22 Jun 2021

WHO warns that Delta variant of coronavirus will “pick off” the unvaccinated

Patrick Martin


Officials of the World Health Organization issued a stark warning Monday that the Delta variant of coronavirus posed a major danger to the world’s population and that rates of serious disease and death could rise significantly unless vaccination efforts were stepped up, particularly in the poorer countries.

At a press briefing, WHO Director-General Tedros Adhanom Ghebreyesus said that Africa, the Americas and Asia “are facing steep epidemics. These cases and deaths are largely avoidable. … The inequitable access to vaccines has demonstrated that in a crisis, low-income countries cannot rely on vaccine-producing countries to supply their needs.”

Cemetery workers transport the remains of a COVID-19 victim for burial in Buenos Aires, Argentina, Saturday, May 22, 2021. (AP Photo/Mario De Fina)

Ghebreyesus harked back to the denial of anti-retroviral drugs to countries affected by HIV, and the price-gouging of insulin supplies for countries affected by diabetes, although the drug has been known for a century. Criticizing the pharmaceutical industry, he argued for sharing technical knowledge and waiving intellectual property rights: “The COVID-19 crisis has shown that relying on a few companies to supply global public needs is limiting and dangerous.”

Dr. Maria Van Kerkove, the WHO technical lead on COVID-19, explained that the Delta variant was spreading rapidly around the world, because “it has an opportunity to spread given that we have increased social mixing, relaxation of public health and social measures, or the inappropriate use of public health and social measures. … And given that we don’t have full vaccination, it will spread.”

The Delta variant has been detected in 92 countries, she said, but so far the two-dose vaccinations “remain effective against severe disease and death, but we need two doses to be administered.

“Public health measures are effective but need to be administered longer,” she said, adding, “Some countries have public health measures and the vaccine. Some have public health measures without the vaccine. That is not a fair fight against this variant.”

Dr. Mike Ryan, executive director of the WHO Health Emergencies Program, also emphasized the dangers of the new variant for people of the poorer countries who have largely been deprived of access to the vaccines by the policies of the main vaccine-producing countries.

“This particular Delta variant is faster, it is fitter, it will pick off the more vulnerable more efficiently than previous variants,” he said, “and therefore if there are vulnerable people left without vaccination, they remain even at further risk.

“All of the viruses have been lethal in their own regard. This virus has the potential to be more lethal, because it is more efficient in the way that it transmits between humans, and it will eventually find those most vulnerable individuals who will become severely ill, have to be hospitalized, and potentially die.”

He concluded, “We can protect those people now with relatively small transfers of vaccine from the global supply. We can protect those vulnerable people, those front-line workers. And the fact that hasn’t happened, as the director-general has said again and again, is a catastrophic moral failure at the global level.”

What all three officials of the global health agency were remarking on—while avoiding naming any names—was the policy of vaccine nationalism, hoarding vaccines, and refusing to waive intellectual property rights, engaged in by the major imperialist powers, particularly the United States, Britain, France and Germany.

The Biden administration in the United States has flatly refused appeals that Pfizer, Moderna and Johnson & Johnson be required to transfer technology to India, South Africa and other developing countries that have existing pharmaceutical production capacity, and to stop price-gouging for shipments of the life-saving vaccines.

Britain and the European Union have adopted a similar policy for their own drug manufacturers.

All the imperialist powers treat vaccine supplies as a weapon in the global struggle for influence, power and strategic advantage against China and Russia, as well as against each other.

As for the warnings by WHO doctors and scientists that the Delta virus will “pick off” the vulnerable, there are many in the ruling classes of the imperialist powers who regard that as a positive feature. They regard the lives of the elderly and infirm in their own countries as a drain on resources that could go to profits and the amassing of personal wealth. They care even less for the lives of hundreds of millions facing disease and death in the poor countries.

Dr. Ryan noted, quite correctly, that “convergent evolution” is a growing threat to humanity as a whole. The mutation of the coronavirus is facilitated and fueled by the existence of a large pool of unvaccinated people. No variant has yet found the deadliest combination of transmissibility and lethality, he said, but the Delta variant is a major step in that direction. There will be many more potential new variants if the pandemic is not shut down.

Hundreds of millions of people are in danger in the imperialist countries as well, despite the efforts by governments and the corporate media to spread complacency and declare the pandemic over. In Britain, the Delta variant has now become the dominant strain. It now accounts for 19 percent of all US cases, up from 7 percent two weeks ago.

Eight US states have had sharp increases in the number of cases over the past week because of the Delta variant. All of them are states with low vaccination rates and state governments which have halted virtually all public health measures against COVID-19.

