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Saturday, January 8, 2022

Which Fully Vaccinated Adults Are Most at Risk of Severe COVID?

 A significant proportion of all fully vaccinated adults who died of COVID-19 had at least four risk factors associated with severe outcomes, researchers found.

In addition to older age (65 and up) and being immunosuppressed, having chronic kidney, cardiac, pulmonary, neurologic, or liver diseases, as well as diabetes, were all associated with higher odds of severe COVID outcomes, and 77.8% of fully vaccinated adults who died had at least four of these risk factors, reported Sameer Kadri, MD, of the NIH Clinical Center in Bethesda, Maryland, and colleagues in the Morbidity and Mortality Weekly Report.

However, there were no increased odds of severe outcomes associated with sex, race/ethnicity, time since primary vaccination, or whether the infection occurred during the Delta variant wave.

Kadri and team examined data from 465 U.S. healthcare facilities in the Premier Healthcare Database Special COVID-19 Release from December 2020 to October 2021, which included adults who were either fully vaccinated, received a third dose as part of their primary series, or received a booster dose after their primary series. Severe outcomes were defined as hospitalization with acute respiratory failure, non-invasive ventilation, ICU admission, and death.

Overall, 1,228,664 adults completed a primary vaccination series, and of those, 2,246 contracted COVID-19. Of these, 327 were hospitalized, 189 had a severe outcome, and 36 had a COVID-related death.

Not surprisingly, older age was associated with a higher risk of death (adjusted OR [aOR] 3.22, 95% CI 1.81-5.74), as was immunosuppression (aOR 1.91, 95% CI 1.37-2.66).

Of the six conditions, chronic pulmonary disease (aOR 1.69, 95% CI 1.31-2.18), liver disease (aOR 1.68, 95% CI 1.12-2.52), and kidney disease (aOR 1.61, 95% CI 1.19-2.19) were associated with the highest odds of severe outcomes.

Interestingly, Pfizer vaccine recipients had comparable risks of severe outcomes to those who received the Johnson & Johnson vaccine (aOR 0.70, 95% CI 0.39-1.26), while these risks were lower for those who received Moderna (aOR 0.56, 95% CI 0.32-0.98).

Kadri and colleagues noted that all adults with severe COVID outcomes had at least one of the eight risk factors. Only 19% of all adults with four or more risk factors had non-severe outcomes, while 57% had respiratory failure or were admitted to an ICU.

Among 36 adults who died, 15 had do-not-resuscitate orders at the time of hospital admission, and nine were discharged to hospice.

The authors noted that these results may not be applicable to time periods when other variants were predominant in the U.S.


Disclosures

COVID-19 Called Risk Factor for New Pediatric Diabetes

 Kids who test positive for COVID-19 may have an increased risk for diabetes, according to new CDC data.

Looking at two different data sources, the risk of being newly diagnosed with diabetes -- including type 1, type 2, and other types of diabetes -- was significantly higher for those with COVID-19 compared with those who never tested positive for the virus, reported Sharon Saydah, PhD, of the CDC COVID-19 Emergency Response Team, and colleagues in the Morbidity and Mortality Weekly Report.

Incidence of diabetes was significantly higher among kids with COVID-19 versus those without the infection in both the HealthVerity (HR 1.31, 95% CI 1.20-1.44) and IQVIA healthcare (HR 2.66, 95% CI 1.98-3.56) claims databases.

This link to diabetes appeared to be specific to COVID-19. To confirm, the researchers compared the IQVIA cohort with cases of non-COVID-related acute respiratory infections (ARI) prior to the pandemic. Those with COVID-19 had more than a twofold higher risk for developing new-onset diabetes compared to those with other respiratory infections (HR 2.16, 95% CI 1.64-2.86).

"New diabetes diagnoses were 166% (IQVIA) and 31% (HealthVerity) more likely to occur among patients with COVID-19 than among those without COVID-19 during the pandemic and 116% more likely to occur among those with COVID-19 than among those with ARI during the pre-pandemic period," Saydah's group concluded.

