Nearly nine months after the first Americans received their shots, the Covid-19 vaccine from Pfizer/BioNTech received full approval from the Food and Drug Administration for people 16 and older on Monday. This could help increase the number of people willing to get vaccines and make it easier to compel those who are less willing — if health officials can cut through the mounting confusion around their efficacy, booster shots, and the threat of the delta variant.

Covid-19 vaccines from Johnson & Johnson, Pfizer/BioNTech, and Moderna have thus far been distributed across the US under emergency use authorizations. This form of limited approval allows the FDA to fast-track the distribution of drugs, vaccines, and medical devices during a public health emergency, like a pandemic.

Getting an emergency use authorization requires data from clinical trials showing that an intervention is safe and effective, but the bar for full approval is higher. Now, with 200 million people at least partially vaccinated, the FDA has effectively removed the asterisks from Pfizer/BioNTech’s mRNA vaccine.

“While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Janet Woodcock, acting commissioner of the FDA, in a statement on Monday.

On Monday, the United Nations announced an environmental and public health milestone: the end of the use of leaded gasoline in automobiles and road vehicles worldwide.

The last holdout was Algeria, which had large stockpiles of leaded gasoline; in July, those stockpiles ran out, and Algeria has now made the transition to unleaded gasoline.

Lead poisoning causes immense societal harm: brain damage, chronic illness, lowered IQ, elevated mortality. Lead exposure in childhood has been linked with violent crime rates decades later. Extremely high lead levels can lead to seizures, coma, and death. Lower levels tend to cause less detectable harm, but there’s no safe level of lead exposure: Scientists’ current best guess is that any lead exposure at all causes harm.

Many of lead’s dangers have been known for decades. Leaded gasoline was invented by a General Motors research lab in the 1920s, and already at that time, there were people noticing that children exposed to high levels of lead suffered devastating health consequences. But Thomas Midgley Jr., leaded gasoline’s inventor, campaigned to convince the world that it was safe. (Midgley also invented ozone-depleting refrigerants called CFCs, which would end up being banned by the 1987 Montreal Protocol; he’s been called a “one-man environmental disaster.”)

For more than 50 years after the invention of leaded gas, virtually all cars around the world pumped aerosolized lead into the air.

In the 1970s, though, following more research firmly establishing lead’s harms, rich countries started addressing the problem. In the US, the Clean Air Act imposed restrictions on lead pollution, and a few years later, the Environmental Protection Agency mandated that gas pumps offer unleaded gas, as the first step toward a transition away from leaded fuels.

The EPA estimates that the amount of lead used in automotive gasoline in the US fell by 99 percent between 1976 and 1989. Measured blood lead levels followed. Crime rates dropped, too. Those benefits were realized even though the lead used in gasoline (and in paint and other consumer products) before bans on its use is still widespread in our soil and dust and still posing a major public health challenge.

In 1996, the EPA completely banned leaded gasoline for on-road vehicles. Japan and Europe issued their own bans over the same time period. In 2000, China and India followed.

How the United Nations phased out leaded gasoline worldwide

In 117 countries around the world, though — largely low-income ones — leaded gasoline was still in use.

In 2002, the UN’s Environment Program (UNEP) launched a sustained effort to phase out leaded gasoline, called the Partnership for Clean Fuels and Vehicles.

UNEP Director Inger Andersen describes it as a “UN-backed alliance of governments, businesses and civil society,” and its tactics were quite flexible: convincing governments of policy bans, teaching businesses how to make cleaner vehicles, finding investment for better refineries, and in one case navigating a massive bribery scandal, when it turned out that a leaded gasoline producer, the chemical company Innospec Ltd., was fighting to keep its product legal in Indonesia by bribing government officials.

The UN’s initiative saw fast adoption in sub-Saharan Africa, where 25 countries signed on to a plan to de-lead their gasoline in 2005. It made slower progress elsewhere, especially in the Middle East, where many countries had enormous stockpiles of leaded gasoline.

In 2011, a study by Peter L. Tsai and Thomas H. Hatfield estimated the phaseout of leaded gas was increasing global GDP by 4 percent, or $2.4 trillion (counting health savings as well as social benefits from higher IQ and lower crime).

They also estimated the direct benefits in lives saved at 1.2 million a year. The phaseout of leaded gasoline has been the “single most important strategy” for combating lead poisoning, they conclude, “with the economic benefits exceeding costs by more than 10 times.”

And while there’s a lot of academic debate about the exact magnitude of lead’s effect on crime, there’s no debate that transitioning away from lead fuels passes almost any cost-benefit analysis: Poisoning your entire population is just really bad, and transitioning away from leaded fuels is one of the cheapest ways to dramatically reduce lead poisoning.

By 2014, automotive leaded gasoline was legal only in parts of Algeria, Iraq, Yemen, Myanmar, North Korea, and Afghanistan.

