U.S. coronavirus cases rise by nearly 50,000 in biggest one-day spike of pandemic

https://www.yahoo.com/news/u-coronavirus-cases-rise-nearly-013221004.html

Dr Fauci warns US could see 100,000 new coronavirus cases PER DAY ...

New U.S. COVID-19 cases rose by nearly 50,000 on Wednesday, according to a Reuters tally, marking the biggest one-day spike since the start of the pandemic.

The record follows a warning by the government’s top infectious diseases expert that the number could soon double to 100,000 cases a day if Americans do not come together to take steps necessary to halt the virus’ resurgent spread, such as wearing masks when unable to practice social distancing.

In the first week of June, the United States added about 22,000 new coronavirus cases each day. But as the month progressed, hotspots began to emerge across the Sun Belt. In the last seven days of June, daily new infections almost doubled to 42,000 nationally.

Brazil is the only other country to report more than 50,000 new cases in one day. The United States reported at least 49,286 cases on Tuesday.

More than half of new U.S. cases each day come from Arizona, California, Florida and Texas, home to 30% of the country’s population. All four states plus 10 others saw new cases more than double in June.

The daily increase in new cases could reach 100,000 unless a nationwide push was made to tamp down the fast-spreading virus, Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told a U.S. Senate committee on Tuesday.

“We can’t just focus on those areas that are having the surge. It puts the entire country at risk,” Fauci said.

The rise in cases is not just the result of more testing. Hospitalizations are also skyrocketing.

Nationally, 7% of coronavirus diagnostic tests came back positive last week, up from 5% the prior week, according to a Reuters analysis. Arizona’s positivity test rate was 24% last week, Florida’s was 16%. Nevada, South Carolina and Texas were all 15%, according to the analysis.

(Open https://tmsnrt.rs/2WTOZDR in an external browser for a Reuters interactive)

Some of the recent increase traces back to Memorial Day holiday celebrations in late May. Health experts are worried about Independence Day celebrations this weekend, when Americans traditionally flock to beaches and campgrounds to watch fireworks displays.

 

 

Six months in, coronavirus failures outweigh successes

https://thehill.com/policy/healthcare/public-global-health/505353-six-months-in-coronavirus-failures-outweigh-successes

Covid-19 news: UK deaths fall below five-year average | New Scientist

In the six months since the World Health Organization (WHO) detected a cluster of atypical pneumonia cases at a hospital in Wuhan, China, the coronavirus pandemic has touched every corner of the globe, carving a trail of death and despair as humankind races to catch up.

At least 10.4 million confirmed cases have been diagnosed worldwide, and the true toll is likely multiples of that figure. In the United States, health officials believe more than 20 million people have likely been infected.

A staggering 500,000 people around the globe have died in just six months. More people have succumbed to the virus in the U.S. — 126,000 — than the number of American troops who died in World War I.

But even after months of painful lockdowns worldwide, the virus is no closer to containment in many countries. Public health officials say the pandemic is getting worse, fueled by new victims in both nations that have robust medical systems and poorer developing countries.

“We all want this to be over. We all want to get on with our lives. But the hard reality is this is not even close to being over,” WHO Director-General Tedros Adhanom Ghebreyesus said Monday. “Globally, the pandemic is actually speeding up.”

In the U.S., the fierce urgency of March and April has given way to the complacency of summer, as bars and restaurants teem with young people who appear largely convinced the virus poses no threat to them. New outbreaks, especially among younger Americans, have forced 16 states to pause or roll back their reopening plans.

“This is a really challenging point in time. It’s challenging because people are tired of the restrictions on their activity, people are tired of not being able to socialize, not being able to go to work,” said Richard Besser, a former acting director of the Centers for Disease Control and Prevention (CDC) who now heads the Robert Wood Johnson Foundation.

“You have people who have reached that point of pandemic fatigue where they just don’t want to hear it anymore, they just want to go back to their life,” he added.

The number of new U.S. cases has risen sharply in recent weeks, led disproportionately by states in the South, the Midwest and the Sun Belt. More than a quarter-million people tested positive for the coronavirus last week, and more than 40,000 tested positive on three consecutive days over the weekend.