This didn't come as a surprise, since a slew of other studies have demonstrated the association between SARS-CoV-2 infection and diabetes in adults.

While the exact mechanism of this link isn't yet known, Saydah and colleagues suggested it might involve pancreatic cells. "COVID-19 might lead to diabetes through direct attack of pancreatic cells expressing angiotensin converting enzyme 2 receptors, through stress hyperglycemia resulting from the cytokine storm and alterations in glucose metabolism caused by infection, or through precipitation of prediabetes to diabetes," they wrote.

They also suggested that the use of steroid treatment during hospitalization for COVID-19 may also contribute -- at least in part -- to "transient hyperglycemia," though this is likely not the root cause, as only about 2% of codes included were for drug-induced or chemical-induced diabetes.

The IQVIA database included 80,893 patients who tested positive for COVID-19 from March 1, 2020, through Feb. 26, 2021. About half of patients were female, with an average age of 12, and only 0.7% were hospitalized for COVID-19. The HealthVerity database included nearly 440,000 patients diagnosed with COVID-19, who tested positive from March 1, 2020 through June 28, 2021. Average age was 13, half were female, and about 0.9% were hospitalized.

In both patient groups, 94% of new diabetes cases were either type 1 or type 2. Diabetic ketoacidosis was common, seen in 49% of the IQVIA group and 40% of the HealthVerity group.

These findings ultimately show how important prevention is, Saydah and colleagues explained, noting that vaccination is key for all eligible children and adolescents. They also underscored how healthcare providers should monitor their pediatric patients for diabetes in the months following a COVID-19 infection.


Disclosures

Federal vaccine mandate enters 'major question' land

 “Major-question-land,” the term coined by Louisiana solicitor general Elizabeth Murrill during Friday’s oral arguments over the Biden vaccine mandates, has an almost Disneyesque sound to it. However, unlike Yesterland or Tomorrowland, major-question-land clearly holds no attraction for the Biden administration or the court’s liberal justices.

The defenders of the mandates worked mightily to avoid the fact that it’s the first-ever national vaccine mandate and was decided without the approval of Congress.  Chief Justice John Roberts, a vital vote needed by the administration, noted that this administration was relying on language passed roughly 50 years ago — closer to the Spanish Flu than the novel coronavirus — and stated ominously, "This is something the federal government has never done before." That sounds not just like a question but a major one.

The major-questions doctrine maintains that courts should not defer to agency statutory interpretations when the underlying questions concern “vast economic or political significance.”

The controversy over the mandates shows the wisdom of the doctrine demanding that Congress not only take action but responsibility, too, for such major decisions.

With increasing confusion over changing CDC guidelines and the risk profile associated with the Omicron variant, congressional action could bring both greater legitimacy and clarity to questions swirling around mandates.

Instead, the Supreme Court is grappling with an executive move that was openly discussed not only as an avoidance of Congress but a circumvention of constitutional limitations. 

It was not a good sign for the administration that the most referenced individual during oral argument was Biden’s chief of staff, Ron Klain, who tweeted that the mandates were “workarounds” of the Constitution. Chief Justice Roberts, Justice Neil Gorsuch, and others referred to Klain’s admission as the administration’s lawyers tried to argue that the executive had the constitutional authority to implement a national mandate.

The liberal justices took the “time is of the essence” argument to an almost apocalyptic degree: Justice Stephen Breyer kept mentioning that every second they wait, more people are getting COVID, and he incorrectly stated there were "750 million new cases yesterday.”

Justice Sonia Sotomayor stated as a fact that “Omicron is as deadly as Delta and causes as much serious disease in the unvaccinated as Delta did.” That is not true. Omicron appears to be far more virulent, but less lethal than Delta. Sotomayor also claimed that “we have over 100,000 children, which we've never had before, in serious condition, and many on ventilators.” That is also untrue. For patients, up to 17 years old, the seven-day average for hospitalizations was 797.

