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.)
Kenny Cervantes rode his motorcycle from Nebraska to Sturgis, S.D. in August. MUST CREDIT: Photo courtesy of family
By The Washington Post · Brittany Shammas, Lena H. Sun · NATIONAL, HEALTH, POLITICS, SCIENCE-ENVIRONMENT
It had been a long ride back from Sturgis, S.D., so when he first felt an ache at the back of his throat, Kenny Cervantes figured he was just tired. He’d traveled the 400-some miles on his Harley, rumbling through wide-open farm and prairie land on his way home to Riverdale, Neb., where his girlfriend was waiting.
A lifelong motorcycle enthusiast, the 50-year-old construction worker and father of five had been determined to go to the Sturgis Motorcycle Rally, a holy grail for bikers. Even when his girlfriend, Angie Balcom, decided to stay back because she was worried about being around so many people during a pandemic, Cervantes was adamant about going.
“I don’t think there was nothing that was going to stop me,” he said.
Back home, Cervantes took Tylenol for his throat and went to bed early. But he woke up the next morning coughing so hard he struggled to catch his breath. Over the next few days, the pain in his chest made him fear that his heart might stop, and a test later confirmed he had the novel coronavirus, which causes the disease covid-19. He was admitted to the hospital 11 days later, on Aug. 27. Soon, his girlfriend and his sister were sick, and Cervantes was going over everything he did and every place he visited in Sturgis, wondering where the virus had found him.
Within weeks of the gathering, the Dakotas, along with Wyoming, Minnesota and Montana, were leading the nation in new coronavirus infections per capita. The surge was especially pronounced in North and South Dakota, where cases and hospitalization rates continued their juggernaut rise into October. Experts say they will never be able to determine how many of those cases originated at the 10-day rally, given the failure of state and local health officials to identify and monitor attendees returning home, or to trace chains of transmission after people got sick. Some, however, believe the nearly 500,000-person gathering played a role in the outbreak now consuming the Upper Midwest.
More than 330 coronavirus cases and one death were directly linked to the rally as of mid-September, according to a Washington Post survey of health departments in 23 states that provided information. But experts say that tally represents just the tip of the iceberg, since contact tracing often doesn’t capture the source of an infection, and asymptomatic spread goes unnoticed.
In many ways, Sturgis is an object lesson in the patchwork U.S. response to a virus that has proved remarkably adept at exploiting such gaps to become resurgent. While some states and localities banned even relatively small groups of people, others, like South Dakota, imposed no restrictions – in this case allowing the largest gathering of people in the United States and perhaps anywhere in the world amid the pandemic and creating huge vulnerabilities as tens of thousands of attendees traveled back home to every state in the nation.
Many went unmasked to an event public health officials pleaded with them to skip, putting themselves and others at risk, because they were skeptical about the risks, or felt the entreaties infringed on their personal liberties. Rallygoers jammed bars, restaurants, tattoo parlors and concert venues; South Dakota officials later identified four such businesses as sites of potential exposure after learning that infected people had visited them.
Despite the concerns expressed by health experts ahead of the event, efforts to urge returnees to self-quarantine lacked enforcement clout and were largely unsuccessful, and the work by state and local officials to identify chains of transmission and stop them was inconsistent and uncoordinated.
Those efforts became further complicated when some suspected of having the virus refused to be tested, said Kris Ehresmann, director of infectious-disease epidemiology at the Minnesota Department of Health.
Such challenges made it all but impossible to trace the infections attendees may have spread to others after they got home. Several infections tied to a wedding in Minnesota, for instance, “linked back to someone who had gone to Sturgis,” Ehresmann said. Those were not tallied with the Sturgis outbreak because “the web just gets too complicated,” she said.
“When it comes to infectious diseases, it’s often the case that the weakest link in the chain is a risk to everybody,” said Josh Michaud, an epidemiologist and associate director for global health policy for the nonprofit Kaiser Family Foundation. “Holding a half-million-person rally in the midst of a pandemic is emblematic of a nation as a whole that maybe isn’t taking [the novel coronavirus] as seriously as we should.”
The Aug. 7-16 gathering has drawn intense interest from scientists and health officials, and will likely be studied for years to come because of its singularity. It’s not just that Sturgis went on after the pandemic sidelined most everything else. It also drew people from across the country, all of them converging on one region, packing the small city’s Main Street and the bars and restaurants along it. And in contrast with participants in the Black Lives Matter protests this summer, many Sturgis attendees spent time clustered indoors at bars, restaurants and tattoo parlors, where experts say the virus is most likely to spread, especially among those without masks.
