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Trump officials promise fair distribution of new covid-19 antibody drug, but limited supply and logistical problems loom

Health & BeautyNov 11. 2020

By The Washington Post · William Wan · NATIONAL, POLITICS 
WASHINGTON – Trump administration officials Tuesday promised to fairly and swiftly distribute the first covid-19 treatment that helps to protect people with mild illness from developing severe symptoms. But the drug’s extremely limited supply and logistical difficulties in administering it could restrict how many people get access to it.

The Eli Lilly & Co. drug is similar to an experimental treatment President Donald Trump received when he was infected with the novel coronavirus. It is a laboratory-brewed antibody that imitates the immune system’s attack on the virus.

The federal government Monday granted emergency use authorization for the drug, seen as a powerful tool that could save people from developing the worst symptoms of covid-19 until a vaccine against the novel coronavirus is widely available.

The federal government has more than 80,000 doses ready for allocation and distribution this week, Health and Human Services Secretary Alex Azar said in a briefing Tuesday. The medication “has the potential to save thousands of lives and significantly reduce the disease’s burden on the health-care system,” he said.

The government has negotiated a contract to buy 300,000 doses through December, with an option to buy 650,000 more through June. But that comes as the nation records more than 100,000 new coronavirus cases each day.

Because of the limited supply, the number of doses each state receives will be determined by the number of confirmed cases and hospitalizations in a given week, federal officials said.

For example, this week, Vermont – with among the fewest cases – will receive only 20 doses. Meanwhile, South Dakota, where the virus is spreading uncontrollably, will get 820. Each week’s allocation will be made on a Wednesday.

By allocating the drug this way, officials hope to drive down hospitalizations because fewer patients will progress from mild symptoms to severe illness.

Federal officials said that before they order more medication for next year, they need to see whether hospitals have the staffing and capacity to give patients the drug, known as a monoclonal antibody.

The medication, bamlanivimab, must be delivered by intravenous infusion early in the illness. It is authorized for patients with mild or moderate cases of covid-19, the illness caused by the novel coronavirus, who also are at high risk of severe disease or hospitalization. Risk factors include being older than 65, having diabetes, obesity with different body mass index cutoffs depending on age, a suppressed immune system, and cardiovascular disease or high blood pressure in people over age 55.

But getting the drug to patients is a challenging proposition. It must be given over the course of an hour.

The Trump administration on Tuesday sent guidelines addressing those problems to hospitals and states. A government document on payment policy released last month mentions that providers could give the drugs in “temporary expansion sites, such as an erected tent, a retrofitted convention center, or the beneficiary’s home.”

“This is something we’ve never done before on this scale,” said Jeanne Marrazzo, the director of the infectious-diseases division at the University of Alabama at Birmingham. “You don’t just need the facilities, but the dedicated staffing to administer this drug. And a lot of hospitals are going to be trying to do this at a time when cases are shooting up and straining capacity in their system.”

Because of those challenges, some experts worry whether patients in poor and disadvantaged communities will receive equal access to the drug.

“In some populations, you have half the people who will meet that high-risk criteria, so who you give it to and how you make that decision isn’t clear,” said Helen Boucher, the chief of infectious diseases at Tufts Medical Center in Boston. “The worry is whether black and brown people get access who we know are being disproportionately affected by this disease.”

Because most people recover from covid-19 without serious symptoms, giving the drug to a general population would waste the limited supply. And the medication is not helpful to patients with severe symptoms. The FDA warned that the drug “may be associated with worse clinical outcomes” in people requiring high-flow oxygen or who are on ventilators.

“For this drug to be helpful, we have to identify and reach people quickly, and sadly, nine months into this pandemic, we have a large proportion of the country that still doesn’t have adequate testing capacity,” Boucher said.

Federal officials said they are basing distribution on a strategy similar to what is used for remdesivir, an antiviral drug administered to hospitalized patients. The Trump administration’s rollout of remdesivir was plagued by problems in its early phases. Doctors reported a confusing and unfair process, marred by incomplete medical information.

Some doses went to the wrong hospitals, to hospitals with no intensive care units and therefore having no eligible patients, and to facilities without the needed refrigeration for storage, meaning some doses were returned to the government

On Tuesday, Trump administration officials said they had learned from those mistakes.