By 2016, it was just Algeria, Yemen, and Iraq. And now, two decades after the campaign kicked off, cars everywhere in the world will use unleaded gas.

The road ahead

The end of leaded gasoline in automobiles is a big step forward, and one worth celebrating. But the fight to end lead poisoning’s effects on our world and on the next generation has a lot further to go.

In the US, leaded gasoline in cars has been illegal for more than 25 years. But the lead from that gasoline has settled in the soil and dust, and still contributes to poisoning children today.

The Centers for Disease Control and Prevention tracks lead exposure across the country. In 2018, the most recent year for which data is available, it found that in most states, between 1 and 5 percent of children had more than 5 micrograms per deciliter of lead in their blood — enough to potentially cause them serious health problems and lifelong harm. (Children exposed to lead in the US today are mostly exposed through soil and dust ingestion. Often, dust has lead in it because paint in old houses contains lead.)

Worldwide, UNICEF estimates that around one in three children have lead levels in excess of the 5 µg/dL line. While leaded gasoline for automotives has historically been the single biggest contributor to lead levels in population centers, there are others: heavy industry, inadequate battery recycling and disposal, decaying pipes, and lead-based pottery glazes, for example.

In the US, lead-based fuels, though illegal on the road, are still allowed in aviation and a few other specialized contexts — and there’s no real progress toward phasing them out. While they cause a lot less lead exposure than automotive leaded gasoline did, the fact that there’s no known safe level of lead exposure should still give us pause — even the smaller exposures from these rarer sources can cause problems.

The end of leaded gasoline throughout the world will do a lot to fight lead poisoning by itself, but ideally it would be accompanied by measures to attack the other ways lead enters children’s bodies. The bipartisan infrastructure bill making its way through the US Congress includes money for lead remediation measures and lead pipe replacement — but it’s probably not enough to replace all aging lead pipes in the US.

UNICEF calls for “completely removing the potential for exposure to lead in areas where children live, play and learn,” and while it would be a tremendous expense, it would have a tremendous return. Poisoning the next generation is about as shortsighted as it gets, and investment in lead protection is an investment in our future.

Celebrating — and learning from — humanity’s achievements

The UN is frequently criticized as “bloated, undemocratic”, not focused on the world’s biggest problems, and not capable of moving us toward meaningful solutions.

But the worldwide elimination of leaded gasoline in cars is a genuine achievement worth celebrating — and worth examining, to see how the world can use the tactics that triumphed against leaded gasoline to combat the other huge problems requiring international coordination that face us in the 21st century.

The team at work on it has already expanded their focus to the next crucial transition for road vehicles: a move from gasoline-based ones to lower-emissions and zero-emissions alternatives. The leaded-gas initiative “is testament to the power of multilateralism to move the world towards sustainability and a cleaner, greener future,” Andersen, the director of UNEP, argued in a press release accompanying the announcement. “We are invigorated to change humanity’s trajectory for the better through an accelerated transition to clean vehicles and electric mobility.”

They’re also at work phasing out lead paint, another major source of household lead exposure.

The road map that the UN used for the fight against leaded gasoline — a combination of technological solutions that made it easier to switch away from lead in engines, political coalition-building, partnerships with businesses, and a few prosecutions of bad actors who used bribery to keep lead in business — is a road map that can be applied to challenges like climate change as well.

And separate from all of that, it’s worth taking a moment to rejoice in humanity’s achievements over death, disease, and our own self-inflicted horrors. Leaded gasoline and its mass use was one of the biggest mistakes of the 20th century. Ending it is one of the first big global triumphs of the 21st.

Click Here:

During the pandemic, I’ve spent a lot of time alone. I live by myself. I work from home. At times, I experienced fits of fidgetiness and restlessness, contributing to feelings of burnout.

Here’s what helped: reappraising the situation.

What I was feeling was isolation, and the loneliness that comes with it. Instead of letting it gnaw at me, I tried to remember: Loneliness is normal, sometimes even useful. I remembered that sadness existed in part to remind me of something I really value, the company of other people. I knew, when the opportunity arose, I’d reorient myself to immersion with others. And when that time came, I’d embrace it; it was a reminder that I was still capable of feeling the joy I had been lacking. And as a consolation, that felt good.

Cognitive reappraisal — sometimes called cognitive reframing — is most commonly encountered in therapy, where it’s used to regulate emotions. It’s a component of cognitive behavioral therapy, a whole suite of strategies that can encourage positive patterns of thinking and behavior.

Reappraisals are useful. But they’re not something people learn exclusively in the context of clinical care. It’s arguably a skill we all can benefit from. And by “we all,” I mean just about everyone, all across the globe.

Recently, hundreds of researchers in 87 countries published the results of the largest cognitive reappraisal study to date in Nature Human Behavior. They were asking a simple question: Could they make people feel better about the pandemic, if only for one moment in time, by teaching reappraisals? The study, which amassed data on more than 20,000 participants, came back with a resounding answer: yes.