“We are now having 40-plus thousand new cases a day. I would not be surprised if we go up to 100,000 a day if this does not turn around. And so I am very concerned,” Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, told a Senate panel on Tuesday.

Public health experts now worry that a rising tide of death is about to crest across the United States. Officials in Alabama, Arizona, California, Mississippi and Texas are reporting a surging number of COVID-19 hospitalizations, leading to fears that health systems could soon be overrun.

“If you’re over the hospital capacity, people will start dying faster,” said Eric Feigl-Ding, an epidemiologist and health economist at the Harvard T.H. Chan School of Public Health and a senior fellow at the Federation of American Scientists.

Already, Arizona has reported more coronavirus deaths per million residents in the last week, at 4.77, than any nation on Earth except Chile and Peru.

The response to the coronavirus pandemic has varied widely, and in some parts of the world, both wealthy and developing nations have brought it under control. In the U.S., some states hit hard early on have wrangled transmission under control.

But even in states that have achieved some measure of success, the spikes in cases stand in stark contrast to countries that have bent the epidemiological curves to manageable levels.

Mass screenings in South Korea crushed the spread, and quick action to identify and isolate contacts in more recent hot spots have meant new outbreaks are quickly contained. South Korea, with a population of 51 million, has reported just 316 new cases in the past week, fewer than the number of new cases reported in Rhode Island, a state with slightly more than 1 million residents.

Germany raced to protect its elderly population and rapidly expanded its hospital capacity. It deployed the world’s most successful diagnostics test, developed at a Berlin hospital, on a massive scale. With a population of 83 million, the country has reported 78 coronavirus deaths in the past week; Mississippi, population 3 million, reported 96 coronavirus-related deaths during the same period.

Vietnam imposed mandatory quarantines on contacts, including international travelers, in government-run centers to stop the spread. Among its 95 million residents, Vietnam has confirmed 355 total cases since the outbreak began. Alabama, population 4.9 million, reported 358 cases on Sunday alone.

Those countries have begun loosening restrictions on their populations and their economies, with few signs of major flare-ups.

The United States has begun to open up too but without bending the curve downward, and the results have been disastrous. The number of daily confirmed cases has more than doubled in nine states over the past two weeks and has increased by more than half in 17 more.

“I have really grave concerns that viral transmission is going to get out of control,” Besser said.

In interviews, public health experts and epidemiologists confess to feelings of depression and disgust over the state of the nation’s response. Some remain exasperated that there is still no coordinated national response from the White House or federal agencies.

President Trump has rarely mentioned the virus in recent weeks, aside from using racial epithets and suggesting his administration would slow testing to reduce the number of confirmed cases. He later said he was joking.

“There should be some sort of federal leadership,” Feigl-Ding said. “Every state’s on its own, for the most part.”

Left to their own devices, some states are trending in the right direction. Connecticut, Maryland, New Hampshire, New York, North Dakota, Rhode Island, South Dakota and the District of Columbia have seen their case counts decline for two consecutive weeks or more. New York reported 4,591 new cases in the last week — a startlingly high figure but only a fraction of the 65,000 cases infecting the state during its worst week, in early April.

States with their numbers on the decline have benefited from fast action and strict measures. They’re also viewed as role models for states that are now experiencing surges.

“States who are now on the rapid upslope need to act quickly, take the advice and example of states that have already been through this,” said Abraar Karan, an internist at Brigham and Women’s Hospital and Harvard Medical School. “We know what needs to be done to win this in the short run, and we are working on what needs to happen for the longer term.”

If there is a silver lining, it is that the number of tests American states are conducting on a daily basis has grown to about 600,000, on its way toward the millions the nation likely needs to fully control the spread.

But that silver lining frames a darkening cloud: As the virus spreads, even the higher testing capacity has been strained, and state and local governments are hitting their limits and running low on supplies.

The greater number of tests does not account for the speed of the spread, as Trump has suggested. The share of tests that come back positive has averaged almost 7 percent over the last week, according to The Hill’s analysis of national figures; in the first week of June, just 4.6 percent of tests were coming back positive.

If greater testing were responsible for more cases, the percentage coming back positive should decrease rather than increase. The higher positive rates are an indication the virus is spreading more rapidly.