“We’re building on lessons learned during remdesivir,” said John Redd, the chief medical officer in the office of the assistant secretary for preparedness and response at HHS. For example, allocation decisions could be made in five hours compared with a matter of days during the early days of remdesivir distribution.

Redd said the distribution of the antibody drug would be “fair, accessible, understandable and equitable.”

As with remdesivir, patients will receive the antibody drug free of charge, federal officials said, but their insurance could be charged for the administration of the medication.

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Pfizer coronavirus vaccine could be cleared by mid-December following release of data showing it is more than 90% effective

Health & BeautyNov 10. 2020A logo sits on a sign outside the headquarters of BioNTech in Mainz, Germany, on July 17, 2020. MUST CREDIT: Bloomberg photo by Alex Kraus 

By The Washington Post · Laurie McGinley, Lena H. Sun, Carolyn Y. Johnson · NATIONAL, HEALTH, HEALTH-NEWS 

The news Monday that Pfizer’s coronavirus vaccine is more than 90% effective sharply increased prospects that federal regulators will authorize the vaccine on an emergency basis as early as mid-December, and that the first shots will be administered before the end of the year or early next year.

The findings, announced by drug giant Pfizer and German biotechnology firm BioNTech, provided much-needed hope for a nation battered by surging virus cases, a stumbling economy and a bitterly fought presidential campaign. It augers well for other vaccines and could accelerate the timetable for reining in the pandemic, said scientists, who cautioned that any successful vaccine will still face obstacles, notably distribution to hundreds of millions of people.

“It’s stunning,” said Eric Topol, director of the Scripps Research Translational Institute, one of several scientists who said they were heartened by the results, which far exceeded the Food and Drug Administration’s standard that a vaccine be more than 50% effective at protecting people compared with a placebo saline shot. “We could have a rollout in December.”

Even with the welcome development, experts warned that the longed-for return to normalcy will take many months or more, and that the path is certain to contain unexpected twists and turns. Even after a vaccine is approved, they said, people will need to wear masks and social distance for some time – in part because the vaccine doses will be limited, and it will take time to immunize enough of the population to stop the virus from spreading.

As if to underscore the difficult days ahead, the United States on Monday hit the latest grim milestone in the pandemic, surpassing 10 million confirmed cases of covid-19, the disease caused by the coronavirus, along with more than 238,000 deaths.

The unchecked spread of the virus threaten to make the coming weeks and months particularly dangerous for the nation, which still has little semblance of a coherent federal strategy to stem the tide of infections. And as yet another member of the Trump administration – Housing and Urban Development Secretary Ben Carson – tested positive for the virus, President-elect Joe Biden on Monday named his coronavirus task force, made up of scientists and physicians, vowing in a speech to “follow the science” when he takes office in January. But he warned that the nation still faces “a very dark winter.”

Still, the vaccine news buoyed scientists who have spent months battling a seemingly implacable foe.

“We will be giving vaccines to people very likely before the end of this year,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, predicted on CNN.

Scott Gottlieb, a former FDA commissioner in the Trump administration and member of Pfizer’s board, said if a vaccine were authorized by mid-to-late December, it would be available for the general public late in the second quarter or early in the third quarter of next year. In addition to Pfizer, Moderna, a biotech firm using a technology similar to Pfizer’s, might apply to the FDA for authorization in the next several weeks, company officials have said.

Fauci said in a separate interview with The Washington Post that although it was too soon to predict when the world would return to normal, “The more effective a vaccine is, the quicker you get to the point where you can get a degree of immunity in the general population, to allow you to get back to some sort of normalcy.” He predicted that a highly effective vaccine means “there will be more enthusiasm” among the public about receiving it.

Still, experts said, more information is needed on the Pfizer vaccine, including how long its protection lasts, how well it protects people in specific groups such as the elderly, and whether it causes side effects. Company officials said Monday it didn’t seem to cause serious safety problems.

In announcing the vaccine data, Pfizer and BioNTech said they plan to submit an application for emergency authorization to the FDA probably the third week of November, after receiving additional information on safety and the manufacturing process. The trial will continue until it reaches its endpoint of 164 cases of the coronavirus, which Jansen said could take a few weeks. The additional data could influence the effectiveness of the vaccine.

The agency has said it will convene its outside advisory committee to consider each vaccine application; a meeting on the Pfizer vaccine could occur in early December, with the agency making a final decision days or weeks afterward.

If the vaccine is cleared by the FDA, an advisory panel to the Centers for Disease Control and Prevention – the Advisory Committee on Immunization Practices – is expected to hold a public meeting within 24 to 48 hours to vote on how the vaccine should be used and who should get the first shots. Its recommendations will go to the CDC director for approval. After that, federal officials have said, they plan to start shipping vaccine vials as soon as possible – probably within a day or two.

Pfizer has projected having 50 million doses – enough for 25 million people – by the end of the year, and 1.3 billion doses in 2021. On CNBC, Pfizer chief executive Albert Bourla said the company was examining ways to increase production.

“We are aware that the demand will be much higher than anything we can produce. We are also looking right now to see if there are other ways, thinking out of the box, that we can increase even further the manufacturing capacity,” Bourla said.

In talking about multiple vaccine candidates, officials with Operation Warp Speed, the government initiative designed to expedite development of vaccines and therapeutics, have repeatedly projected having 100 million doses available by the end of the year, and 600 million to 700 million doses by March or April. That does not ensure that all those vaccine candidates will be proven safe and effective. Along with Pfizer and Moderna, several other companies are working on coronavirus vaccines.

The challenges in distributing the Pfizer vaccine, which must be stored at ultracold temperatures of -70 degrees Celsius (-74 Fahrenheit) can’t be overstated.

“It’s a nontrivial thing to distribute tens of millions of doses, and it has to be given twice,” said John Moore, a virologist at Weill Cornell Medicine. “We won’t be going to motor-biker rallies in the foreseeable future.”

The CDC, which is coordinating the distribution with the Defense Department, has asked states to provide a list of each jurisdiction’s top five sites capable of receiving and administering a vaccine with these ultracold requirements. The ultracold requirement and minimum orders of about 1,000 doses mean that most doctors’ offices will not have the ability to stock it. Hospitals and other institutions that have the necessary freezer storage are likely to be the first to administer the shots.

“It needs to be a perfectly choreographed dance, and we haven’t even started rehearsals yet,” said Soumi Saha, vice president of advocacy at Premier, a major group purchasing organization for hospitals.

Limited initial doses are likely to go first to health care workers, members of the advisory committee on immunization have said. Three additional groups are likely to be close behind: essential workers, people 65 and older, and individuals with underlying medical conditions that put them at higher risk of getting very sick with covid-19.

Close to 200 million people total are in those groups, according to immunization committee estimates.

The federal government will make recommendations on who should have priority to get the vaccine, and make allocations to the states. The final decision rests with states, which have been planning in earnest in recent weeks to get shots into arms.

Local officials still need to recruit thousands of people to staff vaccine clinics and enroll and train providers. They also have to ramp up information technology and data systems to track vaccine inventory and ordering to ensure people get the correct doses at the right times – most vaccines will require two shots – and to monitor for adverse events.

Beth Bell, a member of the immunization committee who also chairs the panel’s covid-19 vaccines work group, said she was hopeful Americans would start having more-normal lives next summer or fall. That assumes, she said, the nation has several effective vaccines by then and that the “virus doesn’t throw us any curveballs and, very importantly, that people have confidence in the vaccination program and are willing to be vaccinated.”

If there are setbacks, “People need to be a little bit calm and to expect bumps in the road and not overreact to them,” said Bell, a global health professor at the University of Washington and former top CDC official overseeing infectious diseases. “I know we’re all sick of the pandemic . . . but we need to keep at it, go forward deliberatively and calmly.”

Peter Lurie, a top FDA official during the Obama administration, agreed much more information is needed about the Pfizer vaccine and that challenges in distributing it lie ahead. “But today is a brighter day,” he said. “And as the scientific and regulatory processes unfold, we will soon know how bright.”

The immunization committee has been holding special meetings to review data on the virus and the vaccines in development, including one last month. Members will review demographic data about the people receiving the vaccine, how different groups responded and side effects before making recommendations.

William Schaffner, an infectious-disease expert at the Vanderbilt University School of Medicine, said he hoped Thanksgiving 2021 would be far different from this year’s holiday.

“We will get back to something that is near normal, but it won’t be exactly the old normal,” he said. “This and the other vaccines won’t be a magic wand – they will be additional barriers to the transmission of the virus.”