Attendees came from every state, with just under half hailing from the Great Plains and substantial numbers journeying from as far as California, Illinois and Arizona, according to an analysis by the Center for New Data, a nonprofit group that uses cellphone location data to tackle public issues. The analysis, shared with The Washington Post, shows just how intertwined the South Dakota rally was with the rest of the country – and how far the decisions of individual attendees could have ricocheted.
Cervantes feels certain he got the virus from his Sturgis trip, and shared that with the contact tracer from the Two Rivers Public Health Department who phoned him after his case was recorded. Nebraska borders South Dakota, and health officials there expected they might see rally-related infections.
Yet his illness was not classified as a Sturgis case, suggesting that even under the best of circumstances, infections might go uncounted. With so much still unknown, it worries him to think people might look at the rally and conclude that massive events aren’t concerning after all – that the risk is worth it.
That was how he saw it before he got sick. He recalls having a fleeting thought as he guided his motorcycle through the turns of the famed Needles Highway two months ago, taking in the sweeping views and rock formations close enough to touch: “If I catch the virus and die, I will be a happy man. I have lived.”
He hadn’t imagined that within a matter of days, he would feel that death was hovering right at his door.
– – –
As the coronavirus scuttled gatherings big and small, from the 2020 Olympics to birthday parties, weddings and funerals, Sturgis officials mulled postponing this year’s rally. The event is synonymous with the 7,000-person city nestled amid state and national park land, where the Harley-Davidson Rally Point Plaza is a defining feature downtown.
But this year, a survey found that 60% of residents wanted the rally postponed. At council meetings, people lined up to argue. A nurse warned there wouldn’t be enough hospital beds if the event went forward, while a business owner said she would lose her building if it didn’t. Calling off this year’s rally, its 80th anniversary, would mean a loss of around $2 million for the city, authorities said. It had only been done during World War II.
“There absolutely was no right decision,” said city council member Terry Keszler.
Officials also knew that canceling would have been an uphill battle: South Dakota Gov. Kristi Noem, a Republican, was one of the few state leaders who never restricted mass gatherings, managing the pandemic by emphasizing personal responsibility over government mandates. Because the rally encompasses hundreds of miles beyond city limits, the council’s authority was limited.
Another concern was that crowds would come regardless of their decision, and, Keszler said, “we had to prepare for it, or it would have been such a mess it’s not even funny.”
The council ultimately voted to allow the event with the understanding that “the covid thing wasn’t going to stop people,” as Keszler put it.
That supposition was likely correct: There is evidence that those who ventured to Sturgis were engaging in riskier behavior than most Americans in response to the pandemic, by leaving home more often and covering more ground, according to the Center for New Data analysis.
Using data from X-Mode, a company that collects location information from smartphone users who grant permission to various apps, the Covid Alliance, a project of the Center for New Data, found 11,000 probable Sturgis rallygoers. The researchers analyzed where those individuals came from and their mobility during the pandemic and extrapolated information about others from them. On average, the analysis found, attendees spent less time at home than others before and after the event, and traveled twice the daily distance of non-rally goers, underscoring concerns about the potential for virus transmission.
That was true even in states where officials asked Sturgis attendees to quarantine after returning home, including Minnesota, New York and New Jersey.
“You can see it in the data,” said Steven Davenport, co-executive director of the Center for New Data. “And from a policy perspective, it’s not about blaming people. It’s about implementing policies that work and using data to learn from them.”
The data doesn’t show whether the rally attendees took other precautions, such as social distancing or wearing masks. It also doesn’t offer any context for their movement – it could be they had jobs that required leaving home or driving greater distances.
In interviews with The Post, several rally attendees said they didn’t deny the threat of the coronavirus but also didn’t believe they needed to stay home indefinitely. Some noted that they take risks each time they get on their bikes. A number said they wore masks or made other minor concessions but were determined to go on with their lives.
Kathy Colville and Darrell Hackler said they decided two weeks before the rally that this was the year they would cross it off their bucket list. The Round Hill, Va., couple reasoned they could lower their risk by wearing masks and sleeping in their RV.
“I believe that we’re going to be living with covid for a year, maybe more,” said Colville, 61. “And I personally would be stir-crazy nuts and divorced if I tried to quarantine in my house for that amount of time.”
Balcom, Cervantes’s girlfriend, made a different calculation. She had been excited to go to Sturgis with Cervantes, her brother and her dad. But her work as an occupational therapy assistant made the virus’s threat real to her, and she worried about the prospect of infecting clients. In the end, she and her family members canceled, leaving Cervantes to travel with friends.