The Biden administration issued Monday an international distribution list for a pathetic 80 million doses of US-owned vaccines. Given that there are nearly 6 billion people unvaccinated in the world, this barely qualifies as a drop in the bucket. Much of it is intended for the use of the ruling elite and military forces in client countries, like the 2.5 million doses for Taiwan, which has rejected the offer of the Chinese-made Sinovax, to the detriment of its own people.

As for the 2 billion doses in aid, pledged by the US and other G7 powers at their recent summit, given that effective vaccination with most vaccines requires two doses, this amounts to a declaration that only 1 billion of the 6 billion unvaccinated people in the world can expect any help from the wealthy imperialist countries. The remaining 5 billion people will face the terrors of a lethal virus with only masks and limited social distancing, if that.

Ousting of National Party leader highlights political instability in Australia

Mike Head


Yesterday’s sudden, apparently largely unanticipated, deposing of the deputy prime minister and National Party leader Michael McCormack has pointed to an accelerating fracturing of Australia’s parliamentary establishment.

No figures were released but reportedly by just 12 votes to 9, National Party members of parliament opted to return Barnaby Joyce to those posts from which he had been ousted in February 2018.

Australian Prime Minister Scott Morrison, right, and deposed Deputy Prime Minister Michael McCormack brief the media in Canberra, Thursday, Feb. 6, 2020. (AP Photo/Rod McGuirk)

The narrow margin is a sign of unresolved rifts in the rural-based party, and the Liberal-National Coalition government as a whole. In the short-term, Agriculture Minister David Littleproud will stay as the Nationals’ deputy leader. He voted for McCormack but then chose not to run after a spill motion was called and may seek to displace Joyce in the months ahead.

Joyce’s “resurrection” has the potential to further destabilise the Coalition government, which has been shaken by one crisis after another in recent months, not least the worsening debacle of the COVID-19 vaccine operation, which has opened the door to a resurgence of the pandemic.

Even as the National MPs were meeting behind closed doors in the parliament building, Prime Minister Scott Morrison was convening an “emergency” meeting of the bipartisan National Cabinet with state and territory government leaders over the vaccine crisis.

Joyce’s revival is a clear blow to Morrison and his authority within the government. Having just returned from the G7 summit in Britain, Morrison was still in quarantine in the official prime ministerial residence as the Nationals “spilled” McCormack, with whom Morrison has worked closely.

The corporate media has largely depicted Joyce’s return in terms of opposition by coal mining industry-related factions of the National Party to Morrison’s efforts to push the Coalition toward accepting the goal of zero net carbon emissions by 2050, as now demanded by the Biden administration in the US as well as the European capitalist powers.

Driving the Coalition infighting, however, are wider and deeper conflicts, bound up with growing popular political disaffection, soaring social inequality and the escalating US offensive against China.

Joyce is a right-wing populist, backed by the most far-right elements within the National Party. Decades of corporate economic restructuring, accompanied by the dismantling of former national-based protectionist measures such as collective marketing schemes, have shattered the National Party’s former base among family farmers. Tens of thousands have been driven from the land to make way for agribusiness conglomerates.

Joyce has a record of railing demagogically against globalisation and big banks, falsely claiming to represent the interests of small farmers and workers in regional areas, and of trying to whip up nationalist and anti-Chinese sentiment. He fully backs Washington’s strident stance against Beijing, having previously branded China “our security threat” and agitated against Chinese investments in Australian-based agribusinesses. In 2019, Joyce succeeded in securing a Morrison government ban on a takeover by a Chinese company of the country’s largest milk processor, Lion Dairy and Drinks.

In the most immediate sense, Joyce’s comeback means the Coalition agreement with the Liberal Party, led by Morrison, must be renegotiated, with Joyce likely to demand stronger representation in the cabinet and more explicit backing for the coal mining industry.

Just over two years ago, in March 2019, during a previous bid to retake the leadership, Joyce raised the prospect of terminating the Coalition if he succeeded. There was “no law saying the Nationals and Liberals must be together,” he declared. Putting the interests of inner-city Liberals ahead of regional Nationals was “just like political serfdom, we will look after ourselves,” he told Australian Broadcasting Corporation radio.

For now, it seems that Morrison and Joyce will seek to patch up the Coalition, although it may be days before a new partnership agreement and ministerial line-up is adopted.

There is dismay in the government and the big business media. Today’s Australian Financial Review editorial voiced alarm over the “running body count of party leaders.” The Australian, a Murdoch flag-bearer, said McCormick’s removal was “an unwelcome reminder of the revolving-door syndrome in which deposed leaders destabilise a party as they plot their return.”

