FDA chief apologizes for overstating plasma effect on virus

https://abcnews.go.com/Health/wireStory/fda-commissioner-overstated-effects-virus-therapy-72595122?fbclid=IwAR3Um3rVuom9rJNCOvccmmTBDOrrRePEu1BX1VgRvAzYbpL2NATGjY2-1IY

FDA chief apologizes for overstating plasma effect on virus

Food and Drug Administration Commissioner Stephen Hahn is apologizing for overstating the life-saving benefits of using convalescent plasma to treat COVID-19 patients.

Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma.

Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trump’s announcement on Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in disease-fighting antibodies.

Trump hailed the decision as a historic breakthrough even though the treatment’s value has not been established. The announcement on the eve of Trump’s Republican National Convention raised suspicions that it was politically motivated to offset critics of the president’s handling of the pandemic.

Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim vastly overstated preliminary findings of Mayo Clinic observations.

Hahn’s mea culpa comes at a critical moment for the FDA which, under intense pressure from the White House, is responsible for deciding whether upcoming vaccines are safe and effective in preventing COVID-19.

The 35% figure drew condemnation from other scientists and some former FDA officials, who called on Hahn to correct the record.

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” Hahn tweeted.

The FDA made the decision based on data the Mayo Clinic collected from hospitals around the country that were using plasma on patients in wildly varying ways — and there was no comparison group of untreated patients, meaning no conclusions can be drawn about overall survival. People who received plasma with the highest levels of antibodies fared better than those given plasma with fewer antibodies, and those treated sooner after diagnosis fared better than those treated later.

Hahn and other Trump administration officials presented the difference as an absolute survival benefit, rather than a relative difference between two treatment groups. Former FDA officials said the misstatement was inexcusable, particularly for a cancer specialist like Hahn.

“It’s extraordinary to me that a person involved in clinical trials could make that mistake,” said Dr. Peter Lurie, a former FDA official under the Obama administration who now leads the nonprofit Center for Science in the Public Interest. “It’s mind-boggling.”

The 35% benefit was repeated by Health and Human Services Secretary Alex Azar at Sunday’s briefing and promoted on Twitter by the FDA’s communication staff. The number did not appear in FDA’s official letter justifying the emergency authorization.

Hahn has been working to bolster confidence in the agency’s scientific process, stating in interviews and articles that the FDA will only approve a vaccine that meets preset standards for safety and efficacy.

Lawrence Gostin of Georgetown University said Hahn’s performance Sunday undermined those efforts.

“I think the integrity of the FDA took a hit, if I were Stephen Hahn I would not have appeared at such a political show,” said Gostin, a public health attorney.

Hahn pushed back Tuesday morning against suggestions that the plasma announcement was timed to boost Trump ahead of the Republican convention.

“The professionals and the scientists at FDA independently made this decision, and I completely support them,” Hahn said, appearing on “CBS This Morning.”

Trump has recently accused some FDA staff, without evidence, of deliberately holding up new treatments “for political reasons.” And Trump’s chief of staff, Mark Meadows, said over the weekend that FDA scientists “need to feel the heat.”

The administration has sunk vast resources into the race for a vaccine, and Trump aides have been hoping that swift progress could help the president ahead of November’s election.

At Sunday’s briefing Hahn did not correct Trump’s description of the regulatory move as a “breakthrough.” He also did not contradict Trump’s unsupported claim of a “deep state” effort at the agency working to slow down approvals.

Former FDA officials said the political pressure and attacks against the FDA carry enormous risk of undermining trust in the agency just when it’s needed most. A vaccine will only be effective against the virus if it is widely taken by the U.S. population.

“I think the constant pressure, the name-calling, the perception that decisions are made under pressure is damaging,” said Dr. Jesse Goodman of Georgetown University, who previously served as FDA’s chief scientist. “We need the American people to have full confidence that medicines and vaccines are safe.”

Convalescent plasma is a century-old approach to treating the flu, measles and other viruses. But the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.

The FDA emergency authorization is expected to increase its availability to additional hospitals. But more than 70,000 Americans have already received the therapy under FDA’s “expanded access” program. That program tracks patients’ response, but cannot prove whether the plasma played a role in their recovery.

Some scientists worry the broadened FDA access to the treatment will make it harder to complete studies of whether the treatment actually works. Those studies require randomizing patients to either receive plasma or a dummy infusion.

 

 

 

Fauci: ‘I seriously doubt’ Russia’s coronavirus vaccine is safe and effective

https://thehill.com/policy/healthcare/511615-fauci-seriously-doubt-russias-coronavirus-vaccine-is-safe-and-effective?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-08-12%20Healthcare%20Dive%20%5Bissue:29035%5D&utm_term=Healthcare%20Dive

The White House has pushed Fauci into a little box on the side

Anthony Fauci, the nation’s top infectious diseases expert, said Tuesday that he has serious doubts about Russia’s announcement that it has a vaccine ready to be used for the novel coronavirus.

“Having a vaccine and proving that a vaccine is safe and effective are two different things,” Fauci said during a panel discussion with National Geographic.

The comments came just hours after Russian President Vladimir Putin said that the country had become the first in the world to gain regulatory approval for a COVID-19 vaccine.

Putin said that the vaccine went through clinical testing and that it had proven to offer immunity to the deadly disease, which has infected more than 20 million people worldwide, according to a Johns Hopkins University database.

However, phase three trials for the drug have reportedly not been completed, triggering skepticism from international health experts about its usefulness. 

Fauci, the director of the National Institute of Allergy and Infectious Diseases and a key member of the White House coronavirus task force, said that he had seen no evidence supporting Putin’s position. 

“I hope that the Russians have actually, definitively proven that the vaccine is safe and effective. I seriously doubt that they’ve done that,” he said, adding that Americans need to understand that the process for gaining vaccine approval requires safety and efficacy. 