The new study validates the concept of reappraisal. But it also suggests that it could potentially be feasible to deploy as a large-scale global health intervention.

It’s a simple skill, but it could help many people foster resilience in a chaotic world.

Cognitive reappraisal, explained

The peer-reviewed paper in Nature Human Behavior is the most recent project from the Psychological Science Accelerator, a group of hundreds of researchers who combine their resources to pull off psychological studies with massive participant pools and an unusually rigorous methodology.

Near the start of the pandemic, the group put out a call for project proposals to test psychological interventions that could, simply, help people feel better.

“The reason why we choose cognitive reappraisal is because it has been the most widely studied and well-understood strategy,” Ke Wang, the Harvard Kennedy School doctoral student who first proposed this massive project, explains. It’s also a strategy that people don’t always use spontaneously on their own: It helps to be taught.

(The group has two other papers testing different psychological interventions, on how public health messaging in the pandemic can influence behavior. Of note: They’re testing whether “loss aversion,” an influential idea that suggests people respond more strongly when they think they have something to lose, encourages people to protect their health during a pandemic.)

Cognitive reappraisal works because “there’s a link between our thoughts and our feelings,” Kateri McRae, a University of Denver psychologist who studies emotion and who was not involved in this study, says. “A lot of times, our feelings are preceded by certain thoughts.” So when we shift our thoughts, that can precipitate a change in our emotions.

It can be a strategy to cope with a bout of anxiety or depression, or it can just be used to foster mental health resilience. “Individuals who report greater amounts of well-being and daily positive emotion report using reappraisal more frequently than people who report daily negative emotion,” McRae says — though she adds that “there is a little bit of a chicken-and-egg thing here.” What comes first: Do positive people reappraise, or do reappraisers become positive people? “But I certainly think that most people consider it to be something that might serve as a buffer.”

Click Here:

Once you get the hang of the technique, it’s easy to apply reappraisal thinking to many different situations. For instance, sometimes when I felt the excruciating boredom of the pandemic winter lockdown, I tried to reappraise the feeling of boredom as peacefulness, the absence of a bad thing. “I’m lucky to be bored,” I’d think. It would make the bitter pill go down more easily.

Emotion regulation passes a massive worldwide test

Wang and the hundreds of other authors wanted to see if they could teach thousands of people around the world similar coping strategies, to help deal with the stress of the pandemic.

They conducted a preregistered study — meaning a study where the methods and analysis plans are locked into place before data collection begins, to help ensure rigor — and tested two subtly different reappraisal methods, targeting negative emotions associated with living through the pandemic.

The first method is called “refocusing.” It might be better described as “looking on the bright side.”

Let’s say you’re feeling sad, staying home during a lockdown. You can refocus your thoughts to some of the more positive aspects of staying at home. Like: “Staying at home is not that bad,” as Wang explains. “You may find more time to spend with your family, or do things you may not have had time to do, such as cooking.”

Another is called “reconstruing.” This goes a little beyond just looking at the bright side of any particular burden, trying to find an overall less-negative narrative to tell ourselves about the pandemic. It’s less about finding the positive in our individual circumstances and more about looking at the big picture in a new light.

In reconstruing the burdens of the pandemic, for example, you could think: “In the past, people have overcome many challenges that seemed overwhelming at the time, and we will overcome Covid-19 related challenges too,” as the study text suggested to participants.

This isn’t about becoming a blinkered robot that’s only allowed to think positive thoughts. “In our intervention, we’re not forcing them to feel positive all the time,” Wang explains. “We’re teaching them to use it to regulate emotions.” It’s about intervening when thoughts become distressing.

It’s not about never acknowledging negative thoughts, either. “I think there’s a really delicate balance between acknowledging the reality, allowing people to sometimes sit with negativity, but also realizing that positive interpretations of things are possible,” McRae says.

In the study, participants were assigned to read about refocusing, reconstruing, or two control conditions. Participants took a survey before they learned the technique to assess their baseline emotional state. Afterward, they were measured again and asked to assess their feelings overall about the pandemic, and how they are responding to it.

Notably, both techniques fared equally well in decreasing people’s negative emotions, and the effects, the authors report, aren’t just statistically significant — they seemed to make a big practical difference for people.

The difference in feelings between those who learned reappraisals, compared to those who did not, was as big as the difference between people who had faced extreme hardships due to the pandemic, compared to those who had not. That’s a notable improvement. (Of course, the interventions are not “guaranteed” to work for any particular individual. The study reported changes on average.)

Also, the interventions didn’t seem to decrease willingness to engage in Covid-safe behaviors like masking. “Some people may worry that if you improve emotions, people may be less cautionary,” Wang says. “But we don’t find that in our study.”