The Morrison-Joyce combination would be the eighth change of leadership since the Coalition took office in 2013. The departure of previous National Party leaders and the deposing of prime ministers Tony Abbott in 2015 and Malcolm Turnbull in 2018 came on top of the ousting of four prime ministers from 2007 to 2013—John Howard, Kevin Rudd (twice) and Julia Gillard.

In 2018, figures within the National Party’s most big business-aligned factions, such as former party leader John Anderson, teamed up with Turnbull to force Joyce to resign from the leadership, supposedly because of an extra-marital affair and sexual assault allegations. But that was a mask for the underlying fissures wracking the Coalition.

Joyce’s “resurrection” marks a revival of attempts by the most right-wing elements within the Coalition to turn it into a more Trump-style movement to divert growing social unrest in nationalist, anti-Chinese directions, amid more signs from recent state elections of collapsing support for both the major ruling parties: Labor and the Coalition.

Joyce has been a strong backer of the coal industry, including a potential government-financed coal-fired power station in central Queensland, advocated by one of his supporters, Senator Matt Canavan.

Many corporate interests, however, including in agribusiness, are now investing in carbon “farming” and trading schemes as profitable means of exploiting the schemes being introduced by the major powers internationally in the name of addressing climate change.

Key business groups, among them the National Farmers Federation and Business Council of Australia, support the Australian government signing on to the net zero 2050 emissions target at November’s United Nations Climate Change Conference in Scotland. They fear the imposition of “carbon tariffs” by US and European governments on the pretext of upholding the target.

From that standpoint, the Australian Financial Review denounced the Nationals’ decision to “rehabilitate a destructive climate populist as its leader.” It would undercut “the confidence of capital markets and investors” in funding gas projects and other supposed “decarbonisation” ventures.

Asked yesterday about his threat as a backbencher to cross the floor of parliament to vote against a net zero 2050 target, Joyce defiantly said he would seek the “best deal for regional” local jobs and industry, “as opposed to a Danish one or a German one.”

On China, Joyce said the Nationals had been right to call for tougher foreign investment laws, “when everyone was calling us bigots and rednecks.” He added: “Now they just call us correct.”

Driving this political crisis are two related factors, both intensified by the global pandemic. One is the anxiety in the ruling class to divert the mounting discontent in the working class—over ever-more glaring social inequality and declining living conditions—into anti-immigrant, jingoistic and militarist directions. These fears are compounded by signs of a global upsurge in working-class struggle.

The other factor is the stepped-up demands from the Biden administration for Australia’s unconditional alignment with the US in its economic and military confrontation with China, Australian capitalism’s largest export market, despite widespread popular opposition to war and US militarism.

In response to the convulsion in the government, the Labor Party has stepped up its pitch to the financial elite, outlined at Labor’s recent national conference, that it is the party best able to govern in periods of social unrest and war.

Party leader Anthony Albanese said the Nationals’ leadership shift showed the government was being “self-indulgent” at a time of national crisis, whereas he was “focused on the needs of the Australian people.” Albanese said he would welcome an early election to “end this circus.”

Working closely with the trade unions, the Labor leaders are talking up the prospect of an early election in order to try to corral working-class discontent back behind the election of yet another big business Labor government, like those of Hawke and Keating, and Rudd and Gillard.

21 Jun 2021

How America’s 50 Largest Inherited-Wealth Dynasties Accelerate Inequality

The “Silver Spoon Oligarch” report finds that inherited wealth dynasties are growing not only due to an inadequate tax system, but also excessive hiding of wealth in dynasty trusts, and low charitable giving by multi-generational wealth dynasties. It also finds that members of the inherited wealth generation are using their wealth and power to rig the rules to get more wealth and power. Some are even using their charitable donations and political giving to press for lower taxes.

Wither Encryption: What Operation Trojan Shield Reveals

Binoy Kampmark


My, were they delighted.  Politicians across several international jurisdictions beamed with pride that police and security forces had gotten one up on criminals spanning the globe.  It all involved a sting by the Federal Bureau of Investigation, led in conjunction with a number of law enforcement agencies in 16 countries, resulting in more than 800 arrests.  The European Union police agency Europol described it as the “biggest ever law enforcement operation against encrypted communication”.

The haul was certainly more than the usual: over 32 tonnes of an assortment of drugs including cocaine, cannabis, amphetamines and methamphetamines; 250 firearms, 55 luxury cars, and some $48 million in cash, both tangible and digital.

Operation Trojan Shield arose because of a grand dupe.  It involved recruiting an FBI informant who had developed an adulterated version of the encryption technology platform Anom, to be used on modified cell phones for distribution through a range of organised crime networks.  The platform included a calculator app that relayed all communications sent on the platform back to the FBI.   “You had to know a criminal to get hold of one of these customised phones,” the Australian Federal Police explained. “The phones couldn’t ring or email.   You could only communicate with someone on the same platform.”

The users were none the wiser.  For three years, material was gathered and examined, comprising 27 million intercepted messages drawn from 12,000 devices.  This month, the authorities could no longer contain their excitement.

While the criminals in question might well have been mocked for their gullibility, the trumpeting of law enforcement did not seem much better.  A relentless campaign has been waged on end-to-end encryption communication platforms, a war against what policing types call “going dark”.  To add some light to the situation, the agencies pine for the creation of tailored back doors to such communications apps as WhatsApp, iMessage and Signal.

Few could forget the indignant efforts of the FBI to badger Apple in 2016 to crack the iPhone of Syed Farook, the San Bernardino shooting suspect.  Apple refused.  The battle moved to the courts.  In what has become something of a pattern, the DOJ subsequently dropped the case by revealing that it had “successfully accessed the data stored on Farook’s iPhone and therefore no longer requires the assistance of Apple Inc.”  The DOJ then requested that a court order of February 16 demanding Apple create software with weakened iPhone security settings be vacated.  By refusing to reveal how it had obtained access to the phone, government authorities had thrown down the gauntlet to Apple to identify any glitches.

In 2020, a number of international politicians with an interest in the home security portfolio released a joint statement claiming to support “strong encryption, which plays a crucial role in protecting personal data, privacy, intellectual property, trade secrets and cyber security.”  A casual glance at the undersigned would suggest this to be markedly disingenuous.  Among them were: Priti Patel, UK Home Secretary; William P. Barr, US Attorney General; Peter Dutton, Australian Minister for Home Affairs.

Having given nods of approval for encryption as “an existential anchor of trust in the digital world”, the ministers took aim at the various platforms using it.  On this occasion, it was the “challenges to public safety” posed by the use of encryption technology, “including to highly vulnerable members of our societies like sexually exploited children.”  (The battle against solid encryption is often waged over the bodies and minds of abused children.)  Industry was urged “to address our concerns where encryption is applied in a way that wholly precludes any legal access.” This would involve companies having to police illegal content and permit “law enforcement to access content in a readable and usable format where an authorisation is lawfully issued, is necessary and proportionate, and is subject to strong safeguards and oversight”.

Cases like Anom demonstrate that there is seemingly no need for such intrusions, bells of alarm, and warnings about safety.  The police have sufficient powers and means, and more besides.  As with such matters, the danger tends to be closer to home: police zeal; prosecutor’s glee; a hatred of privacy.  Joseph Lorenzo Hall, senior vice president at the non-profit Internet Society, is convinced of that fact.  “When law enforcement agencies claim they need companies to build in backdoors to help them gain access to the end-to-end encrypted communications of criminals, examples like Anom show that it’s not the case.”

John Scott-Railton of the Citizen Lab at the University of Toronto’s Munk School of Global Affairs and Public Policy makes the same point.  “What this case shows is that global law enforcement is perfectly capable of mobilising a multiyear caper to get around exactly the kinds of problems about encryptions that they’ve been talking about without breaking the encryption of the apps that keep you and [me] private.”

The Australian wing of the operation had even greater extant powers of access to encrypted messages.  The Telecommunications and Other Legislation Amendment (Assistance and Access) Act 2018 is one of those beastly instruments many law enforcement agencies dream about.  It might also suggest why Australia, a nominally small partner, might have been asked by the FBI to be involved in the first place.  When asked if this was the case, Australian Prime Minister Scott Morrison suggested that the question be put to US authorities.  For him, the AFP’s hardly impressive technical efforts were to be praised.

None of this is enough for the Morrison government, which is intent on further pushing the surveillance cart in such proposed laws as the Surveillance Legislation Amendment (Identify and Disrupt) Bill 2020, and the Telecommunications Legislation Amendment (International Production Orders) Bill 2020 (IPO Bill).  The former would permit the AFP and the Australian Criminal Intelligence Commission to issue a new range of warrants for combating online crime; the latter would create a system by which Australian agencies would be able to access stored telecommunications from identified foreign communication providers in cases where Australia has a bilateral agreement.

