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White House clears Food and Drug Administratration coronavirus vaccine standards it tried to derail

Health & BeautyOct 07. 2020

By The Washington Post · Laurie McGinley, Yasmeen Abutaleb, Carolyn Y. Johnson · NATIONAL, HEALTH, POLITICS, SCIENCE-ENVIRONMENT, HEALTH-NEWS 
WASHINGTON – The White House on Tuesday, after weeks of delay, approved tough new standards for coronavirus vaccines – but only after the Food and Drug Administration unilaterally published the guidelines on its website as part of briefing materials for outside vaccine advisers.

The standards, which would be applied to an emergency use authorization for a vaccine, are the same as ones the agency proposed weeks ago. In many ways, they are similar to the standards for a traditional approval. But the White House, worried that the criteria would delay authorization of a vaccine, presumably beyond the Nov. 3 election, decided to sit on the guidance.

One of the pharmaceutical companies at the forefront of efforts to develop a vaccine, Pfizer, on Tuesday declared its support for the agency in its struggle with the White House. Albert Bourla, the company’s chief executive, said on Twitter, “Pfizer has never discussed [FDA’s] vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence.” He said the agency’s independence “is today more important than ever as public trust in [covid-19] vaccine development has been eroded by the politicization of the process.”

The delayed clearance by the White House occurred days after President Donald Trump accused the FDA of being “political” in fashioning the guidance and after The Washington Post reported that White House Chief of Staff Mark Meadows was demanding detailed justification from the agency about the criteria. Meadows’s action raised fears the White House would thwart or block standards designed to boost public trust in a vaccine, according to individuals familiar with the situation who spoke on the condition of anonymity to discuss internal deliberations.

The FDA, as requested, provided the White House with additional data, but nothing happened, according to a senior administration official who spoke on the condition of anonymity because they did not have permission to talk publicly about the issue. On Tuesday, tired of the delay, the FDA circumvented the White House by publishing the criteria online as part of a briefing package for a meeting with its vaccine advisory committee that is scheduled for Oct. 22.

Shortly after the standards were published, the White House approved the vaccine guidance, according to the official.

The guidance is far more rigorous than what was used for emergency clearance of hydroxychloroquine, an anti-malaria drug used in the early days of the coronavirus pandemic, or convalescent plasma, which is taken from people who have recovered from covid-19 and whose antibodies might offer a measure of protection to other patients. It is an effort to shore up confidence in the vaccine development process and the FDA, which has made missteps during the pandemic.

The guidelines recommend that participants in late-stage vaccine clinical trials be followed for a median of at least two months, starting after they receive a second vaccine shot – which experts said could make it difficult, though not impossible, for a vaccine to be authorized before the election.

On Tuesday night, Trump issued a tweet proclaiming, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” The president tagged FDA Commissioner Stephen Hahn at the end of the tweet.

The Post reported Sept. 22 that the FDA was poised to issue a tough new standard for an emergency authorization of a coronavirus vaccine. As a sign the vaccine works, the agency said it would want to see at least five severe cases of covid-19, the disease caused by the novel coronavirus, in the placebo group for each trial, and some cases of the disease in older people. Assuming there weren’t cases – or not as many – in the group receiving the vaccine, that would be a signal that a shot is working.

At a news conference Sept. 23, President Trump said the FDA plan sounded like “a political move” and warned the White House might reject it.

Even as the White House rattled sabers, the head of the FDA section that oversees vaccines repeatedly said in public he would stick to the criteria and that he had told vaccine companies weeks ago what he was looking for to grant an emergency-use authorization.

“The companies know what we’re expecting,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said last week at an event sponsored by the advocacy group Friends of Cancer Research. He said the publication of the guidance was in large part designed to reassure the public that the FDA would use stringent standards in authorizing a vaccine.

Scott Gottlieb, a former FDA commissioner, said at a symposium on scientific integrity and vaccines Tuesday, “There are few moments I can think of where so much political dust was created by political officials for so little actual practical effect – and perhaps negative effect.”

He added, “The bottom line is FDA is going to stick to the objective criteria that they outlined in the guidance, the [advisory committee] is going to support those principles and the sponsors are going to adhere to them.”

Marks said at the conference that the criteria spelled out in the guidance is an attempt to build trust and confidence in vaccines that receive regulatory approval.

“We’ll continue to be as transparent as we can about what we do, because ultimately we do need to make sure that regardless of where someone comes on the spectrum of their beliefs that they can at least trust in this and feel confident that what comes through our process is something, because we at FDA are comfortable giving that to our families, they will feel comfortable giving it to their families,” Marks said.

He added that the two-month time frame was chosen because data shows that the majority of side effects occur within two to three months of vaccination. For example, he said that side effects such as Guillain-Barre, when the immune system attacks the nerves, could occur about six weeks after vaccination, but an inflammation of the spinal cord would typically happen within three months.

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White House signals stronger coronavirus precautions, but Trump continues to resist

Health & BeautyOct 07. 2020A member of the White House cleaning staff sanitizes in the press area on Monday. MUST CREDIT: Washington Post photo by Jabin Botsford 

By The Washington Post · Ashley Parker, Josh Dawsey · NATIONAL, HEALTH, POLITICS, HEALTH-NEWS 
WASHINGTON – The White House offered an informal nod to coronavirus best practices Tuesday, with mask-wearing prevalent after months of flouting public health recommendations and new internal guidelines for interacting with President Donald Trump, who tested positive for the virus late last week. 

