By The Washington Post · Loveday Morris, James McAuley · WORLD, HEALTH, ASIA-PACIFIC, HEALTH-NEWS
BERLIN – German Chancellor Angela Merkel announced a month-long partial lockdown on Wednesday, saying health authorities have lost track of the virus while hospitals fill rapidly.
Bars, restaurants and theaters will close for a four-week period starting Monday, while schools and places of worship will remain open. Leaders of Germany’s 16 federal states also agreed to new restrictions on social contacts, limiting public gatherings to a maximum of two households, with a limit of 10 people.
Similar measures were expected to be announced across the border in France, with President Emmanuel Macron scheduled to make an evening address. Switzerland also imposed new restrictions on Wednesday.
As she outlined the measures in a news conference in Berlin, Merkel noted that the number of patients in the country’s intensive care units had doubled in the past 10 days.
“If the tempo of infections stays the same, we will reach the capacity of our health care system within weeks,” she said. “That’s why it’s completely clear that we need to act, and act now.”
Germany has witnessed a rapid deterioration of its virus response, after being praised in the first wave of the pandemic. Germany’s contact tracing program – paired with mandatory quarantines – had been held up as a model of how to contain outbreaks. Now, German health authorities are unable to identify where 75% of new infections come from.
“We no longer have control of the spread of the virus,” Merkel said.
Countries across Europe have sought to avoid a return of national lockdowns – but countries are finding that more targeted, piecemeal measures may not be sufficient. Appeals to Germans to reduce contacts in recent weeks failed to slow the growth in new cases.
While Germany has greater ICU capacity than most countries in Europe and fewer daily cases than France, Spain and Britain, infections have been growing exponentially. Germany recorded 14,964 new cases on Wednesday, doubling from just a week earlier.
Parties and gatherings in public and private spaces were “unacceptable,” Merkel said. Social sacrifices must be made to ensure that schools and kindergartens can remain open, she said.
Industry groups said a new lockdown would be a “death blow.” As Merkel and state leaders hashed out new measures over a video call, thousands of restaurant and bar owners marched to the Chancellery. A van pulled a coffin on a trailer with the words “Entertainment Sector” on the side. Merkel said closed businesses would receive financial assistance.
The closures were a “very hard decision,” Health Minister Jens Spahn, who himself came down with coronavirus last week, told German radio. But it was necessary, he said.
“If we wait until the intensive care units are full, it will be too late,” he said.
In France, Macron is also expected to announce a new national lockdown of four weeks, according to French media.
The French government imposed one of Europe’s strictest lockdowns in the spring, but has struggled to curb a rising second wave that reached a record level of more than 50,000 new confirmed cases in a 24-hour period over the weekend.
On Tuesday, France recorded 33,417 new cases, according to figures released by Santé Publique France.
Those higher case numbers have also been accompanied by a steep rise in hospitalizations. On Monday, for instance, French hospitals tracked more than 1,300 new patients, the highest one-day total since early April, in the peak of the first wave.
“We had predicted there would be this second wave, but we ourselves are surprised by the brutality of what’s been happening over the past ten days,” Jean-François Delfraissy, an immunologist and the chair of the French government’s scientific advisory covid response board, told France’s RTL radio on Monday.
Melbourne lifts one of world’s longest lockdowns after 111 days
Health & BeautyOct 28. 2020Diners at a restaurant look out toward St. Kilda Beach in Melbourne, Australia, on Wednesday. (Asanka Brendon Ratnayake/ AP)
By The Washington Post · Antonia Noori Farzan, Miriam Berger · WORLD, ASIA-PACIFIC One of the world’s longest novel coronavirus lockdowns wound down Wednesday morning, allowing roughly 5 million people in the Australian city of Melbourne to leave home anytime they want, eat dinner at a restaurant and drink at bars for the first time in more than three months.
Celebrations ensued. Bookings at low-capacity bars and restaurants quickly filled up for weeks ahead. Businesses popped bottles of champagne as shoppers flocked to stores. Some, including, Kmart, opted to remain open for 24-hours to meet demand, local media reported.
The rollback came after the city reported zero new coronavirus cases on Monday and Tuesday, a dramatic drop from the hundreds logged each day during the outbreak’s peak in late July and early August.
“I’m pretty proud of what we have achieved here,” Sharon Lewin, the director of the Peter Doherty Institute for Infection and Immunity in Melbourne, told the BBC. “The outcome has been extraordinary – not without its pain, though.”
While the 111-day lockdown helped stop the spread of the virus, it has also taken a devastating toll on the local economy and mental health of residents.
Victoria, the state where Melbourne is located, lost an average of 1,200 jobs a day as most businesses were forced to stay closed, according to Bloomberg News. Demand for mental health services grew by 31% in September and October as a lockdown, which began in July and was initially supposed to last only six weeks, dragged on. Meanwhile, alcohol consumption increased, as did domestic violence.
Enduring the prolonged shutdown may have been made even more challenging by the fact that Melbourne had only recently exited a nationwide lockdown that was in place from March to May, giving residents a brief taste of normal life before their daily activities were curtailed again.