More than 100 possible vaccines are being developed around the world as part of efforts to offer immunity protection for the coronavirus. Moderna, in collaboration with the National Institutes of Health, launched a phase three trial for a vaccine in July, making it the first U.S. candidate to reach that stage.

Fauci has said that he’s “cautiously optimistic” that a COVID-19 vaccine will be ready by the end of the year. He told a House committee on July 31 that he was encouraged by everything he’s seen in the early data but that “there’s never a guarantee that you’re going to get a safe and effective vaccine.”

The World Health Organization said Tuesday that it was monitoring Russia’s progress in developing a COVID-19 vaccine. Progress in combating the virus “should not compromise safety,” the health agency said.

Former Food and Drug Administration Commissioner Scott Gottlieb echoed Fauci’s skepticism earlier Tuesday, noting in a tweet that Russia has been behind disinformation campaigns related to the pandemic. 

“Today’s news that they ‘approved’ a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines,” he said.

Russia is reportedly planning to offer its COVID-19 vaccine to medical personnel as soon as this month. It will be made available to the general public in October, according to Reuters

 

 

 

Dr. Anthony Fauci says chance of coronavirus vaccine being highly effective is ‘not great’

https://www.cnbc.com/amp/2020/08/07/coronavirus-vaccine-dr-fauci-says-chances-of-it-being-highly-effective-is-not-great.html?utm_source=&utm_medium=email&utm_campaign=32192

KEY POINTS
  • White House coronavirus advisor Dr. Anthony Fauci that the chances of scientists creating a highly effective vaccine — one that provides 98% or more guaranteed protection — for the virus are slim.
  • Scientists are hoping for a coronavirus vaccine that is at least 75% effective, but 50% or 60% effective would be acceptable, too, he said.
  • The FDA has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective.

White House coronavirus advisor Dr. Anthony Fauci said Friday that the chances of scientists creating a highly effective vaccine — one that provides 98% or more guaranteed protection — for the virus are slim.

Scientists are hoping for a coronavirus vaccine that is at least 75% effective, but 50% or 60% effective would be acceptable, too, Fauci, director of the National Institute of Allergy and Infectious Diseases, said during a Q&A with the Brown University School of Public Health. “The chances of it being 98% effective is not great, which means you must never abandon the public health approach.”

“You’ve got to think of the vaccine as a tool to be able to get the pandemic to no longer be a pandemic, but to be something that’s well controlled,” he said.

The Food and Drug Administration has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective. Dr. Stephen Hahn, the FDA’s commissioner, said last month that the vaccine or vaccines that end up getting authorized will prove to be more than 50% effective, but it’s possible the U.S. could end up with a vaccine that, on average, reduces a person’s risk of a Covid-19 infection by just 50%.

“We really felt strongly that that had to be the floor,” Hahn said on July 30, adding that it’s “been batted around among medical groups.”

“But for the most part, I think, infectious disease experts have agreed that that’s a reasonable floor, of course hoping that the actual effectiveness will be higher.”

A 50% effective vaccine would be roughly on par with those for influenza, but below the effectiveness of one dose of a measles vaccination, which is about 93% effective, according to the Centers for Disease Control and Prevention.

Public health officials and scientists expect to know whether at least one of the numerous potential Covid-19 vaccines in development worldwide is safe and effective by the end of December or early next year, though there is never a guarantee. Drug companies Pfizer and Moderna both began late-stage trials for their potential vaccines last week and both expect to enroll about 30,000 participants.

Fauci has previously said he worries about the “durability” of a coronavirus vaccine, saying if Covid-19 acts like other coronaviruses, it may not provide long-term protection.

Health officials say there is no returning to “normal” until there is a vaccine. Fauci’s comment came a day after the World Health Organization cautioned about the development of vaccines, reiterating that there may never be a “silver bullet” for the virus, which continues to rapidly spread worldwide. The phase three trials underway do not necessarily mean that a vaccine is almost ready to be deployed to the public, the agency said.

“Phase three doesn’t mean nearly there,” Mike Ryan, executive director of the WHO’s emergencies health program, said during a virtual panel discussion with “NBC Nightly News” Anchor Lester Holt hosted by the Aspen Security Forum. “Phase three means this is the first time this vaccine has been put into the general population into otherwise healthy individuals to see if the vaccine will protect them against natural infection.”

While there is hope scientists will find a safe and effective vaccine, there is never a guarantee, WHO Director-General Tedros Adhanom Ghebreyesus said.

“We cannot say we have vaccines. We may or may not,” he said.

On Friday, Fauci reiterated that he is “cautiously optimistic” scientists will find a safe and effective vaccine. He also reiterated that the coronavirus may never be eliminated, but world leaders can work together to bring the virus down to “low levels.”

Some of Fauci’s comments have been at odds with President Donald Trump, who has repeatedly said the virus would “disappear.”

Trump, who is seeking reelection, said Thursday that it’s possible the United States could have a safe and effective vaccine for the coronavirus before the upcoming presidential election on Nov. 3.

 

 

 

 

 

2005 chloroquine study had nothing to do with COVID-19 and the drug wasn’t given to humans

https://www.politifact.com/factchecks/2020/jul/29/facebook-posts/2005-chloroquine-study-had-nothing-do-covid-19-and/?fbclid=IwAR2e4j_lb10FWa5Cyuokzo3pbjlty_ffvwsEfVT_2iQ6ki8a9z-TpzDm9DQ

PolitiFact | 2005 chloroquine study had nothing to do with COVID ...

IF YOUR TIME IS SHORT

  • The 2005 study wasn’t published by the NIH and didn’t prove chloroquine was effective against “COVID-1” because that’s not a real disease.
  • The study found that chloroquine could inhibit the spread of Severe Acute Respiratory Syndrome in animal cell culture, and the authors said more research was needed.
  • There are currently no approved medications or treatments for COVID-19.

 

Chloroquine is back.

The anti-malarial drug first showed up as a possible COVID-19 treatment around May 2020, when President Donald Trump said he had been taking its chemical cousin, hydroxychloroquine, to prevent getting infected with the virus.