But the biggest source of resistance appeared to be Trump himself, who, despite having just come home from a three-night hospitalization, was defiant – lobbying to return immediately to work in the Oval Office, discussing an address to the nation as early as Tuesday evening and clamoring to get back on the campaign trail in the coming days. 

At least nine White House employees have now tested positive for the virus, including senior adviser Stephen Miller, who got his positive result late Tuesday, a senior administration official said. Trump’s aides, allies and advisers find themselves grappling with how to implement more safety measures and precautions without displeasing their boss, who continues to say – as he did in a tweet Monday – “Don’t be afraid of Covid. Don’t let it dominate your life.” 

In a video he recorded maskless from the White House south balcony Monday night, the president also falsely claimed that perhaps he was “immune” to the virus, said he felt “better than 20 years ago” and urged the public to “get out there.” 

The result is a bifurcated culture in Trump’s White House and broader orbit, with informal and halting steps toward more rigorous health measures often undermined or upended by the president. 

His team, for instance, tried to puzzle out if there was a way for him to safely return to the Oval Office on Tuesday but ultimately nixed the request, said two people familiar with the discussions, who like others spoke on the condition of anonymity to reveal internal deliberations.

“The White House really isn’t doing anything you’re supposed to be doing in these situations,” said Angela Rasmussen, a virologist on the faculty of Columbia’s Mailman School of Public Health. 

Rasmussen added that while she agreed with Trump’s call not succumb to fear, “we also shouldn’t not take the virus seriously just because President Trump says he feels better and is flying around on Marine One and standing on the balcony like Evita.”

On Monday, the White House Management Office sent out an email to senior staff who routinely interact with Trump, aimed at protecting both the president and his advisers. The memo, obtained by The Washington Post, urges staffers to “limit all foot traffic on the first floor of the West Wing as well as in the Residence” and says that “staff should only go to the Oval Office or the second floor Residence when they are requested and expected.”

For staffers who do visit the Oval Office or the second floor of the residence, where Trump lives and holds meetings, and who expect to be within six feet of the president, the memo also requires that they wash their hands or use hand sanitizer before entering; remove any outer garments; and don personal protective equipment provided in an “Isolation Cart” – including a yellow gown, surgical mask, protective eyewear and gloves. 

The White House has not changed its mask guidance and is still following Centers for Disease Control and Prevention guidelines that recommend, but do not require, wearing a mask. Several administration officials said that nearly everyone in the White House has been wearing a mask in recent days, including Trump’s son-in-law and senior adviser Jared Kushner, who usually does not sport one. 

Rapid coronavirus testing is still required for anyone in proximity to Trump, and the White House is also offering testing to members of the White House press corps who worry that they may have been exposed to the virus in the past week, an administration official said. 

There has been minimal staffing in the White House since Trump’s positive diagnosis, officials said.

“We feel comfortable working here, those of us who are still here,” Alyssa Farah, the White House communications director, said in an interview with Fox News on Tuesday.

Privately, however, career administration officials and mid-level and junior staffers say they are scared – nervous about coming into work and wary of being the next to test positive. 

Trump, meanwhile, has been pushing to give a national address of some sort, said two people familiar with his discussions. There were active negotiations Tuesday about the president speaking to the nation that night, although no plan ultimately emerged, one of those people added. 

The White House Operations team, the White House Medical Unit and the chief of staff’s office have sought to present Trump with a menu of things he can safely do until he’s declared coronavirus-free, a senior administration official said.

Trump will probably continue to push out videos on social media and, at his request, increase his public visibility by a bit more each day – including offering updates on non-coronavirus topics as early as the end of this week, the official added. 

Tuesday night, Trump was expected to hold a call with campaign volunteers in Georgia to urge them to continue working on his behalf, said someone familiar with his schedule. 

The president wrote in a tweet Tuesday morning that he was looking forward to attending the second presidential debate – in Miami on Oct. 15 – and he has expressed eagerness to return to the campaign trail, according to several people familiar with his thinking.

Advisers are already planning campaign events with large crowds, including bus tours, airport hangar rallies, speeches at local centers and more, campaign officials said. The president’s message in the final stretch, one Republican official involved in the campaign added, is likely to be: “You can beat this. It shouldn’t stop your life.”

Asked specifically what precautions Trump plans to take before appearing again on a debate stage with Democratic nominee Joe Biden – including whether he will do so only after testing negative – Trump campaign spokesman Tim Murtaugh responded in an email, “The president intends to debate in person.”

And asked about Trump’s campaign plans, including if heading back out in public will be contingent on a negative test, Murtaugh referred to the president’s own words, writing, “The president is eager to get back to the campaign trail.”

In private moments, Trump sometimes seems aware of the political problems posed by his handling of the coronavirus – both the pandemic roiling the nation and his personal cases. He recently told an adviser not to reveal their coronavirus diagnosis, as the Wall Street Journal first reported, but the adviser disclosed it anyway. 

The president has also pressed his political advisers on how his hospitalization is playing politically. “How’s it working out?” he asked, according to one person familiar with his calls.

Public polling in recent days has painted a long uphill climb for reelection, including a CNN/SSRS poll released Tuesday showing Trump falling to 16 points behind Biden, who leads 57 to 41%. 

A GOP group working to elect Senate Republicans conducted polling over the weekend in four states – Colorado, Georgia, Montana and North Carolina – as Trump was hospitalized. The president’s numbers dropped “significantly” in every state, falling by about five points in all four. 

“The president is in real trouble,” said one of the group’s operatives, who is also close to the White House. 

