Month: March 2022

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.”

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.)

Click Here:

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.

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).

Click Here:

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.

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.

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.

Click Here:

The world’s leading health organization, the WHO, repeatedly broke its own rules and spent millions of dollars on high-priced management consultants, according to a new independent audit — even as the United Nations agency has struggled to pay for lifesaving equipment and vaccines in its global Covid-19 response.

An unnamed consulting company, which Vox has identified as BCG, charged the World Health Organization $11.72 million since the start of the pandemic for contracts that were dubiously awarded, according to the audit.

These revelations, which one expert called “disturbing” in an interview with Vox, came after a Vox investigation showed how management consulting firms such as BCG and McKinsey have become ubiquitous in global public health organizations, despite the concerns of many health practitioners about multimillion-dollar price tags, potential conflicts of interest, and the opaque nature of consulting work.

WHO researchers told Vox that the auditor report raised questions about the agency’s ability to responsibly and transparently spend public money from the 194 member countries that fund it. In recent months, the WHO has requested donations from its members and the general public, citing a funding gap of more than a billion dollars for its pandemic response.

Given that the WHO’s 2020-21 budget is $5.84 billion, $12 million may not sound like a massive amount — “but $12 million for a health care system in a low-income country would comprise a significant portion of their funding,” says Adam Kamradt-Scott, the incoming global health chair at the School of Transnational Governance in Florence, who studies the WHO. That amount could pay for about 600,000 Covid-19 vaccine doses from Pfizer/BioNTech or Moderna. (The WHO is part of Covax, whose aim is to ensure all countries have equitable access to vaccines.) “If it’s money being wasted, that’s a lot of vaccines that could have been purchased,” Kamradt-Scott added.

The audit, which examines a sampling of the WHO’s biggest contracts, analyzed the agency’s work with BCG, known as “Consulting Firm A” in the report, and uncovered multiple violations of WHO policies. The auditors claim WHO staff sought to circumvent the organization’s public procurement rules in order to help BCG win a contract. Staff at the agency also broke WHO rules by repeatedly starting work with the firm before seeking formal approval to do so, according to the report.

Before the pandemic, Vox revealed the WHO committed at least $12 million on consultants to support the agency’s reform, approximately a quarter of which has been paid for directly by the Bill and Melinda Gates Foundation. At the time, a WHO spokesperson said the agency welcomed consultants’ work. “The [consulting] companies have supported WHO in areas where we lack in-house expertise or want to tap the current best-in-class standards.”

But controversy has surrounded high-priced consultants in a field dedicated to improving the health of the world’s poorest people. The consulting firm McKinsey advised the Trump administration on how to cut spending on food and medical care for migrants and played a role in increasing sales of prescription opioids, which have been linked to the deaths of hundreds of thousands of people around the world. Vox also documented how BCG helped boost sales of sugary drinks in India, although the WHO has called for reducing sugary drinks consumption and supports taxing the products.

The findings in the audit were recently accepted by the WHO’s member states at the annual World Health Assembly. In a statement, the WHO said it “takes seriously the recommendations of our oversight bodies and uses the constructive comments to address any identified weaknesses in our control environment — we are a learning organization, and these reports help us to continuously improve in all identified areas.”

The international agency said the contracts were awarded in the context of an unprecedented health emergency, but added that the agency is taking the recommendations in the report seriously, and has “already begun implementing many of those related to procurement.”

In a statement, BCG said, “As the global pandemic unfolded last year, BCG rapidly mobilized teams to support worldwide efforts to fight the spread of the virus. We are extremely proud of our work that contributed to saving lives in this unprecedented time and remain committed to providing our best minds and efforts to support the progress of public health.”

It’s possible “the high stress and the insufficient human resources at the onset of the pandemic made things worse and made WHO even more in need of consultants’ support and more vulnerable to their conditions,” said Gian Luca Burci, the WHO’s former legal counsel.

But “this seems to have been a misuse of funds,” Kamradt-Scott said. “This is disturbing. At least on the surface, it would appear that due diligence checks in how external agencies are engaged don’t appear to have been followed.”

Click Here:

“The auditor’s report raises a red flag, and the issue of WHO’s contracts with management consulting firms deserves more scrutiny,” said Suerie Moon, co-director of the Global Health Centre at the Graduate Institute of Geneva. At the end of the day, Kamradt-Scott said, the WHO has a “moral obligation to ensure every cent is spent appropriately.”

How the WHO broke its rules to work with BCG

Publicly funded agencies, including those that are part of the UN system like the WHO, are supposed to follow stringent rules when hiring external contractors such as management consultants. According to WHO policy, staff should “obtain the best value for money” when hiring external contractors, allow for “transparent competition among prospective providers,” and treat contractors equally.

According to the audit, BCG won eight contracts with the WHO in 2020 for a total value of $11.72 million, and the auditors closely scrutinized the two highest-value contracts, for which the WHO paid $5.4 million.

1) The auditors found WHO staff changed criteria to help BCG win work at the agency. For a contract that lasted from December 2020 to May 2021, the organization asked consultants for competitive proposals to “support the long-term vision for WHO supply chain and to build capabilities to execute the long-term supply chain vision.” Of the four consultants that submitted bids, BCG was one of two that were deemed technically qualified. But another firm won the highest score and should have been awarded the contract, the audit found. “WHO changed the evaluation criteria and re-evaluated the bids as per which Consultant A [BCG] scored higher and was awarded the consultancy,” the report said.

“The findings of the independent auditor suggest this doesn’t seem to be a case of negligence where protocols haven’t been followed because someone didn’t know what to do,” Kamradt-Scott told Vox. “It would appear WHO staff knowingly sought to circumvent the rules in order to engage a preferred provider.”

2) BCG started working for the WHO ahead of formal approval, according to the report. For the second contract, which ran from March to October 2020, BCG was hired to help the WHO purchase personal protective equipment and other essential supplies during the pandemic. Here, too, the auditors uncovered multiple irregularities.

The WHO started the work with BCG “without due approval of the competent authority, despite the fact that it entailed payment of $2.53 million by WHO,” the auditors wrote. WHO staff only sought formal approval four months after BCG started work for the agency and three of the four phases of their contract were complete, the audit found.

In the report, the WHO says it didn’t have the human resources to go through the proper procurement processes, but the auditors rejected this reasoning. “We are of the view that the formal process of approval should have been adopted before accepting the offer of [BCG] and engaging the firm. The delay in getting the approval of the competent authority was not justified.”

3) The auditors questioned whether BCG provided value for money. In one of the nine purchase orders that BCG negotiated on behalf of the WHO, the consultants got a 20 percent price reduction on protective gowns. The WHO and the consultants placed the order and approved the quality of the gowns. But an external PPE supplier, which was supporting the WHO, deemed the gowns low-quality and canceled the order. In another case, auditors flagged a missed opportunity for savings. Consultants negotiated a discount of 0.08 percent off N95 masks, for a savings of $9,750. In the same month, the same supplier fulfilled another mask order with a discount that amounted to $303,200. “We noted that [BCG] did not negotiate this price, which had better potential for saving,” the auditors wrote.

4) WHO paid millions of dollars for “pro bono” work. Another revealing finding from the audit was that BCG characterized its PPE procurement work as “pro bono,” even though one seven-month contract cost $7.3 million, of which $2.53 million was paid for by the WHO. Only the cost of the first of three phases and a transition period was covered by the consulting firm. “We are of the view that calling this engagement pro bono is not correct,” the report says.

The report comes at a time when the WHO is trying to strengthen its finances and wrangle more flexibility over how it spends money. The agency is asking for more support from countries that fund it — known as “assessed contributions” — which can be spent on a variety of expenses. The WHO is also funded by donors, such as the Gates Foundation, but that money tends to be earmarked for specific purposes.

As troubled as Moon was by the audit report’s findings, she suggested that scrutiny from the auditors is a step toward a stronger World Health Organization. “You can only have less earmarking if it’s followed by more accountability and transparency,” she said. “Heightened scrutiny of contracts with management consulting firms is one place to start.”

Tiny, wriggling horrors are hatching right now, under our feet, across the country.

No, not the billions of Brood X cicadas emerging throughout the eastern US. I’m talking instead about baby invasive “crazy worms” that thrash through garden, farm, city, and forest soil, growing to 3 to 6 inches in length, sucking up nutrients, and transforming rich leaf litter into coarse droppings. All while laying nearly 20 hardy worm cocoons a month, without needing a mate.

Variously known as jumping worms, snake worms, Alabama jumpers, and Jersey wrigglers, common Amynthas species are a super-powered version of the more familiar, squishy languidness of the garden-variety European earthworms (whose genus name, Lumbricus, itself sounds plodding). And their rapid spread into new areas has led to a surge of concern about these worms.