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More than two years since COVID-19 emerged, our kit of solutions – and the mindset needed to use them – is too small. The December 20 announcement, coming at a time when Canadians were preoccupied with Omicron, and the fear hospitals would soon be overwhelmed, received hardly any news coverage. Fluvoxamine is a "repurposed drug," and comes from what might seem like a most unlikely source – psychiatry.
The drug has had two randomized control trials, or RCTs 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. This is a good news story, about our public-health officials doing something right, and showing flexibility, at a time when we are learning the limits of our vaccines and accompanying strategies. Reappraisal is in the air, driven by everyone’s two-year-experience with the pandemic – scientists included.
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. Ugur Sahin, the CEO of BioNTech, told reporters, "Europe will reach herd immunity in July, latest by August." It wasn’t a tough sell. 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. 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. 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.
In a May, 2020, publication, they proposed repurposing it for treating COVID-19. French psychiatrists and scientists next did a multicentre study, looking at 7,230 patients who had been hospitalized in Paris for severe COVID-19. Coincidentally, 300 of the patients were taking antidepressants. Lab research showed that the SSRI fluvoxamine had an antiviral effect, and a salutary effect on blood platelets that might protect patients from blood clots.
Angela Reirson, caught COVID in early 2020. Something akin to sepsis can happen in serious COVID. In the 2019 study, mice with sepsis were given fluvoxamine, which halted the condition. Realizing fluvoxamine had a great safety record, he launched its first small randomized control trial of COVID patients.
Not one of the 80 volunteers who got fluvoxamine deteriorated or got COVID lung damage, whereas 8 per cent of the 72 who got a placebo did deteriorate. Next came the Together Trial, the world’s largest placebo study of COVID drugs, co-led by McMaster researcher Edward Mills and Brazilian physician Gilmar Reis. To do large trials you need a lot of cases, and Brazil had two million. Half were given fluvoxamine, half a placebo.
In those who took the fluvoxamine as prescribed it reduced the odds of hospitalization or emergency care by 66 per cent and death by 90 per cent. The Ontario Science Table noticed these findings and on Dec. That was significant, because early treatment of COVID – measures we can take to avoid symptomatic cases from worsening, requiring hospitalization – has been so minimal. In Ontario, treatment includes monoclonal antibodies for specific people at risk, and steroids.
Otherwise outpatients were told to rest, drink fluids, and hope their immune response would handle the virus. True, there was much talk of brand-new, non-repurposed drugs for early treatment. Pfizer’s Paxlovid, just approved by Health Canada on Monday, is very new. 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 or Molnupiravir.
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. 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. This master narrative was our battle plan and this was a "war" to eradicate the enemy virus.
Reappraisal of any prevailing narrative requires taking in new insights, which, by definition, arise from a minority viewpoint. The circuit, called the behavioural immune response, causes us to fear, loathe and feel rage toward the "impure" germ bearer. 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.
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. 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. 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.
This, in medicine, is called the problem of "medical reversal." An approach thought to be helpful is proven to be harmful, and vice versa. 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. 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.
It wasn’t just the variants’ role in declining vaccine efficacy that surprised people. There was something about the execution of the original clinical trials, conducted by the pharma companies themselves, on their own products that also led to this surprise. In December, 2020, the new mRNA vaccines were rolled out, and were, according to the randomized clinical trials, 95 per cent and 94.5 per cent efficacious in stopping infection. But by the time summer 2021 arrived, real world experience contradicted Mr. 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. 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. 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. 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.
By publication date, only one person had died of COVID in the Moderna study. 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 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. 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.
Now our best hope was that the vaccinated might transmit less than the unvaccinated. One study, conducted in a prison, concluded that the vaccinated prisoners had as much "transmission potential" as the unvaccinated prisoners, adding, "clinicians and public health practitioners should consider vaccinated persons who become infected with SARS-CoV-2 to be no less infectious than unvaccinated persons." Dr. The master narrative was silent about natural immunity and its relationship to vaccination status. " 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. For air and train travel, Canada has also acknowledged recovery from COVID as an exemption, if one presents a recent negative test – but, inconsistently, natural immunity is not recognized in most other quasi-mandate situations here.
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. Those unvaccinated people who were exposed to the virus, make up a huge number. 31, 2021 10 months into the pandemic, 120 million Americans had natural immunity. Now, 12 months later, with the much more infectious Delta and Omicron variants, it is likely a highly significant majority of the unvaccinated now have natural immunity.
A recent pivotal study from South Africa – not yet peer reviewed – shows that in poor communities, where there was modest vaccination, 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.
Of the two main approaches to public health – the participatory, and the coercive – the coercive usually makes enemies, and tears society apart. Israel’s third booster helped beat back the Delta wave. Then Omicron hit. A Kaiser study showed that two doses, over time, fell to zero efficacy against Omicron.
Health Security Agency study showed the protection from the Pfizer booster had dropped to 45-per-cent coverage at only 10 weeks. We had been through a year of defining vaccine success as eliminating the virus, then as lowering infection and stopping the spread, to discovering there were breakthrough infections and transmission to other people, but that they still lowered our risk of hospitalization and death – that’s worth a lot – though not always in the most vulnerable. In the West, many have responded to waning vaccine protection with time by doubling down, proposing ever more 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. Pfizer wanted it on that basis rolled out to millions. The FDA refused Pfizer’s recommendation to approve the booster for the entire U. population, with the top two heads of its Vaccine Research and Review Committee, Dr. "When the head scientists of the FDA Vaccine Review committee and colleagues raise such questions, it can’t be dismissed as fringe fear-mongering. " Krause quit the FDA because the Biden administration was putting pressure on them to approve boosters before the vaccine committee had even met.
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 outweigh the benefits. " "Three doses barely does anything, and the effect will likely attenuate over time." He says, "Booster mandates make no sense. 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. 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. 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. 20, there are 740 unvaccinated, and 2,091 fully vaccinated people in hospital for COVID. In the ICUs there are 208 unvaccinated and 263 fully vaccinated people. True, there are fewer unvaccinated than vaccinated people in Ontario, but if surgeries are delayed, it is clearly because both groups are occupying beds.
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. 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. Since nature can indeed be both "the enemy," but also is our very foundation, and potential ally and friend, no narrative that excludes either side of this friend and foe duality can ever do justice to medicine and healing. If the abandonment of Hippocrates was the first medical reversal, we are seeing in its return, a reversal of a reversal. 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.
Source: NORMAN DOIDGE | THE GLOBE AND MAIL
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