Operation Trojan Shield has again shown that calls for weakened encryption are to be treated with due alarm.  Almost silly in all of this was the fact that the FBI and fellow agencies made it a demonstrable fact, undercutting their very own arguments for a more invasive surveillance system. The next play is bound to come from the criminal networks themselves, who, wounded by this deception, will move towards more conventional encryption technologies. The battle will then come full circle.  In countries such as Australia, where privacy is a withering tree, the encryption debate is a dead letter.

Necropolitics in the Amazon

Eduardo Gudynas


During these pandemic times, everything seems to indicate that the socio-environmental crisis is getting worse in Latin America, especially in regions like the Amazon. This is not always recognized or adequately addressed, as the Covid-19 emergency takes center stage and other problems are put on the back burner.

Governments, the private sector and many other actors are using the pandemic as an excuse to justify harmful practices.  These actors are pushing extraction strategies, such as mining and oil concessions and agricultural expansion, in order to re-start economic growth.

As usual, the Amazon is on the frontlines of the war for the appropriation of the natural world. Most people when they hear ‘Amazon’, think only of Brazil. And while the situation in that country certainly is alarming, the battlefields of the Amazon region span northern Bolivia, various departments of Peru, several areas of Ecuador and southern Colombia and Venezuela.

In all parts of the Amazon, the indigenous populations are the first to be affected. The Amazon region is not empty space; it is their home. Extractive activities destroy their environment, pollute their food supply and cause additional suffering and violence, ranging from displacement, to persecution or assassination. Some groups, like the Yanomami in Brazil, face risk of genocide, fueled by both legal and illegal extraction activities.

This is how the extraction of natural resources operates, especially in virgin areas and protected lands, affecting indigenous territories or reserves, environmental protection areas, or high biodiversity sites.

Multiple interlinking factors exacerbate this dynamic. Pressures imposed by national companies or local subsidiaries of foreign corporations, aligned with discourse from local politicians, academics and even trade unions, reinforce the usual narrative that the Amazon region is either empty space or an area to be exploited for export.

International pressures determined by factors such as the global demand for raw materials, international prices, or investors’ interests also determine what happens to the Amazon. These conditions are the result of globalization dominated by transnational corporations and are much more intense than national or local factors.

For example, as the international price of gold increases, mining spreads across the Amazon and up the slopes of the Andes. In some cases it is formal, carried out by transnational corporations or even local cooperatives (as in Bolivia), but in others it is informal or illegal, feeding contraband networks (as in Colombia or Peru). Its consequences include the deforestation of the forest and mercury contamination in rivers. This environmental degradation destroys the livelihoods of indigenous peoples.  These situations are rampant where extraction activities occur.

The pandemic has only aggravated the situation. Many countries in the Amazon region have redoubled their extraction strategies in hope of increasing exports of their natural resources as a response to the economic crisis. They have reduced social and environmental controls, leading to extreme measures to ease agrochemical regulation  in Brazil and new threats to protected areas in Bolivia. There is no difference between the extractive activities carried out by Jair Bolonaro’s extreme right in Brazil, and the progressive governments of Boliva and Argentina.

This situation can be characterized as ‘necropolitics’–the policy of letting people and the environment die off. Sadly, this phenomenon is becoming normalized for a growing number of citizens. The Covid19 crisis, along with the accompanying diminishing health of people, has caused a vast majority to live with death on a daily basis.

Necropolitics has now reached the Amazon region. By the end of 2020, there were already more than 1.5 million indigenous people affected by Covid19 in the Amazon region, with an estimated 37,747 deaths. In Brazil alone, an estimated 26,000 died.

Human rights defenders, who already were facing many restrictions, were further weakened under these necropolitics.  Governments applied all kinds of restrictions and abused military or police controls already in place. They failed to adequately deal with the pandemic, and left indigenous populations to face the crisis alone.  Jair Bolsonaro shamelessly declared that faced with the health crisis, Brazil’s indigenous people would be fine if they just drank tea.

While all the world’s attention was focused on Covid19, violence increased in the Amazon. The Coordinator of Indigenous Organizations of the Amazon Region (COICA), representing more than 500 indigenous people, stated it would declare a violation of rights emergency.  In 2020, on average, one indigenous leader was assassinated every two days.

Concurrently, citizens’ distrust of politics and elected officials has deepened. Peru presents arguably one of the most extreme cases, facing a succession of political crises that has been going on for years and has led people to believe this is  the country’s institutional norm.  The recent national elections revealed the level of mistrust: about half of Peru’s voters either rejected all candidates outright, or were simply not interested in voting at all.  Of the slightly more than 25 million eligible voters, about 10 million either submitted blank, null or absentee ballots.