Since then, some studies have found that the drugs could help alleviate symptoms associated with COVID-19, but the research is not conclusive. There are currently no FDA-approved medicines specifically for COVID-19. (Chloroquine is chemically similar to hydroxychloroquine, but it is a different drug that’s primarily used to treat malaria. Both carry a particular risk for people with heart problems, plus other possible side effects.)

Now, hydroxychloroquine and chloroquine have been thrust back into the spotlight as misinformation about the drugs’ effectiveness and safety recently reappeared online.

One such post on Facebook falsely claims that Americans have been deceived because health officials at the National Institutes of Health have known all along that chloroquine is effective against “COVID.”

The post reads:

“N.I.H. 15 years ago published a study on chloroquine. It is effective against COVID-(1). We are being lied to America!”

The post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Facebook.) 

 

This is flawed. 

First, there’s no such thing as “COVID-1.” COVID-19 was named for the year it was discovered, not because it’s the 19th iteration. 

Second, the 2005 study found that chloroquine was effective on primate cells infected with severe acute respiratory syndrome, known as SARS, which is caused by a coronavirus. But while the two share similarities, SARS-CoV and COVID-19 are different diseases, and primate cells are far from human patients.

Third, the study was indexed by the NIH’s National Library of Medicine, but the NIH was not involved. It was published in the peer-reviewed Virology Journal and conducted by researchers from the Centers for Disease Control and Prevention and the Montreal Clinical Research Institute.

 

What the study says

The study was published in August 2005 and found that chloroquine has “strong antiviral effects on SARS-CoV infection of primate cells” and that it was effective on cells treated with the drug before and after exposure to the virus.

The drug was not administered to actual SARS patients, and the study’s authors wrote that more research was needed on how the drug interacts with SARS in animal test subjects.

“Cell culture testing of an antiviral drug against the virus is only the first step, of many steps, necessary to develop an antiviral drug,” Kate Fowlie, a spokesperson for the CDC previously told PolitiFact in an email. “It is important to realize that most antivirals that pass this cell culture test hurdle fail at later steps in the development process.”

Dr. Alex Greninger, assistant director of clinical virology at the University of Washington School of Medicine, told us that a problem in virology is trying to determine the difference of how drugs work in cell culture in comparison to humans.

“Data on chloroquine is largely taken from these cell culture studies, but we now have trials in people on hydroxychloroquine that show it’s not as effective,” Greninger said, “and there’s new data out in the last week that suggests that some of the reasons could be because of the cell types that SARS coronaviruses grow in, and this original experiment was done on African green monkey kidney cells, which is not the tissue we are really worried about.”

 

What officials say about the drugs now

The Food and Drug Administration granted emergency use authorizations for some medicines to be used for certain patients hospitalized with COVID-19, but it revoked the authorization for hydroxychloroquine and chloroquine in mid-June due to concerns over the drugs’ serious side effects. There are currently no FDA-approved medicines for COVID-19.

“It is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” FDA Chief Scientist Denise M. Hinton wrote.

The NIH’s COVID-19 treatment guidelines, which were developed to inform clinicians on how to care for patients with COVID-19, also currently recommend against the use of chloroquine or hydroxychloroquine for COVID-19 treatment, except in a clinical trial.

But even those trials have been halted. The World Health Organization and the NIH announced in mid-June that they would stop hydroxychloroquine patient trials, citing safety concerns that include serious heart rhythm problems, blood and lymph system disorders, kidney injuries, and liver problems and failure.

 

Our ruling

A Facebook post says that the NIH published a study 15 years ago that showed chloroquine was effective against “COVID-(1)” and that health officials have been lying to the American people.

This is wrong. There’s no such thing as “COVID-1” and the study cited was not published by the NIH and had to do with animal cells infected with SARS, not COVID-19. The drug was not given to human patients and the study’s authors said more research was needed.

Health officials caution against the use of chloroquine or hydroxychloroquine to treat COVID-19 patients, citing the possibility of serious side effects. There are currently no approved treatments for the virus.

We rate this False. 

 

 

 

 

Virus testing in the US is dropping, even as deaths mount

https://apnews.com/aebdc0978de958f20ab3f398cdf6f769

Virus testing in the US is dropping, even as deaths mount

U.S. testing for the coronavirus is dropping even as infections remain high and the death toll rises by more than 1,000 a day, a worrisome trend that officials attribute largely to Americans getting discouraged over having to wait hours to get a test and days or weeks to learn the results.

An Associated Press analysis found that the number of tests per day slid 3.6% over the past two weeks to 750,000, with the count falling in 22 states. That includes places like Alabama, Mississippi, Missouri and Iowa where the percentage of positive tests is high and continuing to climb, an indicator that the virus is still spreading uncontrolled.

Amid the crisis, some health experts are calling for the introduction of a different type of test that would yield results in a matter of minutes and would be cheap and simple enough for millions of Americans to test themselves — but would also be less accurate.

“There’s a sense of desperation that we need to do something else,” said Dr. Ashish Jha, director of Harvard’s Global Health Institute.

Widespread testing is considered essential to managing the outbreak as the U.S. approaches a mammoth 5 million confirmed infections and more than 157,000 deaths out of over 700,000 worldwide.

Testing demand is expected to surge again this fall, when schools reopen and flu season hits, most likely outstripping supplies and leading to new delays and bottlenecks.

Some of the decline in testing over the past few weeks was expected after backlogged commercial labs urged doctors to concentrate on their highest-risk patients. But some health and government officials are seeing growing public frustration and waning demand.

In Iowa, state officials are reporting less interest in testing, despite ample supplies. The state’s daily testing rate peaked in mid-July but has declined 20% in the last two weeks.

“We have the capacity. Iowans just need to test,” Gov. Kim Reynolds said last week.

Jessica Moore of rural Newberry, South Carolina, said that after a private lab lost her COVID-19 test results in mid-July, she had to get re-tested at a pop-up site organized by the state.