Melbourne residents stuck at home this summer watched travel and part of ordinary life resume in much of Europe while the virus surged across the United States. After stringent lockdowns in countries including Italy and Spain, Europe appeared to have largely contained its major outbreaks for a time, and began reopening borders.
This too came at a cost. Europe is now facing a surge of infections.
European leaders have said their goal is to avoid hard lockdowns like those imposed in the spring, which, as in Melbourne, had painful repercussions for economies and communities. Nonetheless, as hospitals warn of increasing strain, both Italy and Spain have tightened restrictions in recent days, while France is reportedly considering a month-long lockdown and Germany is expected to announce new, tougher rules this week.
The former president of the Psychiatric Association of Thailand said that harming oneself like a Pheu Thai Party MP did in Parliament on Tuesday was not the correct way of managing conflicts.
Dr Yongyut Wongpiromsan, citing the case of Chiang Rai MP Wisarn Techatheerawat using a knife to slash his arm in Parliament, said physical and verbal violence or self-harm cannot be used as a tool to win a debate.
“It will not actually win any sympathy or understanding from others. It is important to respect the opinions of the other party and realise that they have good intentions towards the country as well. The opposite side should not always be seen as bad, otherwise problems will not get resolved in society,” Dr Yongyut said.
He said protests and civil disobedience can be demonstrated in many forms and should always have a valid reason. However, using violence against oneself will only worsen the issue and make the divide between the two sides even deeper.
The psychiatrist said the best way to handle differences is to be open to the other side’s opinions without opting for violence.
“Conflicts should be resolved peacefully, no matter which side you come from. Don’t see people as enemies. Using obnoxious words against the other side will only lead to violence, which people with power, such as the state or public, should be careful about,” he said.
Trump campaign flouted agreement to follow health guidelines at Duluth rally, documents show
Health & BeautyOct 25. 2020President Donald Trump throws hats to the crowd as he arrives for a campaign event at the Duluth International Airport on Sept. 30, in Duluth, Minn. MUST CREDIT: Washington Post photo by Jabin Botsford
By The Washington Post · Shawn Boburg · NATIONAL, HEALTH, POLITICS, WHITEHOUSE, HEALTH-NEWS The start of President Donald Trump’s rally was still hours away when it became clear his campaign would not keep its promise.
In the days leading up to the Sept. 30 event in Duluth, Minn., local officials had privately pressed the campaign to abide by state public health guidelines aimed at slowing the spread of the novel coronavirus, documents show. In response, the campaign signed an agreement pledging to follow those rules, limiting attendance to 250 people.
On the day of the rally, however, Trump supporters flooded onto the tarmac at Duluth International Airport. They stood shoulder to shoulder, many without masks.
“We have been notified that the 250 person limit has been exceeded,” an airport representative emailed a campaign official late that afternoon. “This email serves as our notice of a contract violation and we are requesting you remedy the situation.”
The warning went unheeded – and unanswered.
Held two days before Trump was diagnosed with covid-19, the rally was attended by more than 2,500 people, airport officials estimated.
The Duluth event shows the dilemma local officials face as Trump turns to his signature rallies in the closing weeks of the campaign: They can enforce local guidelines intended to protect the public, and risk antagonizing the campaign and its supporters, or they can look the other way as the campaign holds massive gatherings at a time when coronavirus cases are surging in many states.
Emails and other documents obtained by The Washington Post through open-records requests show that Duluth officials insisted on adherence to the rules, and the campaign responded by making commitments it ultimately did not keep. The documents also show that local officials suspected the campaign would violate the agreement, but shied away from enforcing public health orders for fear of provoking a backlash.
“We will not incite an incident by unilaterally taking physical action to close the event,” the airport’s executive director, Tom Werner, wrote to the airport’s appointed board members the morning before the event.
Minnesota public health officials have traced 19 coronavirus cases to a pair of Trump rallies held in the state in September, three of them to the event in Duluth.
A spokesman for the Trump campaign did not respond to a request for comment.
In a statement, the Duluth Airport Authority said it takes state health mandates seriously. “It was made clear to the Trump Campaign, in the lead up to the event, that compliance with the State of Minnesota’s current public health executive orders was an expectation of the DAA,” the statement said.
In the early months of the pandemic, Trump refrained from holding large gatherings. That changed in June, when he hosted an indoor rally in Tulsa against the advice of local public health officials. With the novel coronavirus raging, Trump has now resumed daily campaign rallies. As of Friday, he had held 14 events in the previous 12 days, often defying limits on crowd size and requirements for social distancing – and sometimes mocking those rules.
Airports are the campaign’s venue of choice for these campaign stops. Because airports are often run by local government entities, their public records provide a window into the private negotiations that take place before the events.
In early September, the Reno-Tahoe Airport Authority told one of its tenants it could not hold a planned 5,000-person Trump rally in a hangar leased at Reno-Tahoe International Airport, citing the state’s 50-person crowd limit, according to a letter obtained by The Post.
Airport officials in Reno publicly said at the time that the decision had nothing to do with politics, but the Trump campaign hit back, saying “Democrats are trying to keep President Trump from speaking to voters.” Trump rescheduled at another Nevada airport that agreed to host the event.
In late September, emails show, the campaign approached Duluth airport officials about holding a rally there. Local officials in the Democratic stronghold almost immediately expressed concerns.
The region was already beginning to see a spike in coronavirus cases. And Minnesota Gov. Tim Walz, D, had issued an executive order in June limiting outdoor gatherings to 250 people.
The campaign initially told city officials it expected up to 9,000 people, according to a Sept. 25 email the local fire chief, Shawn Krizaj, sent to his deputies. Krizaj wrote that he was trying to work with airport officials and the campaign to ensure the rally complied with the governor’s cap on public gatherings.
The following day, City Council member Joel Sipress emailed the city’s Democratic mayor, Emily Larson. “Whether the event is indoors or outdoors, under the law the attendance must be limited to 250 people,” he wrote.
Larson responded that she was still getting more information about the event but added: “We have been explicit and clear on this with them.”
Sipress, a Democrat, also wrote to two airport authority board members that he believed the airport was “legally obliged” to ensure the campaign obeyed the state’s limit. The Duluth Airport Authority, or DAA, has a seven-member board appointed by the mayor.
As airport officials fielded emails and calls, Werner, the airport’s executive director, sought to assure the members of the DAA. He wrote that he would require the campaign to sign a written agreement pledging to follow public health orders.
“That’s all DAA can do,” he said in an email on Sept. 27. “We do not have the resources for enforcement at the event. We will rely on the City’s emergency management and police for strict enforcement.”
The emails show that city officials looked to the state to step in and enforce the governor’s order.
Krizaj, the city’s fire chief, spoke to state officials about the rally but was told they were “not going to actively enforce” the 250-person cap and were “washing their hands of it,” according to a Sept. 28 email Werner sent to airport board members.
In an interview with The Post, Krizaj confirmed that officials in the state’s Department of Public Safety said they would not enforce the governor’s order.
“The message was, ‘It was going to be up to local jurisdictions,’ ” he said.
The Minnesota Department of Public Safety said in a statement that it did not have the authority to enforce the governor’s order. A spokesman for the state’s Department of Public Health said it when it has learned about plans for large events it has “worked to make sure the organizers understand both the executive order requirements and the public health guidance.” The agency also has limited authority to enforce the state guidelines at rallies, said spokesman Doug Schultz.
In his email to board members, Werner wrote that the state balked at enforcing the crowd limit partly because of a provision exempting federal workers conducting official business.
“They said, practically we’ll have a hard time proving POTUS is not acting in his official capacity during his visit, even though we know it’s a campaign. . . . Bottom line, the State will not provide any help here,” Werner wrote.
The following day, Werner and the campaign signed an agreement, a copy of which was released to The Post. It shows the airport was to provide space for the rally, parking, circulation and staging and support facilities for a $20,000 fee. It includes a clause citing the state’s public health emergency and specifying that compliance with the governor’s executive orders is required.
Werner informed the airport’s board members that he had also signed a nondisclosure agreement that would prevent him from discussing details of the agreement with board members or others. “All airports have had to sign them who have seen rallies at their facilities,” he wrote.
Werner declined to comment on the nondisclosure agreement for this story. A clause in the contract he signed prohibited him from disclosing the campaign’s “confidential information” but includes few details about the parameters. There was no separate nondisclosure agreement, according to the DAA’s attorney, Steven Hanke.
The morning of the rally, Werner told the airport’s board that he would reinforce his plea to the campaign to keep the crowds small.
“I will make another appeal to the campaign, this morning, asking for their plan to comply with the 250 person cap on crowds,” he wrote. The records do not show whether the campaign responded.
“If they violate the cap, the security guard will inform DAA senior staff and move on to other duties,” Werner wrote to board members.
Airport personnel would then inform the campaign by email, Werner explained. He also said the airport would later send a formal letter to the campaign, but he said he couldn’t elaborate on that due to the nondisclosure agreement.
“Of course, it is possible things will go just fine,” he wrote. “However, I want to outline the steps in case things go a certain way.”
That afternoon, an airport board member wrote to Werner asking how many people were expected at the rally that night.
Werner said the most recent estimate from the campaign was 1,000. “Perhaps the rain will keep folks home,” he added.
That evening, the crowd filtered in, triggering the contract violation notification from the airport.
Airport officials estimated that between 2,500 and 3,000 people showed up, according to emails.
Krizaj told The Post that city officials expected that the campaign would encourage social distancing and masks. “We were kind of under the impression that there would be a little bit more enforcement from campaign staff and volunteers, which we did not see,” he said.
“It’s really hard to stand up to a president who insists on holding an event that puts the health of your community at risk because presidents have a lot of power,” said Sipress, the city council member.
A little more than 30 hours after the rally, Trump’s diagnosis prompted a flood of media inquiries about the rally and the airport’s decision to host it, records show. Airport officials said nothing about the contract requirement or the violation, only issuing the same statement provided to The Post for this story.
Documents show that the DAA had prepared a public statement before the rally, for possible release afterward, saying: “We are disappointed the Trump campaign did not comply.” That line was ultimately not included in DAA’s statements to the media.
On Oct. 5, Hanke, the attorney for the airport, sent the campaign a formal letter asserting that it had breached the agreement’s 250-person limit. The letter also said the Trump campaign had not paid the airport the $20,000 fee for hosting the event.
Two weeks later, officials won’t say whether that fee has been paid. “That information is covered under our nondisclosure agreement and cannot be released,” a spokeswoman for the airport said in an email.
By Special to The Washington Post · Erin Blakemore · NATIONAL, HEALTH, HEALTH-NEWS In 2019 alone, an estimated 10 million people worldwide got tuberculosis, a deadly bacterial disease that usually affects the lungs. An estimated quarter of the world’s population has a TB infection. Most aren’t actively sick – yet.
People with TB have a 5% to 15% risk of getting ill. Still, the highly contagious disease was one of the top 10 causes of death worldwide last year and is the leading infectious killer worldwide, according to the World Health Organization, the United Nations’ public health agency.
In a new report, WHO provides a global update on the state of TB and the fight against the disease, which is both preventable and curable.
The report paints a dire picture of a disease that remains a public health crisis. Just eight countries – India, Indonesia, China, the Philippines, Pakistan, Nigeria, Bangladesh and South Africa – account for two-thirds of the world’s TB cases. And because many carriers of the disease are not yet ill, it can go untreated until it’s too late.
Tuberculosis incidences are falling, the agency says – between 2015 and 2019, cases were reduced by about 9 percent. But that still falls short of WHO’s targets.
The coronavirus pandemic is expected to make things worse.
Large drops occurred in TB diagnoses between January and June. Due to the economic effects of the pandemic, WHO models predict that cases could annually increase by more than 1 million in the next five years if resources continue to be diverted to covid-19, the disease caused by the coronavirus.
The stark report has positive news however. Funding for TB prevention, diagnosis and treatment has doubled since 2006, and seven high-burden countries reached their death reduction milestone. And people living with HIV are more likely than ever to be given preventive treatment for tuberculosis, which is the leading killer of people with HIV worldwide.
America is poised to enter into its worst stretch yet of the pandemic
Health & BeautyOct 24. 2020President Donald Trump and Democratic presidential candidate Joe Biden participate in the final presidential debate on the campus of Belmont University on Oct. 22, 2020, in Nashville, Tenn. MUST CREDIT: Washington Post photo by Jabin Botsford
By The Washington Post · William Wan, Jacqueline Dupree · NATIONAL, HEALTH, POLITICS, HEALTH-NEWS
America on Friday hit its highest daily number of coronavirus case since the pandemic began, recording at least 81,400 new infections and surpassing the previous record set during the summertime surge of cases across the Sun Belt.
The rising numbers puts the nation on the precipice of what could be its worst stretch to date in the pandemic with some hospitals in the West and Midwest already overwhelmed and deaths counts beginning to rise.
The current surge is considerably more widespread than the waves from last summer and spring. The unprecedented geographic spread of the current surge makes it more dangerous, with experts warning it could lead to dire shortages of medical staff and supplies. Already, hospitals are reporting shortfalls of basic drugs needed to treat covid-19, the disease caused by the novel coronavirus.
And it’s not simply a matter of increased testing identifying more cases. Covid-19 hospitalizations increased in 38 states over the past week and are rising so quickly that many facilities in the West and Midwest are already overwhelmed. The number of deaths nationally has crested above 1,000 in recent days.
The last time the country hit a new daily record for coronavirus cases – 76,533 on July 17 – just four states accounted for more than 40,000 of those cases: Arizona, California, Florida and Texas.
On Thursday, the daily number of cases reached 73,686. But this time, it’s 14 states accounting for that same lion’s share of cases. And 22 states have broken their records for single-day highs of cases in the past two weeks.
More than 170 counties across 36 states were designated rapidly rising hotspots, according to an internal federal report produced Thursday for officials at the Department of Health and Human Services and obtained by The Washington Post.
“One key way we got through previous waves was by moving health-care workers around. That’s just not possible when the virus is surging everywhere,” said Eleanor J. Murray, an epidemiologist at Boston University.
Equally alarming, Murray said, is that no one knows how high this wave will grow before peaking.
“We are starting this wave much higher than either of the previous waves,” she said. “And it will simply keep going up until people and officials decide to do something about it.”
More than 8.3 million Americans so far have been infected with the coronavirus, and at least 222,000 have died, according to a database maintained by The Post.
The high case numbers of recent days have stoked concerns because the country has not even hit the stretch of holidays and cold weather, which experts have long warned will send cases soaring even higher. More interactions could mean more transmission during celebrations of Halloween, Christmas and the New Year. The winter’s cold, dry air will also help the virus stay stable longer, even as it drives people to hunker down together indoors.
On Thursday, Chicago Mayor Lori Lightfoot, D, announced new restrictions on businesses. Hours later, White House coronavirus response coordinator Deborah Birx warned that closing public spaces may not be enough.
“It won’t be as simple as closing public spaces,” Birx said, pointing to increased gatherings in people’s homes. “What has happened in the last three to four weeks is that people have moved their social gatherings indoors.”