Many of Trump’s allies and advisers see his response to his own illness as a missed opportunity. Some had hoped that he would emerge from his hospital stay slightly humbled, with a newfound display of seriousness and empathy, and would receive a boost of public sympathy. 

But so far, that has not happened. Internal Republican polling has consistently shown that the coronavirus – and not taking it seriously enough – remains the president’s electoral albatross. They believe it has caused the president to lose support among senior citizens and suburban women, both key voting blocs. 

Several former administration officials said they were appalled at the president’s conduct over the past few days, as well as the behavior of the people around him. One such official described Trump’s decision to leave the hospital Sunday for a ride in his presidential limo, which required two Secret Service agents to be in the car with him, as “so monstrously wrong.”

“In my lifetime, it was the most appalling thing I’ve seen a president do for a political stunt,” the former official said, speaking on the condition of anonymity to share a candid opinion. “It’s genuinely unhinged.” 

The approach in Trump’s orbit stands in marked contrast to that in other parts of the White House. Vice President Mike Pence’s chief of staff, Marc Short, has told his team to stay home until “further notice.” And the East Wing, where Melania Trump works, has long taken more stringent precautions than White House officials have required.

Early in the pandemic, the first lady’s staff all began working from home whenever possible, coming into the office only for events and travel – and even then with just a skeletal team, an administration official said. Everyone in the East Wing wore masks, and sometimes when doing events with her husband, Melania requested that no one personally staff her, to limit the number of aides at any given event, this official added.

After last week’s outbreak, in which the first lady also tested positive, her chief of staff, Stephanie Grisham, again instructed all East Wing staffers to stay at home.

Some entire corridors of the West Wing were empty Tuesday. A number of advisers who said they’d worked in the White House in recent days did not return with Trump back in the building. 

White House spokesman Judd Deere, in an emailed statement, said Trump will continue to receive “around-the-clock medical care,” provided by the White House Medical Unit, which functions “out of a state-of-the-art clinic.”

“The American people can rest assured with the president’s return that the White House is taking every precaution necessary to protect not only him and the first family, but every staff member working on the complex to support the federal government’s operations consistent with CDC guidelines and best practices,” Deere said. “Physical access to the president will be significantly limited and appropriate PPE will be worn when near him.” 

But some have their doubts about whether the president and his team are really taking adequate precautions – and modeling good behavior for the nation. Referring to Trump’s maskless appearance on the White House balcony Monday, Rasmussen said the president may not have conveyed the vigor and stamina he intended. 

“I supposed the message he was trying to send was that he’s super strong and defeated covid, but it was obvious even to me that he was gasping for breath, and that doesn’t suggest he has, in fact, defeated covid,” Rasmussen said. “It’s really premature to be declaring victory, and it’s also a really bad message to send.” 

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President’s talk of attending debate alarms health experts, who see danger

Health & BeautyOct 07. 2020

President Donald Trump

By The Washington Post · Amy Goldstein, Frances Stead Sellers · NATIONAL, HEALTH, POLITICS, SCIENCE-ENVIRONMENT, HEALTH-NEWS 
WASHINGTON – President Donald Trump’s tweet Tuesday that he looks forward to next week’s presidential debate alarmed some medical and public health experts, who warned that his coronavirus infection might still be contagious then and could endanger others.

A day after the president was discharged from a three-night hospital stay, during which he was put on an aggressive mix of treatments usually reserved for the most severe cases of covid-19, the disease caused by the novel coronavirus, he continued to project an image of being fully in charge and able to conduct all his regular activities.

Some outside health experts, however, said Trump’s determination to attend the Oct. 15 debate is part of a pattern of recklessness that has defined his response to the pandemic, with the president and his aides not wearing masks or observing social distancing. At least 19 people on his staff or his campaign, or who attended recent White House events, have tested positive for the virus in the past week.

On Tuesday, White House physician Sean Conley continued to give upbeat reports on Trump’s recovery, issuing a three-sentence memo saying the president “reports no symptoms” and has stable vital signs. “Overall, he continues to do extremely well,” the memo said.

Neither Conley nor other White House officials have said how they will determine when it might be safe for Trump to go out in public – for his own health, or for others near him. 

Several outside medical experts suggested that the president’s actions indicate he is unchastened by his own experience contracting a virus that has killed more than 210,000 Americans – or by the spreading infections among his own staff and supporters.

Trump’s removal of his mask moments after returning to the White House on Monday evening, and his subsequent assertion that he would appear at the debate “is irresponsible and reckless, and frankly that borders on malicious,” said Michael Mina, a physician and assistant professor of epidemiology at Harvard’s T.H. Chan School of Public Health.

“We should be throwing the kitchen sink at him, not just for treatment, but for ensuring that he is safe to be out in society and he is not imposing a risk to citizens of this country,” Mina said. 

Mina noted that the president’s medical team has many ways to determine the status of his infection. Beyond administering the “PCR” test, considered the most definitive way of assessing whether someone has the virus, he said doctors could ask him to cough onto a petri dish to see whether the virus grows, swab his nose to culture the specimen, or administer antigen tests to see whether he has the virus’s protein in his nose.

“The average American doesn’t have tools to go through this,” Mina said, “but the president is a very special person. We have tools to do this.”

Guidelines from the federal Centers for Disease Control and Prevention recommend that covid-19 patients self-isolate for 10 days after their symptoms begin. The CDC also said they should not go out unless they have been fever-free for at least 24 hours, and their other symptoms should be improving. 

Covid-19 patients who were seriously ill may need to stay isolated for as long as 20 days after their first symptoms, the guidelines say.