Notably, too, the interventions — which were translated by a team of hundreds of people into 44 languages — broadly worked in every country tested, though there was some variability. The interventions were most effective in Brazil, Germany, and Hungary, and they were least effective in Russia, Romania, and Egypt. “So far, we haven’t found anything that can systematically explain what country can benefit more or less,” Wang says. (The researchers didn’t have representative samples in all the countries studied, so there could be a lot of reasons why they found the variation.)

A psychological finding you can trust

The narrower conclusion of this study, that cognitive reappraisal works, is not super surprising. “The finding that reappraisal decreases negative emotion and increases positive emotion is something that has been replicated over and over and over ad nauseam,” McRae says. “I couldn’t just get that finding published if I really wanted to, because it’s been so well-established.”

But there were aspects of the study that are new and significant. “I think this scale, scope, and timeliness to speak to the crisis we’re in right now were the most impressive parts about it,” she says.

There’s a burgeoning research movement in psychology dedicated to testing out single-session interventions, delivered either online or remotely. Mental health care is often inaccessible and expensive, so the more psychological interventions that can be unbundled from a whole suite of intensive therapy, the more good they can potentially do around the world. Many people whose distress doesn’t rise to the level of a mental health diagnosis could still benefit, the study suggests.

That said, there’s still more work to do here. Other researchers not involved in the project wish it had studied these participants over time, to see if the intervention had a lasting effect.

“A study this large would have provided a particularly informative test of whether a single-session universal intervention could exert lasting, more generalized effects,” says Jessica Schleider, a Stony Brook University psychologist who specializes in studying single-session psychological interventions. “I do think it’s scientifically valuable to know that reappraisal can provide in-the-moment support this broadly, and it can be recommended as one coping option to try for folks in distress.”

The authors of the paper acknowledge this limitation, and some others. The study had people view photos reminding them of Covid-19 stresses, which “might not represent local situations for different groups of participants,” the authors report. It also doesn’t represent all the myriad emotional triggers we encounter living during a pandemic. But most of all, they see this work as foundational for other questions.

The Psychological Science Accelerator, the group behind the massive undertaking of the paper, was launched in response to psychology’s “replication crisis.” Over the past decade, many famous psychological theories have collapsed under rigorous re-testing. As many as 50 percent of all psychology papers might not be replicable, though no one knows the true extent of the rot in the foundations of psychology. There have also been some high-profile cases of outright data fraud related to some of psychology’s most popular findings. The Accelerator, which operates on a shoestring budget (it reports that this study of tens of thousands of people cost only $17,000, much of which came from individual lab members), is seeking to rebuild the field on a firmer foundation.

It’s a “credibility crisis,” Patrick Forscher, a psychologist and member of the Accelerator who worked on the reappraisal paper, says. “Because there are more issues rather than just replicability. So my personal view is that you can look at a lot of psychological findings and just put a question mark on them — not that they’re definitely false. We know that some of the practices that were used to produce a lot of those findings are, themselves, not all that credible.”

The latest test of cognitive reappraisals puts the science of mental health interventions on a firmer foundation. Psychology encompasses a lot of flimsy ideas that claim to make your life better. Here’s one that seems to actually work.

Medicare, the federal health insurance program that covers Americans over 65, is facing an impossible dilemma: Should it cover a new and expensive medication for Alzheimer’s disease, which afflicts 6 million Americans and for which there is no existing treatment, even though the drug might not actually work?

It is an enormous question. Alzheimer’s patients and other families with members who endure mild cognitive impairment that may progress to Alzheimer’s have been waiting decades for an effective treatment. For them, even a few more months of life with improved cognition, one more birthday party or a grandchild’s graduation, is the priority.

But the evidence on whether Biogen’s treatment, called aducanumab, is effective is, at best, mixed; the FDA approved it this week over the objections of its own advisory committee. And with a preliminary announced price of nearly $60,000 annually per patient, covering the treatment could cost upward of $100 billion a year, mostly to Medicare, which would almost double the program’s drug spending. Patients themselves could be on the hook for thousands of dollars in out-of-pocket costs.

What Medicare does about aducanumab will have major ramifications not only for the millions of patients who could potentially be eligible for the drug, but for the future of US health care writ large.

The dilemma results from a feature of the American health care system: Unlike in other countries, the federal government has little room to negotiate what Medicare will pay for treatments.

Independent analysts think the drug is worth more like $8,000, but Medicare has no authority to charge a lower price. Instead, the federal program is likely in effect obligated to cover the new drug now that it has FDA approval. The tools it has to make a determination about whether or not to cover aducanumab and for whom are fraught with legal and ethical risk.

The government now finds itself trying to figure out how to satisfy patients who desperately need help, even though scientists think this particular treatment lacks strong evidence for its effectiveness and policy experts warn it is setting up a budgetary nightmare for Medicare in the future.

“Every conversation we’re going to have for the next few years about health care access is going to be about this drug, whether implicitly or explicitly,” Rachel Sachs, a law professor at Washington University in St. Louis who studies drug pricing, told me this week.

The troubled path to aducanumab’s approval

Alzheimer’s is a terrible disease that robs people of their agency during the final years of their lives and robs families of the loved ones they once knew. The emotional and financial costs are severe. And as the number of Americans over 65 grows, those costs are only expected to increase.

In recent history, the decades-long search for an effective treatment or cure has been driven by what’s known as the amyloid hypothesis, which holds that plaque in the brain found in Alzheimer’s patients is at least in part responsible for the disease and removing that plaque could help relieve the symptoms.

Aducanumab, accordingly, targets the amyloid plaque. Clinical trials of the drug started in 2015 but were halted in March 2019 because it did not appear it would meet the threshold for clinical effectiveness established at the start of the trials. It appeared, in other words, as though the drug didn’t work.

Normally, that would be the end of the story. But an unexpected twist came a few months later when Biogen revealed that, after additional data analysis with the FDA, some patients in one trial had actually seen “better but ultimately mixed results,” as the authors of a Health Affairs post on the controversy put it. Biogen announced it would push ahead with seeking FDA approval in October 2019, with the FDA’s apparent support.

Then, in November 2020, Biogen and aducanumab faced what looked like the ultimate setback: The FDA’s advisory committee on neurological therapies voted the data did not demonstrate the drug was clinically effective. The vote was all but unanimous, with zero in favor, 10 nays, and one uncertain. They raised concerns about potential side effects, such as brain swelling in patients who were given high doses.

But, in defiance of its own advisory committee’s recommendation, the FDA granted aducanumab its approval on Monday. The news was welcomed by Alzheimer’s patient groups but roundly criticized by experts in drug development.

“The FDA … has failed in its responsibility to protect patients and families from unproven treatments with known harms,” the Institute for Clinical and Economic Review (ICER), an independent non-government group that gauges the value of new drugs, said in a blistering statement.

And the agency not only approved the drug over the advice of its scientific advisers, but it put effectively no restrictions on which patients with cognitive impairment should be given the drug, a decision that further stunned experts, as STAT reported.

“For the FDA to approve it and with a very broad indication, I was shocked,” Stacie Dusetzina, who studies drug costs at Vanderbilt University, told me. “I really expected them to say no, based on the body of evidence.”

Medicare almost always covers FDA-approved drugs

Now that aducanumab is approved by the FDA, the issue of coverage falls largely to Medicare; because of the age of the patient population most affected by Alzheimer’s, the federal program is likely to bear the brunt of the drug’s costs.

In practice, if the FDA approves a drug, Medicare will pay for it. Aducanumab would be covered through Medicare Part B, which covers outpatient care, because it is an infusion treatment administered directly by doctors. To be covered by Part B, medical care must be “reasonable and necessary” — a vague standard that has, for medications, historically been mostly synonymous with FDA approval.

Because the drug is covered by Part B, doctors will even have a financial incentive to prescribe it. For prescription drugs, the program pays physicians the average price plus 6 percent, a policy that both Presidents Obama and Trump proposed changing but nevertheless remains in place. Determining which patients would benefit from the drug requires expensive scans, and practices will be able to bill Medicare for those, too.

At the individual level, patients could face out-of-pocket costs anywhere from $0 for patients eligible for both Medicare and Medicaid, to $10,000 annually, since Medicare Part B can hold patients responsible for up to 20 percent of costs, advocates told me.

When I asked Russ Paulsen, chief operating officer of UsAgainstAlzheimer’s, about Biogen’s list price, he responded with an audible sigh, saying: “It’s a big number.”

He continued: “We care a lot about making sure the people who are disproportionately affected by this disease, which includes poor people, have the ability to access this drug.”

Medicare’s inability to determine the price it pays for aducanumab is a uniquely American problem compared to health systems in the rest of the developed world. Countries like Australia and the United Kingdom have independent boards that evaluate a new drug’s effectiveness and set a price based on that estimated value. The US pharma industry says the US system is important for encouraging innovation, and companies have made amazing breakthroughs, such as the hepatitis-C drugs that effectively cure that disease.

But, as the standards for approving have sometimes seemed to slip in recent years, the chances of the FDA approving very expensive drugs with only marginal benefits have risen.

“We don’t require prices to reflect the value of treatment, period,” Dusetzina said. “Companies can price their drugs as high as they want. Companies can also get drugs approved with little evidence.”

So Biogen is planning to charge $56,000 annually for aducanumab. ICER, which evaluates the estimated value of new drugs, estimates, based on the clinical evidence, that it’s worth more like $8,000; perhaps as little as $2,500 or as much as $23,100. Regardless, the price announced after Biogen secured FDA approval “far exceeds even this optimistic scenario,” ICER concluded.

“If we were talking about a cure for Alzheimer’s disease, we would figure it out,” Dusetzina told me. “It would be so important to address that burden on our society, we would need to figure it out.”

