Misinformation on coronavirus is proving highly contagious

https://apnews.com/86f61f3ffb6173c29bc7db201c10f141?utm_source=Sailthru&utm_medium=email&utm_campaign=Newsletter%20Weekly%20Roundup:%20Healthcare%20Dive:%20Daily%20Dive%2008-01-2020&utm_term=Healthcare%20Dive%20Weekender

Misinformation on the coronavirus is proving highly contagious ...

As the world races to find a vaccine and a treatment for COVID-19, there is seemingly no antidote in sight for the burgeoning outbreak of coronavirus conspiracy theories, hoaxes, anti-mask myths and sham cures.

The phenomenon, unfolding largely on social media, escalated this week when President Donald Trump retweeted a false video about an anti-malaria drug being a cure for the virus and it was revealed that Russian intelligence is spreading disinformation about the crisis through English-language websites.

Experts worry the torrent of bad information is dangerously undermining efforts to slow the virus, whose death toll in the U.S. hit 150,000 Wednesday, by far the highest in the world, according to the tally kept by Johns Hopkins University. Over a half-million people have died in the rest of the world.

For most people, the virus causes only mild or moderate symptoms, such as fever and cough. For some older adults and people with existing health problems, it can cause more severe illness, including pneumonia.

Hard-hit Florida reported 216 deaths, breaking the single-day record it set a day earlier. Texas confirmed 313 additional deaths, pushing its total to 6,190, while South Carolina’s death toll passed 1,500 this week, more than doubling over the past month. In Georgia, hospitalizations have more than doubled since July 1.

“It is a real challenge in terms of trying to get the message to the public about what they can really do to protect themselves and what the facts are behind the problem,” said Michael Osterholm, head of the University of Minnesota’s Center for Infectious Disease Research and Policy.

He said the fear is that “people are putting themselves in harm’s way because they don’t believe the virus is something they have to deal with.”

Rather than fade away in the face of new evidence, the claims have flourished, fed by mixed messages from officials, transmitted by social media, amplified by leaders like Trump and mutating when confronted with contradictory facts.

“You don’t need masks. There is a cure,” Dr. Stella Immanuel promised in a video that promoted hydroxychloroquine. “You don’t need people to be locked down.”

The truth: Federal regulators last month revoked their authorization of the drug as an emergency treatment amid growing evidence it doesn’t work and can have deadly side effects. Even if it were effective, it wouldn’t negate the need for masks and other measures to contain the outbreak.

None of that stopped Trump, who has repeatedly praised the drug, from retweeting the video. Twitter and Facebook began removing the video Monday for violating policies on COVID-19 misinformation, but it had already been seen more than 20 million times.

Many of the claims in Immanuel’s video are widely disputed by medical experts. She has made even more bizarre pronouncements in the past, saying that cysts, fibroids and some other conditions can be caused by having sex with demons, that McDonald’s and Pokemon promote witchcraft, that alien DNA is used in medical treatments, and that half-human “reptilians” work in the government.

Other baseless theories and hoaxes have alleged that the virus isn’t real or that it’s a bioweapon created by the U.S. or its adversaries. One hoax from the outbreak’s early months claimed new 5G towers were spreading the virus through microwaves. Another popular story held that Microsoft founder Bill Gates plans to use COVID-19 vaccines to implant microchips in all 7 billion people on the planet.

Then there are the political theories — that doctors, journalists and federal officials are conspiring to lie about the threat of the virus to hurt Trump politically.

Social media has amplified the claims and helped believers find each other. The flood of misinformation has posed a challenge for Facebook, Twitter and other platforms, which have found themselves accused of censorship for taking down virus misinformation.

Facebook CEO Mark Zuckerberg was questioned about Immanuel’s video during an often-contentious congressional hearing Wednesday.

“We did take it down because it violates our policies,” Zuckerberg said.

U.S. Rep. David Cicilline, a Rhode Island Democrat leading the hearing, responded by noting that 20 million people saw the video before Facebook acted.

“Doesn’t that suggest that your platform is so big, that even with the right policies in place, you can’t contain deadly content?” Cicilline asked Zuckerberg.

It wasn’t the first video containing misinformation about the virus, and experts say it’s not likely to be the last.

A professionally made 26-minute video that alleges the government’s top infectious-disease expert, Dr. Anthony Fauci, manufactured the virus and shipped it to China was watched more than 8 million times before the platforms took action. The video, titled “Plandemic,” also warned that masks could make you sick — the false claim Facebook cited when it removed the video down from its site.

Judy Mikovits, the discredited doctor behind “Plandemic,” had been set to appear on the show “America This Week” on the Sinclair Broadcast Group. But the company, which operates TV stations in 81 U.S. markets, canned the segment, saying it was “not appropriate” to air.

This week, U.S. government officials speaking on condition of anonymity cited what they said was a clear link between Russian intelligence and websites with stories designed to spread disinformation on the coronavirus in the West. Russian officials rejected the accusations.

Of all the bizarre and myriad claims about the virus, those regarding masks are proving to be among the most stubborn.

New York City resident Carlos Lopez said he wears a mask when required to do so but doesn’t believe it is necessary.

“They’re politicizing it as a tool,” he said. “I think it’s more to try to get Trump to lose. It’s more a scare tactic.”

He is in the minority. A recent AP/NORC poll said 3 in 4 Americans — Democrats and Republicans alike — support a national mask mandate.

Still, mask skeptics are a vocal minority and have come together to create social media pages where many false claims about mask safety are shared. Facebook has removed some of the pages — such as the group Unmasking America!, which had nearly 10,000 members — but others remain.

Early in the pandemic, medical authorities themselves were the source of much confusion regarding masks. In February, officials like the U.S. surgeon general urged Americans not to stockpile masks because they were needed by medical personnel and might not be effective in everyday situations.

Public health officials changed their tune when it became apparent that the virus could spread among people showing no symptoms.

Yet Trump remained reluctant to use a mask, mocked his rival Joe Biden for wearing one and suggested people might be covering their faces just to hurt him politically. He did an abrupt about-face this month, claiming that he had always supported masks — then later retweeted Immanuel’s video against masks.

The mixed signals hurt, Fauci acknowledged in an interview with NPR this month.

“The message early on became confusing,” he said.

Many of the claims around masks allege harmful effects, such as blocked oxygen flow or even a greater chance of infection. The claims have been widely debunked by doctors.

Dr. Maitiu O Tuathail of Ireland grew so concerned about mask misinformation he posted an online video of himself comfortably wearing a mask while measuring his oxygen levels. The video has been viewed more than 20 million times.

“While face masks don’t lower your oxygen levels. COVID definitely does,” he warned.

Yet trusted medical authorities are often being dismissed by those who say requiring people to wear masks is a step toward authoritarianism.

“Unless you make a stand, you will be wearing a mask for the rest of your life,” tweeted Simon Dolan, a British businessman who has sued the government over its COVID-19 restrictions.

Trump’s reluctant, ambivalent and late embrace of masks hasn’t convinced some of his strongest supporters, who have concocted ever more elaborate theories to explain his change of heart. Some say he was actually speaking in code and doesn’t really support masks.

O Tuathail witnessed just how unshakable COVID-19 misinformation can be when, after broadcasting his video, he received emails from people who said he cheated or didn’t wear the mask long enough to feel the negative effects.

That’s not surprising, according to University of Central Florida psychology professor Chrysalis Wright, who studies misinformation. She said conspiracy theory believers often engage in mental gymnastics to make their beliefs conform with reality.

“People only want to hear what they already think they know,” she said. 

 

 

 

COVID-19 More Deadly Than Cancer Itself?

https://www.medpagetoday.com/hematologyoncology/othercancers/87750?xid=nl_mpt_DHE_2020-07-25&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-07-25&utm_term=NL_Daily_DHE_dual-gmail-definition

During the recent months of the pandemic, cancer patients undergoing active treatment saw their risk for death increase 15-fold with a COVID-19 diagnosis, real-world data from two large healthcare systems in the Midwest found.

Among nearly 40,000 patients who had undergone treatment for their cancer at some point over the past year, 15% of those diagnosed with COVID-19 died from February to May 2020, as compared to 1% of those not diagnosed with COVID-19 during this same timeframe, reported Shirish Gadgeel, MD, of the Henry Ford Cancer Institute in Detroit.

And in more than 100,000 cancer survivors, 11% of those diagnosed with COVID-19 died compared to 1% of those not diagnosed with COVID-19, according to the findings presented at the American Association for Cancer Research (AACR) COVID-19 and Cancer meeting.

“Certain comorbidities were more commonly seen in patients with COVID-19,” said Gadgeel. “This included cardiac arrhythmias, renal failure, congestive heart failure, and pulmonary circulation disorders.”

For their study, Gadgeel and colleagues examined data on 154,585 malignant cancer patients from 2015 to the present day with active cancer or a history of cancer treated at two major Midwestern health systems. Among the 39,790 patients with active disease, 388 were diagnosed with COVID-19 from February 15 through May 13, 2020. For the 114,795 patients with a history of cancer, 412 were diagnosed with COVID-19.

After adjusting for multiple variables, older age (70-99 years) and several comorbid conditions were significantly associated with increased mortality among COVID-19 patients with active cancer:

  • Older age: OR 3.4 (95% CI 1.3-9.3)
  • Diabetes: OR 3.0 (95% CI 1.5-6.0)
  • Renal failure: OR 2.3 (95% CI 1.1-4.9)
  • Pulmonary circulation disorders: OR 3.9 (95% CI 1.4-10.5)

In COVID-19 patients with a history of cancer, an increased risk for death was seen for those ages 60 to 69 years (OR 6.3, 95% CI 1.1-35.3), 70 to 99 years (OR 18.2, 95% CI 3.9-84.3), and those with a history of coagulopathy (OR 3.0, 95% CI 1.2-7.6).

Despite Black patients consisting of less than 10% of the total study population, Gadgeel noted that 39.4% of COVID-19 diagnoses in the active cancer group were among Black patients, as were a third of diagnoses in the cancer survivor group.

And the proportion of COVID-19 patients with a median household income below $30,000 was also higher in COVID-19 patients in both groups, he added.

COVID-19 carried a far greater chance for hospitalization, both for patients with active cancer (81% vs 15% for those without COVID-19) as well as those with a history of cancer (68% vs 6%), with higher hospitalization rates among Black individuals and those with a median income below $30,000. Even younger COVID-19 patients (<50 years) saw high rates of hospitalization, at 79% for those with active cancer and 49% for those with a history of the disease.

While few cancer patients without COVID-19 required mechanical ventilation (≤1%) during the study period, 21% of patients with active disease and COVID-19 needed ventilation, as did 14% of those with a history of cancer, with higher rates among those with a history of coagulopathy (36% and 23%, respectively).

CCC-19 Data Triples in Size

Another study presented during the meeting again showed higher mortality rates for cancer patients with COVID-19, with lung cancer patients appearing to be especially vulnerable.

Among 2,749 cancer patients diagnosed with COVID-19, 60% required hospitalization, 45% needed supplemental oxygen, 16% were admitted to the intensive care unit, and 12% needed mechanical ventilation, and 16% died within 30 days, reported Brian Rini, MD, of Vanderbilt-Ingram Cancer Center in Nashville, Tennessee.

“When COVID first started there was a hypothesis that cancer patients could be at adverse outcome risk due to many factors,” said Rini, noting their typically “advanced age, presence of comorbidities, increased contact with the healthcare system, perhaps immune alterations due to their cancer and/or therapy, and decreased performance status.”

Rini was presenting an updated analysis of the COVID-19 and Cancer Consortium (CCC-19), which now includes 114 sites (includes comprehensive cancer centers and community sites) collecting data on cancer patients and their outcomes with COVID-19.

Initial data from the consortium, of about 1,000 patients, were presented earlier this year at the American Society of Clinical Oncology (ASCO) annual meeting and published in The Lancet. The early analysis showed that use of hydroxychloroquine and azithromycin to treat COVID-19 in cancer patients was associated with a nearly threefold greater risk of dying within 30 days.

Notably, in the new analysis, decreased all-cause mortality at 30 days was observed among the 57 patients treated with remdesivir alone, when compared to patients that received other investigational therapies for COVID-19, including hydroxychloroquine (adjusted odds ratio [aOR] 0.41, 95% CI 0.17-0.99) and a trend toward lower mortality when compared to patients that received no other investigational therapies (aOR 0.76, 95% CI 0.31-1.85).

Cancer status was associated with a greater mortality risk. Compared to patients in remission, those with stable (aOR 1.47, 95% CI 1.07-2.02) or progressive disease (aOR 2.96, 95% CI 2.05-4.28) were both at increased risk of death at 30 days.

Mortality at 30 days reached 35% for patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher, as compared to 4% (aOR 4.22, 95% CI 2.92-6.10).

“As you start to combine these adverse risk factors you get into really high mortality rates,” said Rini, with highest risk seen among intubated patients who were either 75 and older (64%) or had poor performance status (75%).

“There are several factors that are starting to emerge as relating to COVID-19 mortality in cancer patients,” said Rini during his presentation at the AACR COVID-19 and Cancer meeting. “Some are cancer-related, such as the status of their cancer and perhaps performance status, and others are perhaps unrelated, such as age or gender.”

Other factors that were significantly associated with higher mortality included older age, male sex, Black race, and being a current or former smoker, and having a hematologic malignancy.

Findings from the study were simultaneously published in Cancer Discovery.

“Importantly, there were some factors that did not reach statistical significance,” said Rini, including obesity.

“Patients who received recent cytotoxic chemotherapy or other types of anti-cancer therapy, or who had recent surgery were not in the present analysis of almost 3,000 patients at increased risk,” he continued. “I think this provides some reassurance that cancer care can and should continue for these patients.”

For specific cancer types, mortality was highest in lung cancer patients (26%), followed by those with lymphoma (22%), colorectal cancer (19%), plasma cell dyscrasias (19%), prostate cancer (18%), breast cancer (8%), and thyroid cancer (3%).

“The COVID mortality rate in cancer patients appears to be higher than the general population,” said Rini. “Lung cancer patients appear especially vulnerable by our data, as well as TERAVOLT‘s.”

 

 

 

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.”

 

 

 

 

Major study finds common steroid reduces deaths among patients with severe Covid-19

Major study finds common steroid reduces deaths among patients with severe Covid-19

What is Dexamethasone? | What Is News,The Indian Express

A cheap, readily available steroid drug reduced deaths by a third in patients hospitalized with Covid-19 in a large study, the first time a therapy has been shown to possibly improve the odds of survival with the condition in the sickest patients.

Full data from the study have not been published or subjected to scientific scrutiny. But outside experts on Tuesday immediately embraced the top-line results. The drug, dexamethasone, is widely available and is used to treat conditions including rheumatoid arthritis, asthma, and some cancers.

In a statement, Patrick Vallance, the U.K. government’s chief scientific adviser, called the result “tremendous news” and “a ground-breaking development in our fight against the disease.” Scott Gottlieb, a former commissioner of the U.S. Food and Drug Administration, called it “a very positive finding” in an interview on CNBC. “I think it needs to be validated, but it certainly suggests that this could be beneficial in this setting.”

Atul Gawande, the surgeon, writer and public health researcher, urged caution, tweeting, “after all the retractions and walk backs, it is unacceptable to tout study results by press release without releasing the paper.”

The study randomly assigned 2,104 patients to receive six milligrams of dexamethasone once a day, by mouth or intravenous injection. These were compared to 4,321 patients assigned to receive usual care alone.

In patients who needed to be on a ventilator, dexamethasone reduced the death rate by 35%, meaning that doctors would prevent one death by treating eight ventilated patients. In those who needed oxygen but were not ventilated, the death rate was reduced 20%, meaning doctors would need to treat 25 patients to save one life. Both results were statistically significant.

There was no benefit in patients who didn’t require any oxygen. The researchers running the study, called RECOVERY, decided to stop enrolling patients on dexamethasone on June 8 because they believed they had enough data to get a clear result.

“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” Peter Horby, one of the lead investigators of the study and a professor in the Nuffield Department of Medicine at the University of Oxford, said in a statement. He added that the drug should now become the standard treatment for patients with Covid-19 who need oxygen. “Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.’”

A different arm of the same study showed on June 5 that hydroxychloroquine, widely touted as a potential Covid treatment, had no benefit in hospitalized patients. Yesterday, based in part on those results, the Food and Drug Administration revoked an Emergency Use Authorization for using hydroxychloroquine in those patients.

From the start of the pandemic in March, researchers have focused on two different stages of Covid-19, which will likely require very different interventions. Some drugs are designed to directly combat the novel coronavirus, SARS-CoV-2, that causes the disease. The first medicine shown to have a benefit, remdesivir from the biotech firm Gilead Sciences, falls into this category, even though, because it must be given intravenously, it has been tested in hospitalized patients. Remdesivir shortens the course of infection, but has not been shown to save lives.

After patients have become profoundly sick, the problem starts to become not only the virus but their own immune system, which attacks the lungs, a condition called acute respiratory distress syndrome, or ARDS. For these patients, doctors have believed, they would need to dampen patients’ immune response even as they fought the virus.

Initially, excitement in this area fell on new and expensive drugs, such as Actemra, a rheumatoid arthritis drug from Roche that is used to treat a similar condition caused by some cancer immunotherapies. But a study in patients who needed oxygen showed no benefit from a similar drug, although another arm in sicker patients is continuing. The National Institutes of Health is conducting a study of an Eli Lilly pill targeting rheumatoid arthritis, an extension of the study that showed remdesivir has a benefit.

Dexamethasone, which reached the market 59 years ago, seemed an unlikely candidate to help these patients; it was seen as too crude a way of tamping down the immune system. In guidelines for physicians treating the disease, the NIH doesn’t even mention the therapy.

Studies that are testing other medicines may now need to incorporate the use of the drug, which could complicate analyzing the results. A spokesperson for Regeneron, which is testing Covid-19 drugs focused on both attacking the virus and dampening the immune system, said the company’s studies are written so that when a new medicine becomes the standard of care, it becomes available to patients in the trial.

Some studies have shown a benefit for using dexamethasone in acute respiratory distress syndrome not related to Covid-19, although the benefit was smaller than in RECOVERY. 

The result, should it hold up to further scrutiny, shows the benefit of the strategy of Horby and Martin Landray, the Oxford researchers who designed the study, leveraging the U.K. health system to start a study of multiple inexpensive potential Covid-19 therapies — including hydroxychloroquine, dexamethasone, and also some older HIV medicines. Several months into the Covid-19 pandemic, two of the most important results come from this single study.

Neither of those results, however, have been scrutinized or published.

 

 

 

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:

 

 

 

Public Health Officials Face Wave Of Threats, Pressure Amid Coronavirus Response

Public Health Officials Face Wave Of Threats, Pressure Amid Coronavirus Response

Public health officials face wave of threats, pressure amid ...

Emily Brown was director of the Rio Grande County Public Health Department in Colorado until May 22, when the county commissioners fired her after battling with her over coronavirus restrictions. “They finally were tired of me not going along the line they wanted me to go along,” she says.

Emily Brown was stretched thin.

As the director of the Rio Grande County Public Health Department in rural Colorado, she was working 12- and 14-hour days, struggling to respond to the pandemic with only five full-time employees for more than 11,000 residents. Case counts were rising.

She was already at odds with county commissioners, who were pushing to loosen public health restrictions in late May, against her advice. She had previously clashed with them over data releases and had haggled over a variance regarding reopening businesses.

But she reasoned that standing up for public health principles was worth it, even if she risked losing the job that allowed her to live close to her hometown and help her parents with their farm.

Then came the Facebook post: a photo of her and other health officials with comments about their weight and references to “armed citizens” and “bodies swinging from trees.”

The commissioners had asked her to meet with them the next day. She intended to ask them for more support. Instead, she was fired.

“They finally were tired of me not going along the line they wanted me to go along,” she said.

In the battle against COVID-19, public health workers spread across states, cities and small towns make up an invisible army on the front lines. But that army, which has suffered neglect for decades, is under assault when it’s needed most.

Officials who usually work behind the scenes managing everything from immunizations to water quality inspections have found themselves center stage. Elected officials and members of the public who are frustrated with the lockdowns and safety restrictions have at times turned public health workers into politicized punching bags, battering them with countless angry calls and even physical threats.

On Thursday, Ohio’s state health director, who had armed protesters come to her house, resigned. The health officer for Orange County, California, quit Monday after weeks of criticism and personal threats from residents and other public officials over an order requiring face coverings in public.

As the pressure and scrutiny rise, many more health officials have chosen to leave or been pushed out of their jobs. A review by KHN and The Associated Press finds at least 27 state and local health leaders have resigned, retired or been fired since April across 13 states.

In California, senior health officials from seven counties, including the Orange County officer, have resigned or retired since March 15. Dr. Charity Dean, the second in command at the state Department of Public Health, submitted her resignation June 4.

These officials have left their posts due to a mix of backlash and stressful, nonstop working conditions, all while dealing with chronic staffing and funding shortages.

Some health officials have not been up to the job during the biggest health crisis in a century. