs or toxins in their bodies.
This past summer, as news broke that there were breakthrough infections and vaccine protection against infection was waning, the North American media began to advise us to lower our expectations for them: “Vaccines Can Only Do So Much,” read a headline in The Washington Post. Many readers were caught completely off guard. In part they were surprised, because the censorship of scientists who held dissenting views – and had been warning this might happen – was much more widespread than many are aware of.
According to an Amnesty International report published in October, censorship and harassment of health professionals, and others, has been a problem “across the world,” during the pandemic. Most singled out are those who express critical opinions of their governments’ policies (e.g. restrictions of movement, lockdown, or criticisms of government dispensing with civil liberties).
The censors justified these actions as simply banning “misinformation” and “prevent[ing] panic.” In North America people were not imprisoned, but many brilliant scientists and physicians with proper credentials from places such as Harvard, Oxford and Stanford, were under fire. Physicians were vilified for questioning government policies on lockdowns, masks, aspects of vaccines, mitigation or unproven treatments – the very things that were, of course, the subject of serious continuing scientific debate. In some jurisdictions in North America physicians are threatened by their regulating boards with suspension or revocation of their medical licenses for spreading “misinformation,” forcing some doctors to have to choose between what they – rightly or wrongly – see as their patient’s best interests, and their own livelihood. But as the Amnesty report states, “Winning the battle against the virus includes not just government led actions and top-down diktats, but also bottom-up approaches which can only come about if the rights to freedom of expression and access to information are fully enabled.”
There were “snake oil” claims on the internet, yes, but generally when scientists and health care workers were party to these quarrels, it was because there was a scientific debate. In such a case, to accuse one’s opponent of spreading “misinformation” is to pre-emptively ascribe to oneself an unjustified certainty – and to one’s opponent bad faith. At times no one really knew what was more harmful – e.g. keeping children out of school, or sending them in. There was incorrect information aplenty in our novel situation, and that included some spread by officials who flip-flopped multiple times on masks, or who, claiming to “follow the science,” differed with officials in similar jurisdictions, based on changing data.
This, in medicine, is called the problem of “medical reversal.” An approach thought to be helpful is proven to be harmful, and vice versa. Sometimes two studies can contradict each other even on the same day. Physician-scientist Vinayak Prasad, of UC San Francisco, argues it is the most important problem facing medicine today. The problem of medical reversals didn’t disappear the day the virus landed on our shores. We had not only a virus problem, but a medical reversal problem.
The medical boards were in an unusual situation, torn between once-cherished traditions of scientific debate, and the atmosphere of crisis and their wish to do their part in “the war.” After all, it is vital that public health, and its officials, in a crisis, be able to convey consistent messages as they ask citizens to change their behaviours, and undergo various privations. But if those messages are to be persuasive, and the requests for such privations scientifically arguable and legitimate, the actions must be based on a full, open, unhampered scientific process solid enough to withstand scientific criticism and debate. Why else should the public go along? Censorship, by giving the public the false impression there are no medical controversies, undermines the censor’s own claim to speak in the name of science and public safety. Ironically, it guarantees the public will be left misinformed.
The authors of the master narrative tend to say the main reason that things have not gone as they predicted is because variants arose. But if anything could have been predicted, it is that viruses mutate. Columbia virologist Vincent Racaniello described how fellow scientists were worried that the new mRNA technology, by focusing on only a small portion of the virus, the spike protein, would make it easy for the virus to “get around” or escape the vaccine through mutations. “That’s partly why,” he said in May, “all the variants are arising now, because we have only the spike epitopes in there.” That view didn’t get much of a hearing...
In December, 2020, the new mRNA vaccines were rolled out, and were, according to the randomized clinical trials, 95 per cent (Pfizer) and 94.5 per cent (Moderna) efficacious in stopping infection. Physician-scientist Eric Topol, head of Scripps Labs, said these vaccines “will go down in history as one of science and medical research’s greatest achievements.”
But by the time summer 2021 arrived, real world experience contradicted Mr. Bourla’s and Dr. Sahin’s claims of potency at six months, no transmission by the vaccinated, and imminent herd immunity. Pfizer’s Mr. Bourla, in his February interview, had called Israel “the world’s lab,” because it was vaccinated with the Pfizer extensively and several months ahead of other countries, giving the world a glimpse of its future. But when Israeli public health released its six-month data, they showed that vaccine effectiveness had dropped to 39 per cent, and Delta was surging. (The FDA had originally said it would not approve a vaccine less than 50-per-cent effective.) A Mayo clinic study showed that after six months, protection granted by the two Pfizer doses dropped from the original 95 per cent to 42 per cent. Another Israeli study showed it had dropped to 16 per cent. That huge discrepancy couldn’t be attributed just to the new variant, Delta, because protection was already fading at five months for the earlier variants too.
So why such a discrepancy? The original studies were clinical trials. The Pfizer study followed about 38,000 people without COVID who were divided in two groups – half got the vaccine, and half a placebo. The investigators asked the question: could the vaccines prevent symptomatic cases of COVID-19? But, as Peter Doshi, senior editor at the British Medical Journal, warned, “None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths.” He explained that, “Because most people with symptomatic COVID-19 experience only mild symptoms, even trials involving 30,000 or more patients would turn up relatively few cases of severe disease.” Susanne Hodgson of the University of Oxford agreed: “The current [randomized control trials] that are ongoing are … not powered to assess efficacy against hospital admission and death.”
The Moderna report to the FDA on Dec. 17, 2020, confirmed “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.” Moderna followed about 30,000 people. When asked by the British Medical Journal, why the trial had not been designed to assess if the vaccine could prevent hospitalization and death, Moderna answered: “You would need a trial that is either 5 or 10 times larger or you’d need a trial that is 5-10 times longer to collect those events.” In the Pfizer study of 38,000 people, not a single person in the placebo or the vaccine group died of COVID. By publication date, only one person had died of COVID in the Moderna study. To state it clearly: One person out of about 70,000 in the combined studies of Pfizer and Moderna actually died of COVID. In the real world, at the time, about 60 per cent of COVID deaths were in people over 75 years of age. But only 4.4 per cent of that age group were in the Pfizer study. The sample chosen was not appropriate to answer the public’s most pressing question: Could the vaccines save lives?
And how long had the Moderna and Pfizer vaccines been studied in the Phase 3 follow-up trials before being released for mass use in the winter of 2021? Two months.
These studies looked at the vaccines at their most potent, in a low risk population, and gave us a flattering snapshot. But COVID-19 is a movie.
In contrast, the Mayo study, and the Israeli data, were looking at data over a more realistic time course to test effectiveness.
The waning created a crisis in Israel... As breakthrough infections became commonplace throughout the world, noted Harvard epidemiologist Michael Mina said, the message that “this is only an epidemic of the unvaccinated … is falling flat.”
As for Dr. Sahin’s claim that we were on the brink of vaccine-induced herd immunity and being rid of COVID altogether, experts such as Larry Brilliant (who had helped eradicate smallpox with vaccines) and five other scientists wrote in Foreign Affairs in July, 2021, “Among humans, global herd immunity, once promoted as a singular solution, is unreachable.” They explained in precise detail why COVID-19 was unlike smallpox, and it could not be “eradicated,” such as the fact it is growing in a dozen animal species already. “If we are forced to choose a vaccine that gives only one year of protection,” said Dr. Brilliant, “then we are doomed to have COVID become endemic, an infection that is always with us …” That vaccines would get us to a vaccine-based herd immunity had been one of the two main scientific justifications for vaccine mandates. Now it was gone.
The other justification for mandates had been that the vaccinated don’t transmit the virus.
Most of us had presumed, when we got our first doses, that we couldn’t pass the virus on to others. Public statements repeatedly praised people for “doing your part to stop the spread.” But in August, CDC director Rochelle Walensky told CNN, when asked why the vaccinated must wear masks, “Our vaccines are working exceptionally well. They continue to work well for Delta; with regard to severe illness and death, they prevent it. But what they can’t do any more is prevent transmission.”
In fact, the original randomized clinical trials for Pfizer and Moderna did not test if the vaccines stop transmission. Now our best hope was that the vaccinated might transmit less than the unvaccinated. Several studies could be interpreted as showing this. But others found the vaccinated likely had equal transmission...
The master narrative was silent about natural immunity and its relationship to vaccination status. Many scientist-physicians, from prominent universities in the U.S. with specialties in public health, argue that one can be for the use of the COVID vaccine, but also against mandating it for unvaccinated people who are already immune.
These scientists maintain what matters is not whether a person is vaccinated or not, but whether they are immune or not. Thus, the European Union recognizes natural immunity in its Digital COVID Certificate, which is in lieu of a vaccine passport, and is not limited to proof of vaccination. You could get a passport and travel if you have been vaccinated or if you have “recovered from COVID-19″ or if you have a recent test saying you are negative... Such scientists think it irrational that government calls for mass mandates are escalating just as the core original justifications for them – that the vaccinated don’t transmit the virus, and the vaccine will bring us to herd immunity – have collapsed...
A recent pivotal study from South Africa – not yet peer reviewed – shows that in poor communities, where there was modest vaccination (39 per cent of adults), more than 70 per cent of people had already been exposed to the virus in previous waves, going into Omicron. The twice vaccinated had more protection than those who were unvaccinated and never had COVID. But the unvaccinated who had COVID and recovered had more protection from severe disease than the vaccinated. One Israeli study showed that the unvaccinated who recovered from COVID have 27 times less risk of reinfection compared with the vaccinated, and nine times less risk of hospitalization.
In a recent Munk Debate, Harvard’s Dr. Martin Kulldorff, an epidemiologist and vaccine safety specialist, argued that mandating vaccines for the naturally immune “actually creates problems because when people see that they are forced to take a vaccine that they don’t need because they already are immune, that causes a lot of distrust in public health. And we have seen during this last year and a half that all the hard work we’ve done over many decades to build trust in vaccines is now disappearing because we’re making these mandates that make no sense from a scientific or public health perspective.”
Public health moves at the speed of trust, as physician Rishi Manchanda wrote. Of the two main approaches to public health – the participatory, and the coercive – the coercive usually makes enemies, and tears society apart. It’s like a hare: it has quick victories. The participatory approach, is a tortoise; when it fails to persuade, instead of blaming those it serves, it asks, as a scientist might, where have I fallen short, and aims to do better...
In the West, many have responded to waning vaccine protection with time by doubling down, proposing ever more boosters. What is the scientific evidence for frequent boosters? That’s a matter of scientific debate.
The original Pfizer study submitted to the FDA booster meeting was shockingly tiny – a mere 306 patients were given the section, and they had been followed for only a month, and, again, most of the subjects were younger than those at risk (18-55). Pfizer wanted it on that basis rolled out to millions. That was enough to get FDA officials asking hard questions. Crucially, nobody had studied the long-term effects of multiple mRNA boosters – there hasn’t been time. The FDA refused Pfizer’s recommendation to approve the booster for the entire U.S. population, with the top two heads of its Vaccine Research and Review Committee, Dr. Marion Gruber, (the head, and former acting chief scientist at the FDA), and Philip Krause (deputy director), and international colleagues, writing in the Lancet:
“There could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines [like the AstraZeneca or Johnson & Johnson]). If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines.”
When the head scientists of the FDA Vaccine Review committee and colleagues raise such questions, it can’t be dismissed as fringe fear-mongering. Shortly after, Dr. Gruber and Dr. Krause quit the FDA because the Biden administration was putting pressure on them to approve boosters before the vaccine committee had even met. The standard practice for approval is for the agencies to convene panels of outside experts to review the data openly, weigh risks and benefits, and take votes. But in December, the FDA and CDC leadership three times took the extraordinary step of not convening those experts for key booster meetings, in essence going around them because committee members had warned that the science supporting boosters for younger people was weak to non-existent, and they had safety concerns. Dr. Paul Offit, perhaps the most high profile provaccine physician-scientist in America, who was on the FDA panel told The Atlantic, he wouldn’t advise a booster for his healthy son in his 20s, or a healthy male in his teens, because the risks of myocarditis (higher in males) outweigh the benefits. Dr. Offit rejects the CDC’s and FDA’s all-or-nothing approach to children’s vaccination.
Vinayak Prasad, the UCSF epidemiologist, says if you put the Danish, Ontario, U.S., and Kaiser studies about Omicron together, “it’s time to face the reality about the vaccines.”
“Two doses of vaccine does nothing or almost nothing to stop symptomatic SARS-CoV-2,” he says. “Three doses barely does anything, and the effect will likely attenuate over time.” He says, “Booster mandates make no sense. … Boosting should happen in populations where it further reduces severe disease and death – a.k.a. older and vulnerable people.”
With Omicron surging, Israeli public health met to discuss a fourth booster. The New York Times reported that some scientists on the Israeli government booster advisory panel, “warned that the plan could backfire, because too many shots might cause a sort of immune response fatigue, compromising the body’s ability to fight the coronavirus.” This immune fatigue was, perhaps, not inconsistent with negative vaccine efficacy. It’s not proven, but the fact that public-health officials were voicing such concerns shows that the doubling down strategy on boosters is being reappraised on safety lines. The EU, in a reversal, has just come out against regular, continuing boosters, saying they are afraid it will weaken the immune response
From the very beginning, some scientists have wondered whether our goal – the conquest and eradication of the virus – was the right one. As Michael Cordingley reminds us in his book Viruses, in each millilitre of seawater there are about 10 to 100 million viruses, and this was a respiratory virus, free-floating, all around us, likely to shape shift and mutate. Could we, conquerors of nature, really overwhelm an enemy so omnipresent and agile?
As we have seen, as part of the reappraisal, there’s an increasingly new goal being articulated by most public-health experts, that it’s not “eradication of the virus,” but it is keeping hospitalizations and deaths down, but also, working with the virus. The chairman of the Israeli Association of Public Health Physicians, professor Hagai Levine, said, “Because Omicron is so contagious, our efforts to stop its spread are probably pretty futile. … We are not going to stop this wave.” Then he dared to say, “We have been trying to dodge the bullet for two years, and in Israel we have been successful to some extent. But most of humanity is still alive after contracting COVID.”
The Jerusalem Post reported, that in Israel some health experts “believe the ‘magic bullet’ this time around will actually be widespread infection.” It cited Dr. Cohen, saying, “The fifth wave might end when a large number of people will be infected.”
Just as deaths have decoupled from cases with Omicron, our COVID mandates have decoupled from the science originally used to justify them. But the goalposts are moving, and now it is argued that only mandates will keep hospitals free of high-risk unvaccinated patients...
Portraying the unvaccinated as the sole cause is inaccurate, and deflects from the painful fact that Canada has fewer ICU and acute care beds per capita than almost any country in the developed world, and that the current vaccines are not working as well as hoped. What is called for is not more scapegoating and coercion, but healing, and more early treatment for both groups, now that we have it. Honouring the bedrock of medical ethics, no treatment without consent, is humane, preferable and possible.
Also reappraising is Bill Gates himself. He admitted this past November, “We need a new way of doing the vaccines.” He also accepted that our focus had been too narrow. “We didn’t get much in the way of therapeutics … way less than should have been the case.”
Consider how different our narrative is now. More and more officials are saying openly what the authors of the Great Barrington Declaration – the ridiculed view of 60,000 public health scientists and physician signatories – said some time ago: Our goal is not eradication of the virus, or a one-size-fits-all policy, but lessening of deaths in the vulnerable through focused protection, and focused vaccination. The immunity we have will be a mix of vaccine immunity and natural immunity, depending on the person. The new plan – to live with the virus and get back to living a normal life – is a departure from the pure Baconian “conquest of nature,” and hearkens back to the ancient, Hippocratic, notion that we must work with nature as an ally, in a kind of collaboration...
It’s been a blow to our Baconian narcissism to be upended by nature these past two years. That thin-skinned Baconian within seems almost offended to admit that protection has come not only from scientific advances, but from natural immunity. Others might see this as a reassuring reminder that natural processes are not always and only the enemy. We shall find out, as we observe the unvaccinated, to what extent natural immunity, accumulating in waves of infection over time, does or does not protect, for the current or future variants."