But aducanumab is not that drug, according to the available data. So what is Medicare to do?

Despite the tradition of honoring FDA approval, experts do not expect Medicare to simply announce it is going to cover the drug with no limitations. One option would be for the program to conduct “national coverage determination,” a lengthy review process to figure out whether to cover the drug and for which patients. (The price would not be on the table.)

The decision that would lead to is unclear. Many experts are urging Medicare to pursue what is called “coverage with evidence development”: essentially setting up its own clinical trial by authorizing aducanumab for use by some patients and collecting real-world data on their outcomes.

“I think it’d be a really smart move,” Dusetzina, who recently joined Medicare’s payment advisory board, said. “This is the perfect time to reevaluate why we need to consider value when we consider what is a fair price for a treatment.”

Along those lines, the private health insurer Cigna announced it would pursue a value-based contract with Biogen to cover the drug, though it did not provide any more details.

But for Medicare, none of these options are ideal. A previous attempt to set up coverage with evidence development for a new cancer drug in 2017 ended up being scuttled after pushback from the drug industry and doctors. Patients with Alzheimer’s and their families are desperate for treatment and will likely object if Medicare tries to restrict access to the drug while undertaking that data collection.

Alzheimer’s advocates are mindful of aducanumab’s cost to the US health care system as well as individual patients, and its potential limitations. They are not necessarily opposed to more evaluation of its effectiveness.

Click Here:

But their ultimate goal is to buy patients more time. As Paulsen told me: “This drug doesn’t do it perfectly, doesn’t do it amazingly well for every single person. But it’s the first one that does that.”

They say they worry about restricting access to patients who are living with this disease right now, for whom time is running out. They point out that cancer drugs with marginal benefits have also been approved by the FDA, with exponentially higher costs per patient than aducanumab.

“We do not want to see delays in the ability of patients and doctors to begin to discuss whether this treatment is right for them,” Robert Egge, chief public policy officer of the Alzheimer’s Association, said. “And if it is, if that’s their decision together, we want them to have access to it. What we do not want to see is a long protracted process that effectively delays the ability for people to begin this treatment now that approval has been given.”

The stakes are enormous — for everyone. The cost of expensive drugs ultimately trickles down in the form of higher premiums or taxes. As the investment advisory firm Capital Alpha DC pointed out this week in a note that warned the drug “could break the Medicare program,” the Medicare trustees are expected to issue a report any time now with an updated estimate of when the program’s hospital benefit might start to become insolvent — which could be as soon as 2024.

As Sachs told me: “It’s very difficult to see how our health system moves through this without significant negative consequences.”

Medicare’s inability to negotiate pharmaceutical prices has meant that a budget crisis is always just one drug approval away. With aducanumab, that crisis has arrived — even when evidence so far suggests there may be minimal benefit for patients in return.

The Covid-19 pandemic upended daily life so drastically that there was a moment when it seemed to be making a dent in the climate crisis. Rush-hour traffic disappeared, global travel slowed to a crawl, and the resulting economic tailspin sent energy-related pollution plummeting almost 6 percent globally. This kind of decline in pollution is unprecedented in modern human history — it’s as though the emissions output of the entire European Union had suddenly disappeared. It led many to wonder if the Covid-19 crisis would at least give us a little extra time to avert climate emergency.

More than a year after Covid-19 abruptly changed everyone’s routines, the United States is itching to return to “normal,” and some parts of the economy are approaching business as usual. But for the climate, “back to normal” means pollution is rebounding and, worryingly, climate change is accelerating.

“We ultimately need cuts that are much larger and sustained longer than the Covid-related shutdowns of 2020,” said Ralph Keeling, a geochemist who measures carbon pollution at Mauna Loa.

As the Covid-19 pandemic continues to rage globally but starts to abate in the US, here are four ways to understand the new “normal” of the climate crisis.

1. Climate change is accelerating despite the pandemic

While emissions dropped last year, carbon and methane concentrations in the atmosphere just reached their highest-known level in millions of years. Think of it as filling a plugged bathtub with water: Even if you turn down the faucet for a little while, the water will keep rising.

The atmospheric concentration of carbon rose to 419 parts per million in June 2021, based on National Oceanic and Atmospheric Association measurements that have been taken in Hawaii since 1958. This is a level probably not seen since around 4 million years ago — when sea levels were 78 feet higher than they are today.

A chart from NOAA shows that CO2 concentrations from human activities are not only increasing, but going up at a faster rate as time goes on. (The red line shows seasonal fluctuations in CO2.)

Methane concentrations also reached a new peak, seeing the largest annual increase recorded since those measurements began in 1983.

As NOAA explained in its recent press release, “There was no discernible signal in the data from the global economic disruption caused by the coronavirus pandemic.” What’s more, Pieter Tans, a climate scientist with NOAA, told me, “If we managed to keep emissions constant, that’s not enough. Then CO2 would continue to go up at the same rate that we’ve seen in the last decade. Emissions really have to go to zero to stop this problem.”

Looking at the longer-term trends, it’s clear that the pandemic did not slow the acceleration of climate change in the way that some hoped.

2. Fossil fuels still rule the economy

In 2020, renewable energy overtook coal consumption in the United States, and electric vehicle purchases soared 43 percent over their 2019 level. But fossil fuels still reign in transportation and the power sector, the world’s two biggest pollution sources.

During the pandemic, transportation took the biggest hit. Travel is still down globally, but in May, the TSA recorded the biggest day for US air travel since March 2020. The number of US air passengers reached 90 percent of 2020 levels, according to TSA data. Passenger car travel also plunged by about half during the pandemic, but some measurements compiled from GPS data show car traffic surging even past its 2019 levels.

The pandemic led to a temporary crash in emissions, as shown by the International Energy Agency’s tracker of 2020’s monthly emissions change compared to 2019. Around the start of December, where the line turns red, monthly emissions surpassed their 2019 levels.

Of course, these are signs of a rebounding economy. But when fossil fuels still run the underlying fundamentals of the economy, we’re gambling dangerously with climate change.

Worse, it’s still possible for pollution to accelerate if the world chooses “business as usual” in its post-pandemic recovery. Last year, climate scientists from the University of East Anglia, Stanford, and other institutions pointed to the possibility that emissions could rebound to levels worse than before if politicians delay climate action for temporary economic gains. The former Trump administration justified environmental rollbacks in part by citing the pandemic’s impact, and now the Wall Street Journal reports that China is limiting the rollout of its national carbon-trading program later in June.

Click Here:
3. The global target of 1.5 degrees Celsius is almost out of reach

One of the key developments of the 2015 Paris climate agreement was a new target for containing climate change: restricting warming to 1.5°C, and “far under” the more disastrous 2°C.

In that effort, “normal” won’t cut it. The return to flying, driving, and commuting carves away from a limited global budget of pollution, which represents everything the atmosphere can afford before the 1.5°C target is reached. A United Nations agency, the World Meteorological Organization, updated its analysis in May and underscored that we’re essentially out of time. It found a fairly good chance — 44 percent — that the Earth will hit 1.5°C of warming in one of the next five years. That’s double the odds from just one year ago.

Last year was also one of the hottest on record, at 1.2°C above the pre-industrial average, and parts of the world are warming unevenly and have already surpassed 1.5°C. These variations don’t sound huge, but their real-world impacts can be catastrophic and concentrated in particular regions.

Parts of the Middle East hit 125 degrees Fahrenheit in June, a dangerous record even before summer settles in. The American Southwest could see similar temperatures this summer. Extreme heat causes more deaths than any other type of weather disaster and can cause power failures and infrastructure problems such as warping roads and railroad tracks.

Not only is the heat a public health threat, it also exacerbates deepening droughts that fuel the conditions for widespread wildfires.

In a warming world, these are not freakish events. These events, and worse than we’ve experienced yet, become the new normal.

4. Public opinion hasn’t changed either, which is surprisingly good news

A return to normal doesn’t have to mean climate change careens out of control. It’s a path governments choose if they continue to subsidize fossil fuels and fail to meet the challenge of investing in renewable infrastructure.

The pandemic hasn’t diminished people’s appetite for action on climate change, argues Anthony Leiserowitz, the director of the Yale Program on Climate Change Communication who has studied American opinions on climate change. “Public opinion about climate change hasn’t changed at all. It actually picked up a little bit,” Leiserowitz said. “I don’t see any evidence that people’s views have changed dramatically, either because of the pandemic or the economic crisis.”

Similarly, in the Great Recession of 2009, Leiserowitz studied the effect of unemployment, home value, and the economic downturn on the public’s views on climate change. He was surprised to find it did not diminish voter attitudes on climate. “A majority of Americans actually think that taking action to deal with climate change will grow the economy and increase the number of jobs,” he said.

Most Americans don’t think there has to be a zero-sum trade-off between climate change and economic growth. The Biden administration has capitalized on that view, making the case for “building back better” and trying to boost the economy with a climate-focused infrastructure package. But this can’t happen without large-scale political action. The US may savor a returning sense of normalcy — but the whole world need to remember that normal was never good enough.

Another Covid-19 vaccine, this one from the biotech firm Novavax, has posted superb results in a phase 3 clinical trial, the company announced on Monday. But with more than half of US adults now vaccinated against Covid-19, the biggest impact of these results may be in other countries.

The Novavax vaccine stands out from other Covid-19 vaccines because it uses a technology that has not been deployed to date. It can also be stored at ordinary refrigerator temperatures, unlike some other vaccines that have strict freezer requirements that complicate distribution.

Click Here:

Novavax said its vaccine candidate was 90 percent effective overall against Covid-19 cases that produce symptoms, and 100 percent effective against moderate and severe disease. The results, from nearly 30,000 participants across the US and Mexico, could make it the fourth Covid-19 vaccine to begin distribution in the US, following vaccines developed by Pfizer/BioNTech, Moderna, and Johnson & Johnson.

But the first approvals of the vaccine will likely come in other countries, Stanley Erck, CEO of the Maryland-based company, told the New York Times. Novavax may not even seek emergency authorization for its vaccine in the US until September. At that point, it may not make much of a difference to the US vaccination effort.

As part of the US government’s Operation Warp Speed, last July Novavax was awarded $1.6 billion for vaccine development and production of 100 million doses. At the time, the 20-year-old company faced skepticism for never having brought a vaccine to market.

Novavax now aims to scale up production, with a goal of 150 million doses per month by the end of the year with factories in the US, South Korea, and India. Its two-dose vaccine comes at an expected cost of $16 per injection. That’s more expensive than the adenovirus-based vaccines developed by Johnson & Johnson and AstraZeneca, but around the same price or cheaper than the mRNA vaccines made by Pfizer/BioNTech and Moderna.

The Novavax vaccine did exhibit lower efficacy against variants of Covid-19, but the company is studying reformulated versions to target them. With Covid-19 continuing to spread in many parts of the world, having another option to counter the disease will bolster the effort to contain the pandemic.

What makes Novavax’s approach different from other Covid-19 vaccines

Vaccines are like target practice for the immune system: They encourage our bodies to build up defenses against a particular threat, without making us sick. When the real pathogen arrives, immune cells are ready to act, preventing infection altogether or dampening the worse effects of the disease.

Traditional vaccines contain weakened or inactivated versions of viruses or bacteria, or fragments of them. But new approaches have been brought to bear on Covid-19. Moderna and Pfizer/BioNTech vaccines use a snippet of genetic material, mRNA, encased in a nanoparticle. Human cells can read those genetic instructions and manufacture a fragment of SARS-CoV-2, the virus that causes Covid-19, which spurs the immune system to prepare for the virus.

The Covid-19 vaccines developed by AstraZeneca and Johnson & Johnson also shuttle genetic instructions to human cells, encouraging them to make a fragment of SARS-CoV-2, but they use a different virus — an adenovirus — that carries a snippet of DNA.

Novavax’s approach blends old and new techniques. To make the vaccine, the company combines another kind of virus — a baculovirus — with the genetic information needed to make a spike protein, a key fragment of SARS-CoV-2. When moth cells are infected with this virus, they manufacture the spike protein. Scientists then harvest and fuse those proteins with a nanoparticle. These nanoparticles combined with spike proteins are what is injected in the Novavax vaccine.

According to Novavax, this approach yields a strong immune response with minimal side effects. The main complaints from vaccine recipients were fatigue, headache, and muscle pain lasting less than two days.

How Novavax fits into the vaccination campaign

While new infections, hospitalizations, and deaths are trending downward in the United States, the Covid-19 pandemic continues to rage in other countries. India, currently an epicenter of the pandemic, recently set a new world record of more than 6,000 daily Covid-19 deaths. Part of the toll stems from the Delta/B.1.617 variant of the virus, which appears to be more transmissible. Health officials warn that other countries with limited resources and low vaccination rates remain vulnerable to their own outbreaks. And as long as the virus continues to spread, it risks mutating in dangerous ways that can reverberate to places like the US.

Leaders at the G7 summit last week committed to sharing 1 billion doses of Covid-19 vaccines with other countries, with half coming from the US. For its part, Novavax is partnering with manufacturers in other countries like India and South Korea to scale up its production. The company had pledged at least 1.1. billion doses of its vaccine through Gavi, an international vaccination consortium.

Novavax may still have a future role in the US. The company is investigating how its vaccine could work as a booster, bolstering protection from other vaccines as immunity wanes over time. A study last month showed that even mixing shots of different vaccine platforms led to robust immune protection. But it’s not clear yet how long the shielding provided by other Covid-19 vaccines will last.

At the same time, the virus itself is continuing to change. Novavax’s results on Monday showed that its vaccine had 86.3 percent efficacy at preventing disease caused by the Alpha/B.1.1.7 variant of the virus, which first appeared in the United Kingdom. It shows that protection was high, but not as high as immunity to earlier strains of the virus.

Early phase 2b results from South Africa, however, showed the vaccine yielded 48.6 percent efficacy against the Beta/B.1.351 variant in HIV-negative participants. The company is now investigating a retooled version of its vaccine aimed specifically at the Beta variant.

The ongoing evolution and spread of Covid-19 shows that the pandemic is not over, and it’s too early to become complacent. A new way to immunize against Covid-19 is a welcome development — particularly if it can reach the most vulnerable, and quickly.