“I said, ‘I’m not going to tell you you can’t go, because you wouldn’t do that to me,” Balcom recalled telling him. “But I think it’s asinine. I don’t think it’s a good idea. And he was like, ‘I’m going to go.’ “
– – –
The rally unfolded in August as it always had. Bikers revved their engines on Main Street and filled highways leading to sites like Custer State Park and Devils Tower. Bands played to shoulder-to-shoulder audiences, and bikini-wearing bartenders sold beer by the bucket. Hardly anyone wore a mask.
Among T-shirts hawked by vendors were ones that made mention of the virus keeping many Americans at home: “Screw covid-19, I went to Sturgis.”
In the run-up to the rally, officials estimated that 250,000 people would come. The actual number, according to the South Dakota Transportation Department, was over 460,000 – down just 7% from 2019.
They came in the greatest numbers from South Dakota, source of an estimated 93,000 attendees, or a fifth of the total, according to calculations by the Center for New Data. Minnesota ranked second, with an estimated 31,000 people, followed by Colorado with 29,000. Many traveled hundreds of miles: 21,000 rallygoers are believed to have come from Texas, and 20,800 from California.
Cervantes was one of an estimated 16,700 from Nebraska, which had the seventh-highest number of rallygoers. After a six-hour ride, he reached Sturgis before sunset on Thursday, almost a week into the rally.
“It was just exhilarating,” he said. “And then pulling down into Sturgis that Thursday night just blew me away.”
From the beginning, Cervantes recalled being struck by the lack of masks. On his ride from Nebraska, Balcom had chided him on a call after he acknowledged he hadn’t worn one at a gas station. He mostly kept one on after that – “Angie really drilled it into my head,” he said – and wondered whether everyone else would get sick.
Andrew Crerar of Ashburn, Va., said he wore a bandanna – “uniform 101 for people riding motorcycles” – but “you go into the grocery store and you could tell who was local and who wasn’t by who was wearing masks.”
Still, there were reminders of the pandemic: Hand sanitizing stations stood downtown, and Cervantes carved “2020: The Year of the Virus” into a table at his campground. The lead singer of Smash Mouth, a headliner in a year when Willie Nelson and ZZ Top canceled, shouted “F— that covid s—!”
“No one that I spoke to there wasn’t aware of coronavirus, and wasn’t aware that there was a risk of them being there,” Crerar said. “It was just a risk that they accepted.”
Cervantes spent much of his time on scenic rides, feeling moved when he went through a tunnel and Mount Rushmore came into view. He and his friends stopped at several stores and, on the final night of the rally, took a bus downtown to “party it up a little bit because it was our last night there.”
The next day, bikers began disappearing as quickly as they had rolled in. Sturgis leaders began offering free coronavirus testing to residents – and waiting.
“I can say that there’s probably been a collective holding of breath,” Keszler, the city council member, said in early September. “This was my big concern, honestly, was what’s going to happen after.”
– – –
What happened afterward was, in certain respects, very clear.
South Dakota, which had the most attendees, saw coronavirus cases surge within weeks of the rally’s Aug. 16 close, with the seven-day rolling average going from 84 on Aug. 6 to 214 on Aug. 27. The numbers remained elevated into October: The first day of the month, the seven-day rolling average was 434. The state is second in the nation in cases per capita behind North Dakota, with numbers high enough for the Harvard Global Health Institute to recommend stay-at-home orders.
But precisely how that outbreak unfolded remains shrouded in uncertainty.
Because symptoms of the coronavirus can take days to surface, rally attendees were unlikely to know they had been infected until returning home. Without a nationally coordinated contact-tracing strategy, the job of identifying chains of transmission was left to a patchwork of local and state health departments with varying approaches, leadership and staffing. Typically, such efforts focus on determining a person’s contacts after they became infectious – and stopping those people from spreading the virus – rather than on pinpointing the source of an infection.
Genomic sequencing, which other countries have harnessed to determine the path of an outbreak, has been underused in the United States. And because it requires culturing and sequencing active virus, the rally is too far in the past for it to be of service now, said Michaud, the Kaiser Family Foundation epidemiologist.
So even as the Dakotas and the Upper Midwest began seeing infections climb, it is impossible to say precisely how many of those cases originated at the rally – or how many of those might have ignited additional clusters elsewhere.
“This motorcycle rally was and is such a big thing that people come from miles and miles away and they come from right next door. And it’s not reported anywhere who they are, where they live,” said Benjamin Aaker, president of the South Dakota State Medical Association.
“Contact tracing on something like that is even harder than it is during normal circumstances,” he added.
But other countries offer examples of more robust and coordinated contact-tracing efforts, Michaud said. Japan uses what’s called retrospective contact tracing – working backward to determine where a person was infected and who else may have gotten the virus there, he said. It’s particularly effective in dealing with the coronavirus, which is often transmitted by a small number of people infecting many others in clusters.
It was “fairly obvious” that a gathering the size of the motorcycle rally represented a risk, Michaud said – and more rigorous contact tracing could have revealed the actual impact. It might also have prevented some of the secondary and tertiary spread.
Hospitals have seen the effects. David Basel, vice president of clinical quality at Avera Medical Group, which has locations on the east side of the state, said on Sept. 30 that facilities had been “busy, and we’re feeling it.” Covid-19 cases make up 10 percent of patients, he said.
“The thing that quite honestly scares us most is personnel,” he said. “If we started to lose personnel to them coming down with covid, that would be probably the biggest risk to us.”
Three of the four South Dakota counties estimated to have the highest share of Sturgis attendees also saw cases spike post-rally. The increase was most pronounced in Pennington County, which is just outside Sturgis. Its seven-day rolling average of new cases leaped from eight on Aug. 6 to 34 on Aug. 27.
State health officials, who linked 125 cases to Sturgis, have not tied the surge to the rally, however. They note it overlapped with school openings and end-of-summer restlessness.
“Anytime you’re bringing individuals together, you’re going to have times where you’re having covid-19 transmission,” state epidemiologist Joshua Clayton said last month. “That’s a risk whether you’re in South Dakota, or in other states.”
Noem, the governor, attributed the rise in cases to increases in testing, echoing President Donald Trump’s explanation of growing U.S. infections. “That’s normal, that’s natural, that’s expected,” she told the Associated Press. She did not explain how extra testing could have accounted for the rise in hospitalizations in the state, which hit record highs in October.
And the increases in coronavirus infections spread beyond South Dakota, post-rally. In Crook County, Wyoming, Corinne Hoard started feeling sick a week afterward but isn’t sure whether she was infected there – or whether health officials counted her case as Sturgis-related.
Hoard, who said motorcycle riding is “kind of in my blood,” was mostly avoiding crowds but kept her annual tradition of going to Sturgis and attended a concert there, viewing it as safe because she sat outdoors. She started feeling sick a week afterward and went to the hospital after waking up one morning feeling like “death had crawled in the bed with me.”
“I was crying because I was like, ‘Oh, my God, I hope this isn’t corona,’ ” she said. “And it ended up being corona.”
– – –
The day Cervantes sat up from the couch and asked Balcom to take him to the emergency room, doctors put him on oxygen. He had been worried about the tightness in his chest, but he hadn’t grasped how bad it was. Only when he was being hooked up to the oxygen machine did he realize he hadn’t said goodbye to his children.
“I was just laying there thinking, ‘This could be it. This could be it,'” Cervantes said. “And, am I going to get another chance?”
He spent eight days in the hospital before being discharged Sept. 4. He was still sick when he left, but the doctors said he could recuperate at home. Walking across the hospital parking lot, though, he was so winded he had to take a moment to sit down.
Balcom, whose case was mild, cried in the car, relieved he was coming home. She never said “I told you so,” or got angry with him. She was upset, though, when she found out Cervantes’s case wasn’t included in covid-19 tallies linked to Sturgis.
“If we had an accurate representation of what’s going on, then people might say, ‘Maybe it’s not a good idea to go to the concert or go to the gathering,'” she said. “Everyone is just muddling through this because no one knows what the hell is going on.”
Cervantes now looks at things differently. Watching football, he worried how many of the thousands of fans admitted to a recent Kansas City Chiefs game might become infected, even as he noticed they sat apart. He once put on a mask to humor Balcom; now he says he has to resist the urge to yell at strangers to wear them.
After weeks of missed work, his stint in the hospital and a return visit to the ER over a blood clot concern, he’s come to deeply regret his decision.
“I was naive,” he said. “I was dumb, you know? I shouldn’t have went. I did; I can’t change that, so I just got to move forward. But sitting here just the past few days, that’s all I keep thinking about. I’m like, Jesus, look at the hell I’m going through, the hell I put everybody through. It ain’t worth it. It wasn’t. It really wasn’t.”
By Syndication Washington Post, Bloomberg · Emma Court · NATIONAL, BUSINESS, HEALTH, SCIENCE-ENVIRONMENT, HEALTH-NEWS The Food and Drug Administration has cleared a 10-minute covid-19 test that doesn’t need added equipment to process, manufacturer Access Bio said Tuesday.
The assay, known as CareStart, is among a group of new antigen tests that detect the novel coronavirus by looking for proteins on its surface.
Because antigen screening can provide rapid results in doctor’s offices, urgent care clinics and hospitals, they could have a key role in expanding access to testing and providing timely information to patients and providers. But use of these tests has remained limited. The government purchased many early tests for use in nursing homes, with efforts ongoing to extend the assays into states more broadly and settings like schools.
“To reopen society, we’re going to need to have these rapid tests,” said Reeve Benaron, founder of Intrivo Diagnostics, Access Bio’s U.S. arm.
CareStart is a self-contained, single-use product that operates using lateral flow technology, similar to at-home pregnancy tests. The assay includes a swab, a vial of extraction solution and a cassette the size of a small flash drive. A line appears visible on the cassette if the test is positive, and it doesn’t require special training to administer, said Crystal Nguyen, head of research and development at Intrivo.
The cost will be under $20 a test, though the exact price depends on the volume purchased, Benaron said. That makes it competitive with a $20 antigen test sold by Becton Dickinson & Co. that requires added equipment to produce a result.
Another self-contained antigen test from Abbott Laboratories cleared for U.S. sale this summer is priced at just $5. The U.S. government bought 150 million of Abbott’s BinaxNOW antigen tests in late August, which it is distributing to states, potentially for use in places like schools, as well as elder-care facilities, historically Black colleges and universities and Native American tribes.
The company plans to begin selling the tests in November, with goals of producing about 10 million monthly by the end of November, and 60 million to 80 million a month by the middle of February, when a new facility is expected to open, according to Benaron.
The vast majority of tests produced will be sold in the U.S., to health-care facilities, the government and the private sector, he said.
Benaron said he’s heard particular interest in the antigen test from leaders of Fortune 500 companies. “They’re being forced to make medical decisions. They’re no longer just CEOs,” he said. “It’s just unprecedented, uncharted waters.”
Antigen screenings, though speedy, are also less accurate than the gold-standard PCR diagnostic tests, with concerns largely revolving around the tests missing people who are infected.
Worries about the opposite phenomenon, or false positives, led Nevada to tell nursing homes this month to stop using antigen tests to screen residents and workers. Manufacturers and government officials, however, say some false positives are inevitable with any test.
CareStart is 88.4% sensitive, a measure of how often it correctly identifies infections, and 100% specific, the rate of correct negative tests, Nguyen said.
“It’s not meant to replace PCR” and, in fact, a positive result will be confirmed with a PCR test, Benaron said.
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J&J halts covid-19 vaccine trial because of unexplained illness
Health & BeautyOct 13. 2020The Johnson & Johnson logo. MUST CREDIT: Bloomberg photo by Scott Eells
By Syndication Washington Post, Bloomberg · Riley Griffin · NATIONAL, BUSINESS, HEALTH, HEALTH-NEWS Johnson & Johnson said its covid-19 vaccine study has been temporarily halted after a clinical trial participant experienced an unexplained illness, the second time that a front-runner developer has paused a trial amid the intensifying race to create a viable immunization against the novel coronavirus.
The New Brunswick, New Jersey-based company said in a statement late Monday the participant’s illness is being evaluated, and that it would share more information after further investigation. J&J’s statement confirmed an earlier report by health-care news provider STAT that the study was paused.
“We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate,” J&J said in its statement. “Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies.”
While pauses in late-stage testing are routine in the pharmaceutical industry, J&J’s interruption may contribute to concerns over safety with covid-19 vaccine research progressing at an unprecedented speed this year. British drugmaker AstraZeneca last month temporarily stopped tests of its own vaccine candidate after a trial participant fell ill. That study has resumed in a number of countries, but it remains halted in the U.S.
J&J executives probably will face questions about the trial halt Tuesday morning when they present third-quarter earnings. Representatives for the U.S. Food and Drug Administration could not immediately be reached by phone or email for comment after business hours.
J&J’s setback is the latest reality check for a world anxiously awaiting a vaccine against the virus, which has sickened more than 37 million globally. It’s a reminder of how long it takes to bring a successful shot to market, despite promises from politicians and governments that a covid-19 fix is around the corner.
The pursuit of a vaccine has become a political topic, with some observers concerned that President Donald Trump’s eagerness to see a shot authorized before the election could compromise the scientific process.
While there are hundreds of covid-19 vaccines being developed around the world, J&J is among a small group of vaccine makers that have progressed into final-stage human studies. The company is dosing up to 60,000 volunteers in the first big trial of a covid-19 inoculation that may work after just one shot.
AstraZeneca is still waiting for a decision from U.S. regulators on whether it can resume tests in the country after halting global trials on Sept. 6 because of concerns about a U.K. participant who became ill. Developed with Oxford University, that experimental vaccine has seen trials resume outside the U.S. in locations including the U.K. and South Africa.
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Trump says he’s not contagious. Health experts say that’s not certain.
Health & BeautyOct 12. 2020President Donald Trump removes his mask as he arrives to speak to supporters at the White House on Saturday, Oct. 10, 2020. MUST CREDIT: Washington Post photo by Jabin Botsford
By The Washington Post · Karin Brulliard, Felicia Sonmez · NATIONAL, HEALTH, POLITICS, HEALTH-NEWS
WASHINGTON – President Donald Trump tweeted on Sunday that he is “immune” to the novel coronavirus and “can’t give it,” even though the White House has not released negative test results and immunity to the virus remains poorly understood.
The tweet was quickly flagged by Twitter, which said it contained “misleading and potentially harmful misinformation” related to the coronavirus. It was the latest example of the social media giant pushing back against the president’s posts on the deadly virus, and it appeared to refer to Trump’s claim to immunity. Some recovered patients with covid-19, the disease caused by the novel coronavirus, have been reinfected, and experts say many questions remain about immunity, including how long it may last.
“A total and complete sign off from White House Doctors yesterday,” Trump said. “That means I can’t get it (immune), and can’t give it. Very nice to know!!!”
Trump’s claim came one day after his physician said he is “no longer considered a transmission risk to others,” in a memo that seemed to clear Trump to return to his normal activities a little more than a week after he announced that he had tested positive for the coronavirus. Trump is expected to hold a campaign rally Monday in Florida.
But experts say there would be no way to know for sure whether the president is contagious so soon after a covid-19 diagnosis, and they noted that the White House has never made clear the severity of Trump’s illness, which could influence how long he should isolate.
The letter from Sean Conley said that Trump had met the Centers for Disease Control and Prevention’s criteria for “safe discontinuation of isolation” and that “an assortment of diagnostic tests” found no evidence of actively replicating virus, which must be present for someone to infect others.
It did not say that Trump had tested negative for the virus, however, and its brevity left experts puzzled over what evidence had led the White House physician to conclude the president is no longer contagious.
Trump, Conley wrote, was 10 days from the onset of symptoms, he had been fever-free for well over 24 hours and his symptoms had improved. That would mean he had met standards at which the CDC says people with mild to moderate cases of covid-19 can stop isolating.
But people with severe cases are advised to isolate for up to 20 days, the CDC says. Trump was hospitalized, administered supplemental oxygen and treated with the steroid dexamethasone, a drug typically used for serious cases, said Albert Ko, an infectious-disease expert at the Yale University school of public health.
“I think the big question is whether the president had severe or he had mild, moderate disease,” Ko said. “Regardless of what the rules are, I think most physicians would want to be cautious not only about protecting the president, but protecting the people around him. That’s usually our rules of practice. Why risk it?”
Tests can provide other clues as to a person’s contagiousness, but none are foolproof, experts said.
Conley’s memo did not detail the “assortment of diagnostic” tests Trump’s health-care team has used to assess his level of illness. But it said testing throughout the president’s illness had “demonstrated decreasing viral loads that correlate with increasing cycle threshold times, as well as decreasing and now undetectable subgenomic mRNA.”
A negative PCR test, the common laboratory test that detects the virus from nasal and throat swabs, would provide a fairly clear indication that Trump is no longer infectious, so releasing a negative result would “be to his benefit,” Ko said. But the president’s medical team has not released information about any of his test results other than the first positive test on Oct. 2.
A positive PCR test, however, would not necessarily mean Trump is contagious, experts said. People can test positive for weeks, even months, after they’ve been infected, because the test is “just as good at picking up the remnant dead fragments of virus DNA as it is picking it up when it’s alive,” said Jeanne Marrazzo, an infectious-disease expert at the University of Alabama at Birmingham.
Trump’s doctors might have been using quantitative PCR testing, which is not used widely for the coronavirus but would allow them to measure the amount of virus over time, Marrazzo said. “In general, the more virus you have, the earlier you are in the course of illness and the more likely it is to be healthy, replicating alive, infectious virus,” she said.
Conley’s reference to “increasing cycle threshold times” means the PCR test takes longer to detect the virus, which can be another sign that the level of virus is decreasing, she said. But Ko said that hasn’t been rigorously tested, and “we don’t know what the cutoff is” for a cycle length that indicates someone is no longer infectious.