Justice Elena Kagan also raised eyebrows by claiming that “the best way” to prevent the spread of COVID-19 is “for people to get vaccinated,” and the “second best way” is to “wear masks.” Both claims were immediately challenged. While the vaccine can moderate or lessen the symptoms, states like Massachusetts are reporting that 95 percent of new cases involve the Omicron variant and that vaccinated people are contracting the variant in large numbers. Moreover, while long denied as “disinformation,” medical experts are now admitting that widely-used cloth masks are largely ineffective as protection. Even CNN’s experts now call the cloth masks “little more than facial decorations.”

The questionable claims by the justices were ironic in a case where they were arguing for sweeping deference to support sweeping agency mandates.

Putting aside the factual claims supporting the mandates, there remains the even more dubious constitutional claims. Of the two rules at issue, the OSHA rule has the greatest reach and likely the greatest chance of being struck down. The conservative justices seemed more willing to recognize the government’s inherent authority to issue a mandate for health care workers. However, virtually no health care facilities challenged the rule, and the impact of the rule is not especially great given the industry-wide practice of requiring vaccinations. The OSHA rule attracted the most skepticism from all six conservative justices.

The OSHA rule was issued after months of President Biden claiming the authority to impose a national mandate and then admitting that he did not likely have such authority.

The OSHA rule was clearly “Plan B.”

Notably, while OSHA had discussed whether it could — or should — issue an “Infectious Diseases Regulatory Framework” covering airborne infectious diseases — long before the advent of COVID — it never did so. When the White House was looking for a workaround of the Constitution, OSHA suddenly found what it now claims to be clear authority.

It is not clear — from either a historical or a statutory perspective.

OSHA used an “emergency temporary standard” (ETS) that applies to a “grave danger” when such action is “necessary to protect employees from such danger.” An ETS is generally used to protect employees “from exposure to substances or agents determined to be toxic or physically harmful, or from new hazards.” It can only be used in emergencies when “necessary to protect employees from such danger.”

The emergency need for the ETS seems as much political as health-based. After waiting for over a year, OSHA suddenly declared the need to promulgate an ETS without going through the required “notice and comment” process.

When President Trump sought to skip such notice and comment steps, it was challenged by Democrats as abusive.

If the Biden administration loses on the OSHA case, it would constitute a major political and legal blow. The administration has racked up an impressive list of losses in federal court — but this one could be particularly costly.

Various justices like Neil Gorsuch have long criticized the “Chevron Doctrine,” the basis for courts deferring to federal agencies in their interpretations and policies. The liberal justices continually returned to such deference in their comments on Friday. This case could offer a perfect vehicle to curtail that doctrine and reduce that deference in future cases. That would impact policies across the legal landscape — from environmental laws to work-safety regulations to banking rules.

At a time when liberals are demanding more unilateral action from Biden due to congressional opposition to his agenda, such a ruling could curtail the ability of federal agencies to circumvent Congress.

This is also a major question.

That’s why neither the administration nor the liberal justices want to visit “major-question-land.” For those who want unilateral presidential power, that is not the “Happiest Place on Earth.” It is, however, the most democratic.

Jonathan Turley is the Shapiro Professor of Public Interest Law at George Washington University. 

https://thehill.com/opinion/judiciary/588852-federal-vaccine-mandate-enters-major-question-land

NY Covid nursing home deaths rising

 COVID-19 deaths in New York nursing homes are rising amid the Omicron surge — but the tally is a fraction of those who died in the facilities in the same period last year, state records show.

There were 69 confirmed and presumed deaths from the virus among nursing-home residents for the week ending Jan. 4, up from 43 the week before.

In the first week of January 2021, fatalities in nursing homes reached 341, according to state Department of Health statistics complied by the Empire Center.

In one week alone in April 2020, 5,156 nursing home patients died of the virus, the state stats show.

Nursing homes became COVID-19 hotspots at the outset of the pandemic. Former Gov. Andrew Cuomo’s Health Department issued a controversial March 25, 2020, directive saying the facilities could not bar infected patients, a decision some reports have said caused more deaths.