The CDC does not define a serious case, and Trump’s doctors have withheld certain information that would provide a clearer picture of his medical condition – for instance how low his blood-oxygen levels dropped on two occasions or whether CT scans showed signs of pneumonia or lung damage. 

If Trump developed symptoms late last week, the 10-day window would end before the debate.

Outside doctors debated whether the 10-day period for mild and moderate cases should apply to the president and whether it would be premature for him to go out in public next week.

Thomas File Jr., an Akron, Ohio, infectious-disease specialist and president of the Infectious Diseases Society of America, said that Summa Health, the company for which he works, generally follows the CDC guidelines. In all but the most serious cases, he said, “we would allow someone to go into the general public within 10 days of their symptoms appearing.”

Georges Benjamin, executive director of the American Public Health Association, said most patients are no longer infectious after 10 to 14 days. But given the known timing of when Trump began feeling ill, “he’ll be really close. All you have to do is be wrong within a day or two, and he could easily still be infected . . . it’s going to be tight.”

Rajesh Gandhi, an infectious-diseases physician at Massachusetts General Hospital and Harvard Medical School, said the CDC guidelines make sense but emphasized that covid-19 cases vary widely. About 80 percent of people have no symptoms or are mildly to moderately ill. Another 15% are hospitalized with serious cases like the president’s, while the remaining 5% become critically ill, Gandhi said.

“I would reiterate on average that we are most cautious around the week or so after the onset of symptoms,” Gandhi said. 

Mina said the CDC guidelines are an average for a whole population, balancing risk of transmitting the virus with the desire for people to return to jobs and other aspects of their normal interactions. 

“The president is in a position he should be serving as the absolute gold standard,” he said, adding that Trump should get every possible method of testing, “given that he is the president, given that he goes to things that have so many people and have so many opportunities for transmission to occur.”

Despite some apparently labored breathing by the president, experts saw little to be concerned about in Trump’s brief appearance at the White House.

“What I saw was that he took a couple of deep breaths standing up there. He had just climbed up two flights with a mask on his face,” said David Hager a specialist in pulmonary and critical-care medicine at Johns Hopkins. “I think he looks well.”

Other doctors thought it might be premature for Trump to be making plans for his own health, simply because of the unpredictable course of the disease. John Zerlo, chief of the infectious-diseases division of Philadelphia-based Jefferson Health, said that any plans the president makes could change, depending on the progression of a disease that sometimes fools physicians and patients alike.

People who look and feel well can suddenly crash and need to be put on ventilators, Zerlo said. “If [the president’s doctors] are not waiting at the ready to do that, they would be foolish. This infection is pretty capricious.” 

Kevin Sheth, a critical-care neurologist at Yale Medicine, said that the president should be monitored and tested for cognitive issues. “You want to survive the respiratory piece,” he said, “but we know there are neurological complications.” Those can include problems such as stroke and inflammation and longer-term cognitive changes. 

“For somebody in a leadership position, that’s what I’d be concerned about,” Sheth said. “Clearly the virus in some patients is having effects on the brain.”

Many public health officials and some physicians said they were angered by the symbolism of the president’s tweets and actions since his diagnosis – and the damage they think he has inflicted on the safety messages they have been trying to convey to curb the nation’s worst public health crisis in more than a century.

Hours before his discharge Monday, Trump tweeted: “Don’t be afraid of Covid. Don’t let it dominate your life.”

His tweet also said, “I feel better than I did 20 years ago!” Outside physicians noted that the treatment Trump has been receiving includes dexamethasone, a steroid used to treat inflammation that has been shown to increase the survival rate among the sickest covid-19 patients. The drug’s side effects can include insomnia, irritability or a feeling of euphoria.

“He really probably does feel a lot better,” said Keith Hamilton, an infectious-disease specialist and associate professor of Clinical Medicine at the Perelman School of Medicine at the University of Pennsylvania. “Steroids make everyone feel better.”

Several physicians said they had seen patients on the steroid become angry, confused or manic, but that such instances were rare and typically occurred when people received high doses.

Al Sommer, former dean of the Johns Hopkins Bloomberg School of Public Health, who has used the public health tools to wage global battles against diseases such as smallpox, said, the president is thinking short term, about his own recovery and reelection.”But the pandemic has far from run its course.” 

Trump displays “an outrageous, irresponsible disregard of the advice of our best, most informed medical knowledge and public health practice,” Sommer contended.

Peter Beilenson, director of Sacramento County’s Department of Health Services, where coronavirus cases have seesawed, called the president’s actions “totally irresponsible” as he described his own efforts to counter people’s desire to do away with public health measures as the dangers seem to wane.

“This is a guy who got taxpayer-funded world’s best treatment, acting as if it were no big deal and we should deal with it,” Beilenson said. Beyond the 210,000 deaths, he noted, are countless patients known as long haulers – “people who have extensive problems, respiratory, cardiac, neurological, for months, maybe permanently. We don’t know.”

Josh Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, said that even if the president wins his own battle against the virus, he is damaging Americans’ well-being. The confusion he causes is to the benefit of the virus,” Sharfstein said.

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Doctors withhold some details of Trump’s recovery, say they remain ‘on guard’

Health & BeautyOct 06. 2020President Donald Trump returns to the White House on Marine One after being treated for covid-19 at Walter Reed National Military Medical Center on Monday, Oct. 5, 2020. MUST CREDIT: Washington Post photo by Matt McClain 

By The Washington Post · Frances Stead Sellers, Laurie McGinley, Ariana Eunjung Cha, Amy Goldstein · NATIONAL, HEALTH, HEALTH-NEWS
WASHINGTON – President Donald Trump left an elite medical center Monday evening as his doctors acknowledged that they were entering “uncharted territory” and – citing privacy laws – continued to withhold information that could illuminate the president’s prognosis for recovering from covid-19.

Trump’s determination to appear in control in the waning weeks of the presidential race left unclear whether he or his doctors were calling the shots, especially because members of his medical team at Walter Reed National Military Medical Center continued to cherry-pick what they shared with the public. They said that his oxygen levels were normal and that he had no fever, but they refused to answer questions about results from lung scans, his last negative test for the coronavirus or why he is receiving the steroid dexamethasone, typically reserved for patients with severe illness.

The president returns to the White House at a fraught moment in his recovery – before he has seemingly escaped a period when some patients are known to crash.

“The problem with covid-19 is that people’s condition can deteriorate rapidly, even after days of stability,” said Harlan Krumholz, a cardiologist and health-care researcher at Yale University and Yale New Haven Hospital. “And so we are more accustomed to be cautious with people with high risk.”

The president has received care accessible to few other Americans. He was given a brew of laboratory-made antibodies that fewer than 10 other patients have received outside of clinical trials. And for him, returning home means arriving at a place that can be adapted to cater to his needs, Krumholz and others said.

Jonathan Reiner, a George Washington University Hospital cardiologist, said that in an emergency, the White House medical unit “can do what an emergency room can do in the first 15 minutes” – someone could be resuscitated and stabilized during a heart attack, for example, and then transferred to a hospital. For ongoing treatment, he said, it would be wise for Trump to remain hospitalized.

“It makes zero sense to move him from Walter Reed,” Reiner said.

At a Monday news conference, White House physician Sean Conley said doctors were “cautiously optimistic and on guard” about Trump’s discharge. But he said the benefits of returning to the White House outweighed the risks.

“Every day a patient stays in the hospital unnecessarily is a risk to themselves,” Conley said. “And right now there’s nothing that’s being done upstairs here that we can’t safely conduct down home.”

But Conley acknowledged that the medical team is in “uncharted territory” with the mix of medications the president has been given and that the dangerous period for the infection is not over. He’s “looking to this weekend” for assurance that Trump has cleared rough waters.

“If we can get through to Monday” of next week, he said, doctors will “take that final deep sigh of relief.”

Conley declined for the third briefing in a row to answer additional questions about X-rays and other images taken of Trump’s lungs, and about other key data, such as when he last received a negative coronavirus test before falling ill. Instead, Conley emphasized symptoms the president was not experiencing: A “slight cough” was gone. There were never complaints of muscle aches. And fever-reducing drugs had not been deployed for at least 72 hours.

“He’s up and back to his old self, predominantly,” Conley said.

In the White House, Trump’s doctors will be vigilant for sudden changes, specialists predicted.

“You would want to be prepared to take care of any sudden unanticipated or very concerning event,” said Jeanne Marrazzo, an infectious-diseases expert at the University of Alabama at Birmingham. The biggest risk, she said, would be the sudden onset of acute respiratory distress syndrome, which sometimes occurs with covid-19, the illness caused by the novel coronavirus. Patients’ lungs fill with fluid, and they cannot breathe on their own.

While Trump could get supplemental oxygen at the White House, “if I were that sick, I would want to be at Walter Reed,” she said.

Marrazzo said she would also be on the lookout for cardiac abnormalities, especially given Trump’s age and lack of exercise. She said covid-19 causes heart problems including myocarditis, heart failure and clotting. While Trump could be whisked back to Walter Reed in the Maryland suburbs if problems developed, she said, “lots of things can happen in 20 minutes, lots of things can happen in five minutes.”

Daniel Kaul, an infectious-diseases expert at the University of Michigan, said people of Trump’s age and with similar severity of illness – to the extent that is known – “usually have a pretty slow recovery, with weeks and sometimes months of cognitive difficulties, shortness of breath, severe fatigue.”

Like other experts, Kaul said it is highly probable that Trump had pneumonia.

At the briefing, Conley selectively invoked health privacy laws known as HIPAA – the Health Insurance Portability and Accountability Act – when questions arose about the president’s respiratory-system scans or whether he remained infectious.

Asked when Trump last tested negative for the coronavirus, Conley replied, “HIPAA precludes me from going into too much depth.”

When asked about imaging tests of the president’s lungs, Conley responded, “So there are HIPAA rules and regulations that restrict me in sharing certain things for his safety and his own health.”

The president’s doctors showed no such hesitancy in disclosing details about his temperature, blood pressure, heart rate and blood oxygen level – all of which they said were normal.

Trump minimized in a tweet Monday the dangers presented by the virus that has felled at least 209,000 people in the United States.

“Don’t be afraid of Covid. Don’t let it dominate your life,” he tweeted. “We have developed, under the Trump Administration, some really great drugs & knowledge. I feel better than I did 20 years ago!” 

Trump returns to a White House complex with two medical clinics, according to people familiar with the facilities: a small one on the ground floor available to the first family and others working in the building, and a larger one in the Executive Office Building. The latter unit is equipped to stabilize patients needing urgent care after incidents ranging from an accident to a heart attack or stroke. The goal is to stabilize patients before transferring them to a hospital.

For a scheduled procedure, presidents typically go to Walter Reed; for trauma, they go to George Washington University Hospital, where Ronald Reagan was treated after being shot almost four decades ago.

Health officials from current and past administrations agreed that the White House medical unit can bulk up on staffing and equipment to ensure that it can care for and at least stabilize a patient who takes a turn for the worse. 

“But it’s really inefficient and risky compared to being on site in a hospital” with Walter Reed’s capability, said a health official from a previous administration who spoke on the condition of anonymity to freely discuss the topic.

Greg Martin, a pulmonary critical-care specialist at Emory University, said Trump’s blood oxygen levels could be tracked constantly through a finger monitor available at drugstores. The president would be watched for changes in mental status as a side effect of medications, especially the steroid dexamethasone, which might include difficulty with attention, depression or mania.

His blood would probably be tested several times a day for changes in coagulation or inflammation – those might indicate a higher risk of clotting or that his body may be heading into a dangerous “cytokine storm,” which would require more serious interventions. Doctors may run an echocardiogram on his heart once a day to look for signs of a hardening of the walls, which is a known and relatively common issue with covid-19.

But Martin cautioned that there are complications of covid-19 for which there is often no warning or advance notice: strokes or heart failure due to microclots, or a pulmonary embolism from a clot in the legs or other part of the body suddenly moving to the lungs.

“These are things you wouldn’t know are going to happen until they do,” Martin said. 

The White House did not respond to questions Monday afternoon about whether new equipment or personnel had been brought in to treat Trump.

The degree of monitoring available from a staff of physicians, nurses and physician assistants could be important for a patient such as Trump, whose risk factors include his age and weight, and who may be contagious for days to come.

“I think he has to be assumed to be infectious,” said William Schaffner, a professor of infectious diseases at Vanderbilt University’s medical school.

“We need to know some details – how closely is he going to be monitored?” Schaffner said. “That’s very important. The concern is, though he’s feeling rather chipper, he could still crash.”

In particular, he said, the president faces a potential hazard of developing cardiac problems that could disrupt his heart rhythm or breathing difficulty that could damage his lungs.

Schaffner said one of the metrics of improving health highlighted by the president’s physician Monday – Trump’s lack of a fever for more than 72 hours – could be a byproduct of the fever-suppressing qualities of dexamethasone.

One significant question Trump’s doctors have not addressed is how long they plan to continue giving him the steroid and a combination of disease-fighting antibodies, said John Mellors, chief of the division of infectious diseases at the University of Pittsburgh school of medicine.

Mellors said some patients with symptoms similar to those described by the president’s doctors achieve a full recovery. Others feel unwell for weeks or months, with symptoms that can include fatigue, body aches, shortness of breath, low-grade fever and mental fogginess. 

In other cases, the virus can be suppressed temporarily but come back to cause major damage in the lungs or the heart, or by developing blood clots. Which trajectory any given patient takes “is all emerging” in terms of medical research findings.

The president probably is still contagious, experts said. Conley said doctors were using “advanced diagnostics” to determine “when it’s safe to get around and be around people.”

The real question, Marrazzo said, is why Trump returned.

“Is it a continued theatrical effort to assure us he is well enough to be discharged, or is it that they think he truly improved that quickly and can recover in the comfort of his own home?”

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https://www.nationthailand.com/lifestyle/30395618?utm_source=category&utm_medium=internal_referral

Russia ramps up rhetoric to defend vaccine efforts

Health & BeautyOct 05. 2020The Washington Post · Isabelle Khurshudyan · WORLD, HEALTH, EUROPE, HEALTH-NEWS · Oct 04, 2020 – 8:34 PM 

By The Washington Post · Isabelle Khurshudyan · WORLD, HEALTH, EUROPE, HEALTH-NEWS

MOSCOW – Included in Russian President Vladimir Putin’s speech at the United Nations last month was an offer: All U.N. staff could receive Russia’s Sputnik V coronavirus vaccine, free of charge.

https://www.washingtonpost.com/video/c/embed/b2a8c7a9-e514-42f8-b5a9-085a72349a7a?ptvads=block&playthrough=false

Russia’s race to be first with a credible vaccine is also an exercise in the science of state-run spin.

Nationalism has inevitably crept into the breakneck vaccine stakes. President Donald Trump used Tuesday’s debate to tout U.S. pharmaceutical companies in the vaccine hunt and British Prime Minister Boris Johnson donned a white lab coat during a mid-September tour of an Oxford lab seeking a vaccine.

Russia, too, had turned up the patriotic volume along with the vaccine push. In a promotional video that was part of the rollout for Sputnik V – whose name itself taps into the pride of the Soviet Union being first out of the blocks in the Cold War’s space race with a satellite in 1957 – the vaccine is portrayed circling a coronavirus-infected earth, wiping out the disease as it goes.

Now that the global competition is heating up – 10 possible vaccines are undergoing Phase 3 testing, according to the World Health Organization – Russia has further amped up its rhetoric around Sputnik V. 

Russia is now going on the offensive. 

The Kremlin-directed campaign to promote Sputnik V has largely dismissed any criticism – especially claims that Russia is cutting corners on safety – as anti-Russian smears. Meanwhile, Russian officials are attempting to cast doubt on rival vaccine hunters with unsupported assertions, such as making claims that Western approaches to find a vaccine are less effective and riskier.

In August, Putin announced that Russia registered the world’s first coronavirus vaccine, even before the start of Phase 3 large-scale clinical trials. That day, he said one of his two daughters received the prospective vaccine and experienced only mild symptoms – a startling disclosure since he rarely mentions his children in public. 

On Wednesday, Kremlin spokesman Dmitry Peskov said Putin “is thinking” about getting vaccinated himself. 

