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A Trump-touted covid therapy awaits proof to back up his boasts

InternationalDec 31. 2020Stephen Hahn, commissioner of food and drugs at the U.S. Food and Drug Administration (FDA), center, speaks during a news conference in the James S. Brady Press Briefing Room at the White House in Washington on Aug. 23, 2020. MUST CREDIT: Bloomberg photo by Stefani Reynolds.

By Syndication Washington Post, Bloomberg · Anna Edney

One day before the Republican National Convention kicked off, President Donald Donald Trump and top drug regulator Stephen Hahn held a White House press conference to tout emergency authorization of a promising covid-19 treatment.

Convalescent plasma, a soup of immune factors derived from the blood of recovered covid-19 patients, had shown “an incredible rate of success” and would “save countless lives,” Trump said Aug 23. Yet more than four months later and with more than 330,000 U.S. coronavirus deaths reported since the pandemic began, the jury is still out how much the treatment benefits patients, if at all.

It wasn’t the first or last time that Trump was to promote a therapy for covid-19 based on skimpy data. His faith in since-discredited hydroxychloroquine is well known, and he proclaimed Regeneron Pharmaceuticals Inc.’s antibody cocktail a wonder drug after receiving it to treat his infection in October. Now, as vaccines developed to slow the pandemic begin their roll-out, the saga of convalescent plasma highlights the lack of effective treatments for the killer virus.

As the pandemic consumed thousands of lives around the world, the FDA authorized the use of promising drugs with only early evidence to go on. From Gilead Sciences’s remdesivir to antibody treatments like Regeneron’s, drugs for covid-19 that were cleared to great fanfare have failed to gain backing from top scientists and infectious disease groups.

Convalescent plasma is supported by one of the fuzzier datasets, and just days after Trump’s August victory lap, Food and Drug Administration Commissioner Hahn began walking back remarks that exaggerated its effectiveness. National Institutes of Health advisers who compile covid-19 treatment guidelines said in September that there wasn’t enough evidence convalescent plasma works to recommend its use against the virus.

Data continues to support the FDA’s emergency authorization, Stephanie Caccomo, a spokeswoman, said in an email. The agency in September posted evidence that it said backs the use of convalescent plasma.

While one trial cited by the agency indicated a significant help to patients, others “tended to indicate a modest benefit.” The FDA acknowledged that the studies were less rigorous scientifically than it normally requires to prove efficacy.

The White House didn’t respond to a request for comment.

More than 100,000 people in the U.S. have already been treated with convalescent plasma. That includes a nationwide Mayo Clinic program that infused more than 90,000 people before the FDA’s emergency authorization.

Clinical trials that were supposed to clear up any doubts about the treatment were expected to read out in September or October, just a month or two after the FDA cleared it for emergency use. Those data have yet to appear, but the raging U.S. outbreak should soon serve to enroll more patients in those studies.

Still, the effect is likely to be much more modest than Trump or Hahn originally claimed, experts said.

“It became evident in most people, even when it works, it’s not a Lazarus thing,” said Christopher Austin, director of the NIH’s National Center on Advancing Translational Sciences. “The effect was going to be smaller.”

The center is leading or involved in key clinical trials that will finally offer insight into convalescent plasma’s efficacy more than 100 years after it began being deployed during pandemics. The rationale behind the treatment is that the antibodies people develop after enduring a disease will help newly diagnosed patients recover.

“We do not know whether it works” against covid-19, Austin said. “We all want to know the answer. I want to know the answer more than anybody. We have an obligation to future patients.”

Trials could produce critical data in January or February, Austin said, at least for a potential subset of people who respond to the therapy. Patients who receive convalescent plasma with a high level of antibodies early in their disease course appear to fare better. But whether certain age, race or gender groups are more likely to respond is still unknown.

Andrea Troxel, director of the Division of Biostatistics at New York University School of Medicine, is hoping to soon have answers as well. Troxel is the principal investigator of an effort to combine data from eight trials of convalescent plasma around the world. Among them is an NIH-sponsored trial at NYU Langone Health as well as studies in India, Spain, Belgium, and other countries.

Austin and Troxel are keeping in close touch with the FDA, which could possibly narrow its emergency authorization for the therapy based on what the studies reveal.

When the FDA cleared convalescent plasma over the summer, some researchers were concerned wider use would stymie enrollment in clinical trials. Troxel said this hasn’t been the case for the most part because the Infectious Diseases Society of America advised doctors against using convalescent plasma outside of clinical trials until a benefit was seen.