More than 15,000 New York nursing home patients have died of COVID-19 since the pandemic started.

https://nypost.com/2022/01/08/new-york-covid-19-nursing-home-deaths-increase/

Get The Courts Out Of Science

 by Jeffrey Tucker via The Brownstone Institute,

Yesterday morning I listened to the oral arguments in the case of the Biden administration’s vaccine mandates as enforced by OSHA. It was a demoralizing experience.

I heard some crazy things, such as a claim that “750 million” Americans just got Covid yesterday, and that 100,000 kids with Covid are in the hospital, many on ventilators. The correct number is 3,300 with positive tests, but not necessarily suffering from Covid. I further heard strong claims that the vaccines block disease spread, despite every bit of evidence to the contrary.  

It was my first time hearing oral arguments in the Supreme Court. I might have thought that facts on the ground would actually matter to people who are holding the fate of human liberty in their hands. I might have thought that they would be getting their information from somewhere other than their political intuition, mixed with wildly inaccurate claims from bloggers and media pundits. 

I was wrong. And that is deeply alarming. Or maybe it is a wake up call to us all. We have learned today that these people are no smarter than our neighbors, no more qualified to address complicated questions than our friends, and arguably far less informed than the Twittersphere about basic issues of Covid and public health. 

The backdrop of today’s arguments is that 74% of Americans of all ages have had at least one shot. Meanwhile, case numbers are up 500% in many places, and 721,000 new cases have been logged throughout the country, and that’s obviously a large underestimate because it does not count at-home tests which are selling out in stores around the country. 

The extremely obvious point – the most basic observation one can make about this data – is that the vaccinations are not controlling the spread. This has been granted already by the CDC and every other authority. 

No matter what people say in retrospect, I seriously doubt that anyone would have predicted a future in which the pandemic highs would be reached following mass vaccination. It’s not only true in the US but also all over the world. However much they help with mitigating severe outcomes of the disease, at least for a time, they have not been successful in stopping the spread of the virus. They will not end the pandemic. 

And yet, so far as I can understand this, that is the whole point of the vaccine mandate. It is to protect workers from getting Covid. There is no zero evidence that this is possible with mass mandates in the workforce. People can get and are getting Covid anywhere and everywhere, among which surely means the workplace too. The vaccine is not stopping that. What will bring this pandemic to an end will not be the vaccines but the adaptation of human immune systems, exposed and then developing resilience. 

Apparently there was not one mention of natural immunity during the oral arguments, which is truly astounding. From what I could hear, there was a strangely truncated environment in which no one was willing to say certain obvious truths, almost as if a pre-set orthodoxy had been defined at the outset. There were certain givens that simply were not questioned; namely that this is a disease without precedent, that the state can stop it, that vaccines are the best ticket we have, that the unvaccinated have absolutely no good reason to remain that way. 

To be sure, the oral arguments are not what decides a case. The briefs filed for the court are much better on the side of opposing the mandates, while the briefs for the mandates are filled with untruths that are easily exploded. In the end, it is very likely that the mandate will be struck down in a 6 to 3 vote. I’m glad for that. We should be relieved. 

However, we need to do some serious thinking about what is going on here.

We are talking about a mandate that profoundly affects the health and well-being of millions of people.

The question of whether someone should take the vaccine is bound up with extremely complex empirical questions, and opinions run in every direction, from those who think it is the greatest gift of modern science to those who think the vaccines themselves are not only dangerous but also unleashing ever more variants. These are matters of science and should be subject to debate, with the final choices made by individuals. 

What absolutely cannot happen in any free, civilized, and stable country is to have such fundamental questions of liberty and bodily autonomy adjudicated by a panel of lawyers who have limited curiosity in the science, a lack of knowledge of facts on the ground that are available to anyone who cares, and who get their basic facts about a pandemic from TV talk shows and a prevailing media ethos that has no basis in reality. 

How did we end up here?

We need the answers to this question. Certain issues should be absolutely off limits to the courts. Those issues pertain to fundamental questions concerning science and its application to human health. Of all things that need to be outside the realm of politics and the courts, it is these. The courts lack the competence. Even if the decision goes the right way, there is no real basis for feeling relieved and secure about our future. 