As with so much else in American life, the coronavirus has become a political battleground. The new front is over face masks, which studies show dramatically reduce transmission. States that have mandated wearing masks in public saw the number of new cases decline by a quarter between the first and third weeks of June; states that do not require masks in any setting saw the number of cases rise by 84 percent over that same span.

“From a public health perspective, it’s demoralizing, it’s tragic … because our public health leaders know what to do to get this under control, but we’re in a situation where the CDC is not out front in a leadership role. We’re not hearing from them every day. They’re not explaining and capturing people’s hearts and minds,” said Besser, the former CDC chief. “If we have a vaccine, that will be terrific if it’s safe and effective. But until that point, these are the only tools we have, these tools of public health, and they’re very crude tools.”

 

 

 

 

 

Coronavirus Cases may be 10x higher than official count says CDC

https://www.axios.com/newsletters/axios-vitals-59e9ac1a-ab86-4f8a-917a-8c9d52f5835f.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

NC coronavirus update June 25: North Carolina's mask mandate goes ...

The real number of U.S. coronavirus cases could be as high as 23 million — 10 times the 2.3 million currently confirmed cases — the Centers for Disease Control and Prevention told reporters yesterday, Axios’ Marisa Fernandez reports.

Between the lines: The new estimate is based on antibody testing, which indicates whether someone has previously been infected by the virus regardless of whether they had symptoms.

  • “This virus causes so much asymptomatic infection. The traditional approach of looking for symptomatic illness and diagnosing it obviously underestimates the total amount of infections,” CDC director Robert Redfield said.

The agency also expanded its warnings of which demographic groups are at risk, which now include younger people who are obese and who have underlying health problems.

  • The shift reflects what states and hospitals have been seeing since the pandemic began, which is that young people can get seriously ill from COVID-19.

The new guidance also categorizes medical conditions that can affect the severity of illness:

  • Conditions that increase risk: Chronic kidney disease; chronic obstructive pulmonary disease; obesity; weakened immune system from solid organ transplant; serious heart conditions, such as heart failure, coronary artery disease or cardiomyopathies; sickle cell disease; Type 2 diabetes.
  • Conditions that may increase risk: Chronic lung diseases, including moderate to severe asthma and cystic fibrosis; high blood pressure; a weakened immune system; neurologic conditions, such as dementia or history of stroke; liver disease; pregnancy.

 

 

 

 

The U.S. divide on coronavirus masks

https://www.axios.com/political-divide-coronavirus-masks-1053d5bd-deb3-4cf4-9570-0ba492134f3e.html

Politics, not public health, drive Americans' attitudes toward ...

Mask-wearing has become the latest partisan division in an increasingly politically divided pandemic.

Why it matters: It’s becoming increasingly clear that wearing even a basic cloth mask is one of the most effective ways to prevent the spread of COVID-19. But whether or not people are willing to wear one has less to do with the risk of the pandemic than their political affiliation.

By the numbers: Results from months of the Axios-Ipsos coronavirus polls show a clear and growing political divide between Democrats and Republicans on mask-wearing habits.

  • Nationally, the percentage of Democrats who reported wearing a mask all the time when leaving home rose from 49% between April 10 and May 4 to 65% between May 8 and June 22.
  • During the same time period, the percentage of Republicans who reported constant mask-wearing rose from 29% to just 35%.

Context: The political divide Americans are reporting on mask use echoes one seen within nearly all levels of the government.

  • President Trump has not been seen to wear a mask, and he told Axios last week that attendees at his Tulsa campaign event on June 20 should “do what they want” on masks, which were not required at the rally.
  • Governors in many red states like Nebraska have refused to mandate facial masks in public, even as cases have begun to rise in recent weeks. At the same time, leaders in blue states — especially those that grappled with large outbreaks of COVID-19 — have urged residents to wear masks, with California Gov. Gavin Newsom mandating their use last week as cases in the state passed 4,000 a day.
  • The situation is even more divided at the local level, with leaders of red towns in blue states pushing back against mask mandates, and vice versa.

Flashback: Some of the blame for the divide can be traced back to muddled public health messaging on mask use in the early stages of the pandemic, when Americans were urged not to go out and buy masks in bulk because of concerns that there wasn’t enough personal protective equipment for front-line health care workers.