Marrazzo said quantitative PCR test results typically correlate with results from the gold standard for detecting live, actively replicating virus: culturing it in a lab to see whether it infects and grows on cells. Culturing is rare because it is time-consuming and dangerous, and even its results can vary widely and be inaccurate. Conley’s letter did not say whether this was done to determine Trump’s infectiousness.
Conley’s reference to “subgenomic mRNA” indicates that Trump’s medical team has used an emerging lab test that detects actively replicating virus, experts said, and that it found none. New research suggests this test, too, may serve as a proxy for culturing.
“These are all kind of experimental diagnostic methods that kind of make sense, and I think Conley is putting it in there to bolster the argument,” Ko said. “But it doesn’t tell us that the president absolutely does not have infectious virus.”
Taken together, the references to testing and symptoms in the memo – while cryptic – are “reassuring,” Marrazzo said. But that assessment, she said, depends on believing that Trump is 10 days past the onset of symptoms and had a mild case, which the sketchy details released from the White House over the course of his illness have not made clear.
“What’s driving this very clearly is his desire to be able to be out and about and mingle,” Marrazzo said of Trump.
The president, who has been lagging behind Democratic nominee Joe Biden in polls, is expected to tout his swift return to work and his administration’s response to the coronavirus at rallies this week in Florida, Iowa and Pennsylvania. A new Trump campaign ad released Saturday claims that Trump “tackled the virus head-on, as leaders should.”
But part of that TV ad was rebutted Sunday by Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who said the Trump campaign used his words out of context and without his permission.
“In my nearly five decades of public service, I have never publicly endorsed any political candidate,” Fauci said in a statement to CNN. “The comments attributed to me without my permission in the GOP campaign ad were taken out of context from a broad statement I made months ago about the efforts of federal public health officials.”
The ad includes a clip of Fauci speaking during an interview with conservative Fox News host Mark Levin in late March, during which Levin asked Fauci about the coordinated response of the Trump administration.
In his response, Fauci noted that he is “one of many people on a team” and spoke at length about the long days that he and others within the administration were working to combat the pandemic.
“There’s a whole group of us that are doing that,” Fauci said. “It’s every single day. So I can’t imagine that under any circumstances, that anybody could be doing more. I mean, obviously, we’re fighting a formidable enemy, this virus.”
Although Fauci did not mention Trump in his answer, the Trump campaign clip is edited to make it appear that Fauci is praising the president’s personal leadership during the crisis.
Tim Murtaugh, a Trump campaign spokesman, defended the ad Sunday.
“The video is from a nationally broadcast television interview in which Dr. Fauci was praising the work of the Trump administration,” he said. “The words spoken are accurate, and directly from Dr. Fauci’s mouth. As Dr. Fauci recently testified in the Senate, President Trump took the virus seriously from the beginning, acted quickly, and saved lives.”
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Thanksgiving in Canada comes amid virus’s second wave, mixed messages
Health & BeautyOct 11. 2020Photo by: The Washington Post — The Washington Post
By The Washington Post · Amanda Coletta · WORLD, HEALTH, THE-AMERICAS, HEALTH-NEWS
TORONTO – With cases of the coronavirus rising this spring, Carole Robert’s “close-knit” family scrapped Easter. A family reunion planned for the summer was also a wash.
So when Robert got on the phone with a sister recently to talk Thanksgiving – a holiday she typically celebrates with some 35 family members – she knew what was coming.
“It’s completely canceled,” said Robert, who lives in Vankleek Hill, Ontario, roughly 60 miles from Ottawa. “There’s always next year.”
Canadian Thanksgiving comes earlier than the American version – families will gather to eat turkey and avoid discussing politics on Monday. But in this pandemic year, the timing is unfortunate.
As a second wave of the coronavirus prompts new restrictions in several provinces, authorities across the country are urging Canadians to curtail their holiday plans. Some suggest celebrating only with others who are already living under the same roof. Others advise moving the party outdoors or online.
In a rare nationally televised address last month, Prime Minister Justin Trudeau said it might be necessary to cancel Thanksgiving to “have a shot at Christmas.”
Whether Canadians obey those pleas remains to be seen. Forty percent of Canadians surveyed by the Montreal polling firm Leger this month said they haven’t or won’t change their Thanksgiving plans because of the pandemic.
Canada’s experience Monday might offer a preview of what Americans can expect next month – and a warning about what to avoid.
The United States has recorded nearly five times as many cases of coronavirus per capita than Canada and more than twice as many deaths. But Canada’s numbers are moving in the wrong direction, reversing gains made in the late spring and early summer. Officials worry the worst is yet to come as winter approaches, bringing with it flu season and temperatures that force more people indoors.
The country reported an average of 2,052 new daily cases over the last seven days on Thursday, up 30 percent from the week before, according to Theresa Tam, Canada’s chief public health officer. Daily case counts have eclipsed the records set in the spring when tougher restrictions were in place. Hospitalizations are up.
The second wave has hit the country unevenly. Roughly 80 percent of new cases are in Ontario and Quebec, Canada’s most populous provinces. The four provinces that formed an “Atlantic bubble” in July and the remote northern territories have largely been spared. Most of the infected are young people, who generally fare better then the elderly with covid-19, but the virus is spreading to other demographics.
Infectious-disease specialists see several reasons for the surge: Large social gatherings; the reopening of bars and restaurants; the failure of officials to take advantage of a summer of comparatively few cases to prepare for a fall wave; pandemic fatigue.
“My fear here is that we’re going to have a really dark fall and winter if we don”t act,” said University of Toronto professor Andrew Morris, an infectious-disease specialist at the Mount Sinai Hospital and University Health Network.
As in Europe, provinces are shying away from reimposing the broad business closures and stay-at-home orders of the spring, opting instead for targeted local measures that officials hope will inflict less damage on their economies.
Quebec has gone the furthest. Its three hardest hit areas – Montreal, Quebec City and parts of the southeastern Chaudière-Appalaches region – entered a 28-day partial lockdown on Oct. 1. More regions followed. Bars, theaters, casinos and museums are closed. Restaurants are limited to takeout. Private gatherings among people from different households are mostly prohibited.
Christian Dubé, the provincial health minister, said there’s more community transmission in more parts of the province than there was in the spring, when many outbreaks occurred in long-term care homes and cases were largely concentrated in Montreal.
“Don’t take the risk,” he said. “Don’t test the system. … Stay home.”
In Ontario, testing centers are so overwhelmed that officials have tightened the criteria for who can get a test. A backlog of tens of thousands of samples has left officials flying blind on the source of infections and the scope of the problem. Toronto, Canada’s largest city, has scaled back contact tracing.
Progressive Conservative Ontario Premier Doug Ford has responded with harsh words for rule breakers. The organizers of large social gatherings, he said, are “a few fries short of a Happy Meal.” The hundreds who attended a car rally in a parking lot in Hamilton last month should get their brains scanned, he said.
He had for several weeks resisted calls, including from Toronto’s top doctor, to do more. He said early last week that he needed to see more evidence before taking “someone’s livelihood away” and that the province was “flattening the curve.”
But on Friday, Ford’s tone changed, and he warned that Ontario was at risk of the “worst-case scenarios” seen in northern Italy. He announced restrictions in hard-hit areas, including a ban on indoor dining at bars and restaurants, and the closing of indoor gyms, theaters and casinos for at least 28 days.
Infectious-disease specialists say the response has been hampered by muddled messaging. Dubé has admitted that communication in Quebec could have been better. Different officials in Ontario have offered varying definitions of “household” and contradictory advice on how or whether to gather for Thanksgiving – even within the same news conference.
Ford described his own holiday plans, then appeared to change them after it was pointed out that they contradicted his own government’s advice to celebrate only with those in one’s immediate household.
Morris, the University of Toronto professor, said the messaging mishaps risk damaging public trust in officials when it’s most needed.
“There’s been a failure to recognize the inconsistent messaging … and an almost delusion that if you implore people to behave differently, then they will behave differently,” he said. “In almost every jurisdiction that hasn’t occurred, and we’ve failed to learn from other jurisdictions.”
Canadians observe Thanksgiving each year on the second Monday of October. As in the United States, many celebrate with turkey, stuffing and pumpkin pie. College students return home. The Canadian Football League typically plays a game or two – the Thanksgiving Day Classic – but the league canceled the season this year after failing to secure financial aid from the federal government.
Thanksgiving accounts for 39 percent of annual whole turkey sales, according to the Turkey Farmers of Canada. The national supermarket group Loblaw says it’s emphasizing smaller birds this year, in the expectation they’ll be more popular for smaller gatherings, but will still have large turkeys, “because, really, who doesn’t love leftovers?”
Robert is skipping the turkey this year. She said it’s been “extremely hard” not to see her family, but she has two brothers with cancer, and everyone has agreed that gathering isn’t worth the risk.
She’s keeping her fingers crossed for a more normal Christmas, but she’s not optimistic.
“When you look at the numbers,” she said, “I doubt that we’re all going to see each other.”