Still, he and others said, the virus will become like the flu – it won’t go away, but humans will have learned to live with it.

Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, noted that tens of thousands of people die of the flu every year, but it doesn’t end Americans’ activities.

“We live with that, I go to Eagles games,” he said. “I feel comfortable I’m not going to be one of those people who die of the flu. The question is – when will we feel that way about the coronavirus?”

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Pfizer’s coronavirus vaccine is more than 90% effective in first analysis, company reports

Health & BeautyNov 10. 2020

By The Washington Post · Carolyn Y. Johnson · NATIONAL, HEALTH, SCIENCE-ENVIRONMENT
A front-runner coronavirus vaccine developed by drug giant Pfizer and German biotechnology firm BioNTech was more than 90% effective at protecting people compared with a placebo saline shot, according to an interim analysis by an independent data monitoring committee that met Sunday.

The early look at the ongoing trial provides a decisive initial glimpse of the real-world performance of one of the four coronavirus vaccines in the last stages of testing in the United States. It is the strongest signal yet that the unprecedented quest to develop a vaccine that could help bring the pandemic to an end might succeed, breaking every scientific speed record.

“I would say it’s a historical moment. Something like this has never happened before. First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years,” Kathrin Jansen, head of vaccine research and development at Pfizer, said in an interview. “Hearing that at the interim analysis we are over 90% effective – it was almost stunning to hear.”

In Pfizer’s 44,000-person trial, there have so far been 94 cases of covid-19, the illness caused by the coronavirus, in people who were not previously infected. Fewer than nine of those cases were among people who received two shots of the vaccine, a strong signal of efficacy. The company’s shares soared more than 13% in premarket trading.The data is not yet published or peer-reviewed.

“The results are really quite good, I mean extraordinary,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, adding that the results might bode well for a vaccine being developed by biotech firm Moderna and his institute that uses a similar technology, “which gives you hope we might even have two vaccines.”

Fauci said he had spoken with Pfizer chief executive Albert Bourla about the results, but had not yet reviewed the individual data.

The rapid surge of coronavirus infections in the cooler months, while devastating for the country, means the trial is rushing toward completion faster than company executives anticipated. With more people being exposed to the virus amid the surge, testing the vaccine becomes easier – and faster.

The race for a vaccine had become inextricably tied to election-year politics, and for months, outside experts had worried that Pfizer’s vaccine might be an “October surprise” pushed prematurely through the regulatory process. In the end, the data arrived nearly a week after the election, and shortly after the race was called for President-elect Joe Biden.

President Donald Trump, who had called Bourla to ask about the vaccine and previously accused regulators of a “political hit job” for slowing down a vaccine, celebrated the news. “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” Trump tweeted Monday morning.

The data committee noted no serious safety concerns. Jansen said the side-effect profile of the vaccine was similar to what was reported in an earlier study. That included pain at the injection site and fatigue, chills and fever – which occurred more frequently in younger trial participants than in adults over age 65.

Pfizer and BioNTech said they plan to submit an application for emergency authorization from the Food and Drug Administration after the third week of November, when they will have two months of safety follow-up data on half of the participants in their trial, along with data on their manufacturing process. The trial will continue until it reaches its endpoint of 164 cases of covid-19, which Jansen said could take a few weeks.

Vaccine development typically takes many years, even decades. But the coronavirus vaccines have been a rare success story in the response to the virus, able to move forward because of a flourishing of new vaccine technologies, a backbone of prior work on emerging pathogens and a mentality that rarely exists in the world of vaccine development – of governments and companies willing to devote nearly unlimited resources to make sure that a vaccine succeeds.

Outside experts said crucial details of the data need to be examined: How did the vaccine perform in high-risk populations, such as elderly people? Were the cases of disease mostly mild, or did the vaccine also prevent severe disease? Will the effectiveness hold up at this high level as the trial moves toward completion? How long will protection last? What do detailed safety data show?

Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said the data look encouraging. The trial’s faster-than-expected progress to 94 cases, he said, was “the upside of having a virus that’s out of control.”

David Benkeser, a biostatistician at Emory University Rollins School of Public Health, said in an email that he was still digesting the news.

“It looks to be an incredibly promising result,” Benkeser wrote, noting that the two biggest questions are how long the effect lasts and how well the vaccine works to prevent severe cases of covid-19. “Both will still require more data to get a definitive answer, but for now, I think this is really good news.”

Regulators had set a far lower bar for the minimum performance of a vaccine, requiring it be at least 50% effective. The FDA has also set forth a requirement for five severe cases of the disease in the placebo group, but Jansen said that to preserve the integrity of the trial, Pfizer’s scientists remain blind to the details of the cases at this time.

The vaccine requires two doses, given three weeks apart. Pfizer and BioNTech are working around-the-clock to scale up production, in hopes of having 50 million doses – enough for 25 million people to receive both shots – by the end of the year, and 1.3 billion doses in 2021.

The vaccine uses a new technology never before deployed in an approved medical product. Each injection contains lipid nanoparticles – fat bubbles – that surround a strip of genetic material called messenger RNA. The genetic material carries the blueprint for the distinctive spiky protein that studs the coronavirus surface. After being injected into a person’s arm, the fat capsule delivers its payload to the body’s cells, and the messenger RNA instructs those cells to build the spike protein, effectively teaching the immune system how to recognize and block the coronavirus.

Pfizer’s early signal is encouraging not just for messenger RNA, Fauci said, but as a proof of concept that vaccine candidates that present the spike protein – the approach being pursued by essentially all the major candidates – can succeed.

Pfizer, unlike its competitors, did not join Operation Warp Speed, the government initiative designed to erase the financial risk of vaccine and therapeutics development by providing funding to companies and helping coordinate the trials. Instead, Pfizer plowed $2 billion of its own money into the project and then struck a $1.95 billion contract with the U.S. government to provide 100 million doses, contingent on the vaccine being effective.

Its trial initially had a more aggressive design than other late-stage studies in the United States, allowing earlier and more frequent peeks at the data. That raised concern from outside scientists that the company might seek authorization of its vaccine when there were only 32 cases among participants.

The FDA shared those concerns, according to Jansen, and urged the company to wait to do its first data look until there were more cases. Pfizer scientists were initially concerned it would take too long to reach that milestone, particularly as it appeared the pandemic might be coming under control in late summer, thus depriving the study of potentially infected participants. But Pfizer scientists amended their protocol to wait to look at the data until they reached 62 cases as the virus began to surge, and they completed that paperwork last week.

“We saw that huge upswing, we realized that maybe we should listen and come back to the suggestion of the FDA to have more cases,” Jansen said. “It just shows you the enormous uptick right now of the pandemic, that certainly it took us by surprise – how quickly it really went.”

Once the independent data committee met Sunday, there were 94 cases in the trial – meaning the study is more than halfway done.

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White House hit with fresh outbreak of coronavirus cases

Health & BeautyNov 08. 2020White House Chief of Staff Mark Meadows greets supporters during a Nov. 1 rally in Michigan. MUST CREDIT: Washington Post photo by Jabin Botsford 

By The Washington Post · Anne Gearan, Josh Dawsey · NATIONAL, HEALTH, WHITEHOUSE, HEALTH-NEWS 
WASHINGTON – The White House has been hit with a fresh wave of coronavirus infections, an administration official said Saturday, with Chief of Staff Mark Meadows and five other Trump aides having received positive test results in the period around Election Day.

Meadows, who tested positive Wednesday, at first told others not to disclose his condition. But after his diagnosis became public late Friday, the official confirmed that a broader outbreak threatens to create a new crisis in the West Wing just as Meadows and other top aides are trying to help President Donald Trump navigate a bitter loss at the polls to Democrat Joe Biden.

The official, who spoke on the condition of anonymity because they were not authorized to discuss the matter on the record, declined to name the affected aides or provide information about their conditions. In addition to the six White House staffers, a Trump campaign official said campaign adviser Nick Trainer has also tested positive.

The outbreak comes as coronavirus cases are spiking across the nation: Saturday brought more than 134,000 new cases – setting a record for the fourth day in a row – and deaths and hospitalizations are also on the rise. Biden may have won the presidency by relentlessly attacking Trump’s decision to downplay the severity of the virus and disregard basic advice from public health experts for combating a pandemic that so far has killed more than 237,000 Americans.

Meadows, for instance, has rarely worn a mask in public, has ridiculed Democratic governors for locking down bars, restaurants and other businesses. and has fought with federal science advisers about the administration’s response to the pandemic. 

The influence of health professionals such as Anthony Fauci, the nation’s top infectious-disease specialist, has steadily waned under Meadows’s management. And Meadows has supported Trump’s strategy of pressing to reopen schools and send people back to work, arguing last month on CNN’s “State of the Union” that “we’re not going to control the pandemic.”

A majority of Americans have disapproved of the president’s handling of the coronavirus almost from the start. As Election Day neared with the outbreak raging, some older voters, politically moderate women and other constituencies, blamed Trump for doing too little to blunt it.

Declared the winner on Saturday, Biden has promised that, as president, he will listen to public health experts and try to bring the pandemic under control. Trump has not conceded the election, however, and his campaign issued a statement Saturday accusing Biden of “falsely posing” as the victor. 

The White House outbreak is at least the third wave of infections to strike White House employees and residents. The first erupted in the days after a Sept. 26 Rose Garden ceremony honoring Trump’s most recent appointee to the U.S. Supreme Court, Justice Amy Coney Barrett, which Fauci called a “superspreader event.” 

Trump, first lady Melania Trump and their son Barron Trump all tested positive, and Trump was briefly hospitalized. Senior adviser Hope Hicks and White House press secretary Kayleigh McEnany also were infected.

Two weeks later, at least five aides or advisers to Vice President Mike Pence tested positive, including Pence Chief of Staff Marc Short. 

Despite the repeated infections, Trump, Meadows and their allies have continued to flout public health guidelines, holding large indoor gatherings where few people wear masks or follow advice for social distancing. On election night, for instance, Trump hosted an event at the White House billed as a victory party where people mingled close together and few wore masks.

“The contrast is really disheartening between what we’re seeing at the White House and what we know to be critical to controlling the virus. As a scientist – and a parent – it’s particularly exasperating,” said Ben Sommers, a doctor who teaches at the Harvard T.H. Chan School of Public Health.

“Kids are wearing masks for soccer outside and for hours a day in schools, and millions of children gave up trick-or-treating this year to avoid large crowds. Meanwhile, key White House leaders can’t bring themselves to follow those same guidelines,” Sommers said.

It is not clear when or how Meadows became infected. But it often takes several days after exposure to the virus before an infection can be detected through testing. Though Meadows tested positive on Wednesday, his diagnosis did not become widely known until late Friday, when it was first reported by Bloomberg News.

Many White House staffers are angry with Meadows for not disclosing his infection sooner, according to the administration official who confirmed the new infections. The official said top White House officials and Cabinet officers who had close contact with Meadows in the days around Election Day had been kept in the dark. 

Meadows had traveled with Trump for whirlwind election rallies in several states during the week before his diagnosis. The stops included Wisconsin and Michigan, states where coronavirus cases are spiking. 

Last Sunday, Meadows was photographed greeting supporters lined up along a barricade at a Trump rally in Opa-Locka, Fla. Meadows was a yard or so away from the crowd. Neither he nor many in the tightly packed group of supporters wore masks.

On Election Day, Meadows visited the campaign office with Trump, where he was photographed standing close to campaign and White House staffers. Later, he watched election returns with Trump in the family’s residence quarters and the Map Room. And in the wee hours after midnight, he was at the White House as Trump addressed supporters during an election night party in the East Room. 

The event included a buffet where people could load their own plates with chicken wings and sliders, according to one person who attended. “It was basically like a large cocktail party,” the attendee said. 

Those milling about included Cabinet officials, allies and donors. Meadows was in and out of the room but walked in with the Trump family just before the president spoke. He meandered toward the back of the room, speaking to a handful of reporters and standing amid the throng, the attendee said. 

Later Wednesday, Meadows worked from campaign headquarters, but did not notify campaign staff that he had tested positive, officials said. Instead, he told only the president and Jared Kushner, officials said. 

Meadows did not respond to calls seeking information about his diagnosis, symptoms and whereabouts. He was not seen at the White House on Saturday, as huge crowds gathered outside the gates to celebrate Biden’s victory. 

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Frozen shoulder – a painful and enigmatic ailment

Health & BeautyNov 08. 2020

By The Washington Post
Jill U. Adams

The pain sneaked up on me – my shoulder hurt though I didn’t remember doing anything to injure it. I would reach behind my back to rearrange a throw pillow and feel a painful twinge in my shoulder.

