We are sticking our heads into the sand of reality on Omicron, and the results may be catastrophic.
Omicron is over 4 times more infectious than Delta. The Pfizer two-shot vaccine offers only 33% protection from infection. A Pfizer booster vaccine does raises protection to about 75%, but wanes to around 30-40 percent 10 weeks after the booster.
That’s because the much faster disease transmission and vaccine escape undercut the less severe overall nature of Omicron. That’s why hospitals have a large probability of being overwhelmed, as the Center for Disease Control warned, in this major Omicron wave.
Yet despite this very serious threat, we see the lack of real action. The federal government tightened international travel guidelines and is promoting boosters. Certainly, it’s crucial to get as many people to get their booster – and initial vaccine doses – as soon as possible. But the government is not taking the steps that would be the real game-changers.
Pfizer’s anti-viral drug Paxlovid decreases the risk of hospitalization and death from COVID by 89%. Due to this effectiveness, the FDA approved Pfizer ending the trial early, because it would be unethical to withhold the drug from people in the control group. Yet the FDA chose not to hasten the approval process along with the emergence of Omicron in late November, only getting around to emergency authorization in late December once Omicron took over. That delay meant the lack of Paxlovid for the height of the Omicron wave, since it takes many weeks to ramp up production, resulting in an unknown number of unnecessary deaths.
We humans are prone to falling for dangerous judgment errors called cognitive biases.
Widely available at-home testing would enable people to test themselves quickly, so that those with mild symptoms can quarantine instead of infecting others. Yet the federal government did not make tests available to patients when Omicron emerged in late November. That’s despite the obviousness of the coming wave based on the precedent of South Africa, UK, and Denmark and despite the fact that the government made vaccines freely available. Its best effort was to mandate that insurance cover reimbursements for these kits, which is way too much of a barrier for most people. By the time Omicron took over, the federal government recognized its mistake and ordered 500 million tests to be made available in January. However, that’s far too late. And the FDA also played a harmful role here, with its excessive focus on accuracy going back to mid-2020, blocking the widespread availability of cheap at-home tests. By contrast, Europe has a much better supply of tests, due to its approval of quick and slightly less accurate tests.
Neither do we see meaningful leadership at the level of employers. Some are bringing out the tired old “delay the office reopening” play. For example, Google, Uber, and Ford, along with many others, have delayed the return to the office for several months. Those that already returned are calling for stricter pandemic measures, such as more masks and social distancing, but not changing their work arrangements or adding sufficient ventilation to address the spread of COVID.
Despite plenty of warnings from risk management and cognitive bias experts, leaders are repeating the same mistakes we fell into with Delta. And so are regular people. For example, surveys show that Omicron has had very little impact on the willingness of unvaccinated Americans to get a first vaccine dose, or of vaccinated Americans to get a booster. That’s despite Omicron having taken over from Delta in late December.
What explains this puzzling behavior on both the individual and society level? We humans are prone to falling for dangerous judgment errors called cognitive biases. Rooted in wishful thinking and gut reactions, these mental blindspots lead to poor strategic and financial decisions when evaluating choices.
These cognitive biases stem from the more primitive, emotional, and intuitive part of our brains that ensured survival in our ancestral environment. This quick, automatic reaction of our emotions represents the autopilot system of thinking, one of the two systems of thinking in our brains. It makes good decisions most of the time but also regularly makes certain systematic thinking errors, since it’s optimized to help us survive. In modern society, our survival is much less at risk, and our gut is more likely to compel us to focus on the wrong information to make decisions.
One of the biggest challenges relevant to Omicron is the cognitive bias known as the ostrich effect. Named after the myth that ostriches stick their heads into the sand when they fear danger, the ostrich effect refers to people denying negative reality. Delta illustrated the high likelihood of additional dangerous variants, yet we failed to pay attention to and prepare for such a threat.
We want the future to be normal. We’re tired of the pandemic and just want to get back to pre-pandemic times. Thus, we greatly underestimate the probability and impact of major disruptors, like new COVID variants. That cognitive bias is called the normalcy bias.
When we learn one way of functioning in any area, we tend to stick to that way of functioning. You might have heard of this as the hammer-nail syndrome: when you have a hammer, everything looks like a nail. That syndrome is called functional fixedness. This cognitive bias causes those used to their old ways of action to reject any alternatives, including to prepare for a new variant.
Our minds naturally prioritize the present. We want what we want now, and downplay the long-term consequences of our current desires. That fallacious mental pattern is called hyperbolic discounting, where we excessively discount the benefits of orienting toward the future and focus on the present. A clear example is focusing on the short-term perceived gains of trying to return to normal over managing the risks of future variants.
The way forward into the future is to defeat cognitive biases and avoid denying reality by rethinking our approach to the future.
The FDA requires a serious overhaul. It’s designed for a non-pandemic environment, where the goal is to have a highly conservative, slow-going, and risk-averse approach so that the public feels confident trusting whatever it approved. That’s simply unacceptable in a fast-moving pandemic, and we are bound to face future pandemics in the future.
The federal government needs to have cognitive bias experts weigh in on federal policy. Putting all of its eggs in one basket – vaccinations – is not a wise move when we face the risks of a vaccine-escaping variant. Its focus should also be on expediting and prioritizing anti-virals, scaling up cheap rapid testing, and subsidizing high-filtration masks.
For employers, instead of dictating a top-down approach to how employees collaborate, companies need to adopt a decentralized team-led approach. Each individual team leader of a rank-and-file employee team should determine what works best for their team. After all, team leaders tend to know much more of what their teams need, after all. Moreover, they can respond to local emergencies like COVID surges.
At the same time, team leaders need to be trained to integrate best practices for hybrid and remote team leadership. Companies transitioned to telework abruptly as part of the March 2020 lockdowns. They fell into the cognitive bias of functional fixedness and transposed their pre-existing, in-office methods of collaboration on remote work. Zoom happy hours are a clear example: The large majority of employees dislike them, and research shows they are disconnecting, rather than connecting.
Yet supervisors continue to use them, despite the existence of much better methods of facilitating colalboration, which have been shown to work, such as virtual water cooler discussions, virtual coworking, and virtual mentoring. Leaders also need to facilitate innovation in hybrid and remote teams through techniques such as virtual asynchronous brainstorming. Finally, team leaders need to adjust performance evaluation to adapt to the needs of hybrid and remote teams.
On an individual level, people built up certain expectations during the first two years of the pandemic, and they don't apply with Omicron. For example, most people still think that a cloth mask is a fine source of protection. In reality, you really need an N-95 mask, since Omicron is so much more infectious. Another example is that many people don’t realize that symptom onset is much quicker with Omicron, and they aren’t prepared for the consequences.
Remember that we have a huge number of people who are asymptomatic, often without knowing it, due to the much higher mildness of Omicron. About 8% of people admitted to hospitals for other reasons in San Francisco test positive for COVID without symptoms, which we can assume translates for other cities. That means many may think they're fine and they're actually infectious. The result is a much higher chance of someone getting many other people sick.
During this time of record-breaking cases, you need to be mindful about your internalized assumptions and adjust your risk calculus accordingly. So if you can delay higher-risk activities, January and February might be the time to do it. Prepare for waves of disruptions to continue over time, at least through the end of February.
Of course, you might also choose to not worry about getting infected. If you are vaccinated and boosted, and do not have any additional health risks, you are very unlikely to have a serious illness due to Omicron. You can just take the small risk of a serious illness – which can happen – and go about your daily life. If doing so, watch out for those you care about who do have health concerns, since if you infect them, they might not have a mild case even with Omicron.
In short, instead of trying to turn back the clock to the lost world of January 2020, consider how we might create a competitive advantage in our new future. COVID will never go away: we need to learn to live with it. That means reacting appropriately and thoughtfully to new variants and being intentional about our trade-offs.
At age 52, Glen Rouse suffered from arm weakness and a lot of muscle twitches. “I first thought something was wrong when I could not throw a 50-pound bag of dog food over the tailgate of my truck—something I use to do effortlessly,” said the 54-year-old resident of Anderson, California, about three hours north of San Francisco.
In August, Rouse retired as a forester for a private timber company, a job he had held for 31 years. The impetus: amyotrophic lateral sclerosis, or ALS, a progressive neuromuscular disease that is commonly known as Lou Gehrig’s disease, named after the New York Yankees’ first baseman who succumbed to it less than a month shy of his 40th birthday in 1941. ALS eventually robs an individual of the ability to talk, walk, chew, swallow and breathe.
Rouse is now dependent on ventilation through a nasal mask and uses a powerchair to get around. “I can no longer walk or use my arms very well,” he said. “I can still move my wrists and fingers. I can also transfer from my chair to the toilet if I have two of my friends help me.”
It’s “shocking” that modern medicine has very little to offer to people with this devastating condition, Rouse said. But there is hope on the horizon. Yesterday, the U.S. Food and Drug Administration approved Relyvrio, a drug made up of two parts, sodium phenylbutyrate and taurursodiol, to treat patients with ALS.
“This approval provides another important treatment option for ALS, a life-threatening disease that currently has no cure,” said Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a statement. “The FDA remains committed to facilitating the development of additional ALS treatments.”
Until this point, the FDA had approved only two other medications—Riluzole (rilutek) in 1995 and Radicava (edaravone) in 2017—to extend life in patients with ALS, which typically kills within two to five years after diagnosis. That’s why earlier this week, Rouse was optimistic about the FDA’s likely approval of a controversial new drug for ALS.
When Relyvrio is taken in addition to Riluzole, it appears to slow functional decline by an additional 25 percent and extend life by another 6 to 10 months, said Richard Bedlak, director of the Duke ALS Clinic. “It is not a cure, but it is definitely a step forward.”
“The whole ALS community is extremely excited about it,” he said the day before Relyvrio’s expected approval. “We are very hopeful. We’re on pins and needles.”
A study of 137 ALS patients did not result in “substantial evidence” that Relyvrio was effective, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee concluded in March. However, after some persuasion from FDA officials, patients and their families, the committee met again and decided to recommend approving the drug.
In January 2019, following an ALS diagnosis in October the previous year, Jeff Sarnacki, of Chester, Maryland, was accepted into a trial for Relyvrio. “Because of the trial, we did experience hope and a greater sense of help than had we not had that opportunity,” said Juliet Taylor, his wife and caregiver. They both believed the drug “worked for him in giving him more time.”
In June 2019, Sarnacki chose an open-label extension, offered to patients by drug researchers after a study ends, and took the active drug until he died peacefully at home under hospice care in May 2020, five days after his 60th birthday. A retired agent with the federal Bureau of Alcohol, Tobacco, Firearms and Explosives who later worked as a security consultant, Sarnacki lived about 19 months after diagnosis, which is shorter than the typical prognosis.
His symptoms had begun with leg cramps and foot drop in late fall 2017. At the end of life, he could only move a few fingers on his left hand and could not speak or eat by mouth; a feeding tube became necessary, Taylor said. He also took Radicava and Riluzole, the two previously approved drugs, for his ALS. “We were both incredulous that, so many years after Lou Gehrig’s own diagnosis, there were so few treatments available,” she said.
The dearth of successful treatments for ALS is “certainly not for lack of trying,” said Karen Raley Steffens, a registered nurse and ALS support services coordinator at the Les Turner ALS Foundation in Skokie, Ill. “There are thousands of researchers and scientists all over the world working tirelessly to try to develop treatments for ALS.”
Unfortunately, she adds, research takes time and exorbitant amounts of funding, while bureaucratic challenges persist. The rare disease also manifests and progresses in many different ways, so many treatments are needed.
As of 2017, the Centers for Disease Control and Prevention estimated that more than 31,000 people in the U.S. live with ALS, and an average of 5,000 people are newly diagnosed every year.
Most cases of ALS are sporadic, meaning that doctors don’t know the cause. There is about a one-year interval between symptom onset and an ALS diagnosis for most patients, so many motor neurons are lost by the time individuals can enroll in a clinical trial, said Richard Bedlack, professor of neurology and director of the Duke ALS Clinic in Durham, North Carolina.
Bedlack found the new drug, Relyvrio, to be “very promising,” which is why he testified to the FDA in favor of approval. (He’s a consultant and disease state speaker for multiple companies including Amylyx, manufacturer of Relyvrio.)
The “drug has different mechanisms of action than the currently approved treatments,” said Bedlack, who is also chief of neurology at the Durham Veterans Affairs Medical Center. He adds that, when Relyvrio is taken in addition to Riluzole, it appears to slow functional decline by an additional 25 percent and extend life by another 6 to 10 months. “It is not a cure, but it is definitely a step forward.”
T. Scott Diesing, a neurohospitalist and director of general neurology at the University of Nebraska Medical Center in Omaha, said he hopes the drug is “as good as people anticipated it should be, because there are not too many options for these patients.”
So far, Rouse's voice is holding up, but he knows the day will come when ALS will steal that and much more from him.
ALS is 100 percent fatal, with some patients dying as soon as a year after diagnosis. A few have lasted as long as 15 years, but those are the exceptions, Diesing said.
“If this drug can provide even months of additional life, or would maintain quality of life, that’s a big deal,” he notes, adding that “the patients are saying, ‘I know it’s not proven conclusively, but what do we have to lose?’ So, they would like to try it while additional studies are ongoing.” The drug has already been approved in Canada.
As his disease progresses, Rouse hopes to get a speech-to-text voice-generating computer that he can control with his eyes. So far, his voice is holding up, but he knows the day will come when ALS will steal that and much more from him. He works at I AM ALS, a patient-led community, and six of his friends have already died of the disease.
“Every time I lose a friend to ALS, I grieve and am sad but I resolve myself to keep working harder for them, myself and others,” Rouse said. “People living with ALS find great purpose in life advocating and trying to make a difference.”
The Friday Five covers important stories in health and science research that you may have missed - usually over the previous week, but today's episode is a lookback on important studies over the month of September.
Most recently, on September 27, pharmaceuticals Biogen and Eisai announced that a clinical trial showed their drug, lecanemab, can slow the rate of Alzheimer's disease. There are plenty of controversies and troubling ethical issues in science – and we get into many of them in our online magazine – but this news roundup focuses on scientific creativity and progress to give you a therapeutic dose of inspiration headed into the weekend and the new month.
This Friday Five episode covers the following studies published and announced over the past month:
- A new drug is shown to slow the rate of Alzheimer's disease
- The need for speed if you want to reduce your risk of dementia
- How to refreeze the north and south poles
- Ancient wisdom about Neti pots could pay off for Covid
- Two women, one man and a baby