Politics as an exercise in dialogue and deliberation is quickly fading away. This only serves to benefit the imposition of more extractive activities, as this retrenchment circumvents the processes of disseminating information and collaboration. Channels for addressing complaints or criticizing impacts are disappearing, and human rights are being violated. If politics crumble, alternatives to these extraction activities will not have a way to be presented or discussed.  It is as if necropolitics has devoured what politics truly used to be.

While it is true that prior to 2020, indigenous peoples’ rights were repeatedly ignored, marginalized and violated, after more than a year of this pandemic, the situation has become even more dire. This is true for indigenous populations and for the environment as a whole.

Today, the Amazon region is in the center of the battle between the policies of death and alternatives that emphasize  health and life. Even at this difficult time, this contrast deserves to be highlighted and addressed.

Why the Approval of That Alzheimer’s Drug Is So Disturbing

Tim Requarth


Last week, the Food and Drug Administration ignored the advice of its own expert advisory committee and approved the first new treatment for Alzheimer’s in 18 years.

Called Aduhelm, it carries a substantial risk of painful brain swelling and bleeding, requires monthly infusions, and comes with an eye-popping list price of $56,000 per year.

These caveats might be fine if the drug, which is manufactured by Biogen, miraculously restored the memories lost by the 6 million Americans with Alzheimer’s—or at least measurably improved the lives of patients in some meaningful way.

But according to even the FDA’s own statisticians, the clinical data fail to show the new drug can slow Alzheimer’s devastating cognitive decline.

The FDA’s surprise approval has ignited a firestorm within the medical community. People are justifiably angry about the felonious cost for a risky drug that may offer little, if any, benefit. Aduhelm is, for now, a confusing and foregone conclusion; Biogen is slated to ship the drug starting next week.

But a closer look at the FDA’s approval process reveals a deeper scientific issue at stake about what constitutes adequate evidence for desperately needed treatments. How the Aduhelm saga played out could have far-reaching implications not just for Alzheimer’s patients, but for anyone taking a drug approved by the FDA in the future.

To understand why the FDA approved the drug, and why this approval is so problematic beyond Aduhelm itself, it’s helpful to understand a bit about how clinical studies are designed.

Some drugs are approved based on real-world outcomes, such as whether they prevent death. But others are approved based on so-called surrogate outcomes, such as whether they, say, suppress an abnormal heartbeat. If the surrogate outcome (abnormal heartbeat) is meaningfully associated with the real-world outcome (death), it follows that a drug suppressing the abnormal heartbeat should help prevent life-threatening heart attacks. Aduhelm doesn’t seem to show much benefit to patients according to a clinical dementia rating scale (a real-world outcome, approximately—some researchers say it’s not quite as firm as an outcome like “death”). But the drug does do one thing well—it removes some of the amyloid plaques that build up in the brains of Alzheimer’s patients (a surrogate outcome). It’s seemingly on the basis of this surrogate outcome that the FDA saved Aduhelm from joining a long list of failed Alzheimer’s treatments.

Approving drugs based on the surrogate-outcome approach, in principle, offers huge advantages. It’s easier, cheaper, and faster to design a clinical study that measures a drug’s effect on abnormal heartbeats than to wait for enough people to suffer a heart attack and die. Drug approvals based on surrogate outcomes have indeed proved to be lifesaving in the past. In 1992, in the midst of the HIV crisis, the FDA created a special Accelerated Approvalprogram to fast-track urgently needed treatments based on surrogate outcomes alone. (The only catch was companies had to perform post-approval confirmatory studies to assess real-world outcomes like sickness and death, or the FDA could withdraw the drug.) The first wave of treatments approved in this program were HIV drugs, brought to market based on improving surrogate outcomes such as levels of a type of white blood cell. These drugs were later proved to prevent sickness and death from AIDS, which wasn’t surprising because scientists had established a tight linkage between white blood cell count and disease progression. The surrogate-outcome approach was considered a success.

Aduhelm now joins this group of drugs that merely fiddle with the body’s physiology but potentially leave patients worse off and much poorer for it.

 

But HIV drugs are among the only unqualified successes for surrogate approvals. Joseph Ross, a professor of medicine and public health at Yale University, studies the FDA regulatory process and notes that apart from the HIV drugs, “in almost every other instance, surrogates have proven to be far more fallible.”

Several diabetes drugs have been approved because they lower hemoglobin A1c, a measure of average blood sugar levels. That might seem clearly useful.

 However, these drugs have wildly different effects on diabetic complications and overall mortality. At least one drug is thought to increase heart attacks.