“This is not a gentlemanly stroll in the park by a bunch of people who all agree that there’s some common public good we all need to strive for,” said J. Stephen Morrison, director of the Center on Global Health Policy at the Center for Strategic and International Studies in Washington. “This has become a geopolitical race, and it’s one that’s seen as tied to domestic stability and support amid lots of adversity.”

The Russian Direct Investment Fund, which bankrolled the country’s vaccination effort, has frequently hailed Sputnik V’s delivery system: two doses to carry different, harmless cold viruses, or human adenoviruses. They have been engineered in hopes of carrying cells of the gene for the coronavirus. 

The investment fund’s head, Kirill Dmitriev, has taken aim at other labs seeking a vaccine using adenoviruses from monkeys or messenger RNA. 

After Oxford University and pharmaceutical company AstraZeneca resumed their coronavirus vaccine trial following a week-long pause because of an unexplained illness in a trial participant, Dmitriev issued a comment that he was “delighted” trials resumed. Unlike Sputnik V, their vaccine uses a cold virus from a monkey rather than a human. 

“At the same time, the suspension of trials clearly showed the fallacy of the approach, when entire countries exclusively rely on novel and untested platforms when choosing a vaccine for widespread use,” Dmitriev’s statement continued.

Morrison said Dmitriev’s comments “sound like propaganda.”

“Trying to bad-mouth other competitors’ vaccines seems like a little bit of rowdy behavior,” Morrison said.

Sputnik V is undergoing Phase 3 testing with 40,000 volunteers, but the production rights for millions of doses have already been sold to several countries, including India, Brazil and Mexico. 

In another move to show confidence in the potential vaccine, Russia will shoulder some of the legal risks should anything go awry, Dmitriev said, rather than seeking full indemnity as many other vaccine-makers have sought. 

That could be an international selling point for Russia compared to vaccine candidates that use a similar technology, such as ones from pharmaceutical giant Johnson & Johnson and the Chinese company CanSino Biologics.

“Countries have a choice to make, and we think they’ll focus on a portfolio of different vaccines,” Dmitriev said. “But we’re absolutely sure that a human adenovirus vaccine will be in the portfolio of most countries.”

But for all of Russia’s efforts to convince its international skeptics, Sputnik V doesn’t have strong domestic support yet. 

An August poll found that 54 percent of the more than 1,600 respondents said they were not ready to volunteer for vaccination, according to the independent Levada Center. 

Russian Health Minister Mikhail Murashko told the state-run Tass news agency in September that Sputnik V will be more widely available to the general population in late November or December. 

Alexey Kuznetsov, an aide to Murashko, said in a statement that “voluntary vaccination of citizens at risk has begun: first of all, medical workers and teachers.” But the Health Ministry has declined to say how many teachers and front-line health-care workers have so far volunteered to receive Sputnik V. 

Leonid Perlov, a 66-year-old who teaches geography in Moscow, said he was offered the potential vaccine but declined because it “has not passed all of the necessary stages of testing.”

“This is all premature,” he added.

But not for everyone. He noticed a divide among his colleagues – perhaps influenced by the Kremlin’s heavy emphasis on the possible vaccine as a symbol of national pride. 

“The biology teachers are not in a hurry to get vaccinated,” Perlov noted. “They’re more cautious. But the history teachers are the ones who are ready to volunteer.”

After Russia’s daily ticker of confirmed new coronavirus cases showed steady decline over the summer, infections have started rising again to more than 8,000 per day, sparking local fear that another nationwide lockdown could soon follow. 

The economy suffered from the closures in April and May, and Putin’s approval ratings consequently slumped. Russia may point to its vaccine as justification for avoiding a second round of strict restrictions. 

Olga Demicheva, an endocrinologist in Moscow, said she volunteered to be a Phase 3 clinical trial participant for Sputnik V, but doesn’t believe that the possible vaccine should be available even for high-risk groups before that large-scale testing is completed.

Semyon Galperin, head of the Doctors’ Defense League rights group, opted for a similar compromise.

“My volunteering is to hopefully prevent a situation where there is some pressure on our (medical) colleagues to get vaccinated,” Galperin said. “Before the clinical trials are complete, we shouldn’t tell anyone to get vaccinated or not.”

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Secret Service agents, doctors aghast at Trump’s drive outside hospital

Health & BeautyOct 05. 2020

By The Washington Post · Josh Dawsey, Carol D. Leonnig, Hannah Knowles · NATIONAL, HEALTH, POLITICS, HEALTH-NEWS 
WASHINGTON – Secret Service agents and medical professionals were aghast Sunday night at President Donald Trump’s Sunday evening trip outside the hospital where he is being treated for the coronavirus, saying the president endangered those inside his SUV for a publicity stunt.

As the backlash grew, aides who were not authorized to speak publicly also called Trump’s outing to wave at supportive crowds an unnecessary risk, but said the move was not surprising. Trump had said he was bored in the hospital, advisers said. He wanted to show strength after his chief of staff offered a grimmer assessment of his health than doctors, according to campaign and White House officials.

A growing number of Secret Service agents have been concerned about the president’s seeming indifference to the health risks they face when traveling with him in public, and a few reacted with outrage to the trip, asking how Trump’s desire to be seen outside of his hospital suite justified the jeopardy to agents protecting the president. The president’s coronavirus diagnosis has already brought new scrutiny to his lax approach to social distancing, as public health officials scramble to trace those he may have exposed at large in-person events.

“He’s not even pretending to care now,” said one agent after the president’s jaunt outside Walter Reed National Military Medical Center.

“Where are the adults?” said a former Secret Service member.

They spoke on the condition of anonymity out of fear of retribution.

White House spokesman Judd Deere defended the outing, telling reporters that “appropriate precautions were taken in the execution of this movement to protect the president and all those supporting it.” Deere said precautions included personal protective equipment, without providing further details, and added that the trip “was cleared by the medical team as safe to do.”

The White House did not immediately respond to questions from The Washington Post on Sunday night.

Trump wore a mask as he waved to a crowd from the back of his vehicle, after announcing that he would “pay a little surprise to some of the great patriots that we have out on the street.” But the face covering was little comfort to doctors, who took to Twitter to criticize the trip as irresponsible. Masks “help, but they are not an impenetrable force field,” tweeted Saad Omer, director of the Yale Institute for Global Health.

Among critics was a doctor affiliated with Walter Reed.

“Every single person in the vehicle during that completely unnecessary Presidential ‘drive-by’ just now has to be quarantined for 14 days,” tweeted James Phillips, who is also a professor at George Washington University. “They might get sick. They may die. For political theater. Commanded by Trump to put their lives at risk for theater. This is insanity.”

Phillips said the risk of viral transmission inside the car is “as high as it gets outside of medical procedures.” Jonathan Reiner, a professor of medicine and surgery at George Washington University, noted that people inside a hospital wear extensive protective gear — gowns, gloves, N95 masks and more – when they will be in close contact with a coronavirus patient such as Trump.

“By taking a joy ride outside Walter Reed the president is placing his Secret Service detail at grave risk,” he tweeted.

Trump had been irked that White House Chief of Staff Mark Meadows suggested that he was not doing well as he fought the virus, according to campaign and White House officials.

“The president’s vitals over the last 24 hours were very concerning, and the next 48 hours will be critical in terms of his care,” Meadows said Saturday afternoon, in sharp contrast to doctors who offered rosy assessments at an earlier news conference. “We’re still not on a clear path to a full recovery.”

Later that day, Meadows said Trump’s condition had improved significantly but maintained that the president was “not out of the woods,” echoing Trump’s doctor.

Trump’s outing Sunday came as White House officials acknowledged that the president’s health deteriorated to the point where he received supplemental oxygen, something they previously refused to disclose. Trump’s doctor Sean Conley said Sunday that he was “trying to reflect the upbeat attitude that the team, the president, over his course of illness, has had.”

“Optics matter right now,” said one senior aide close to Meadows, adding: “Shows of strength and resilience are crucial. For the American public, but also those watching abroad.”

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Spa Cenvaree offers ultimate in mix-and-match pampering

Health & BeautySep 25. 2020

By The Nation

Spa Cenvaree at Centara Grand Ladprao is promising the ultimate in pampering by introducing a new “spa buffet”, which allows guests to mix and match popular services to create a perfect 120-minute treatment for themselves.

Guests can opt for a natural scrub session for detoxification or a spa body wrap to stimulate circulation, and then go for a relaxing body massage, hot stone therapy, aromatherapy, back and shoulder massage, among others. They can also go for facial spa, such as organic or jade stone treatment, before surrendering to total relaxation with a green-tea eye mask.

Visit Spa Cenvaree at Centara Grand, Central Plaza Ladprao for a perfect spa day.

The “spa buffet” is available every day from 9am to 11pm from October 1 to 31.

A 120-minute treatment for one person costs Bt2,200 net, and Bt4,100 net for two persons.

Call (02) 541 1234 for more information or reservation.

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Hopefuls flaunt their style in Miss Universe swimsuit competition

Health & BeautySep 24. 2020Photos by Tanachai Pramarnpanich 

By The Nation

Beauties vying for the Miss Universe Thailand 2020 crown were seen strutting down the catwalk in swimsuits at InterContinental Hua Hin Hotel on Thursday (September 24).

The swimsuit competition was held under the concept of “Real You, Real Universe”, in which the contestants did not just have to show off their physical beauty but also their persona, attitude and talent.The swimsuits were provided by BSC and came from its “Uniquely You” line, which was inspired by traditional Thai textiles.The preliminary round to select semi-finalists will be held on October 7 and the final on October 10.

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Amazon offers $500 ‘Prime Bike,’ encroaching on Peloton’s niche

Health & BeautySep 23. 2020

By Syndication Washington Post, Bloomberg · Isabelle Lee · BUSINESS, FEATURES, HEALTH, HEALTH-NEWS 
Amazon.com launched a “Prime Bike” on Tuesday, a bid to compete with an array of at-home exercise bikes that have become popular in the pandemic, like those offered by Peloton Interactive.

The new EX-Prime Smart Connect Bike is available on the e-commerce giant’s website for $500, a steep discount to Peloton machines that cost well over $1,000. 

The Prime Bike is only available to Amazon Prime subscribers and was developed through a partnership with Echelon Fitness. Included with the purchase of the Prime Bike is a free 30-day Echelon membership trial, which includes live exercise classes.

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https://www.nationthailand.com/lifestyle/30394954?utm_source=category&utm_medium=internal_referral

Miss Universe hopefuls visit Hua Hin for photoshoot

Health & BeautySep 22. 2020Photos By Tanachai Pramarnpanich 

By The Nation

All 30 Miss Universe Thailand contestants graced Prachuap Khiri Khan’s Hua Hin district with their style and beauty on Tuesday (September 22).

They were at the charming seaside resort town to pose for photographs as well as interact with locals and learn of their way of life.The beauties posed for a photoshoot with vintage Rolls Royce and Mercedes Benz cars, and attractions like the iconic Hua Hin Railway Station.