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Haiti fights large COVID-19 spike as it awaits vaccines
Ever since the pandemic began, Haiti had perplexed experts with seemingly low infection and death rates from COVID-19 despite its rickety public health system, a total lack of vaccines and a widespread disdain for safety measures like masks and distancing.
That is no longer the case.
The few Haitian hospitals treating COVID cases have been so swamped in recent days that they report turning away patients, while plans to open another hospital to treat the infected have been delayed.
Official figures remain relatively low for a nation of more than 11 million people: Just 2,271 cases and 62 deaths have been recorded over the past month in government data collected by Johns Hopkins University. A total of 15,700 cases and more than 330 deaths have been reported since early last year.
Read:Sinovac vaccine restores a Brazilian city to near normal
But experts are united in saying those figures miss the true scale of what they say is the largest spike in cases since the new coronavirus first landed.
The government declared a health emergency on May 24 and imposed a curfew and safety measures — though few Haitians appear to be following them. Most shun, or can’t afford, face masks and it’s nearly impossible to keep a distance while shopping in bustling marketplaces or riding the crowded, colorful buses known as tap taps that most Haitians rely on to get around.
“There is no time to waste,” said Carissa Etienne, director of the Pan American Health Organization, which is working with the government to scale up testing to identify and isolate infected people — a difficult task in a place where few think they can afford to be sick.
Sanorah Valcourt, a 27-year-old mother and hairstylist, said she felt sick for for two weeks last month with a fever and symptoms including loss of taste. But she didn’t get tested, or even take measures such as wearing face masks she finds uncomfortable.
“I didn’t feel well enough to hop on a tap tap and spend hours at a hospital to get tested,” she said.
The lack of cases early this year had led authorities to reduce the number of beds available for COVID patients to about 200 — more than half of those at the nonprofit St. Luke Foundation for Haiti in the capital of Port-au-Prince.
But by early this month, that clinic was at capacity and announced it was turning away patients.
“Many people are dying on arrival in ambulances,” the foundation said. “We have received many nuns as patients, a sure sign (COVID-19) is in the poorest areas.”
Marc Edson Augustin, medical director of the St. Luke hospital, said he’s especially worried about the deaths he has seen among those aged 17 to 22, and that groups of up to seven people are showing up at the same time seeking treatment for COVID.
Read:In Argentina, doctors adapt as COVID-19 strains hospitals
“The situation is real, and we want to tell people that the situation is getting worse,” he said. “We’re working to keep people alive as much as possible.”
Haiti’s Health Ministry had planned to have another 150 beds elsewhere for COVID-19 patients, but that effort was delayed. Meanwhile, Bruno Maes, representative in Haiti for UNICEF, said the children’s agency is working to help hospitals get oxygen and fuel.
“It’s not enough, for sure,” he said. “We have to be ready for a bigger influx of cases. ...It could get out of control.”
So far, Haiti hasn’t received a single vaccine, though officials say they expect to get 130,000 AstraZeneca doses this month.
The U.S. government also said it would donate a portion of six million doses for Haiti, though officials haven’t specified how many or when they will arrive.
Some 756,000 doses of AstraZeneca shots had been slated to arrive in May via the United Nations’ COVAX program for low-income countries, but they were delayed due to the government’s concern over possible clotting as a side effect and a lack of infrastructure to keep the vaccines properly refrigerated.
PAHO said it would help Haiti’s Health Ministry solve those problems, and is prioritizing vaccinating health workers.
The medical system also has been struggling with other problems, including unpaid wages for some workers. President Jovenel Moïse recently asked the Ministry of Economy and Finance to ensure they get paid.
Even when vaccines arrive, experts worry many people may not get a jab — some for fear of venturing through crime-wracked neighborhoods to reach a clinic.
Read:Why are so many babies dying of Covid-19 in Brazil?
Valcourt mentioned such dangers as one reason why she avoided getting tested. Like many Haitians, she turned to a home remedy — in her case, a tea made with parsley, garlic, lime, thyme and cloves.
Manoucheka Louis, a 35-year-old street merchant who sells plantains and potatoes, said she got sick earlier this year but didn’t have the roughly $20 needed to see a private doctor, who she trusts more than public institutions.
“Health care is not something I can afford,” she said, adding that she was coughing a lot and was fighting a fever, loss of taste and an aching body and head. Her two children had the same symptoms, and they all relied on homemade teas and regular cold medicine.
She said she still can’t afford to always wear a mask. They can cost about 50 cents each in a country where many people make less than a dollar or two a day.
US deaths from heart disease and diabetes climbed amid COVID
The U.S. saw remarkable increases in the death rates for heart disease, diabetes and some other common killers in 2020, and experts believe a big reason may be that many people with dangerous symptoms made the lethal mistake of staying away from the hospital for fear of catching the coronavirus.
The death rates — posted online this week by federal health authorities — add to the growing body of evidence that the number of lives lost directly or indirectly to the coronavirus in the U.S. is far greater than the officially reported COVID-19 death toll of nearly 600,000 in 2020-21.
For months now, researchers have known that 2020 was the deadliest year in U.S. history, primarily because of COVID-19. But the data released this week showed the biggest increases in the death rates for heart disease and diabetes in at least 20 years.
“I would probably use the word `alarming,’” said Dr. Tannaz Moin, a diabetes expert at UCLA, said of the trends.
Read:AP source: US to buy 500M Pfizer vaccines to share globally
Earlier this year, the Centers for Disease Control and Prevention reported that nearly 3.4 million Americans died in 2020, an all-time record. Of those deaths, more than 345,000 were directly attributed to COVID-19. The CDC also provided the numbers of deaths for some of the leading causes of mortality, including the nation’s top two killers, heart disease and cancer.
But the data released this week contains the death rates — that is, fatalities relative to the population — which is considered a better way to see the impact from year to year, since the population fluctuates.
Of the causes of death for which the CDC had full-year provisional data, nine registered increases. Those included Alzheimer’s disease, Parkinson’s, chronic liver disease, stroke and high blood pressure.
Some of the increases were relatively small, but some were dramatic. The heart disease death rate — which has been falling over the long term — rose to 167 deaths per 100,000 population from 161.5 the year before. It was only the second time in 20 years that the rate had ticked up. This jump, of more than 3%, surpassed the less than 1% increase seen in 2015.
In raw numbers, there were about 32,000 more heart disease deaths than the year before.
Diabetes deaths rose to 24.6 per 100,000 last year, from 21.6 in 2019. That translated to 13,000 more diabetes deaths than in 2019. The 14% increase was the largest rise in the diabetes death rate in decades.
The death rate from Alzheimer’s was up 8%, Parkinson’s 11%, high blood pressure 12% and stroke 4%.
Read:EXPLAINER: The US investigation into COVID-19 origins
The CDC offered only the statistics, not explanations. The agency also did not say how many of the fatalities were people who had been infected with — and weakened by — the coronavirus but whose deaths were attributed primarily to heart disease, diabetes or other conditions.
Some experts believe a larger reason is that many patients did not seek treatment in an emergency because they feared becoming infected with the virus.
“When hospitalization rates for COVID would go up, we would see dramatic declines in patients presenting to the emergency room with heart attacks, stroke or heart failure,” Dr. Donald Lloyd-Jones, a Northwestern University researcher who is president-elect of the American Heart Association.
Other possible explanations also point indirectly to the coronavirus.
Many patients stopped taking care of themselves during the crisis, gaining weight or cutting back on taking high blood pressure medications, he said. Experts said the stress of the crisis, the lockdown-related disappearance of exercise options, and the loss of jobs and the accompanying health insurance were all factors, too.
Increases in Kentucky, Michigan, Missouri, and West Virginia pushed the four into the group of states with the highest rates of death from heart disease, the CDC data showed. For diabetes, similar changes happened in Indiana, New Mexico, West Virginia and some other Southern and Plains states.
The death rate from the nation’s No. 2 killer, cancer, continued its decline during the year of COVID-19. It fell about 2% in 2020, similar to the drop seen from 2018 to 2019, even though cancer screenings and cancer care declined or were often postponed last year.
Read:FDA approves much-debated Alzheimer’s drug panned by experts
Lloyd-Jones’ theory for the decline: Many of the virus’s victims were fighting cancer, “but COVID intervened and became the primary cause of death.”
Earlier research done by demographer Kenneth Johnson at the University of New Hampshire found that an unprecedented 25 states saw more deaths than births overall last year.
The states were Alabama, Arizona, Arkansas, Connecticut, Delaware, Florida, Indiana, Kentucky, Maine, Massachusetts, Michigan, Mississippi, Missouri, Montana, New Hampshire, New Mexico, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, West Virginia, and Wisconsin.
Traditionally the vast majority of states have more births than deaths.
AP source: US to buy 500M Pfizer vaccines to share globally
The U.S. will buy 500 million more doses of the Pfizer COVID-19 vaccine to share through the global COVAX alliance for donation to 92 lower income countries and the African Union over the next year, a person familiar with the matter said Wednesday.
President Joe Biden was set to make the announcement Thursday in a speech before the start of the Group of Seven summit. Two hundred million doses — enough to fully protect 100 million people — would be shared this year, with the balance to be donated in the first half of 2022, the person said.
National security adviser Jake Sullivan told reporters Wednesday that Biden was committed to sharing vaccines because it was in the public health and strategic interests of the U.S. As Biden embarks on his first foreign trip, he is aiming to show “that democracies are the countries that can best deliver solutions for people everywhere,” Sullivan said.
“As he said in his joint session (address), we were the ‘arsenal of democracy’ in World War II,” Sullivan said. “We’re going to be the ‘arsenal of vaccines’ over this next period to help end the pandemic.”
Also read: G7 must ensure vaccine access in developing countries: UN experts
The news of the Pfizer sharing plan was confirmed to The Associated Press by a person familiar with the matter, who spoke on condition of anonymity ahead of the president’s formal announcement. The news was first reported by the Washington Post.
The U.S. has faced mounting pressure to outline its global vaccine sharing plan. Inequities in supply around the world have become more pronounced, and the demand for shots in the U.S. — where nearly 64% of adults have received at least one dose — has dropped precipitously.
The announcement comes a week after the White House unveiled its plans to donate an initial allotment of 25 million doses of surplus vaccine overseas, mostly through the United Nations-backed COVAX program, promising infusions for South and Central America, Asia, Africa and others at a time of glaring shortages abroad.
Overall, the White House has announced plans to share 80 million doses globally by the end of June, most through COVAX. Officials say a quarter of the nation’s excess will be kept in reserve for emergencies and for the U.S. to share directly with allies and partners.
The White House has also directed doses to allies including South Korea, Taiwan and Ukraine.
Also read: WTO panel considers easing protections on COVID-19 vaccines
Global public health groups had been aiming to use the upcoming G-7 meetings in Cornwall, England, to press the nation’s wealthiest democracies to do more to share vaccines with the world, and Biden’s plans drew immediate praise toward that end.
“The Biden administration’s decision to purchase and donate additional COVID-19 vaccine doses is the kind of bold leadership that is needed to end this global pandemic,” said Tom Hart, acting CEO at The ONE Campaign, a nonprofit that seeks to end poverty. “This action sends an incredibly powerful message about America’s commitment to helping the world fight this pandemic and the immense power of US global leadership.”
Sullivan told reporters Wednesday that he does not expect the U.S. push to waive the patents on vaccines to cause tension with European counterparts.
“We’re all converging around the idea that we need to boost vaccine supply in a number of ways, sharing more of our own doses,” Sullivan told reporters aboard Air Force One. “We’ll have more to say on that, helping get more manufacturing capacity around the world.”