Cancer drugs with astronomical price tags might reduce tumor size but fail to prolong life or improve its quality. The list goes on: Blockbuster drugs lower cholesterol but fail to prevent cardiovascular disease. Osteoporosis drugs improve bone density but fail to decrease fractures. And in some cases, these drugs have damaging side effects only discovered years later.

In fact, the writing has long been on the wall that the surrogate-outcome approach can be a bit dicey. Take the heartbeat example above—which is actually real.

In the mid-’80s, two class IC antiarrhythmics were brought to market largely based on the evidence that they suppressed abnormal heartbeats. Yet, no one had ever done a clinical study to confirm the drugs actually prevented death.

When such a study was conducted years later, it had to be stopped midway through: It turns out these drugs actually increased the chance of death.

Although the human toll is impossible to know, the surrogate-outcome approach in this case may have caused thousands of unnecessary deaths.

Although the link between abnormal heartbeats and death was plausible in theory, it turned out quite differently in the real world.

There’s a clear lesson from using surrogate outcomes to evaluate a drug. Without strong evidence of a link between the surrogate outcome and the clinical outcome, the FDA should be wary to greenlight treatments based on surrogate outcomes alone. For HIV drugs, this link was already established, and the drugs panned out. For the heart drug, this link was less established, and the drug did not pan out.

Aduhelm now joins this group of drugs that fiddle with the body’s physiology but potentially leave patients worse off and much poorer for it.

Recall that with this drug, about 30–40 percent of study participants experienced either brain swelling or bleeding. Not to mention the $56,000 annual price tag—much of which Medicare is required to cover—could be a fiscal catastrophe for American health care.

No one disputes that amyloid plaques appear in the brains of Alzheimer’s patients, and no one doubts Aduhelm can clear amyloid plaques (by a respectable 30 percent), but how valid of a surrogate outcome are amyloid plaques for the real-world outcomes Alzheimer’s patients care about? Given the pent-up demand, the worrisome side effects, and the steep price, you’d hope the amyloid hypothesis is a slam-dunk. Unfortunately, it’s not even close.

What amyloid plaques mean—and in turn, what Aduhelm’s actual effect on people might be—is still a hotly debated scientific question. Do they cause Alzheimer’s? Do they worsen it? Are they incidental? Are they protective?

Scientists have made reasonable cases one way or another, but it’s very far from settled that amyloid plaques are a valid surrogate outcome for Alzheimer’s. What’s worse, the amyloid hypothesis doesn’t have a great track record with regard to therapeutics.

Several drugs targeting amyloid plaques have been developed and then fizzled during clinical trials because not a single one had any effect on dementia. And yet, when approving Aduhelm, the FDA relied almost entirely on the amyloid hypothesis.

What makes the FDA’s decision so baffling is that surrogates are used when researchers can’t, or don’t, collect data that better reflects the real-world outcome of interest—in this case, slowing or preventing cognitive decline due to Alzheimer’s. But that’s exactly the data that Biogen submitted.

The two clinical studies—which looked at cognitive decline, something that patients and doctors definitely care about—showed almost no benefit. One study was a total dud, and the other raised a score on a cognitive scale by a minuscule amount. Although that improvement reached statistical significance, it is almost certainly not going to make a difference in the lives of patients. “The effect sizes are trivial from a clinical point of view,” said Chiadi Onyike, a professor of psychiatry and behavioral sciences at Johns Hopkins and a member of the 11-person committee of outside experts tapped by the FDA to review the data. “They are meaningless—no different from the ebb and flow a patient might show from week to week.”

Not a single member of the FDA’s outside advisory committee recommended approval. The fallout has already been widespread. So far, three members of the FDA’s advisory committee have resigned, one of them calling the process a “sham.”

Doctors who helped run Biogen’s clinical studies are speaking out, and others are penning editorials that they won’t be prescribing Aduhelm until they see evidence of effectiveness. But no one should hold their breath.

When the FDA greenlit Aduhelm for use, it told Biogen it had nine years to run the confirmatory studies necessary to prove Aduhelm’s effectiveness. Nine years of people taking this drug that existing data suggests might not do anything meaningful.

 With Aduhelm poised to become among the biggest blockbuster drug in history—analysts estimate annual revenues could peak at $10 billion—Biogen probably isn’t in a hurry.

But they might not even have to collect that extra data at all (for its part, Biogen said in an email to Slate, “We are working diligently to initiate the confirmatory trial”).

Ross, the Yale FDA regulatory expert, looked at FDA approvals from 2005–12, and found that post-market confirmatory studies—ones that truly verified the clinical value of a surrogate outcome—only took place about 10 percent of the time.

Despite this dismal compliance rate, according to Ross, the FDA has never fined a company for failing to do a confirmatory study and rarely uses its power to withdraw a drug later shown to be clinically ineffective.

In an email to Slate, the FDA did not offer comment on whether it would use its power to withdraw Aduhelm should the drug ultimately prove clinically ineffective but “will carefully monitor trial progress and support efforts to complete this trial in the shortest possible timeline.”

What specifically caused the FDA to approve Aduhelm based on such a shaky outcome and over the protests of its own committee is anyone’s guess, even in the context of the FDA’s frequent reliance on surrogate outcomes—nearly 45 percent of all drugs, according to the agency’s own analysis.

(In a press release acknowledging the contention around the decision, the FDA explained that it ultimately decided “the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”)

Aduhelm may well help fuel a trend in leaning too heavily on surrogate outcomes: Because the Aduhelm example is so egregious, it establishes a far-reaching precedent that some believe could undermine the regulatory process.

“Presumably,” says Ross, “[companies] could look at what just happened with this product and say, ‘Hey, you have to treat me the same way.’ ”

In other words, when a company fails to show a drug actually works, why not try for back-door approval based on an unproven idea of how the drug is supposed to work. This might seem grim, and it is.

But there’s a lesson you can take as a patient: just because a number goes up or down at the doctor’s office—whether it’s cholesterol, blood pressure, or even weight—that doesn’t necessarily mean you’re better or worse off for it.

Because of the FDA’s widespread endorsement of surrogate metrics, it’s been all too easy for patients—and doctors—to believe these metrics for health are health itself.

With a false sense of understanding comes a false sense of hope, a false promise of control. That’s the true tragedy of the Aduhelm approval.

‘Epic Failure of Humanity’: Global Displaced Population Hits All-Time High

Jake Johnson


A report released Friday by the United Nations Refugee Agency finds that more than 82 million people across the globe were forcibly displaced by war, persecution, the climate crisis, and other factors by the end of 2020, a record high that one international aid group called “an epic failure of humanity.”

The U.N.’s annual Global Trends in Forced Displacement (pdf) assessment estimates that girls and boys under the age of 18 account for 42% of the 82.4 million people who have fled their homes in search of safety and basic human dignity. Nearly a million children were born as refugees between 2018 and 2020, the report shows.

“Behind each number is a person forced from their home and a story of displacement, dispossession, and suffering. They merit our attention and support not just with humanitarian aid, but in finding solutions to their plight,” said Filippo Grandi, the U.N. high commissioner for refugees (UNHCR). “The tragedy of so many children being born into exile should be reason enough to make far greater efforts to prevent and end conflict and violence.”

Though the deadly coronavirus pandemic led countries around the world to close off their borders to refugees and asylum-seekers, many people still fled across national lines in 2020, the ninth consecutive year in which the number of forcibly displaced people has reached a record high.

According to the new U.N. report, 26.4 million people were living as refugees in 2020, and more than two-thirds of those who fled abroad came from just five countries: Syria (6.7 million), Venezuela (4 million), Afghanistan (2.6 million), South Sudan (2.2 million) and Myanmar (1.1 million).

The U.N. figures show that in addition to those who were forced by circumstance to leave their home countries, 48 million people were internally displaced by the end of last year, up from 45.7 million in 2019.

“Climate change is driving displacement and increasing the vulnerability of those already forced to flee,” the report states. “Forcibly displaced and stateless people are on the front lines of the climate emergency. Many are living in climate ‘hotspots’ where they typically lack the resources to adapt to an increasingly inhospitable environment. The dynamics of poverty, food insecurity, climate change, conflict, and displacement are increasingly interconnected and mutually reinforcing, driving more and more people to search for safety and security.”

Jan Egeland, secretary general of the Norwegian Refugee Council, said in a statement that “despite the staggering statistics, world leaders have been inept to resolve the greatest emergency of our generation.”

“Far more people are on the move today than anytime during World War II, yet we say we live in an unprecedented era of global peacetime,” Egeland added. “We need to rewrite tomorrow’s history books to reflect today’s reality, that we live in an unprecedented era of persecution and suffering.”

Absent dramatic action from the international community to end conflicts, combat the climate crisis, and mitigate other major factors driving forced displacement, the U.N. report warns that “forecasts for 2021 are equally worrying, with some of the world’s worst food crises—including in displacement-affected countries such as South Sudan, Syria, and the Central African Republic—at risk of turning into famine.”

“The question is no longer if forced displacement will exceed 100 million people—but rather when,” the report states. “Clearly, the need for preventing conflicts and ensuring that displaced people have access to solutions has never been more pressing than now.”