I had to turn my whole body around to plump that pillow.

Over time, my pain-free arm movement became more limited and my repertoire of workarounds increased. I switched arms to back the car out of the driveway.

I did my best to rest the shoulder and let it recover. But then I’d do something and be met with a jolt of pain that brought tears to my eyes. Eventually, I went to the doctor.

My doctor sent me to a physical therapist, who diagnosed me within minutes. I couldn’t raise my arm over my head and she couldn’t either. It’s the classic test for frozen shoulder. (If I’d had a rotator cuff injury, which is more common, she’d have been able to move my arm all the way.)

Frozen shoulder is painful, aggravating and inscrutable. Sometimes it occurs after a shoulder injury, but more often, “It just happens,” says Todd Schmidt, an orthopedic surgeon in Atlanta.

An inflammatory process causes the ligaments that hold the shoulder together to contract and tighten up. “It’s like a shrink wrap around the joint,” Schmidt says.

The condition affects women more often than men, and tends to occur between the ages of 40 and 60. People with diabetes, hypothyroidism or lipid disorders have elevated odds of getting frozen shoulder. These characteristics hint at some hormonal contribution, but precisely what triggers frozen shoulder is unknown. It can happen to someone who’s physically active and it can happen to someone who is sedentary.

Here’s another curiosity: The shoulder freezes, and then it thaws. That’s the natural course of the condition, even without treatment. “It might take two years,” Schmidt says. “But it will resolve on its own.”

Still, treatment helps. Physical therapy and corticosteroid injection into the shoulder are typical first-line treatments for frozen shoulder.

My physical therapy sessions began with 10 minutes of transcutaneous electrical nerve stimulation, or TENS, and a very warm heating pad. Next, the therapist would stretch me, moving my arm to the point of resistance repeatedly. After that, I’d head out to the gym for a customized series of stretches and exercises with various pieces of equipment.

Being stretched by another person was painful – there’s no other way to say it. But by the end of the hour-long session, I always felt better – I gained more range of movement and more confidence. Some of that confidence came from an unexpected place: Learning that inadvertently triggering pain with an unwise reach was not reinjuring myself, it was not going to set me back.

My physical therapist also advised me how to stretch at home, and she measured my progress.

“Physical therapy is all about function – increasing mobility and managing pain,” says Brian Eckenrode, associate professor of physical therapy at Arcadia University near Philadelphia. In addition to monitoring your progress, therapists alter stretches and exercises as needed and they can help you find a more comfortable position for sleep. “They can fine-tune everything.”

The evidence for physical therapy alone tends to be scientifically wanting in that studies often don’t have a placebo group. And because physical therapy sessions are multidimensional and customized, it’s hard to pinpoint precisely what is most helpful.

In the clinic, Eckenrode says, success is measured by “reduced pain, improved function, increased motion and satisfied patients.”

Steroid injections into the shoulder joint may improve both pain and mobility. A 2014 review of studies found more improvement when steroid injections were combined with physical therapy compared with physical therapy alone.

Although, Eckenrode points out, the improvements were measured over the course of weeks. “It’s not clear that it improves long-term outcomes,” he says.

A 2020 review of studies reported that steroid injection may be more effective as the shoulder is in the freezing stage, while physical therapy manipulation may be more effective once the joint is frozen.

If you don’t see progress after three to six months of physical therapy and steroid injections, the orthopedic surgeon can offer more invasive treatments, Schmidt says. One puts the patient under general anesthesia while the doctor forces the arm beyond the frozen position. Another option is arthroscopic surgery to cut through the tightened joint capsule. Both of these treatments would typically be followed with more physical therapy.

How do you know what doctor to see first? A general practitioner, a physical therapist or an orthopedic surgeon?

“If you have a good relationship with your primary care provider, that’s a good place to start,” says Schmidt, the orthopedic surgeon. “But we’re here when needed.”

A final note. Most people recover from frozen shoulder, although recovery may not be complete. A 2013 paper highlighted several studies in which researchers could measure less-than-full arm mobility while at the same time noting that subjects were satisfied with their recovery. That means, my left arm’s range of movement may never match my right arm’s, but if I can do everything I could do before, I’ll be happy.