Moore and her husband arrived early on a Saturday morning at the site, a community center, where they waited for two hours for her test. Moore watched in the rear-view mirror as people drove up, saw the long line of cars, and then turned around and left.

“If people have something to do on a Saturday and they want to get tested, they’re not going to wait for two hours in the South Carolina heat for a test, especially if they’re not symptomatic,” Moore said.

Before traveling from Florida to Delaware last month, Laura DuBose Schumacher signed up to go to a drive-up testing site in Orlando with her husband. They were given a one-hour window in which to arrive.

They got there at the start of the window, but after 50 minutes it looked as if the wait would be another hour. Others who had gone through the line told them that they wouldn’t get their results until five days later, a Monday, at the earliest. They were planning to travel the next day, so they gave up.

“Monday would have been pointless, so we left the line,” Schumacher said.

The number of confirmed infections in the U.S. has topped 4.7 million, with new cases running at nearly 60,000 a day on average, down from more than 70,000 in the second half of July.

U.S. testing is built primarily on highly sensitive molecular tests that detect the genetic code of the coronavirus. Although the test is considered the gold standard for accuracy, experts increasingly say the country’s overburdened lab system is incapable of keeping pace with the outbreak and producing results within two or three days, the time frame crucial to isolating patients and containing the virus.

“They’re doing as good a job as they possibly can do, but the current system will not allow them to keep up with the demand,” said Mara Aspinall of Arizona State University’s College of Health Solutions.

Testing delays have led researchers at Harvard and elsewhere to propose a new approach using so-called antigen tests — rapid technology already used to screen for flu, strep throat and other common infections. Instead of detecting the virus itself, such tests look for viral proteins, or antigens, which are generally considered a less accurate measure of infection.

A number of companies are studying COVID-19 antigen tests in which you spit on a specially coated strip of paper, and if you are infected, it changes color. Experts say the speed and widespread availability of such tests would more than make up for their lower precision.

While no such tests for the coronavirus are on the U.S. market, experts say the technology is simple and the hurdles are more regulatory than technical. The Harvard researchers say production could quickly be scaled into the millions.

A proposal from the Harvard researchers calls for the federal government to distribute $1 saliva-based antigen tests to all Americans so that they can test themselves regularly, perhaps even daily.

Even with accuracy as low as 50%, researchers estimate the paper strip tests would uncover five times more COVID-19 cases than the current laboratory-based approach, which federal officials estimate catches just 1 in 10 infections.

But the approach faces resistance in Washington, where federal regulators have required at least 80% accuracy for new COVID-19 tests.

To date, the Food and Drug Administration has allowed only two COVID-19 antigen tests to enter the market. Those tests require a nasal swab supervised by a health professional and can only be run on specialized machines found at hospitals, doctor’s offices, nursing homes and clinics.

Also, because of the risk of false negatives, doctors may need to confirm a negative result with a genetic test when patients have possible symptoms of COVID-19.

On Tuesday, the governors of Maryland, Virginia, Louisiana and three other states announced an agreement with the Rockefeller Foundation to purchase more than 3 million of the FDA-cleared antigen tests, underscoring the growing interest in the technology.

When asked about introducing cheaper, paper-based tests, the government’s “testing czar,” Adm. Brett Giroir, warned that their accuracy could fall as low as 20% to 30%.

“I don’t think that would do a service to the American public of having something that is wrong seven out of 10 times,” Giroir said last week. “I think that could be catastrophic.”

___

This story has been corrected to show that Iowa’s daily testing rate has declined 20%, not 40%.

 

 

 

A Viral Epidemic Splintering into Deadly Pieces

Once again, the coronavirus is ascendant. As infections mount across the country, it is dawning on Americans that the epidemic is now unstoppable, and that no corner of the nation will be left untouched.

As of Wednesday, the pathogen had infected at least 4.3 million Americans, killing more than 150,000. Many experts fear the virus could kill 200,000 or even 300,000 by year’s end. Even President Trump has donned a mask, after resisting for months, and has canceled the Republican National Convention celebrations in Florida.

Each state, each city has its own crisis driven by its own risk factors: vacation crowds in one, bars reopened too soon in another, a revolt against masks in a third.

“We are in a worse place than we were in March,” when the virus coursed through New York, said Dr. Leana S. Wen, a former Baltimore health commissioner. “Back then we had one epicenter. Now we have lots.”

To assess where the country is heading now, The New York Times interviewed 20 public health experts — not just clinicians and epidemiologists, but also historians and sociologists, because the spread of the virus is now influenced as much by human behavior as it is by the pathogen itself.

Not only are American cities in the South and West facing deadly outbreaks like those that struck Northeastern cities in the spring, but rural areas are being hurt, too. In every region, people of color will continue to suffer disproportionately, experts said.

While there may be no appetite for a national lockdown, local restrictions must be tightened when required, the researchers said, and governors and mayors must have identical goals. Testing must become more targeted.

In most states, contact tracing is now moot — there are simply too many cases to track. And while progress has been made on vaccines, none is expected to arrive this winter in time to stave off what many fear will be a new wave of deaths.

Overall, the scientists conveyed a pervasive sense of sadness and exhaustion. Where once there was defianceand then a growing sense of dread, now there seems to be sorrow and frustration, a feeling that so many funerals never had to happen and that nothing is going well. The United States is a wounded giant, while much of Europe, which was hit first, is recovering and reopening — although not to us.

“We’re all incredibly depressed and in shock at how out of control the virus is in the U.S.,” said Dr. Michele Barry, the director of the Center for Innovation in Global Health at Stanford University.

With so much wealth and medical talent, they asked, how could we have done so poorly? How did we fare not just worse than autocratic China and isolated New Zealand, but also worse than tiny, much poorer nations like Vietnam and Rwanda?

“National hubris and belief in American exceptionalism have served us badly,” said Martha L. Lincoln, a medical anthropologist and historian at San Francisco State University. “We were not prepared to see the risk of failure.”

Since the coronavirus was first found to be the cause of lethal pneumonias in Wuhan, China, in late 2019, scientists have gained a better understanding of the enemy.

It is extremely transmissible, through not just coughed droplets but also a fine aerosol mist that is expelled when people talk loudly, laugh or sing and that can linger in indoor air. As a result, masks are far more effective than scientists once believed.

Virus carriers with mild or no symptoms can be infectious, and there may be 10 times as many people spreading the illness as have tested positive for it.

The infection may start in the lungs, but it is very different from influenza, a respiratory virus. In severely ill patients, the coronavirus may attach to receptors inside the veins and arteries, and move on to attack the kidneys, the heart, the gut and even the brain, choking off these organs with hundreds of tiny blood clots.

Most of the virus’s victims are elderly, but it has not spared young adults, especially those with obesity, high blood pressure or diabetes. Adults aged 18 to 49 now account for more hospitalized cases than people aged 50 to 64 or those 65 and older.

Children are usually not harmed by the virus, although clinicians were dismayed to discover a few who were struck by a rare but dangerous inflammatory versionYoung children appear to transmit the virus less often than teenagers, which may affect how schools can be opened.

Among adults, a very different picture has emerged. Growing evidence suggests that perhaps 10 percent of the infected account for 80 percent of new transmissions. Unpredictable superspreading events in nursing homes, meatpacking plants, churches, prisons and bars are major drivers of the epidemic.

Thus far, none of the medicines for which hopes were once high — repurposed malaria drugs, AIDS drugs and antivirals — have proved to be rapid cures. One antiviral, remdesivir, has been shown to shorten hospital stays, while a common steroid, dexamethasone, has helped save some severely ill patients.

One or even several vaccines may be available by year’s end, which would be a spectacular achievement. But by then the virus may have in its grip virtually every village and city on the globe.

Some experts, like Michael T. Osterholm, the director of the University of Minnesota’s Center for Infectious Disease Research and Policy, argue that only a nationwide lockdown can completely contain the virus now. Other researchers think that is politically impossible, but emphasize that localities must be free to act quickly and enforce strong measures with support from their state legislators.

Danielle Allen, the director of Harvard University’s Edmond J. Safra Center for Ethics, which has issued pandemic response plans, said that finding less than one case per 100,000 people means a community should continue testing, contact tracing and isolating cases — with financial support for those who need it.

Up to 25 cases per 100,000 requires greater restrictions, like closing bars and limiting gatherings. Above that number, authorities should issue stay-at-home orders, she said.

Testing must be focused, not just offered at convenient parking lots, experts said, and it should be most intense in institutions like nursing homes, prisons, factories or other places at risk of superspreading events.

Testing must be free in places where people are poor or uninsured, such as public housing projects, Native American reservations and churches and grocery stores in impoverished neighborhoods.

None of this will be possible unless the nation’s capacity for testing, a continuing disaster, is greatly expanded. By the end of summer, the administration hopes to start using “pooling,” in which tests are combined in batches to speed up the process.

But the method only works in communities with lower infection rates, where large numbers of pooled tests turn up relatively few positive results. It fails where the virus has spread everywhere, because too many batches turn up positive results that require retesting.

At the moment, the United States tests roughly 800,000 people per day, about 38 percent of the number some experts think is needed.

Above all, researchers said, mask use should be universal indoors — including airplanes, subway cars and every other enclosed space — and outdoors anywhere people are less than six feet apart.

Dr. Emily Landon, an infection control specialist at the University of Chicago Pritzker School of Medicine, said it was “sad that something as simple as a mask got politicized.”

“It’s not a statement, it’s a piece of clothing,” she added. “You get used to it the way you got used to wearing pants.”

Arguments that masks infringe on personal rights must be countered both by legal orders and by persuasion. “We need more credible messengers endorsing masks,” Dr. Wen said — just before the president himself became a messenger.

“They could include C.E.O.s or celebrities or religious leaders. Different people are influencers to different demographics.”

Although this feels like a new debate, it is actually an old one. Masks were common in some Western cities during the 1918 flu pandemic and mandatory in San Francisco. There was even a jingle: “Obey the laws, wear the gauze. Protect your jaws from septic paws.”

“A libertarian movement, the Anti-Mask League, emerged,” Dr. Lincoln of San Francisco State said. “There were fistfights with police officers over it.” Ultimately, city officials “waffled” and compliance faded.

“I wonder what this issue would be like today,” she mused, “if that hadn’t happened.”

Images of Americans disregarding social distancing requirements have become a daily news staple. But the pictures are deceptive: Americans are more accepting of social distancing than the media sometimes portrays, said Beth Redbird, a Northwestern University sociologist who since March has conducted regular surveys of 8,000 adults about the impact of the virus.

“About 70 percent of Americans report using all forms of it,” she said. “And when we give them adjective choices, they describe people who won’t distance as mean, selfish or unintelligent, not as generous, open-minded or patriotic.”

The key predictor, she said in early July, was whether or not the poll respondent trusted Mr. Trump. Those who trusted him were less likely to practice social distancing. That was true of Republicans and independents, “and there’s no such thing as a Democrat who trusts Donald Trump,” she added.

Whether or not people support coercive measures like stay-at-home orders or bar closures depended on how scared the respondent was.

“When rising case numbers make people more afraid, they have more taste for liberty-constraining actions,” Dr. Redbird said. And no economic recovery will occur, she added, “until people aren’t afraid. If they are, they won’t go out and spend money even if they’re allowed to.”

As of Wednesday, new infections were rising in 33 states, and in Puerto Rico and the District of Columbia, according to a database maintained by The Times.

Weeks ago, experts like Dr. Anthony S. Fauci, the director of the National Institute for Allergy and Infectious Diseases, were advising states where the virus was surging to pull back from reopening by closing down bars, forbidding large gatherings and requiring mask usage.

Many of those states are finally taking that advice, but it is not yet clear whether this national change of heart has happened in time to stop the newest wave of deaths from ultimately exceeding the 2,750-a-day peak of mid-April. Now, the daily average is 1,106 virus deaths nationwide.

Deaths may surge even higher, experts warned, when cold weather, rain and snow force Americans to meet indoors, eat indoors and crowd into public transit.

Oddly, states that are now hard-hit might become safer, some experts suggested. In the South and Southwest, summers are so hot that diners seek air-conditioning indoors, but eating outdoors in December can be pleasant.

Several studies have confirmed transmission in air-conditioned rooms. In one well-known case cluster in a restaurant in Guangzhou, China, researchers concluded that air-conditioners blew around a viral cloud, infecting patrons as far as 10 feet from a sick diner.

Rural areas face another risk. Almost 80 percent of the country’s counties lack even one infectious disease specialist, according to a study led by Dr. Rochelle Walensky, the chief of infectious diseases at Massachusetts General Hospital in Boston.

At the moment, the crisis is most acute in Southern and Southwestern states. But websites that track transmission rates show that hot spots can turn up anywhere. For three weeks, for example, Alaska’s small outbreak has been one of the country’s fastest-spreading, while transmission in Texas and Arizona has dramatically slowed.

Deaths now may rise more slowly than they did in spring, because hospitalized patients are, on average, younger this time. But overwhelmed hospitals can lead to excess deaths from many causes all over a community, as ambulances are delayed and people having health crises avoid hospitals out of fear.

The experts were divided as to what role influenza will play in the fall. A harsh flu season could flood hospitals with pneumonia patients needing ventilators. But some said the flu season could be mild or almost nonexistent this year.

Normally, the flu virus migrates from the Northern Hemisphere to the Southern Hemisphere in the spring — presumably in air travelers — and then returns in the fall, with new mutations that may make it a poor match for the annual vaccine.

But this year, the national lockdown abruptly ended flu transmission in late April, according to weekly Fluview reports from the Centers for Disease Control and Prevention. International air travel has been sharply curtailed, and there has been almost no flu activity in the whole southern hemisphere this year.

Assuming there is still little air travel to the United States this fall, there may be little “reseeding” of the flu virus here. But in case that prediction turns out be wrong, all the researchers advised getting flu shots anyway.

“There’s no reason to be caught unprepared for two respiratory viruses,” said Tara C. Smith, an epidemiologist at Kent State University’s School of Public Health.

Experts familiar with vaccine and drug manufacturing were disappointed that, thus far, only dexamethasone and remdesivir have proved to be effective treatments, and then only partially.

Most felt that monoclonal antibodies — cloned human proteins that can be grown in cell culture — represented the best hope until vaccines arrive. Regeneron, Eli Lilly and other drugmakers are working on candidates.

“They’re promising both for treatment and for prophylaxis, and there are companies with track records and manufacturing platforms,” said Dr. Luciana Borio, a former director of medical and biodefense preparedness at the National Security Council. “But manufacturing capacity is limited.”

According to a database compiled by The Times, researchers worldwide are developing more than 165 vaccine candidates, and 27 are in human trials.

New announcements are pouring in, and the pressure to hurry is intense: The Trump administration just awarded nearly $2 billion to a Pfizer-led consortium that promised 100 million doses by December, assuming trials succeed.

Because the virus is still spreading rapidly, most experts said “challenge trials,” in which a small number of volunteers are vaccinated and then deliberately infected, would probably not be needed.

Absent a known cure, “challenges” can be ethically fraught, and some doctors oppose doing them for this virus. “They don’t tell you anything about safety,” Dr. Borio said.

And when a virus is circulating unchecked, a typical placebo-controlled trial with up to 30,000 participants can be done efficiently, she added. Moderna and Pfizer have already begun such trials.

The Food and Drug Administration has said a vaccine will pass muster even if it is only 50 percent effective. Experts said they could accept that, at least initially, because the first vaccine approved could save lives while testing continued on better alternatives.

“A vaccine doesn’t have to work perfectly to be useful,” Dr. Walensky said. “Even with measles vaccine, you can sometimes still get measles — but it’s mild, and you aren’t infectious.”

“We don’t know if a vaccine will work in older folks. We don’t know exactly what level of herd immunity we’ll need to stop the epidemic. But anything safe and fairly effective should help.”

Still, haste is risky, experts warned, especially when opponents of vaccines are spreading fear. If a vaccine is rushed to market without thorough safety testing and recipients are hurt by it, all vaccines could be set back for years.

No matter what state the virus reaches, one risk remains constant. Even in states with few Black and Hispanic residents, they are usually hit hardest, experts said.

People of color are more likely to have jobs that require physical presence and sometimes close contact, such as construction work, store clerking and nursing. They are more likely to rely on public transit and to live in neighborhoods where grocery stores are scarce and crowded.

They are more likely to live in crowded housing and multigenerational homes, some with only one bathroom, making safe home isolation impossible when sickness strikes. They have higher rates of obesity, high blood pressure, diabetes and asthma.

Federal data gathered through May 28 shows that Black and Hispanic Americans were three times as likely to get infected as their white neighbors, and twice as likely to die, even if they lived in remote rural counties with few Black or Hispanic residents.

“By the time that minority patient sets foot in a hospital, he is already on an unequal footing,” said Elaine Hernandez, a sociologist at Indiana University.

The differences persist even though Black and Hispanic adults drastically altered their behavior. One study found that through the beginning of May, the average Black American practiced more social distancing than the average white American.

Officials in ChicagoBaltimore and other communities faced another threat: rumors flying about social media that Black people were somehow immune.

The top factor making people adopt self-protective behavior is personally knowing someone who fell ill, said Dr. Redbird. By the end of spring, Black and Hispanic Americans were 50 percent more likely than white Americans to know someone who had been sickened by the virus, her surveys found.

