Month: March 2022

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.

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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.

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.

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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.

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.

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.

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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.

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.

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.

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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.”

“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.