  • Those fears were real, as government virus expert Anthony Fauci pointed out in congressional testimony on Tuesday. And public health officials worried that pushing masks would inadvertently encourage Americans to continue going out in public at a moment when lockdowns demanded they stay inside.
  • Like the divide among experts on whether mass protests would increase coronavirus cases, just the perception that health advice might be based on politics rather than science gives cover to those who would forego masks, especially since the outbreak itself initially seemed like a blue state problem.

Health experts now know that cloth masks are most effective not so much at protecting individuals from infection as protecting the community from infected individuals. But that makes masks as much about social signaling as they are about public health.

  • Conservatives who prize individual autonomy over social responsibility experience “a massive pushback of psychological resistance” when presented with mask mandates, says Steven Taylor, the author of “The Psychology of Pandemics.”
  • That reaction is reinforced “if leaders like Trump downplay the significance of COVID-19 or if they won’t wear masks,” says Taylor. As a result, wearing a mask in conservative communities means visibly going against public opinion, while the opposite is true in communities where mask use is common.
  • The Axios-Ipsos data reflects this reality, showing that while Republicans in blue states use masks less than Democrats, they wear them at higher rates than Republicans in red states, just as Democrats in red states use masks at lower rates than Democrats in blue states.

What to watch: The one factor that seems capable of breaking the political deadlock is the outbreak itself. As cases have skyrocketed in red states like Arizona recently, there’s been a significant increase in Google searches for masks.

 

 

 

 

Cartoon – Flattening the I.Q. Curve

Editorial cartoons

Trump says Covid-19 is ‘dying out.’ Experts fear his dismissiveness could prolong the crisis

Trump says Covid-19 is ‘dying out.’ Experts fear his dismissiveness could prolong the crisis

The Trump Administration Paid Millions for Test Tubes — and Got ...

The White House is taking a new position on the coronavirus pandemic: a daily count of 750 deaths is a testament to the federal government’s successful pandemic response.

On Wednesday, when U.S. health officials reported nearly 27,000 new Covid-19 cases, President Trump said in a television interview that the virus was “dying out.” He brushed off concerns about an upcoming rally in Tulsa, Okla., because the number of cases there is “very miniscule,” despite the state’s surging infection rate. In a Wall Street Journal interview Wednesday, Trump argued coronavirus testing was “overrated” because it reveals large numbers of new Covid-19 cases, which in turn “makes us look bad,” and suggested that some Americans who wear masks do so not only to guard against the virus, but perhaps to display their anti-Trump animus.

But a range of public health experts told STAT that this messaging not only diverts attention from a pandemic that has already caused 120,000 U.S. deaths, but has more practical implications: It could make it difficult for local governments to enlist the public in the mitigation measures necessary to reduce the continued spread of the virus.

“The science behind how people process public warnings in a crisis supports this: You have to have people speaking with one voice,” said Monica Schoch-Spana, a medical anthropologist at the Johns Hopkins Center for Health Security. “You need a chorus.”

Conflicting directives can make it more difficult for recommendations coming from state and local leaders to have an impact, said Sara Bleich, a professor of public health policy at Harvard’s T.H. Chan School of Public Health.

“It sends a mixed message, which is confusing, particularly because while many people will get infected, most will not get severely sick, so it’s easy to say this won’t happen to me,” she said. “And it’s that sort of attitude that will keep us in this situation for a very long time.”

While the president has for weeks, if not months, underplayed the pandemic, his sharp and repeated remarks this week represent a remarkable attempt from the leader of American government to effectively declare the U.S. Covid-19 epidemic over.

The president’s rhetoric comes at a time that his coronavirus task force, which once conducted daily briefings, has not addressed the public since May. The president’s resumption of campaign rallies flouts federal guidance that encourages mask use (Trump’s campaign will hand out masks and hand sanitizer at the rally, but has not said it will require attendees to use them) and discourages large indoor gatherings. And the president has repeatedly claimed, misleadingly, that persistently high U.S. case totals are simply the result of increased testing.

Health experts say that political leaders preaching caution and modeling proper behavior — such as wearing a mask and demonstrating proper hand hygiene — can send a powerful signal to people that these steps can not only protect them, but their communities. They say that, essentially, national and state leaders need to walk the walk in a situation when individual behavior, like staying home when sick and cooperating with contact tracing, can make a large impact in curbing contagion.

Trump’s counterproductive behavior, Schoch-Spana said, extends far beyond the consistently dismissive tone he has taken toward the health risks of Covid-19. With few exceptions, the president has refused to wear a mask in public, and has insisted on continuing in-person briefings and White House events that effectively defy federal health guidance about gathering indoors in large groups.

“It’s not just words, it’s actions,” she said. “So when you have the nation’s top executive refusing to wear a mask, holding meetings where people are shoulder to shoulder, where he’s signing executive orders — that is also a form of communication.”

Experts also say continued federal commitments to combating the virus are crucial as the public grows tired of abatement measures. Instead, Trump has only elevated his monthslong campaign of downplaying the virus.

And Vice President Mike Pence, in a Wall Street Journal op-ed, framed the declines in cases and deaths since April as “testament to the leadership of President Trump” — even as hundreds of Americans are still dying every day and cases are not dropping further.

Rep. Donna Shalala (D-Fla.), who served as health secretary during the Clinton administration, said she hoped Americans would listen to public health guidance from local officials, not Trump and Pence.

“The president of the United States is dangerous to the health of the people of my district, because he’s giving out misinformation and false hope,” she said. “For those that believe him, they’re putting themselves and their families at risk.”

Public health experts have raised a number of issues with the administration’s messaging.

For one, a plateau of cases and deaths should not be celebrated, they say. While some countries in Europe and Asia have not only flattened their curve but driven them down, that hasn’t happened in the United States. Daily cases and deaths dipped from the peak in April, but have averaged about 20,000 and 800, respectively, for weeks.

Beyond those numbers representing real people getting sick and dying, there are other problems with sustained high levels of spread. The more cases there are, the more difficult it is for the surveillance system, including contact tracing, to keep up. It’s also more likely that some of the cases will spiral into explosive spread; 20,000 cases can turn into 40,000 a lot faster than one case can turn into 20,000.

Plus, a failure to suppress spread now could lead to more prolonged disruptions to daily life. If transmission rates come fall are still what they are now in certain communities, that makes it harder to reopen schools, for example.

Experts also point to evidence suggesting that the daily case and death numbers won’t stay flat for long. While new cases in the Northeast and Midwest are declining, a number of states in the West and South — Arizona, Texas, Florida, California, and Oregon among them — have reported record number of new cases this week. What worries public health officials is that, without measures to stem those increases, those outbreaks could keep growing. Those thousands of new cases also signal that, in a week or two, some portion of those people will show up in the hospital, and, about a week after that, a number of them will be dead, even as clinicians have learned more about treating severe Covid-19.

Some states in the South and West are already reporting record hospitalizations from Covid-19.

The White House’s shrug has been echoed by some governors, who insist, like Pence and Trump, that increased testing explains away the rise in cases. That is certainly one reason; testing has become more widespread, so states are capturing a more accurate reading of their true case burden.

But experts say increased testing can only account for some of the data states are reporting. Other metrics — including rising hospitalizations, filling ICUs, and the increasing rate of tests that are positive for the virus — signal broader spread.

Until Wednesday, leaders of Texas and Arizona also bristled at efforts from city and county officials to institute mask requirements, but acceded to growing pressure even as they have not ordered statewide mandates.

Cameron Wolfe, an infectious disease expert at Duke University, said he was seeing a growing “fatigue” among the public to keep up with precautionary steps like physical distancing and mask wearing. People letting down their guard was coinciding with an increase of cases in states, including North Carolina.

He said medical experts and health workers needed to model proper behavior to show others that the coronavirus epidemic was still something that required action. But, he added, “that also comes from political leaders buying into this.”

Federal and state authorities, he said, need to be “taking this to heart. That has not yet happened. That needs to change if we’re going to get people to buy into this.”

 

 

 

 

Coronavirus drugmakers’ latest tactics: Science by press release

https://www.politico.com/news/2020/06/05/drugmakers-media-coronavirus-303895

Coronavirus drugmakers' latest tactics: Science by press release ...

Pharmaceutical companies are using the media to tout treatments that are still under review.

Vaccine maker Moderna attracted glowing headlines and bullish investors when it revealed that eight participants in a preliminary clinical trial of its coronavirus vaccine had developed antibodies to the virus. The company’s share price jumped nearly 20 percent that day as it released a massive stock offering.

But the full results of the 45-person safety study haven’t been published, even though Moderna began a second, larger trial in late May aimed at determining whether the vaccine works. Several vaccine researchers say the scant public information on the earlier safety study is hard to evaluate because it addresses less than 20 percent of participants.

Call it science by press release — a tactic that pharmaceutical companies are increasingly relying upon to set their experimental coronavirus drugs and vaccines apart in a crowded field, shape public opinion and court regulators. Public health experts say the approach could increase political pressure on federal health officials to green-light drugs and vaccines before it is clear they are safe or effective, with potentially dangerous consequences.

“There’s a long history of pharmaceutical manufacturers putting out self-serving press releases related to clinical trial data that they’re developing that present an overly rosy picture of the data, usually with a boilerplate disclaimer at the end, which is fairly useless,” said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug regulation and pricing.

There are already signs of hype and political pressure influencing the U.S.’ coronavirus response. The Food and Drug Administration authorized emergency use of the malaria drug hydroxychloroquine in March without any proof that it was safe or effective for coronavirus patients — but with the backing of President Donald Trump, who had begun touting the treatment during daily White House briefings.

Subsequent studies have found that hydroxychloroquine doesn’t help those with Covid-19 and can cause potentially fatal side effects. And a top government scientist, Rick Bright, filed a whistleblower complaint in May alleging that he was ousted from his job leading the Biomedical Advanced Research Authority after he resisted political pressure to greenlight widespread use of the drug.

“The FDA has remained an unwavering, science-based voice helping to guide the all-of-government response,” agency Commissioner Stephen Hahn said in a statement. “I have never felt any pressure to make decisions, other than the urgency of the situation around COVID-19.”

But observers aren’t so sure. “From the outside looking in, there seems to be more political pressure than ever,” said Marc Scheineson, a former associate commissioner at the FDA and head of the FDA group at Alston & Bird. “The example in the White House is trickling down and there is a lot of pressure on the FDA … to color information on the optimistic side for political purposes and that is a hugely disturbing trend.”

A spokesperson for Moderna, which has received nearly a half billion dollars from the U.S. government and praise from Trump, said the company previewed its vaccine trial results by press release because it was concerned that the data might leak. The National Institutes of Health’s top infectious disease expert, Anthony Fauci, had hinted at the results in an interview with National Geographic, and data from a trial of the experimental drug remdesivir had leaked in April.

“You had this data moving widely around NIH and the remdesivir leak was also in our minds,” the Moderna spokesperson said.

But Peter Bach, director of Memorial Sloan-Kettering’s Center for Health Policy and Outcomes, said Moderna’s effort to preview its findings in the press “could be construed as an effort to make sure they are part of the conversation — and it worked on that front.”

Other groups have also previewed their hotly anticipated vaccine studies in the press. In late April, The New York Times revealed that six monkeys given a vaccine developed by researchers at the U.K.’s University of Oxford had stayed healthy for 28 days despite sustained exposure to the coronavirus. The article quoted Vincent Munster, a researcher at the NIH’s Rocky Mountain Laboratory, which conducted the monkey study at the British scientists’ behest.

The Oxford researchers, who signed a deal with AstraZeneca two days later to develop the experimental vaccine, did not publish a formal scientific analysis of the monkey data until mid-May. The study revealed that the noses of vaccinated monkeys and unvaccinated monkeys contained similar levels of coronavirus particles, suggesting that the vaccinated animals could still spread the disease — and the vaccine might not be as effective as the earlier data had hinted.

AstraZeneca has since inked a $1.2 billion deal with the U.S. government to provide 300 million vaccine doses, and a £65.5 million ($80 million) agreement with the U.K. government to supply 30 million doses.

Liz Derow, a spokesperson for Oxford’s Jenner Institute, where the vaccine researchers are based, said they did not give the monkey data to The New York Times. The NIH’s National Institute of Allergy and Infectious Disease, which operates the Rocky Mountain Laboratory, said it did not provide the data to the newspaper — but one of its researchers, Vincent Munster, spoke to a Times reporter about the monkey findings at the request of the Jenner Institute.