Dr. Hernandez, whose parents live in Arizona, said their neighbors who had not been scared in June had since changed their attitudes.

Her father, a physician, had set an example. Early on, he wore a mask with a silly mustache when he and his wife took walks, and they would decline friends’ invitations, saying, “No, we’re staying in our bubble.”

Now, she said, their neighbors are wearing masks, “and people are telling my father, ‘You were right,’” Dr. Hernandez said.

There was no widespread agreement among experts about what is likely to happen in the years after the pandemic. Some scientists expected a quick economic recovery; others thought the damage could persist for years.

Working at home will become more common, some predicted, while crowded, open-plan offices may be changed. The just-in-time supply chains on which many businesses depend will need fixing because the processes failed to deliver adequate protective gear, ventilators and test materials.

A disease-modeling system like that used by the National Weather Service to predict storms is needed, said Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. Right now, the country has surveillance for seasonal flu but no national map tracking all disease outbreaks. As Dr. Thomas R. Frieden, a former C.D.C. director, recently pointed out, states are not even required to track the same data.

Several experts said they assumed that millions of Americans who have been left without health insurance or forced to line up at food banks would vote for politicians favoring universal health care, paid sick leave, greater income equality and other changes.

But given the country’s deep political divisions, no researcher was certain what the outcome of the coming election would be.

Dr. Redbird said her polling of Americans showed “little faith in institutions across the board — we’re not seeing an increase in trust in science or an appetite for universal health care or workers equity.”

The Trump administration did little to earn trust. More than six months into the worst health crisis in a century, Mr. Trump only last week urged Americans to wear masks and canceled the Republican convention in Florida, the kind of high-risk indoor event that states have been banning since mid-March.

“It will probably, unfortunately, get worse before it gets better,” Mr. Trump said at the first of the resurrected coronavirus task force briefings earlier this month, which included no scientists or health officials. The briefings were discontinued in April amid his rosy predications that the epidemic would soon be over.

Mr. Trump has ignoredcontradicted or disparaged his scientific advisers, repeatedly saying that the virus simply would go away, touting unproven drugs like hydroxychloroquine even after they were shown to be ineffective and sometimes dangerous, and suggesting that disinfectants or lethal ultraviolet light might be used inside the body.

Millions of Americans have lost their jobs and their health insurance, and are in danger of losing their homes, even as they find themselves in the path of a lethal disease. The Trump presidency “is the symptom of the denigration of science and the gutting of the public contract about what we owe each other as citizens,” said Dr. Joia S. Mukherjee, the chief medical officer of Partners in Health in Boston.

One lesson that will surely be learned is that the country needs to be better prepared for microbial assaults, said Dr. Julie Gerberding, a former director of the C.D.C.

“This is not a once-in-a-century event. It’s a harbinger of things to come.”

 

 

 

KHN’s ‘What The Health?’: Trump Twists on Virus Response

https://khn.org/news/khn-podcast-what-the-health-trump-twists-on-virus-response/

KHN's 'What The Health?': Trump Twists on Virus Response | Kaiser ...

President Donald Trump — who has spent the past six months trying to play down the coronavirus pandemic — seems to have pivoted. In back-to-back briefings on July 21 and 22, Trump cautioned that the U.S. is in a dangerous place vis-a-vis the pandemic. He urged the public to wear masks — although he has rarely worn one in public.

Meanwhile, Republicans in the Senate are scrambling to put together a package for the next COVID-19 relief bill, facing a July 31 deadline, when some of the benefits passed in the spring expire. House Democrats passed their bill in May.

This week’s panelists are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Tami Luhby of CNN.

Among the takeaways from this week’s podcast:

  • Although Trump’s renewed emphasis on COVID-19 has surprised some of his critics, it may persuade his supporters to take actions promoted by public health officials. Trump’s emphasis on the importance of face coverings, perhaps coupled with the rising number of cases in parts of the country, could convince people who were otherwise dismissive of masks. People who do not necessarily trust public health officials may listen to Trump.
  • Republicans on Capitol Hill are in disarray on how to approach the next coronavirus relief bill. They are not in lockstep with the White House and are not supporting Trump’s call for a payroll tax cut.
  • One reason members of Congress are not eager to cut the payroll taxes is that the economic downturn has spurred concerns the Medicare and Social Security trust funds are being depleted faster than expected. However, analysts point out that when employment rises again, some of those concerns could dissipate.
  • A key sticking point in the economic relief package is whether to extend the bump in unemployment benefits that Congress approved in the spring. Lawmakers are facing a hard deadline on the issue because that money runs out next week, and the prohibition on evictions that was also part of an earlier COVID-19 relief bill ends even sooner. With rent, mortgages and other bills coming due Aug. 1, unemployed consumers could face a tough beginning of the month.
  • The Food and Drug Administration has approved limited use of pool testing for COVID-19. That allows approved labs to put together a small number of tests to run at once, thus conserving some of the materials needed for the process. If the pool tests positive, then those people whose results were pooled have to be tested again individually. The efforts have limited usefulness when rates of transmission are high in a community, but they may be helpful in specific settings, such as schools or workplaces.
  • New data shows that opioid addiction ticked back up in 2019, after a slight decline. Part of the problem is the growing use of the powerful — and dangerous — drug fentanyl. Economic woes also play a role. Addiction is often referred to as an epidemic of despair.
  • Although it’s unlikely the judicial system will overrule the administration’s efforts to bolster short-term insurance plans — which are generally less expensive but don’t offer as much protection for consumers as policies sold on the Affordable Care Act’s marketplaces — they could be circumvented if Democrats take over the White House. Even still, Democrats would likely have to find a way to make ACA plans more affordable.

 

 

 

 

 

We’re still in the early stages of the vaccine race

https://www.axios.com/newsletters/axios-vitals-a91eb4fb-e10d-46cf-b919-96e1e6e08b22.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Oxford and CanSino released coronavirus vaccine data. It's still ...

New clinical trial data from two experimental coronavirus vaccines — one from Oxford University and AstraZeneca in the U.K., and the other from CanSino Biologics in China — are providing cautious optimism in the race to combat the pandemic, Axios’ Bob Herman reports.

The big picture: Science has never moved this fast to develop a vaccine. And researchers are still several months away from a clearer idea of whether the leading candidates help people generate robust immune responses to this virus.

Driving the news: The Oxford and CanSino vaccines didn’t lead to any severe adverse reactions or hospitalizations, according to the results released yesterday.

  • Safety — not efficacy — was the main thing these studies were supposed to be testing. And they performed well enough to move on to further trials.
  • Competing candidates from Moderna and Pfizer/BioNTech have also performed well in safety trials.

Yes, but: Future trials will be the ones that tell us whether any of these potential vaccines actually trigger patients’ immune systems to respond to the virus.

  • In the results released yesterday, Oxford researchers gave their vaccine to 543 people but only tested 35 for “neutralizing antibodies.” A separate, nonrandomized group of 10 people got a booster dose of the Oxford vaccine a month after the initial dose.
  • Preliminary antibody responses from CanSino’s vaccine were “disappointing” to several experts.

The bottom line: There are 23 coronavirus vaccines in clinical testing right now, according to the World Health Organization.

  • We now have data on the first four, but the studies mostly are confirming that the vaccines aren’t severely harmful and that large-scale studies are warranted — not that they definitely work yet.
  • “It is good and hopeful news indeed, but we’ll only know when the large trials are done,” tweeted Robert Califf, a former FDA commissioner under President Obama.

 

 

 

Op-Ed: We Still Don’t Know the Risk Posed by COVID-19

https://www.medpagetoday.com/infectiousdisease/covid19/87629?xid=fb_o&trw=no&fbclid=IwAR2V6CbOCIXDf2K9sJCcRb0PhbqM4inXixe_poOFYudOcoUFZCmU2JzyrDg

Op-Ed: We Still Don't Know the Risk Posed by COVID-19 | MedPage Today

The need for a coordinated national research strategy

Confused about the risks of dying from the coronavirus or of catching it from someone who seems healthy? We all are, and the dizzying differences in scientific opinion are now linked to political perspectives. Progressives cite evidence that loosening restrictions would cost lives and offer little benefit to the economy, while conservatives embrace evidence that the risks are low. We offer a guide to help navigate the tangle of numbers and suggest a way forward.

Google and many others display the number of cases and deaths (3.6 million and 138,840, respectively, by July 17). This invites a simple calculation for understanding the risk: divide the number who have died by the number who have been diagnosed. So, the chance of dying if infected is about 3.9%. Right? Well, not so fast. Six months into the pandemic, neither the number of deaths nor the number of people infected is known.

Some argue that deaths have been overemphasized since people who die of COVID are mostly older and sicker. Others suggest deaths have been overcounted since if a patient tests positive for COVID-19, it will likely be listed as the cause of death even if the person succumbs to another illness or, in some jurisdictions, dies due to an accident or suicide. Others argue that deaths have been undercounted.

Missing from the tally on any given day are those who died before testing was available, those who died shortly before or after but whose death has not yet been reported, or who died as an indirect result of the epidemic such as failing to seek medical care for fear of going to the hospital.

One carefully designed recent analysis compared deaths this year to the number of people who die during a “normal” year. The analysis concluded that through May, almost 100,000 people died from COVID-19 in addition to 30,000 who died from other causes related to the pandemic.

In short, uncertainty remains about the number of deaths due to COVID-19, which is supposed to be the easy part.

Estimating the number of people who have been infected is harder still. Most infected people are never formally diagnosed and never become one of the “cases” in the news. The limitations of the tests and the difficulty of attracting a representative population to be tested make it hard to estimate the true number of infections. The preferred test (reverse transcription polymerase chain reaction-based tests) uses RNA technology to see if the virus is present in nasal or oral swabs. It is a good test, but still may miss infections in up to 30% of cases.

A second type of test uses blood samples to look for an antibody called immunoglobulin (Ig)G that implies the person was previously infected. Based on IgG test results, the CDC assumes that 5% to 8% of the population has been infected. That would mean 24 million Americans have already had COVID-19 or a very similar illness. That is more than 10 times the number of confirmed cases.

The number is consequential: a higher infection rate for the same number of deaths implies that the virus is less deadly.review by a prominent epidemiologist considered 23 population studies with sample sizes of at least 500 people and found the percentage who have positive antibodies ranged from 0.1% to 48% — a 480-fold difference. Although the study was robustly criticized and at odds with highly citedpeer-reviewed research, it has appeared in over 30 news outlets, and the range of estimates allows people to pick a number that justifies their political position.

Contributing to this uncertainty is the FDA decision to, in a hurry to catch up for lost time, temporarily relax its standards for approving tests. Among over 300 antibody tests currently on the market, data on only a handful are publicly available, and some are being recalled.

The other number we need to know is how many people are spreading the infection without knowing it. Estimates are all over the place. Some major employers, including Stanford Healthcare, have systematically tested all of their employees and found very few infected people who do not have symptoms. In contrast, a CDC study of young, healthy adults working on an aircraft carrier found that 20% of those infected reported no symptoms.

So here we are, months into the epidemic without consensus on the basic information about how many people are infected, the risk of death for those infected, or the risk of asymptomatic transmission. In contrast to official agencies that use transparent methods to report the weather or the unemployment rate, trust in our official health statistics agencies has broken down as reports continue to emerge form myriad sources with conflicting methodologies and motivations.

The time has come to activate impartial groups, like the National Academy of Medicine, to build consensus on how to monitor the epidemic. We know the risks are serious. As cases have started to rise, whether or not the number of U.S. deaths is higher or lower than 130,000, the risk of inaction is too high.

We are staying near home, wearing masks, and treating COVID-19 as a serious threat to public health.

 

 

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.”