Liberty can win this one and lose the next one. It all depends on the court appointments. This is not how a social order can operate. We need a system in which foundational issues of health, science, and liberty are outside the scope of the court system. 

I wish I knew how to get there. We’ve been on a very long trajectory in which government exercises ever more control over our lives, inch by inch, for the better part of a century. We’ve come to the point where this control is a severe threat to our capacity to live free and dignified lives without being subject to the arbitrary whims of “experts” with power. 

The courts have been too acquiescent for too long. If we had a really functioning court system and a Constitution that it followed, the forced closures of March 2020 would have been struck down in hours and ruled out as incompatible with freedom itself. 

My highest hope is that the majority opinion here, if it goes the right way, will not be narrow and evasive, picking apart the mandate based on technicalities, but sweeping and fundamental. It should say in no uncertain terms that this mandate should never have been issued and that the court should never have to intervene in such matters in the future. 

Freedom requires at least the presumption that businesses (and all institutions) can operate without acting as proxies for the federal health police – pushing injections on their workers against their will – and that workers have the right to determine what medicines they will and will not take. 

The very existence of this case in the Supreme Court reveals that something is fundamentally broken about our presumptions about the relationship between the individual and the state. It must be fixed. It won’t finally be fixed by a court but rather a dramatic cultural change that embraces certain fundamental propositions about liberty itself. We’ve played too many games and taken too many risks for too long.

 Let us hope that this case awakens a culture and a world to a desperate need for dramatic reform. Human rights and public health are too important to be left in the hands of high courts. 

https://www.zerohedge.com/political/get-courts-out-science

Could Being Cold Actually Be Good for You?

 NOBODY LIKES A frozen butt. So when François Haman attempts to recruit subjects to his studies on the health benefits of uncomfortable temperatures, he gets a lot of, well … cold shoulders. And he doesn’t blame them. “You're not going to attract too many people,” says Haman, who studies thermal physiology at the University of Ottawa, Canada.

The human body is simply lousy at facing the cold. “I've done studies where people were exposed to 7 degrees Celsius [44.6 Fahrenheit], which is not even extreme. It's not that cold. Few people could sustain it for 24 hours,” he says. (Those subjects were even fully dressed: “Mitts, a hat, boots, and socks. And they still couldn't sustain it.”)

People strive to keep cozy or cool—not shivering, and not sweaty—by flattening temperature variations in indoor spaces. It’s easy to reach for the space heater or yell “Alexa, warm my ass up!” the moment you feel a touch of discomfort. But maybe you shouldn’t tinker so much with the thermostat. Some reasons for easing up on the heat are obvious: About 47 percent of American homes burn natural gas for heat, and 36 percent use electricity, which in the US is still mostly sourced from fossil fuels. And there may be other reasons to embrace the cold—health factors that physiologists like Haman have begun to uncover.

Before industrialization, says Haman, “these extremes were actually part of life.” Bodies dealt with cold in the winter and heat in the summer. “You kept on going back and forth, and back and forth. And this probably contributed to metabolic health,” he says.

Researchers know that your body reacts when it’s cold. New fat appears, muscles change, and your level of comfort rises with prolonged exposure to cold. But what all this means for modern human health—and whether we can harness the effects of cold to improve it—are still open questions. One vein of research is trying to understand how cold-induced changes in fat or muscle can help stave off metabolic disease, such as diabetes. Another suggests it’s easier than you might think to get comfortable in the cold—without blasting the heat.

To Haman, these are useful scientific questions because freezing is one of our bodies’ oldest existential threats. "Cold, to me, is [one of] the most fascinating stimuli because cold is probably the biggest challenge that humans can have,” he says. “Even though heat is challenging, as long as I have access to water, and to shade, I will survive fairly well. The cold is completely the opposite.”

“If you're not able to work together,” he continues, “if you don't have the right equipment, if you don't have the right knowledge–you're not going to survive. It's as simple as that." Figuring out how our bodies change in response to such a formidable and ancient opponent offers clues to how they work, and how they might work better.

HAMAN BEGINS EVERY day with a cold bath or shower. It’s a rush because the cold triggers the body to release hormones called catecholamines, which are involved in the fight or flight response. “I do have that sense of Oh my God, I'm feeling so strong, and I'm awake,” he says. “This is kind of my coffee.”

But those hormones are stress hormones, and Haman does not sugar-coat the truth: “Humans are amazingly ill-adapted to the cold.” People are fur-less and have gangly extremities. Our arms extend to distant fingers and our legs to distant toes. We have to move blood over a long distance to warm them up. And when it gets too cold, the body readily sacrifices blood flow to each, in favor of preserving the core temperature.

At rest, humans make up to 100 watts of heat. (“In French, if somebody is not very bright, you say they're not 100 watts,” Haman notes.) But if you're losing too much heat to the environment through your skin, that energy balance falls apart. The body responds by ordering more heat production. Your first urge is behavioral: You try to find warmth, whether by a furnace, under a blanket, or with the help of a cup of cocoa. The second is physiological, and it begins when your skin temperature drops by just a couple degrees: You shiver. Your teeth probably chatter first, then the rest of you. “You're contracting. And you basically have no control over your body,” Haman says.

Other animals, like mice, rats, and squirrels, aren't so poorly designed. They have plenty of “brown fat,” or adipose tissue that burns calories to create heat. Biologists refer to this trick as “nonshivering thermogenesis.”

At first, scientists thought this was unique to rodents, but in 2009, The New England Journal of Medicine published three separate discoveries proving that adult people also have brown fat—and therefore capacity for nonshivering thermogenesis. Haman has since shown that braving the cold can teach your body to stockpile more of it. In 2013, he asked his subjects to wear “cold suits” circulating water at 10 degrees Celsius (about 50 Fahrenheit) two hours a day, five days a week, for four weeks. It was cold and uncomfortable, but this “low intensity, long duration” acclimation caused people to double their amount of brown fat, which appeared around the spinal column, adrenal glands, and pelvic muscles.

Once it appears, brown fat doesn’t just sit around: Its activity replaces shivering as the body’s go-to heat factory. “Everything is being compensated by nonshivering thermogenesis,” says Haman. For the participants in the study, wearing the cold suit also tripled how active that fat was, or how much it burned. Shivering decreased about 10 to 20 percent after acclimating, according to his study. In other words, he concluded that the subjects acclimated to the cold by producing more brown fat, which in turn made them more comfortable at lower temperatures, without needing to shiver.

Then, in 2019, Haman aimed higher. Or perhaps lower. He recruited seven men to undergo seven days of intense cold acclimation. Each day, they sat in 58-degree-Fahrenheit water, submerged up to their clavicles, for up to one hour, until their core temperatures dropped to 95 degrees. They were then dried and slowly warmed back up. “It's basically an hour of, uh … not having fun,” Haman says. “But after seven days, you're basically a totally different person.” Participants could go an hour longer before shivering than they could before the trials. And they would shiver 36 percent less intensely, on average.

Other labs around the world have tried to figure out if brown fat matters in other ways. In rodent studies, activating brown fat with cold temperatures has been found to regulate fatty acid and glucose levels. That led some researchers to suspect that the tissue can help protect against dysfunctional glucose processing in diabetes and fatty acid processing in obesity. So far, some studies in adult people have linked brown fat’s presence to leanness and normal blood sugar. (In 2013, WIRED covered an independent researcher’s quest to harness brown adipose for weight loss.)

But it’s not as simple a proposition as braving a little cold, tacking on some brown fat, and then losing weight. The story is a bit more complicated.

After the brown fat discoveries in 2009, Joris Hoeks, a diabetes researcher at Maastricht University in the Netherlands, was curious about its role in controlling blood sugar. His team recruited people with type 2 diabetes for a cold acclimation study. An important hallmark of type 2 diabetes is insulin resistance, in which organs take up less sugar from the blood. Participants endured six hours of cold, right on the edge of shivering, for 10 days. Their sensitivity to insulin, a key hormone in controlling blood glucose, improved by 43 percent on average—a boost comparable to the effect of a 12-week workout program.

“We thought, ‘OK, that's a great result,’” Hoeks recalls. The cold seemed to have caused the change in insulin response. But there wasn’t a clear connection to brown fat activity. “It was stimulated by the cold, but not much,” he says.

So Hoeks’ team doubled down. In a study published in March 2021, they repeated the test but took precautions to avoid all shivering by raising the temperature and giving the subjects extra clothing if needed. In these conditions, mild cold acclimation caused no improvements in glucose regulation or fat metabolism.

Instead, the results from this pair of studies point to changes in muscle as more important for diabetes than brown fat. Muscle cells change in the cold. Proteins responsible for transporting glucose fuel into muscle cells appear to migrate toward the outside of the cell. Hoeks thinks that change may help the body process more glucose, either because of mild or unnoticeable shivering contractions, or some other muscle process altogether. “We don't know what it is,” he says.

“Cold works, it really works. But it’s not going through brown fat” to make diabetics more sensitive to insulin, Hoeks says. Other studies have shown that muscle is in fact responsible for metabolizing about 50 times more glucose than brown fat because muscle is so much more prevalent in the body. And Haman agrees that muscle cells are likely very important in regulating blood sugar. “If I'm doing this, all day,” Haman says, flexing his bicep with a couple of quick curls, “I'm likely using way more glucose and fatty acids than what brown fat would be.”

So far, the evidence seems to support Haman and Hoeks’ hunches that cold acclimation is good for people—but there’s still much more to learn. For Haman, the next step is to try to factor in dietary restrictions. In the future, he’d like to figure out how cold exposure and calorie restriction affect weight loss. One group will restrict their diet, another will do that in the cold, and another will just be cold. The study will track how much weight they lose. But, of course, Haman says, recruiting volunteers will be a slog: “How easy do you think it's going to be to recruit the people that are just going to do cold exposure for nine weeks?”

Government Communication around COVID Fuels Mistrust of Science

 The highly contagious COVID Omicron variant is shattering new U.S. daily case records. With Omicron carrying a risk of breakthrough infection five times higher than that of the Delta variant, we are witnessing a significant impact on the American workforce in all sectors. The increase in cases among essential workers has sidelined many health care workers, resulted in thousands of holiday flights being canceled, and once again disrupted our supply chain.

In the meantime, the U.S. Centers for Disease Control and Prevention (CDC) is adding to the chaos in the way they changed its isolation recommendations. What originally was 10 days of isolation after initial contact with someone who tested positive for COVID has turned into five days of isolation, and upon reentry into civilization, five more days of wearing a mask. To complicate matters further, the CDC has also introduced an option to test out of isolation if a test is readily available (which in the United States is currently not the case).

These changes, which started as guidance focused on health care personnel before it was suggested to the general public, give reason to suspect the agency was motivated by pressure from the business community rather than consideration of the science. As recently reported, the CEO of Delta Air Lines sent a letter pressing the head of the CDC for such a move in order to preserve the airline’s workforce. With such a shift from our top public health agency comes a palpable sense of frustration in the country, and the further eroding of public faith in science, the scientific process and scientists themselves.

For us as physicians steeped in empirical evidence, to think that our health and the health of our patients potentially could be compromised because of business interests feels like a serious blow, undermining even our confidence in the agency.

But perhaps we all saw this coming.

Throughout the pandemic, we have seen how inconsistent messaging around COVID has fueled doubt around science, giving place to consistently messaged misinformation that has found its way into communities all across America. This has undermined our ability to implement data-driven policymaking.

Even before the pandemic, science has been under attack with debates over whether climate change is real, whether tobacco or vaping causes lung damage, whether guns are associated with gun violence, and whether mental illness is simply a chemical imbalance or more broadly related to a bio-psycho-social model.

We have seen anti-vaccine sentiment prevail after Andrew Wakefield’s work linking autism to vaccines was published. Dozens of peer-reviewed studies have found exactly the opposite. Wakefield’s paper was retracted, and he’s been resoundingly discredited as a scientist, but the damage is done. Prior to COVID-19, we saw measles outbreaks reach their highest numbers since measles was all but eliminated. Why? Pockets of American communities, fearing autism, simply refused vaccination. Children died of a preventable disease.

As the pandemic continues, our public health agencies, starting at the very top, need to be reliable, evidence-driven, and consistent sources of information. But the CDC is not alone. Our top drug regulatory agency, the U.S. Food and Drug Administration (FDA), has shown inconsistency that not only affects the general public, but everyone who is involved in health care delivery.

Take Aduhelm, for instance. Several months prior to the approval of the Alzheimer’s disease drug, a group of senior FDA officials agreed that there wasn’t enough evidence for approval of the drug. The officials said the agency should require further evidence that the drug worked the way the company said it did prior to re-review or approval. This came as a blow to patients, clinicians and researchers who were incredibly hopeful for a potential treatment of such a devastating disease that lacks therapeutic options.

Despite the setback, the scientific community agreed that further clinical work should be done. Shortly after the consensus decision by advisory members and senior scientists, the FDA controversially approved the drug with no additional clinical studies and zero acknowledgment of the lack of data behind the approval. After weeks of incredible backlash and the resignation of several key advisory members, then acting FDA commissioner Janet Woodcock made a 180-degree reversal that went from making statements expressing confidence in the agency’s decision to then supporting an independent investigation that led to the approval of the drug.

That flip left the medical community dumbfounded over the decision to initially approve Aduhelm, which still defies explanation.

Scientists and health care professionals have long viewed institutions such as the CDC and FDA with respect. However, the mixed messages, and the doubt they have created in our minds signal a much deeper problem that will require innovative solutions.

We are entering the third year of an infectious disease war that has killed over 800,000 Americans. At the same time, many more Americans are dying from firearm injuries, drug overdoses, suicides and delayed medical care. Health care professionals are physically and emotionally exhausted and have worked through some of the darkest periods of this pandemic—whether it’s the lack of protective personal equipment (PPE), the personal sacrifice of their lives, or putting their families and loved ones at risk for contracting the virus.

Meanwhile, people are still not getting vaccinated, government leaders like U.S. Secretary of Defense Lloyd Austin are contracting breakthrough cases of COVID, and the American workforce is being crippled by the exponential uptick in positive cases.

It’s clear that we are struggling to smother this fire. Part of our success in doing so rests in our ability to restore trust in our scientific institutions.

The leaders of government agencies and the public sector, including public and for-profit health care and research institutions, should create a rapid response system that evaluates the newest data around COVID and quickly provides feedback to best ensure the most consistent, evidence-based messaging is released to the health care workforce and the general public. Similar to the peer review process, elevating the evaluation of significant policies to a larger peer group is a strategy that may be useful.

It’s also important to include frontline healthcare workers in these conversations. They are closest to the struggle and often know what the best solutions are.

As an important group of trusted professionals, public health practitioners and scientific organizations must do a better job at communicating our message, especially during a crisis where the landscape is rapidly changing. All of us are prone to mistakes, and while no one expects any individual or organization to be perfect, setting consistent expectations during a public health crisis is critical. The strategy and approach in how we communicate the message, is just as important as having the right idea.


Joseph V. Sakran is an associate professor of surgery and nursing, and director of emergency general surgery, Johns Hopkins Hospital, and senior fellow, Satcher Health Leadership Institute. He holds M.D., M.P.H. and M.P.A. degrees. Follow him on Twitter @JosephSakran.

Kavita K. Patel is a primary care physician at Mary’s Center in Washington, D.C., and was previously a director of policy in the Obama White House. She holds M.D. and M.S.H.S. degrees. Follow her on Twitter @kavitapmd.

https://www.scientificamerican.com/article/how-communication-around-covid-fuels-a-mistrust-of-science/