It’s part of a familiar pattern for covid-19 drugs touted by Trump. For example, the government has distributed hundreds of thousands of antibody therapies from Regeneron and Eli Lilly & Co. to hospitals around the country, but uptake has been minimal. Only 5% to 20% of the antibody treatments were being used, Moncef Slaoui, chief scientific adviser to the Operation Warp Speed drug and vaccine accelerator, said earlier this month.

Like convalescent plasma, antibody therapies are hoped to work best when used early to prevent high-risk patients from worsening. They must be infused typically in a hospital setting, which can be a tough sell for people who don’t feel very ill.

The antibody therapies are basically synthetic versions of convalescent plasma that are more complex and expensive to make. If convalescent plasma does work for some people, Austin said, the relative ease of getting it to patients could make it valuable.

“If you’re a rural hospital in Africa, you can give convalescent plasma,” he said. “You don’t need a supply chain, storage or a pharmacy. Heaven knows we need things like that, and we have areas like that in this country too.”

And drugs with even a potentially modest benefit can be helpful against the virus “both in terms of hospitalization and what we’re learning about its long-term effects,” said Megan Ranney, an emergency physician and associate professor at Brown University. The danger lies in over-promising, she said.

“There is no magic pill that you can take and suddenly avoid all the horrible effects of covid,” Ranney said. Implying otherwise is “dangerous because it gives people a false sense of assurance.”

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Was 2020 the worst year ever? Historians weigh in.

InternationalDec 31. 2020Twenty thousand chairs, each representing 10 deaths from the coronavirus pandemic in the United States, are lined up on the Ellipse south of the White House. MUST CREDIT: Washington Post photo by Katherine Frey.

By The Washington Post · Michael S. Rosenwald

So, just to recap, the following events occurred in 2020:

– The coronavirus pandemic swept the globe, killing more than 1.7 million people (so far), including more than 337,000 (so far) in the United States.

– The president of the United States was tried and acquitted, after being impeached at the end of 2019.

– Protests stemming from several police killings of unarmed Black Americans erupted throughout the country, including just outside the White House, where federal law enforcement officers used tear gas on U.S. citizens.

– Wildfires devastated the U.S. West Coast and Australia.

– The president of the United States contracted the coronavirus and then dismissed it.

– Kobe Bryant and his 13-year-old daughter died in a helicopter crash.

The president of the United States disputed the valid results of a peaceful election. (He lost.)

– Alex Trebek died.

– Prince Harry and Meghan, Duchess of Sussex, broke up with the royal family.

– Murder hornets arrived.

As the year finally, mercifully, comes to a close, the above events – and more – have inspired the Internet’s meme machine to declare that 2020 is the worst year ever.

But it’s not just the Internet meme machine that thinks 2020 was the worst year ever.

Earlier this month, Time magazine ran an extraordinary cover image with a big red X drawn over the number 2020. “THE WORST YEAR EVER,” the cover line read. Time certainly wasn’t alone. A recent headline from the Hill: “Why 2020 really was the worst year ever.” Even the York Daily Record of Pennsylvania wondered: “Was 2020 the worst year ever? With pandemic, social unrest, election chaos, it’s in the running.”

Historians demur.

In a clever bit of marketing, the self-therapy app Bloom recently asked 28 historians from Yale, Oxford, Stanford and other major universities to choose the worst year in history – or, as they put it, the most stressful. British historian Philip Parker led the effort. Following a depressing dive down the rabbit hole of historical misery, Parker compiled a list of the top worst/most stressful years in world, British and U.S. history. Then the historians made their picks.

The worst year in world history wasn’t even a close contest.

It was 1348, the height of the Black Death, during which as many as 200 million people died. That would be like wiping out about 65% of the U.S. population. The Holocaust in 1944 ranked second, followed by 1816, when a volcano eruption in Indonesia blocked out the sun, starving millions. 2020 ranked sixth.

In U.S. history, 2020 was well down the list at No. 8, just behind the 2001 terrorist attacks on Sept. 11, the Cuban missile crisis of 1962, the tumult of 1968’s riots and assassinations, the 1918 flu pandemic, the Trail of Tears of 1838, the 1929 stock market crash marking the beginning of the Great Depression, and at the very, very top, 1862.

That was, most historians say, the grimmest year of the Civil War, when the country’s total collapse seemed imminent.

“It’s a symbol of a time when the nation almost broke apart,” Parker said in an interview, “and that, really, goes to the essence of what it is to be a country and a society. It’s almost like a dagger to the heart of the country.”

In many ways, Parker said, we’re still too close to 2020 to understand what its real ranking will be, seen through the lens of time passed.

“As Chairman Mao is reputed to have said about the French Revolution,” Parker said, “it’s a little too early to say.”

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Samsung heir faces nine years in jail as bribery trial wraps

InternationalDec 31. 2020Jay Y. Lee, center, arrives at the Seoul Central District Court in Seoul, South Korea, on Dec. 30, 2020. MUST CREDIT: Bloomberg photo by SeongJoo Cho.

By Syndication Washington Post, Bloomberg · Sohee Kim, Heesu Lee, Shinhye Kang

South Korean prosecutors requested a nine-year prison term for Samsung Electronics Co.’s Jay Y. Lee, seeking to put the heir apparent back in jail in a bribery case that rocked the nation and ignited a backlash against its most powerful conglomerates.

Special prosecutors proposed the sentence during a Wednesday hearing at the Seoul High Court, which will make its ruling on the billionaire’s fate Jan. 18. “There’s no denying that it has made a lot of positive impact on our society,” according to a transcript of closing arguments from prosecutors, referring to Samsung. “But just because there’s been an economic contribution, there should be no hesitation in legal enforcement based on the rule of law.”

The 52-year-old billionaire is fighting allegations of graft in a retrial of a case that started four years ago and led to his imprisonment and the ouster of former President Park Geun-hye. The outcome of the case could snarl succession at Samsung, just as Lee is expected to formally take the helm of the mobile and electronics giant after the death of his father in October.

The executive stands accused of making gifts to cement his control over the world’s largest smartphone maker and smooth his ascension. Lee served a year in jail before his release in 2018 after an initial five-year prison term was halved and suspended by an appeals court. But in August, the Supreme Court voided that decision, thrusting the executive back before a judge. Lee faced a tougher sentence this time — a minimum of five years — because the amount of alleged bribery acknowledged by the top court increased.

Yet experts viewed a decreasing chance of imprisonment as the trial drew to a close. Judges at the high court asked Samsung and Lee to impose measures to prevent illegal activity and improve credibility among the group. Lee responded by setting up an independent compliance committee and issuing a personal apology in May over past wrongdoings related to the succession process. He also pledged publicly not to hand down leadership of the Korea’s largest conglomerate to his children. The compliance committee’s activities will be factored into Lee’s eventual sentencing.

“Even though it’s tough and difficult, I’ll walk on the right path,” the billionaire said Wednesday in prepared remarks before the court. “I promise that I’ll create a company with the highest level of transparency and morality.”

“I will make sure, again, my children will not be mentioned in relation to the succession of the company. Samsung will never get into controversy over these related matters,” he added.

The bribery allegations stem from a controversial merger in 2015 between two Samsung units, which helped Lee gain control over the group. Prosecutors argued that Samsung offered horses and financial contributions, via an intermediary, to a confidante of former president Park to try and win the government’s support for the deal.

Lee, who stepped down from an internal director post, remains the tech company’s vice chairman and de facto leader. Although his father and chairman Lee Kun-hee died in October, the Samsung scion has not been immediately crowned his successor. Samsung is likely to hold off on naming Lee to that role at least until the trial is completed.

Separately, Lee is embroiled in another case related to the controversial 2015 merger, with allegations ranging from violation of capital market laws to breach of duty. Prosecutors indicted Lee in September and hearings are set to resume on Jan. 14.

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Swedish PM slammed for shopping tour amid latest covid surge

InternationalDec 31. 2020Stefan Lofven, Sweden’s prime minister, at a European Union leaders summit in Brussels on Dec. 10, 2020. MUST CREDIT: Bloomberg photo by Geert Vanden Wijngaert.

By Syndication Washington Post, Bloomberg · Rafaela Lindeberg

A number of the most senior members of Sweden’s government, including the prime minister, have been caught apparently ignoring their own covid guidelines.

Prime Minister Stefan Lofven and Justice Minister Morgan Johansson were among those named in Swedish media this week for seeming to flout restrictions they insist must be followed if the country is to rein in the coronavirus.

Lofven went Christmas shopping in a mall without a face mask after explicitly appealing to Swedes to avoid such excursions ahead of the festive season. His spokesman has acknowledged the trip took place, which he says was “carefully planned” to avoid unnecessary risks.

The development adds a layer of potential embarrassment to Sweden’s handling of the covid crisis. The country initially defended its no-lockdown strategy, before backtracking in recent weeks amid a resurgence of cases that threatens to overwhelm its health-care system. Lofven is now trying to persuade parliament to give him the power to impose a full lockdown.

The government has already seen confidence in its covid strategy sink, with even King Carl XVI Gustaf delivering a rare rebuke for Sweden’s failure to contain the death toll. About 8,500 Swedes have died of covid-19, roughly seven times as many as in neighboring Denmark.

Lofven’s shopping trip lit up Twitter, with several of Sweden’s best known political commentators warning that the incident risks denting his credibility among voters.

“Who should follow the rules if not even the Prime Minister and the Minister of Justice do so?” Dagens Nyheter, Sweden’s biggest morning newspaper, wrote in an editorial published Tuesday evening.

Other government members have also reportedly engaged in conduct that breached covid guidelines, including Sweden’s Finance Minister Magdalena Andersson, Aftonbladet reported on Wednesday. According to the newspaper, she was seen in a ski rental shop in the popular Swedish winter resort of Salen, which is on the list of destinations the National Health Authority has warned against visiting.

With infection rates spreading since the fall, Lofven has had to step up his rhetoric entreating his countrymen to “refrain from staying in indoor environments such as shops, shopping centers.” Last month, he reminded Swedes “how dangerous” such conduct is.

At a briefing this month, Lofven said, “I hope and I think that everyone in Sweden understands the seriousness” of the situation.

A spokesman for Lofven said his Christmas shopping tours included purchases of alcohol and a present for his wife. He also visited a shop that fixes watches and looked for spare parts for his razor. His most recent known shopping trip was on Dec. 23.

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Germany’s new virus deaths surpass 1,000 for the first time

InternationalDec 31. 2020

By Syndication Washington Post, Bloomberg · Daniel Schaefer, Raymond Colitt

Germany’s daily coronavirus deaths surpassed 1,000 for the first time since the beginning of the pandemic, underscoring the urgency facing Europe’s leaders to slow the spread and roll out vaccines.

There were 1,122 fatalities in the 24 hours through Wednesday morning, according to data from Johns Hopkins University. Along with the mounting death toll, the number of Covid-19 patients in German intensive care units has risen steadily, prompting warnings that the health-care system could become overburdened.

Germany joined its European Union partners in rolling out vaccinations last weekend, but officials have said it will take months for the program to have a tangible impact on contagion rates. Europe’s largest economy has so far inoculated almost 42,000 people, according to data from the RKI public health institute.

On Tuesday, the EU agreed to trigger an option to buy an extra 100 million doses of the shot developed by Pfizer Inc. and BioNTech SE. Vaccines from other producers will follow once they’ve been approved, European Commission President Ursula von der Leyen said on Twitter.

Europe has become an epicenter of the pandemic, with more than 400,000 coronavirus-related deaths and 16.2 million infections.

The rise in Germany’s fatalities comes as Chancellor Angela Merkel’s government considers extending a hard shutdown that was imposed in December. Schools and non-essential stores remain shuttered until Jan. 10, but senior politicians have urged prolonging at least some of the measures.

Karl Lauterbach, a health expert for the ruling Social Democrats, on Wednesday warned that if the virus numbers aren’t slashed to around 25 per 100,000 people over 7 days, the risks will multiply. The current figure is 141.

If the situation doesn’t improve, “we’ll go from one lockdown to the next and then we have the risk of mutations against which vaccines may not work perfectly,” Lauterbach said on ZDF television.

While some countries in the region are gradually relaxing measures to contain the virus, others are still tightening curbs. Ireland’s government is set to announce new restrictions on Wednesday. Among the measures under consideration are the closure of non-essential retail and the reintroduction of a five-kilometer (three-mile) limit on travel from home. Bars and restaurants have already been shuttered.

Authorities are also grappling with ways to ensure widespread uptake of the Covid-19 vaccine. In Italy, where restrictions were severely tightened for most of the Christmas period, cases and deaths have declined sharply from the highs recorded in November. However, concerns are growing over delays and mishaps in the vaccination campaign.

Around 8,000 people have received the first dose of the Pfizer-BioNTech vaccine so far, and the country is behind schedule in hiring personnel and preparing the logistics for mass inoculation.

France is having even less success in the face of strong anti-vaccination sentiment across the country. Less than 100 people have been given a shot, according to the government. It’s target is to administer 1 million doses by the end of February, Health Minister Olivier Veran said late Tuesday.

On Monday, Spain became the fourth European country to record more than 50,000 coronavirus deaths. An initiative to track people who refuse to get inoculated could help the hard-hit country regain trust in its tourism sector, which was linked to the spread of the coronavirus after rules were relaxed in the summer.

For its part, Germany has recorded just over 32,000 deaths since the start of the pandemic. In the 24 hours through Wednesday morning, the number of infections rose by another 19,466, bringing the total to more than 1.69 million.