Globally, there have been more than 3.7 million confirmed deaths from COVID-19, and more than 174 million people have been confirmed infected.
World Bank lifts global growth outlook to 5.6% on US, China rebounds
The World Bank on Tuesday forecast global growth for this year at 5.6 percent, up 1.5 percentage points from its estimate in January as the United States and China showed robust rebounds from the coronavirus pandemic-induced downturn.
The Washington-based lender also revised up Japan's growth for this year by 0.4 point to 2.9 percent on the back of fiscal support measures, but noted that the economic benefits from this summer's Tokyo Olympics will be limited due to the absence of foreign spectators.
While emphasizing that this year's global growth outlook will mark the strongest recovery from any of the global recessions in the past 80 years, the World Bank warned in its semiannual Global Economic Prospects report that the rebound is "highly uneven" amid "highly unequal" coronavirus vaccine access.
Also read: China among top 10 improvers in business climate 2nd year in a row: World Bank
"Growth is concentrated in a few major economies, with most emerging market and developing economies lagging behind," the report said.
While about 90 percent of advanced economies are expected to regain their pre-pandemic per capita income levels by 2022, only about one-third of emerging market and developing economies are expected to do so, it added.
Global growth, which is estimated to have contracted 3.5 percent last year due to the pandemic, is projected to rise to 4.3 percent next year, a 0.5 point upgrade from the earlier estimate.
Also read: Emerging, developing economies less prepared for downturn than 10 years ago: World Bank
Among major economies, U.S. growth is expected to reach 6.8 percent this year, its fastest pace since 1984, owing to large-scale fiscal support, mass vaccination efforts and an ongoing easing of pandemic restrictions, according to the World Bank.
In March, U.S. President Joe Biden signed into law a $1.9 trillion stimulus bill, bringing the total fiscal support provided since the beginning of the pandemic last year to over one-quarter of the gross domestic product, it said.
But U.S. growth next year will soften to 4.2 percent amid diminishing fiscal support.
Japan's growth is expected to moderate to 2.6 percent in 2022, held back by lingering weakness in consumption amid subdued wage growth, the report said.
Also read: World Bank prediction on Bangladesh economy inconsistent: Finance Minister
China, after expanding 2.3 percent in 2020, is expected to see its growth jump to 8.5 percent in 2021, an upward revision of 0.6 point on expectations of stronger foreign demand. Its growth is expected to slow to 5.4 percent in 2022.
The eurozone economy is believed to grow 4.2 percent and 4.4 percent in 2021 and 2022, respectively.
Global trade is forecast to grow 8.3 percent this year after plunging by the same percentage a year earlier.
EXPLAINER: The US investigation into COVID-19 origins
Once dismissed by most public health experts and government officials, the hypothesis that COVID-19 leaked accidentally from a Chinese lab is now receiving scrutiny under a new U.S. investigation.
Experts say the 90-day review ordered on May 26 by President Joe Biden will push American intelligence agencies to collect more information and review what they already have. Former State Department officials under President Donald Trump have publicly pushed for further investigation into virus origins, as have scientists and the World Health Organization.
Many scientists, including Dr. Anthony Fauci, say they still believe the virus most likely occurred in nature and jumped from animals to humans. Virus researchers have not publicly identified any key new scientific evidence that might make the lab-leak hypothesis more likely.
Virologists also say it is unlikely that any definitive answer about virus origins will be possible in 90 days. The work to fully confirm origins and pathways of past viruses — such as the first SARS or HIV/AIDS — has taken years or decades.
Read: ‘This IS INSANE’: Africa desperately short of COVID vaccine
A look at what is known about the U.S. investigation of the virus.
WHAT ARE INTELLIGENCE AGENCIES REVIEWING?
Biden ordered a review of what the White House said was an initial finding leading to “two likely scenarios,” an animal-to-human transmission or a lab leak. The White House statement says two agencies in the 18-member intelligence community lean toward the hypothesis of a transmission in nature; another agency leans toward a lab leak.
One document drawing new attention is a State Department fact sheet published in the last days of Trump’s administration. The memo notes that the U.S. believes three researchers at a Wuhan, China, lab sought medical treatment for a respiratory illness in November 2019. However, the report is not conclusive: The origin and severity of the staffers’ illness is not known — and most people in China regularly go to hospitals, not primary-care physicians, for routine care.
The memo also pointed to “gain of function” studies — which in theory could enhance the lethality or transmissibility of a virus — allegedly done at the Wuhan lab with U.S. backing. However, National Institutes of Health Director Francis Collins has since adamantly denied that the U.S. supported any “gain-of-function” research on coronaviruses in Wuhan.
David Feith, who served as deputy assistant secretary of state for East Asian and Pacific Affairs under Trump, said he supported Biden’s call for an enhanced review. “Implicit in the president’s statement is that there is more to analyze and more to collect than has been analyzed or collected to date,” Feith said.
The Director of National Intelligence declined to comment.
IS CHINA HAMPERING INVESTIGATIONS?
The White House statement criticized China for a lack of transparency, echoing previous criticisms by Democrats and Republicans. “The failure to get our inspectors on the ground in those early months will always hamper any investigation into the origin of COVID-19,” the White House said.
The Associated Press has reported on China’s interference in the World Health Organization’s probes of the virus and its fanning of conspiracy theories online. China has also forced journalists to leave the country in recent years and silenced or jailed whistleblowers from Wuhan and elsewhere.
The lack of transparency in China is a significant and familiar challenge. But that does not in itself signal that something in particular is being hidden.
“The problem is when you make that announcement (Biden’s call for investigation) in a highly politicized environment, it makes it even less likely that China will cooperate with efforts to find the origins of the virus,” said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations.
Read: WTO panel considers easing protections on COVID-19 vaccines
WHAT DO SCIENTISTS BELIEVE ABOUT VIRUS ORIGINS?
The most compelling argument for investigating the possibility of a lab leak is not any new hard evidence, but rather the fact that another pathway for virus spread has not been 100% confirmed.
“The great probability is still that this virus came from a wildlife reservoir,” said Arinjay Banerjee, a virologist at the Vaccine and Infectious Disease Organization in Saskatchewan, Canada. He pointed to the fact that spillover events – when viruses jump from animals to humans – are common in nature, and that scientists already know of two similar beta coronaviruses that evolved in bats and caused epidemics when humans were infected, SARS1 and MERS.
However, the case is not completely closed. “There are probabilities, and there are possibilities,” said Banerjee. “Because nobody has identified a virus that’s 100% identical to SARS-CoV-2 in any animal, there is still room for researchers to ask about other possibilities.”
HOW LONG DOES IT TAKE TO CONFIRM THE ORIGIN OF A VIRUS?
Confirming with 100% certainty the origin of a virus is often not fast, easy, or always even possible.
For example, scientists never confirmed the origin of smallpox before the disease was eradicated through a global vaccination program.
In the case of Severe Acute Respiratory Syndrome (SARS) – a disease caused by a beta coronavirus, like the current coronavirus – researchers first identified the virus in February 2003. Later that year, scientists discovered the likely intermediary hosts: Himalayan palm civets found at live-animal markets in Guangdong, China. But it wasn’t until 2017 that researchers traced the likely original source of the virus to bat caves in China’s Yunnan province.
HOW IMPORTANT IS IT TO UNDERSTAND THE ORIGIN?
From a scientific perspective, researchers are always keen to better understand how diseases evolve. From a public health perspective, if a virus has transitioned to being spread mostly by human-to-human contact, discovering its origins is not as essential to strategies for containing the disease.
“Questions of origins and questions of disease control are not the same thing once human-to-human transmission has become common,” said Deborah Seligsohn, an expert in environment and public health at Villanova University.
Republicans have pressed for more inquiries into a possible lab leak as part of a broader effort to blame China and vindicate Trump’s handling of the pandemic. Nearly 600,000 people in the United States have died of COVID-19, the highest toll of any country.
Read:US to swiftly boost global vaccine sharing, Biden announces
WHAY HAPPENS AFTER THE 90 DAYS?
Many scientists caution that it’s unlikely a 90-day investigation will yield definitive new answers.
“We rarely get a ‘smoking gun,’” said Stephen Morse, a disease researcher at Columbia University. “Even under the best of circumstances we rarely get certainty, just degrees of likelihood.”
Any findings will likely be politically explosive, especially if new evidence comes to light supporting or dismissing the zoonotic transfer or lab-leak theory. And a failure to reach definitive conclusions, almost inevitable after a 90-day review, could provide grist for Trump supporters and opponents alike, as well as embolden conspiracy theorists.
Meanwhile experts like the Council on Foreign Relations’ Huang suspect China may simply clamp down more, adding another complication to already tense relations. “This will likely make it even more challenging to extract concessions from China to allow another team to visit Wuhan, or have unfettered access to investigate there,” he said.
Biden to assure allies, meet Putin during 1st overseas trip
Set to embark on the first overseas trip of his term, President Joe Biden is eager to reassert the United States on the world stage, steadying European allies deeply shaken by his predecessor and pushing democracy as the only bulwark to rising forces of authoritarianism.
Biden has set the stakes for his eight-day trip in sweeping terms, believing that the West must publicly demonstrate it can compete economically with China as the world emerges from the coronavirus pandemic.
Building toward his trip-ending summit with Russia’s Vladimir Putin, Biden will aim to reassure European capitals that the United States can once again be counted on as a dependable partner to thwart Moscow’s aggression both on their eastern front and their internet battlefields.
The trip will be far more about messaging than specific actions or deals. And the paramount priority for Biden, who leaves Wednesday for his first stop in the United Kingdom, is to convince the world that his administration is not just a fleeting deviation in the trajectory of an American foreign policy that many allies fear irrevocably drifted toward a more transactional outlook under former President Donald Trump.
Read: Biden rebuffs GOP infrastructure offer, citing broader goals
“The trip, at its core, will advance the fundamental thrust of Joe Biden’s foreign policy,” said national security adviser Jake Sullivan, “to rally the world’s democracies to tackle the great challenges of our time.”
Biden’s to-do list is ambitious.
In their face-to-face sit-down in Geneva, Biden wants to privately pressure Putin to end myriad provocations, including cybersecurity attacks on American businesses by Russian-based hackers, the jailing of opposition leader Alexei Navalny and repeated overt and covert efforts by the Kremlin to interfere in U.S. elections.
Biden is also looking to rally allies on their COVID-19 response and to urge them to coalesce around a strategy to check emerging economic and national security competitor China even as the U.S. expresses concern about Europe’s economic links to Moscow. Biden also wants to nudge outlying allies, including Australia, to make more aggressive commitments to the worldwide effort to curb global warming.
The week-plus journey is a big moment for Biden, who traveled the world for decades as vice president and as chair of the Senate Foreign Relations Committee, and will now step off Air Force One on international soil as commander in chief. He will face world leaders still grappling with the virus and rattled by four years of Trump’s inward-looking foreign policy and moves that strained longtime alliances as the former president made overtures to strongmen.
“In this moment of global uncertainty, as the world still grapples with a once-in-a-century pandemic,” Biden wrote in a Washington Post op-ed previewing his diplomatic efforts, “this trip is about realizing America’s renewed commitment to our allies and partners, and demonstrating the capacity of democracies to both meet the challenges and deter the threats of this new age.”
The president first travels to Britain for a summit of the Group of Seven leaders and then Brussels for a NATO summit and a meeting with the heads of the European Union. It comes at a moment when Europeans have diminished expectations for what they can expect of U.S. leadership on the foreign stage.
Central and Eastern Europeans are desperately hoping to bind the U.S. more tightly to their security. Germany is looking to see the U.S. troop presence maintained there so it doesn’t need to build up its own. France, meanwhile, has taken the tack that the U.S. can’t be trusted as it once was and that the European Union must pursue greater strategic autonomy going forward.
“I think the concern is real that the Trumpian tendencies in the U.S. could return full bore in the midterms or in the next presidential election,” said Alexander Vershbow, a former U.S. diplomat and once deputy secretary general of NATO.
Read:US to swiftly boost global vaccine sharing, Biden announces
The sequencing of the trip is deliberate: Biden consulting with Western European allies for much of a week as a show of unity before his summit with Putin.
His first stop late Wednesday will be an address to U.S. troops stationed in Britain, and the next day he sits down with British Prime Minster Boris Johnson. The two men will meet a day ahead of the G-7 summit to be held above the craggy cliffs of Cornwall overlooking the Atlantic Ocean.
The most tactile of politicians, Biden has grown frustrated by the diplomacy-via-Zoom dynamics of the pandemic and has relished the ability to again have face-to-face meetings that allow him to size up and connect with world leaders. While Biden himself is a veteran statesman, many of the world leaders he will see in England, including Johnson and French President Emmanuel Macron, took office after Biden left the vice presidency. Another, Germany’s Angela Merkel, will leave office later this year.
There are several potential areas of tension. On climate change, the U.S. is aiming to regain its credibility after Trump pulled the country back from the fight against global warming. Biden could also feel pressure on trade, an issue to which he’s yet to give much attention. And with the United States well supplied with COVID-19 vaccines yet struggling to persuade some of its own citizens to use it, leaders whose inoculation campaigns have been slower will surely pressure Biden to share more surplus around the globe.
Another central focus will be China. Biden and the other G-7 leaders will announce an infrastructure financing program for developing countries that is meant to compete directly with Beijing’s Belt-and-Road Initiative. But not every European power has viewed China in as harsh a light as Biden, who has painted the rivalry with the techno-security state as the defining competition for the 21st century.
The European Union has avoided taking as strong a stance on Beijing’s crackdown on Hong Kong’s democracy movement or treatment of Uyghur Muslims and other ethnic minorities in the western Xinjiang province as the Biden administration may like. But there are signs that Europe is willing to put greater scrutiny on Beijing.
The EU in March announced sanctions targeting four Chinese officials involved with human rights abuses in Xinjiang. Beijing, in turn, responded by imposing sanctions on several members of the European Parliament and other Europeans critical of the Chinese Communist Party.
Biden is also scheduled to meet with Turkish President Recep Tayyip Erdogan while in Brussels, a face-to-face meeting between two leaders who have had many fraught moments in their relationship over the years.
Biden waited until April to call Erdogan for the first time as president. In that call, he informed the Turkish leader that he would formally recognize that the systematic killings and deportations of hundreds of thousands of Armenians by Ottoman Empire forces in the early 20th century were “genocide” — using a term for the atrocities that his White House predecessors had avoided for decades over concerns of alienating Turkey.
Read:Free beer, other new incentives for Biden’s ‘vaccine sprint’
The trip finale will be Biden’s meeting with Putin.
Biden has taken a very different approach to Russia than Trump’s friendly outreach. Their sole summit, held in July 2018 in Helsinki, was marked by Trump’s refusal to side with U.S. intelligence agencies over Putin’s denials of Russian interference in the election two years earlier.
Biden could well be challenged by unrest at home as Russia looks to exploit the Jan. 6 Capitol insurrection and the debate over voting rights to undermine the U.S. position as a global role model. The American president, in turn, is expected to push Russia to quell its global meddling.
“By and large, these are not meetings on outcomes, these are ‘get to know you again’ meetings for the U.S. and Europe,” said Richard Haass, president of the Council on Foreign Relations. “It’s about delivering a message to Putin, to reviving old alliances and to demonstrate again that the U.S. is back on the right course.”
FDA approves much-debated Alzheimer’s drug panned by experts
Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.
The Food and Drug Administration approved the drug from Biogen based on study results showing it seemed “reasonably likely” to benefit Alzheimer’s patients. It’s the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.
The decision, which could impact millions of Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given as an infusion every four weeks.
Read:Justice Dept. says it’ll no longer seize reporters’ records
Dr. Caleb Alexander, an FDA adviser who recommended against the drug’s approval, said he was “surprised and disappointed” by the decision.
“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a medical researcher at Johns Hopkins University.
The FDA’s top drug regulator acknowledged that “residual uncertainties” surround the drug, but said Aduhelm’s ability to reduce harmful clumps of plaque in the brain is expected to help slow dementia.
“The data supports patients and caregivers having the choice to use this drug,” Dr. Patrizia Cavazzoni told reporters. She said the FDA carefully weighed the input of people living with the “devastating, debilitating and deadly disease.”
Under terms of the so-called accelerated approval, the FDA is requiring Biogen to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.
Biogen said the drug would cost approximately $56,000 for a typical year’s worth of treatment, and said the price would not be raised for four years. Most patients won’t pay anywhere near that thanks to insurance coverage and other discounts. The company said it aims to complete the FDA-mandated follow-up trial by 2030.
Biogen shares jumped 38% in trading Monday on the news, with analysts forecasting billions in future sales. The Cambridge, Massachusetts-based company plans to begin shipping millions of doses within two weeks.
The non-profit Institute for Clinical and Economic Review, which studies drug value, said Biogen’s drug would have to halt dementia entirely to justify its $56,000 per-year price tag.
Some 6 million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks. In the final stages of the disease, those afflicted lose the ability to swallow. The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s.
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Aducanumab (pronounced “add-yoo-CAN-yoo-mab”) helps clear a protein called beta-amyloid from the brain. Other experimental drugs have done that but they made no difference in patients’ ability to think, care for themselves or live independently.
The pharmaceutical industry’s drug pipeline has been littered for years with failed Alzheimer’s treatments. The FDA’s greenlight Monday is likely to revive investments in therapies previously shelved by drugmakers.
The new medicine is manufactured from living cells and will be given via infusion at a doctor’s office or hospital.
Researchers don’t fully understand what causes Alzheimer’s but there’s broad agreement the brain plaque targeted by aducanumab is just one contributor. Evidence suggests family history, education and chronic conditions like diabetes and heart disease may all play a role.
“This is a sign of hope but not the final answer,” said Dr. Richard Hodes, director of the National Institute on Aging, which wasn’t involved in the Biogen studies but funds research into how Alzheimer’s forms. “Amyloid is important but not the only contributing factor.”
Patients taking aducanumab saw their thinking skills decline 22% more slowly than patients taking a placebo.
But that meant a difference of just 0.39 on an 18-point score of cognitive and functional ability. And it’s unclear how such metrics translate into practical benefits, like greater independence or ability to recall important details.
The FDA’s review of the drug has become a flashpoint in longstanding debates over standards used to evaluate therapies for hard-to-treat conditions. On one side, groups representing Alzheimer’s patients and their families say any new therapy — even one of small benefit — warrants approval. But many experts warn that greenlighting the drug could set a dangerous precedent, opening the door to treatments of questionable benefit.
The approval came despite a scathing assessment in November by the FDA’s outside panel of neurological experts. The group voted “no” to a series of questions on whether reanalyzed data from a single study submitted by Biogen showed the drug was effective.
Biogen halted two studies in 2019 after disappointing results suggested aducanumab would not meet its goal of slowing mental and functional decline in Alzheimer’s patients.
Read:Heart reaction probed as possible rare vaccine link in teens
Several months later, the company reversed course, announcing that a new analysis of one study showed the drug was effective at higher doses and the FDA had advised that it warranted review. Company scientists said the drug’s initial failure was due to some patients not receiving high enough doses to slow the disease.
But the changes to dosing and the company’s after-the-fact analysis made the results hard to interpret, raising skepticism among many experts, including those on the FDA panel.
The FDA isn’t required to follow the advice of its outside panelists and has previously disregarded their input when making similarly high-profile drug decisions.
About 900 U.S. medical facilities are ready to begin prescribing the drug, according to Biogen, with many more expected in coming months. But key practical questions remain: How long do patients benefit? How do physicians determine when to discontinue the drug? Does the drug have any benefit in patients with more advanced dementia?
With FDA approval, aducanumab is almost certain to be covered by most insurers, including Medicare, the government plan for seniors that covers more than 60 million people.
Insurers could try to manage the drug’s costs by requiring strict conditions, including brain scans to confirm plaque, before agreeing to cover it.
Additional scans will be needed to monitor potential side effects. The drug carries a warning about temporary brain swelling that can sometimes cause headaches, confusion and dizziness. Other side effects included allergic reactions, diarrhea and disorientation.
Although Biogen studied the drug in people with mild dementia or early-stage Alzheimer’s, the FDA label approved the drug for anyone with Alzheimer’s, a sweeping population given doctors have broad leeway in diagnosing the condition.
“The FDA is empowering the physician to make the decision on diagnosis,” Biogen CEO Michel Vounatsos said in an interview.
Read:US to swiftly boost global vaccine sharing, Biden announces
For patients already enrolled in Biogen’s trials, Monday’s announcement means they can continue taking a drug many believe has helped.
Phillip Lynn, 63, was diagnosed with Alzheimer’s in the spring of 2017 after having trouble with conversation and memory, including forgetting a recent vacation to Hawaii.
His husband Kurt Rehwinkel says Lynn’s cognitive ability has stabilized since starting on Biogen’s drug more than three years ago. And his performance on short-term memory tests has actually improved, though the couple acknowledges most patients are unlikely to see similar results.
“But even for those who it has little or no effect, I think hope is a good thing,” said Rehwinkel. “I don’t think there’s such a thing as false hope.”
Justice Dept. says it’ll no longer seize reporters’ records
The Justice Department said Saturday that it no longer will secretly obtain reporters’ records during leak investigations, a policy shift that abandons a practice decried by news organizations and press freedom groups.
The reversal follows a pledge last month by President Joe Biden, who said it was “simply, simply wrong” to seize journalists’ records and that he would not permit the Justice Department to continue the practice. Though Biden’s comments in an interview were not immediately accompanied by any change in policy, a pair of statements from the White House and Justice Department on Saturday signaled an official turnabout from an investigative tactic that has persisted for years.
Read:Facebook suspends Trump for 2 years, then will reassess
Democratic and Republican administrations alike have used subpoenas and court orders to obtain journalists’ records in an effort to identify sources who have revealed classified information. But the practice had received renewed scrutiny over the past month as Justice Department officials alerted reporters at three news organizations — The Washington Post, CNN and The New York Times — that their phone records had been obtained in the final year of the Trump administration.
The latest revelation came Friday night when the Times reported the existence of a gag order that had barred the newspaper from revealing a secret court fight over efforts to obtain the email records of four reporters. That tussle had begun during the Trump administration but had persisted under the Biden Justice Department, which ultimately moved to withdraw the gag order.
White House press secretary Jen Psaki said in a statement Saturday that no one at the White House was aware of the gag order until Friday night, but that more broadly, “the issuing of subpoenas for the records of reporters in leak investigations is not consistent with the President’s policy direction to the Department.”
In a separate statement, Justice Department spokesman Anthony Coley said that “in a change to its longstanding practice,” the department “will not seek compulsory legal process in leak investigations to obtain source information from members of the news media doing their jobs.”
He added: “The department strongly values a free press, protecting First Amendment values, and is committed to taking all appropriate steps to ensure the independence of journalists.”
In ruling out “compulsory legal process” for reporters in leak investigations, the department also appeared to say that it would not force journalists to reveal in court the identity of their sources.
Bruce D. Brown, executive director of the Reporters Committee for Freedom of the Press, said he welcomed the Justice Department’s policy change but that serious unanswered questions remain about what happened in each of these cases.
Read:US to swiftly boost global vaccine sharing, Biden announces
“To ensure it does not happen again, we look forward to pursuing additional policy reforms with the Biden administration to further safeguard these essential rights,” he said in a statement.
The two newspapers whose reporters’ phone records had been secretly obtained also said more needed to be done.
“This is a welcome step to protecting the ability of the press to provide the public with essential information about what their government is doing,” New York Times publisher A.G. Sulzberger said in a statement. “However, there is significantly more that needs to be done and we are still awaiting an explanation on why the Department of Justice moved so aggressively to seize journalists’ records.”
Washington Post executive editor Sally Buzbee said the newspaper was calling on the Biden administration and Justice Department “to provide a full accounting of the chain of events in both administrations and to implement enduring protections to prevent any future recurrence.”
The Justice Department statement did not say whether it would still conduct aggressive leak investigations without obtaining reporters’ records. It also did not define who exactly would be counted as a member of the media for the purposes of the policy and how broadly the protection would apply.
Even so, it marked a startling reversal concerning a practice that has persisted across multiple presidential administrations. The Obama Justice Department, under then-Attorney General Eric Holder, alerted The Associated Press in 2013 that it had secretly obtained two months of phone records of reporters and editors in what the news cooperative’s top executive called a “massive and unprecedented intrusion” into newsgathering activities.
After blowback, Holder announced a revised set of guidelines for leak investigations, including requiring the authorization of the highest levels of the department before subpoenas for news media records could be issued.
But the department preserved its prerogative to seize journalists’ records, and the recent disclosures to the news media organizations show that the practice continued in the Trump Justice Department as part of multiple investigations.
Separately on Saturday, the Justice Department said it was withdrawing its subpoena that demanded USA Today provide information to identify readers of a story about a suspect in a child pornography case who fatally shot two FBI agents in February.
The subpoena was issued in April but came to light this past week when USA Today and its parent company Gannett filed documents in federal court asking a judge to quash it. The subpoena sought the IP addresses and mobile phone identification information of readers who clicked on the article for a period of about 35 minutes on the day after the shooting.
Read:US to impose tariffs over digital taxes, but action on hold for now
The government hadn’t provided details about the case or why it was specifically interested in the readers who clicked on the USA Today story during that brief period. Officials had only said the subpoena was connected to an ongoing federal criminal investigation.
But a federal prosecutor notified lawyers for USA Today on Saturday that the FBI was withdrawing its subpoena because authorities had been able to identify the subject of their investigation — described in an email as a “child sexual exploitation offender” — by “other means.” The prosecutor’s email was included in a court filing by Gannett.
Facebook suspends Trump for 2 years, then will reassess
Facebook announced Friday that former President Donald Trump’s accounts will be suspended for two years, freezing his presence on the social network until early 2023, following a finding that Trump stoked violence ahead of the deadly Jan. 6 insurrection at the Capitol.
At the end of the suspension, the company will assess whether Trump’s “risk to public safety” has subsided, Nick Clegg, Facebook’s vice president of global affairs, wrote in a blog post. He said Facebook will take into account “external factors” such as instances of violence, restrictions on peaceful assembly and other markers of civil unrest.
Facebook also announced that it would end a contentious policy that automatically exempted politicians from rules banning hate speech and abuse, and that it would stiffen penalties for public figures during times of civil unrest and violence.
READ: Online speech shield under fire as Trump Facebook ban stays
The former president called Facebook’s decision on the suspension “an insult.” The two-year ban replaced a previous ruling that ordered Trump to be suspended indefinitely.
“They shouldn’t be allowed to get away with this censoring and silencing, and ultimately, we will win. Our Country can’t take this abuse anymore!” Trump said in a news release.
Social platforms like Facebook and Twitter have become indispensable tools for politicians to get their messages out and to raise small-dollar donations. Without the megaphone of Twitter and the targeted fundraising appeals his campaign mastered on Facebook, Trump could be at a serious disadvantage relative to other politicians.
Trump has teased running for president again in 2024. His aides say that he has been working on launching his own social media platform to compete with those that have booted him, but one has yet to materialize. A blog he launched on his existing website earlier this year was shut down after less than a month. It attracted dismal traffic.
On Facebook, Trump’s suspension means that his account is essentially frozen. Others can read and comment on past posts, but Trump and other account handlers are unable to post new material. Twitter, by contrast, has permanently banned Trump from its service, and no trace of his account remains.
“What they’ve done here is shield themselves from potential presidential rage” with a reassessment of Trump’s account in two years, said Jennifer Grygiel, a Syracuse University communications professor.
In a color-coded chart on its blog post, the company said public figures who violate its policies during times of crisis can be restricted from posting for a month (yellow) or as long as two years (red). Future violations, it said, will be met with “heightened penalties, up to and including permanent removal.”
READ: Facebook board’s Trump decision could have wider impacts
The policy that exempted politicians from rules on hate speech and abuse was once championed by CEO Mark Zuckerberg. The company said it never applied the policy to Trump, but on Friday backtracked to say it did use it once, in 2019 for a video of a rally on his Facebook page.
The social media giant said it will still apply the “newsworthiness” exemption to certain posts it deems to be in the public interest, even if they violate Facebook rules. But it will no longer treat material posted by politicians any differently than other posts. In addition, Facebook said it will make public whenever it does apply the exemption to a post.
The announcements are in response to recommendations from the company’s quasi-independent oversight board. Last month, that panel upheld a decision by Facebook to keep Trump suspended, but the board said the company could not merely suspend him indefinitely. It gave the company six months to decide what to do with his accounts.
In its decision last month, the board agreed with Facebook that two of Trump’s Jan. 6 posts “severely violated” the content standards of both Facebook and Instagram.
“We love you. You’re very special,” Trump said to the rioters in the first post. In the second, he called them “great patriots” and told them to “remember this day forever.”
Those comments violated Facebook’s rules against praising or supporting people engaged in violence, the board said. Specifically, the board cited rules against “dangerous individuals and organizations” that prohibit anyone who proclaims a violent mission and ban posts that express support for those people or groups.
The two-year suspension is effective from Jan. 7, so Trump has 19 months to go.
A group calling itself the Real Facebook Oversight Board, which is critical of Facebook and its oversight panel, said in a statement Friday that the ban brings Trump back just in time for the 2024 presidential election and shows “no real strategy to address authoritarian leaders and extremist content, and no intention of taking serious action against disinformation and hate speech.”
Due to its sheer size and power, Facebook’s decision has broad implications for politicians and their constituencies around the globe. Chinmayi Arun, a fellow at Yale Law School’s Information Society Project, said it’s good that the company laid out a standard for when it will suspend political leaders and for how long.
“What’s tremendous is that Facebook took the oversight board’s recommendation to reevaluate the real-world context and the offline tensions, while deciding what to do with a politician’s online speech,” she said. But she remains concerned that suspensions cannot be reviewed unless Facebook asks.
READ: Trump goes after Pence, McConnell in speech to party donorsFor years, Facebook gave the former president special treatment and free reign to spread misinformation and threats on the platform. Outside critics and even Facebook’s own employees called for the company to remove Trump long before the Jan. 6 comments.
Last summer, for instance, Zuckerberg decided to leave up posts by Trump that suggested protesters in Minneapolis could be shot, using the words “when the looting starts, the shooting starts.” Trump’s comment evoked the civil-rights era by borrowing a phrase used in 1967 by Miami’s police chief to warn of an aggressive police response to unrest in Black neighborhoods.
While Facebook put labels on many of Trump’s election posts, he did not face penalties such as suspension for repeatedly and falsely claiming victory in 2020.
In Friday’s post, Clegg anticipated criticism from both sides of the political aisle.
“We know that any penalty we apply — or choose not to apply — will be controversial. There are many people who believe it was not appropriate for a private company like Facebook to suspend an outgoing President from its platform, and many others who believe Mr. Trump should have immediately been banned for life,” he wrote.
Facebook’s job, he said, is “to make a decision in as proportionate, fair and transparent a way as possible, in keeping with the instruction given to us by the Oversight Board.”
But by staying in the middle, some experts said Facebook had once again punted the decision instead of taking a firm stance.
“It’s the wait-and-see approach,” said Sarah Kreps, a Cornell professor and director of the Cornell Tech Policy Lab. “I think they’re hoping this can just resolve itself with him not being kind of an influential voice in politics anymore.”
Heart reaction probed as possible rare vaccine link in teens
Health authorities are trying to determine whether heart inflammation that can occur along with many types of infections could also be a rare side effect in teens and young adults after the second dose of COVID-19 vaccine.
An article on seven U.S. teen boys in several states, published online Friday in Pediatrics, is among the latest reports of heart inflammation discovered after COVID-19 vaccination, though a link to the vaccine has not been proven.
The boys, aged 14 to 19, received Pfizer shots in April or May and developed chest pain within a few days. Heart imaging tests showed a type of heart muscle inflammation called myocarditis.
Read:US to swiftly boost global vaccine sharing, Biden announces
None were critically ill. All were healthy enough to be sent home after two to six days in the hospital and are doing ’’doing pretty well,” said Dr. Preeti Jaggi, an Emory University infectious disease specialist who co-authored the report.
She said more follow-up is needed to determine how the seven fare but that it’s likely the heart changes were temporary.
Only one of the seven boys in the Pediatrics report had evidence of a possible previous COVID-19 infection and doctors determined none of them had a rare inflammatory condition linked with the coronavirus.
The cases echo reports from Israel in young men diagnosed after receiving Pfizer shots.
The U.S. Centers for Disease Control and Prevention alerted doctors last month that it was monitoring a small number of reports of heart inflammation in teens and young adults after the mRNA vaccines, the kind made by Pfizer and Moderna.
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The CDC hasn’t determined if there’s really a link to the shots, and continues to urge that everyone 12 and older get vaccinated against COVID-19, which is far riskier than the vaccine. The Pfizer vaccine is available to those as young as 12; the Moderna shot remains cleared only for adult use.
This kind of heart inflammation can be caused by a variety of infections, including a bout of COVID-19, as well as certain medications -- and there have been rare reports following other types of vaccinations.
Authorities will have to tease out whether cases following COVID-19 vaccination are occurring more often than that expected “background rate.”
For now, the CDC says most patients were male, reported symptoms after the second dose, and their symptoms rapidly improved.
“I think we’re in the waiting period where we need to see whether this is cause-and-effect or not,” said John Grabenstein of the Immunization Action Coalition, a former director of the Defense Department’s immunization program.
Read: Free beer, other new incentives for Biden’s ‘vaccine sprint’
A Pediatrics editorial noted that among U.S. children under age 18, there have been over 4 million COVID-19 cases, more than 15,000 hospitalizations and at least 300 deaths.
It said the heart inflammation cases warrant more investigation but added that ’’the benefits of vaccination against this deadly and highly transmissible disease clearly far outweigh any potential risks.”
Editorial co-author Dr. Yvonne Maldonado, head of an American Academy of Pediatrics infectious diseases committee, is involved in Pfizer vaccine studies, including a COVID-19 vaccine study in children.