“I was really disturbed by not just Moderna, but the Oxford group as well, presenting a press release without data, without a scientific review, without knowing what the press release was based on,” said Barry Bloom, an immunologist at the Harvard School of Public Health. “And very positively enough to raise the stock price so two days later officials within the company sold their stock and made a whole lot of money, whether or not the vaccine works.”

Four of the pharmaceutical firm’s top executives together saw gains of $29 million from prescheduled sales of shares in the company in the two days following the vaccine announcement. The company has not yet responded to a request for comment on the stock sales.

Neither the Oxford nor Moderna vaccines are available to the public. But some drugs whose safety and efficacy are now being studied have already been repurposed or authorized for emergency use during the pandemic. The rush to release snippets of information on drug trials to the press ahead of full results has left some doctors wondering how to best treat their patients.

After leaked data from a trial of Gilead’s experimental antiviral remdesivir suggested the drug might be the first shown to help coronavirus patients, the company put out a press release in late April teasing results from a larger, government-run study. Hours later, Fauci revealed some findings of the study during an Oval Office press spray.

But the full analysis of the NIAID trial results was not published until three weeks later. Until that point, frontline physicians had no way to know that patients on ventilators did not benefit from remdesivir treatment — meaning that doctors may have inadvertently wasted some of the United States’ limited stock of the drug.

This lack of understanding on how to use remdesivir was evident in a recent survey more than 250 hospitals by the American Society of Health-System Pharmacists, which found that just 15 percent planned to use their remdesivir doses as described in the FDA’s emergency authorization for the drug.

Andre Kalil, an infectious disease doctor at the University of Nebraska Medical Center who led the NIAID trial, told POLITICO that physicians could have patterned their use of remdesivir on the dosages given during the trial.

Others say doctors using experimental treatments should have as much information as possible.

“If we want doctors to make rational medical decisions based on data, then before an authorized product reaches patients, the data should be available to review in some way, not just a press release,” said Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing.

Kesselheim, too, said that clinical trial data should be made public alongside any emergency authorizations to give physicians “the maximum amount of help they need in figuring out how to prescribe the drug.”

Gilead did not respond to a request for comment. But NIAID said that the urgency of the coronavirus prompted Fauci to share initial results before a full analysis was ready for publication.

Ivan Oransky, a professor of medical journalism at New York University and co-founder of the blog Retraction Watch, which monitors errors and misconduct in scientific research, told POLITICO he fears that the temptation to conduct science by press release will get “worse before it gets better.”

The world is growing more desperate for drugs and vaccines that could bring the coronavirus to heel. And many members of the public and politicians are treating every scrap of scientific information about the pandemic equally, he said — whether data comes from a peer-reviewed study or a company press release.

“There have been mechanisms to review science critically that, given the speed of Covid, have gone out the window,” said Bloom.

And interpreting results of clinical trial data can be difficult under the best of circumstances — especially when that data concerns a virus that was unknown to science until December of last year. When to end a trial and which conclusions to highlight are in many cases a matter of discretion, said Scheineson.

“It’s an art, not a science, in that respect,” he said. “I, for one, will not be the first in line to the new Moderna vaccine.”

 

 

 

 

Cartoon – Sheep at a Crossroads

Florida needs an executive order requiring wearing of face masks

FDA ends emergency use authorization for hydroxychloroquine

https://www.axios.com/hydroxychloroquine-fda-ends-emergency-use-authorization-f5353a2c-115a-4a57-b8e2-360b735b4937.html?stream=health-care&utm_source=alert&utm_medium=email&utm_campaign=alerts_healthcare

FDA withdraws emergency use authorization for hydroxychloroquine ...

The FDA ended Monday its emergency use authorizations for two controversial drugs, hydroxychloroquine and chloroquine, as a potential coronavirus treatment.

Why it matters: Despite gaining President Trump’s adamant support and use, the drugs have failed in several clinical trials and have been found to possibly cause serious heart problems.

What they’re saying: The FDA said it believes the drugs “are unlikely to be effective in treating COVID-19” under the emergency use authorization.

  • It also said that “in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of [the drugs] no longer outweigh the known and potential risks for the authorized use.”

Read the letter and memo regarding the revocation: