Time to ‘Listen to the Science’ in A Broader Way

Written by Norman Doidge on January 25, 2022. Posted in Current News

Vaccines are a tool, not a silver bullet. If we’d allowed more scientific debate, we would have realized this earlier

More than two years since COVID-19 emerged, our kit of solutions – and the mindset needed to use them – is too small. It’s time to listen to the science in a broader way.

Just before Christmas, without much fanfare, Ontario became the first province to approve fluvoxamine – a decades-old drug few had heard of – for the early treatment of COVID-19. 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. 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.

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.

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? The staff homed in on chlorpromazine, a common antipsychotic medication, and learned it had antiviral properties against SARS-Cov-1 and MERS-CoV (the predecessors to SARS-CoV-2). 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. The data showed that those on Selective Serotonin Uptake Inhibitors (SSRI) – a kind of antidepressant – were less likely to require intubation or die.

Not all SSRIs worked equally, but those that did reduced major inflammatory problems (the COVID “cytokine storm” that often kills). 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.

Meanwhile, back in the U.S., in parallel process, a child psychiatrist, Dr. Angela Reirson, caught COVID in early 2020. Sick at home, she started doing research. She recalled a study on mice she had read the previous year. The mice had sepsis – a dangerous response to infection that can kill. Something akin to sepsis can happen in serious COVID. In the 2019 study, mice with sepsis were given fluvoxamine, which halted the condition.

So, in March, 2020, Dr. Reirson contacted another psychiatrist, Eric Lenze, a colleague of hers at Washington University in St. Louis. Dr. Lenze was a specialist in repurposing drugs. 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. The findings were published in JAMA in November, 2020.

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. The study was published Oct. 27, 2021, in the Lancet. It studied about 1,500 unvaccinated patients with COVID-19 who also had another serious illness and were at high risk for hospitalization.

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. 20 it put fluvoxamine in the guidelines, for doctors to prescribe on an outpatient basis if needed, recognizing “the need for outpatient treatment options with a reasonable safety profile during an anticipated spike in COVID-19 cases due to the Omicron variant.”

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 (now only one works with Omicron) for specific people at risk, and steroids. Otherwise outpatients were told to rest, drink fluids, and hope their immune system 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. But 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 a sponsor to get approved for that. But drug companies have no financial incentive to do so. So usually there are no sponsors, and the drugs 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.

Scientists were to be soldiers in this new army. And here a problem arose. Despite some similarities, science (and medicine) is really best not construed as warfare – and the kind of virtues that may suit soldiers in an army (following an authority without questioning), are vices in science, which is a mode of critical inquiry. Modern science arose because the world was filled with too many dogmas and orthodoxies that were not to be questioned.

That is why the motto of the Royal Society, the first national scientific institution, became Nullias in verba, “Take Nobody’s Word For It.” It’s the role of scientists, as Nobel Prize-winning physicist Richard Feynman said, to question the experts, and fellow scientists, and debate each experimenter’s conclusions, which are based on human judgments and interpretations of data, until there is certainty the conclusion can resist all onslaughts.

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 system, 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 is taken from a long document. Read the rest here: theglobeandmail.com

About the author: Norman Doidge, MD, is a psychiatrist, psychoanalyst and author of The Brain That Changes Itself. He is executive director of Health and the Greater Good.

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