In some areas of Wisconsin, 90 percent of hospital intensive care unit beds are full, the office of Gov. Tony Evers, D, said. The first patient was admitted Wednesday to a makeshift field hospital erected at a state fairgrounds.
Hospitals from Missouri to Idaho are starting to reach capacity. On Thursday, America had more than 40,000 current covid-19 hospitalizations – the first time that level has been reached since August. In the past three weeks, 34 states saw sizable increases in hospitalizations, and the number has more than doubled in Connecticut, Montana, New Mexico and Wyoming.
In Utah, leaders are trying to open a field hospital at an exposition center. State epidemiologist Angela Dunn warned that the health-care system is at capacity, hospital staff are exhausted, and Utahans are getting scared.
“You know, I just, I don’t know what to do anymore,” Dunn said at a Thursday news conference, pleading for residents to be more cautious. “I’m really not trying to scare anyone. I’m just trying to inform you of what’s going on.”
Experts said the problem facing many hospitals this winter won’t be finding enough beds. It will be ensuring that hospitals have sufficient specialized staffing.
“Creating beds is relatively easy, but what do you do when you outstrip ICU nurses, doctors and teams?” said Michael T. Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy.
In recent months, health-care workers have been able to lower mortality rates – the ratio of patients who die once infected. Much of that progress has come through hard-earned expertise by ICU staff – new approaches and knowledge about how to combat the virus, such as when to use ventilators, the adoption of treatments such as steroids and proning patients, which helps with breathing by shifting them onto their abdomens.
But the hard-won battle to lower mortality rates could be imperiled as hospitals are overwhelmed and staffing gets stretched, Osterholm said. And as the pandemic has seeped into rural swatches of the Midwest, skeleton staffs at smaller hospitals are shrinking further as doctors and nurses fall ill.
A report this week by Osterholm’s center showed shortages in 29 of the 40 basic but critical drugs often used for covid-19 patients. That includes antibiotics, sedatives like propofol that are used to calm patients during intubation and heart medication such as norepinephrine. And because of the widespread nature of the infections, hospitals are finding it harder to draw from excess supplies of such drugs elsewhere.
The nation’s growing fatigue with the pandemic will likely make it even harder to contain a wintertime wave, specialists fear.
Even as hundreds of people are dying each day, “there’s this false sense of calm right now,” said Tom Inglesby, director of the Johns Hopkins Center for Health Security. “We have the president saying, ‘We’re rounding the corner.’ We have state leaders openly defying public health guidances.”
Inglesby pointed to plans and metrics many states laid out last spring for reopening. “That’s been completely disregarded in many places,” he said.
In North Dakota – among the hardest-hit states – Gov. Doug Burgum, R, put the onus on individuals to wear masks and avoid gatherings.
“It’s not a job for government,” Burgum recently declared.
At Thursday night’s final presidential debate, President Donald Trump claimed the virus was “going away” and “we’re learning to live with it.” His Democratic rival, former vice president Joe Biden, responded, “We’re learning to die with it.”
Experts say rapid action is needed by leaders and residents to tamp down virus transmission.
“It’s been framed as this false choice between full shutdowns and doing nothing, but that’s not the case,” said Inglesby, who urged people to wear masks and avoid large gatherings.
Politicians also need to stop minimizing the risk posed by the virus and start discussing openly with the public the hard decisions and trade-offs that lie ahead, Murray said. Is it, for example, worth keeping bars open if it means having to close schools?
“I worry sometimes about being too pessimistic,” she said. “We are not making predictions and saying this dark winter is somehow inevitable. We’re trying to warn people this is how it will be if we don’t do something about it.
By The Washington Post · Carolyn Y. Johnson · NATIONAL, HEALTH, HEALTH-NEWS
The Johnson & Johnson coronavirus vaccine trial, paused earlier this month due to an unexplained illness in a participant, is preparing to restart after investigators concluded the man’s stroke did not appear to be related to the vaccine, according to two individuals familiar with the trial who spoke on the condition of anonymity.
The AstraZeneca vaccine trial, on hold in the United States since early September, also got the greenlight Friday to restart from the Food and Drug Administration, according to a company statement.
When a potential adverse event occurs during a clinical trial, the testing is typically stopped so that an independent data and safety monitoring board can thoroughly investigate and determine whether the problem was likely related to the vaccine. Rules around clinical trials and patient privacy usually restrict details from being released, but the tremendous scrutiny of the coronavirus vaccine trials has led many experts to call for greater transparency in disclosing and explaining the reasons for such halts.
In the Johnson & Johnson trial, which was paused on Oct. 12, a man who received a vaccination suffered a stroke that may have been triggered by an infection. To conclude it was not likely to be related to the shot, investigators probed not only the medical details of the event, but also examined a safety database of 100,000 people who have received vaccines that use the same underlying technology.
The investigation found “no clear cause” of the incident, according to a company statement. It also found no evidence the vaccine triggered the event, the details of which were not disclosed by the company. The independent board that monitors the trial recommended lifting the pause.
“With the information which we gathered to date and the information from external experts, the company found no evidence the vaccine candidate caused it,” Paul Stoffels, chief scientific officer of Johnson & Johnson said in an interview. He did not offer any details of the illness, citing patient privacy.
The company is testing the only vaccine that aims to protect people with a single shot; other prospective vaccines require a return visit and second shot three to four weeks after the first to trigger a protective immune response.
It was the second late-stage vaccine trial put on hold in recent weeks; the vaccine being developed by AstraZeneca and the University of Oxford was halted on Sept. 6 after a British participant developed a neurological problem. While the AstraZeneca study had resumed in the rest of the world, it did not get clearance to restart in the U.S. until Friday.
AstraZeneca spokeswoman Michele Meixell did not provide further information on the illness, but said the FDA reviewed data from the trials running around the world before concluding it was safe to restart. She said the company was adding a new expert panel “to provide advice on diagnosis and causality assessment of neurological events,”in addition to continuing standard company oversight and the independent data and safety committee.
Pausing and unpausing clinical trials happens routinely, and experts have said that the public should be confident the process worked as intended to protect the health and safety of participants.
“We see this all the time during clinical research,” said Carlos del Rio, an infectious diseases physician at Emory University School of Medicine. “As long as the data and safety monitoring board has reviewed the data and says its OK to proceed, we proceed.”
But whether the temporary halts — particularly the prolonged pause of the AstraZeneca trial — dampens volunteers’ interest in participating remains to be seen.
“We are excited to get this trial back up and running,” said William Hartman, a principal investigator of the AstraZeneca trial at the University of Wisconsin Hospital and Clinics. “It is too soon to tell whether participant enthusiasm will approach what it was prior to the pause. We certainly hope it will.”
By The Washington Post · Meryl Kornfield, Christopher Rowland, Lenny Bernstein, Devlin Barrett · NATIONAL, BUSINESS, HEALTH, COURTSLAW
WASHINGTON – The Justice Department announced a historic $8.3 billion settlement Wednesday with OxyContin-maker Purdue Pharma, capping a long-running federal investigation into the company that, for critics, became a leading symbol of corporations profiting from America’s deadly addiction to opioid painkillers.
As part of the deal – the largest such settlement ever reached with a pharmaceutical company, officials said – Purdue Pharma agreed to plead guilty to three felonies. But state authorities and families who have lost loved ones to their products said the Justice Department’s terms, which include a $225 million civil settlement with the billionaire Sackler family that once ran the firm, are too lenient.
Wednesday’s announcement comes as the Justice Department has pushed to settle a number of outstanding investigations involving major corporations. Administrations often seek to resolve significant cases as they near the possible end of their time in office, and with Election Day drawing near, the Trump administration has pushed to finalize a number of such matters this month. A multibillion-dollar settlement with Goldman Sachs over alleged financial misdeeds is expected to be announced later this week.
While numerous other lawsuits and court fights over opioids will continue, the Purdue Pharma settlement highlights how, for more than two decades, the widespread problem of overprescribing, diverting, and abusing pain pills raged across America while drug manufacturers, distributors, pharmacists, and doctors profited from the problem and largely deflected responsibility.
Deputy Attorney General Jeffrey Rosen said the settlement “will redress past wrongs, and will also provide extraordinary new resources for treatment and care of those affected by opioid addiction.”
Massachusetts Attorney General Maura Healey, a Democrat, said the Justice Department “failed” because justice in this case “requires exposing the truth and holding the perpetrators accountable, not rushing a settlement to beat an election. I am not done with Purdue and the Sacklers, and I will never sell out the families who have been calling for justice for so long.”
As part of the settlement, officials said, Purdue Pharma will admit in federal court in New Jersey to defrauding the United States and violating the anti-kickback statute from 2009 to 2017. The settlement includes a criminal fine of more than $3.5 billion, criminal forfeiture of $2 billion and a civil settlement of $2.8 billion.
The proposal must be approved by the bankruptcy court judge if it is to be enacted.
Federal prosecutors alleged the company, which manufactured millions of opioid pills during the height of the epidemic, paid two doctors through Purdue’s doctor-speaker program and an electronic health records company to drive up prescriptions for its opioid products, including its top seller OxyContin.
“The kickback effectively put Purdue’s marketing department in the exam room with their thumb on the scale at precisely the moment doctors were making critical decisions about patient health,” District of Vermont U.S. Attorney Christina Nolan said at the Justice Department briefing.
Purdue acknowledged the wrongdoing the company was resolving, saying Wednesday that it is a “very different company” today.
“Purdue deeply regrets and accepts responsibility for the misconduct detailed by the Department of Justice in the agreed statement of facts,” said Steve Miller, who has headed the company’s board since July 2018.
The criminal plea, officials said, does not preclude the potential for criminal charges in the future against any executive or member of the Sackler family, who own Purdue Pharma.
In a statement, family members denied criminal and civil culpability. They sought to distinguish between their ownership and leadership of the company, and the individual criminal acts of lower level managers.
“No member of the Sackler family was involved in that conduct or served in a management role at Purdue during that time period,” they said in a statement. The family’s $225 million civil settlement with the government stems from its drive, as past directors of the company, to increase OxyContin sales.
The family members – including Richard Sackler, David Sackler, Mortimer D.A. Sackler, Kathe Sackler, and Jonathan Sackler (who is now deceased) – demanded in 2012 that company executives come up with a plan to generate greater revenue in response to slumping sales, according to the settlement. They approved a new marketing plan called “Evolve to Excellence” in which “Purdue sales representatives intensified their marketing of OxyContin to extreme, high-volume prescribers who were already writing ’25 times as many OxyContin scripts’ as their peers,” the Justice Department said.
Those efforts directly led to uses of the addictive tablets that were “unsafe, ineffective, and medically unnecessary, and that often led to abuse and diversion,” the government said.
The $8 billion figure is largely symbolic – the bankrupt drugmaker is already indebted to states, communities and other creditors. The company is among numerous drugmakers and distributors embroiled in litigation over the deaths and economic devastation inflicted by the opioid epidemic. In the past two decades, more than 400,000 Americans have died of opioid overdoses.
About 2,800 cities, counties, Native American tribes and other groups have sued drug retailers, distributors and manufacturers, including Purdue, in a mammoth case that has been consolidated before a federal court judge in Cleveland. Separately, most states have sued the company in their courts, believing those venues give them a legal advantage.
By declaring bankruptcy, Purdue shielded itself from that litigation. Purdue has a tentative deal with about half the states and the lawyers representing the municipalities, but the remainder of the states want the Sackler family to contribute more. The divide is largely along party lines, with Republican attorneys general agreeing to the deal and Democratic states opposed.
Purdue has said it wanted the federal investigations settles before it finalized any global settlement of the thousands of cases.
Critics of the Sacklers and Purdue blame OxyContin for fueling the epidemic and have argued for harsher penalties. Like Healey in Massachusetts, attorneys general in the middle of litigation reacted harshly to the settlement news Wednesday.
North Carolina Attorney General Josh Stein, a Democrat, said he doesn’t support the settlement because it “does not force the Sacklers to take meaningful responsibility for their actions. A real agreement to resolve these cases would force the Sacklers to pay more and would provide funding to help pay for the treatment and programs people need to get well.”
“Today’s deal doesn’t account for the hundreds of thousands of deaths or millions of addictions caused by Purdue Pharma and the Sackler family,” New York Attorney General Letitia James wrote in a statement. “Instead, it allows billionaires to keep their billions without any accounting for how much they really made.”
With the federal government now in line with other creditors, it is unclear what money will remain for states, cities and towns to fund addiction recovery programs and supply overdose reversal medication, said Carl Tobias, a professor at Richmond University School of Law.
“If the federal government actually does get any of these resources, is there anything left for the states?” Tobias asked.
Purdue Pharma filed for bankruptcy in September 2019, as it faced thousands of civil lawsuits brought by states, counties and cities across the country. As part of the bankruptcy proposal, the Sackler family has agreed to relinquish ownership of the company, which now has a shrinking base of revenue amounting to a few hundred million dollars a year. It would be reestablished as a for-profit public trust corporation with the goal of distributing anti-addiction and overdose rescue drugs.
The family is not part of the bankruptcy filing, but it has asked the court to be shielded from lawsuits as part of their agreement to a proposed bankruptcy settlement, which would include a family contribution of $3 billion.
States have hotly contested the request for the family’s shield from lawsuits, contending it should pay more. A company-hired consultant has said that Sackler family members paid themselves up to $13 billion from the company.
The modern version of the family-owned company, based in Stamford, Conn., got its start in 1952 when three brothers – Arthur, Raymond, and Mortimer – bought it. The Purdue Pharma affiliate was founded by two of the brothers, Raymond and Mortimer, in the early 1990s. It introduced OxyContin in 1996.
The company aggressively marketed the drug and its timed-release properties to doctors for use in patients with chronic pain. But it was soon blamed for contributing to a spike in addiction and was investigated by federal and state authorities who said it helped fuel a nationwide crisis.
In 2007, Purdue Frederick, an associated company, and three of its executives, none of them Sackler family members, pleaded guilty to deceptive marketing charges.
Gary Mendell, who lost his son Brian in 2011 to suicide after years of an opioid addiction, said he supports the settlement’s proposal to reestablish the company as a public trust corporation to ensure that funding is devoted to advanced treatment programs.
“The most important thing is that we prevent parents from having to bury a child,” Mendell said. “It’s very important now to use this funding to apply toward treatment that is based on science, to help those that are addicted get care that will help them live full and fulfilling lives, and also use it to change the way that society thinks about this disease.”
By The Washington Post · Ian Duncan · NATIONAL, BUSINESS, HEALTH, TRANSPORTATION, US-GLOBAL-MARKETS, HEALTH-NEWS
A Texas woman died of covid-19 while she was on board a Spirit Airlines flight heading home to Dallas from Las Vegas in late July, officials said this week.
The Spirit flight left Las Vegas on the evening of July 24, bound for Dallas-Fort Worth International Airport and was diverted to Albuquerque because the woman was unresponsive, said Stephanie Kitts, a spokeswoman for Albuquerque International Sunport. The woman was dead by the time she arrived, Kitts said.
The woman, who was 38, fell unconscious on the flight and stopped breathing, according to a police report documenting the incident. A member of the flight’s crew tried to administer CPR and passed out from exhaustion, according to the report.
When the plane landed, emergency crews carried the woman from the jet on a gurney and tried to resuscitate her but gave up after several minutes.
The Dallas County Judge’s Office, which first disclosed the woman’s death, said she had an underlying medical condition. The investigation into her death by officials in New Mexico concluded that her cause of death was a covid-19 infection, contributed to by asthma and morbid obesity.
Airport managers in Albuquerque did not learn until later that the woman had covid-19, so the case was handled as a typical medical diversion, Kitts said. Officials in Dallas County added the woman to their virus death toll on Sunday.
“She expired on an interstate airline flight, and did have underlying high risk health conditions,” the county said in a new release updating its tally.
Erik Hofmeyer, a spokesman for Spirit, offered the airline’s condolences to the woman’s family and friends. He said that the airline remains confident in its protocols for handling coronavirus cases and that it works with the Centers for Disease Control and Prevention on any contact-tracing requests.
“Our Flight Attendants have in-depth training to respond to medical emergencies and utilize several resources, including communicating with our designated on-call medical professionals on the ground, using onboard medical kits and personal protective equipment, and receiving assistance from credentialed medical personnel traveling on the flight,” Hofmeyer said.
It’s unknown how many people where on the flight or whether they were notified that they might have been exposed to the virus. Spirit referred questions about any contact tracing to the CDC.
The CDC has said it has investigated about 1,600 cases of people who traveled while they posed a risk of spreading the coronavirus, identifying 11,000 people who were potentially exposed. It wasn’t immediately clear whether the agency investigated the case of the woman who died on the Spirit flight.
The New Mexico Office of the Medical Investigator, which handles unusual deaths in the state, responded to the airport and investigated the woman’s death, said Alex Sanchez, a spokeswoman for the office. The office’s report shows that the woman was tested for the coronavirus as part of the investigation.
“SARS-CoV-2 (COVID-19) has been shown to be more severe in people with comorbidities such as obesity and asthma,” a medical investigator wrote. “The manner of death is natural.”
A relative traveling with the woman who died told police she had been suffering from shortness of breath, but it’s not known whether she was aware that she was infected with the coronavirus. The relative declined to comment when reached by phone.
Officials in Dallas initially said the woman died in Arizona, a detail that was widely reported, before confirming that she actually died in New Mexico.
Although it appears to be an extreme case, the woman’s death was disclosed as airlines continue to try to convince potential passengers that flying is safe during the pandemic. Trade organizations have stressed that there have not been confirmed cases of people catching the virus on planes in the United States and that only a few cases have been documented globally.
Nevertheless, passenger numbers continue to be down considerably from normal times as businesses curtail travel and some states impose quarantine requirements on travelers.
The meat-free dishes served up at Thailand’s annual vegetarian festival may not always be as healthy – or vegetarian – as they seem, new findings suggest.
Dr Supakit Sirilak, acting chief of the Medical Sciences Department under the Public Health Ministry, said vegetarian foods are imported as well as being produced domestically, but not all products were labelled. Some also contained dairy products or were even contaminated with meat because producers failed to properly clean machines usually used to make meat products, he added.
The Public Health Ministry has been testing food offered during the annual festival since 2013.
This year, the ministry’s Medical Sciences Department and Food and Drug Administration (FDA) visited factories and distributors to test samples of four popular vegetarian foodstuffs – imitation meat, pickles, noodles, and vegetables and fruits.
The test results were as follows:
1. Imitation meat: 3.8% of samples were contaminated with meat.
2. Pickled vegetables (mustard, radish): Levels of benzoic acid exceeded safety standards but had dropped from last year.
3. Noodles (rice noodle, vermicelli, etc): 34.5% of samples contained sorbic acid and 20% contained synthetic organic colouring – additives banned by the Public Health Ministry because they can cause nausea, vomiting and diarrhoea.
4. Vegetables and fruit (bok choy, kale, long beans, celery, sweet peppers, radish, white cabbage, cabbage, oranges and rose apple): 20.8% of samples exceeded safe levels of chemical residue.
Dr Supakit urged people to buy labelled vegetarian products and examine vegetables and fruit carefully before consumption. The vegetarian festival runs until Sunday (October 25.)
Angela Dorothea Merkel 
Diners at a restaurant look out toward St. Kilda Beach in Melbourne, Australia, on Wednesday. (Asanka Brendon Ratnayake/ AP) 
President Donald Trump throws hats to the crowd as he arrives for a campaign event at the Duluth International Airport on Sept. 30, in Duluth, Minn. MUST CREDIT: Washington Post photo by Jabin Botsford 
President Donald Trump and Democratic presidential candidate Joe Biden participate in the final presidential debate on the campus of Belmont University on Oct. 22, 2020, in Nashville, Tenn. MUST CREDIT: Washington Post photo by Jabin Botsford 
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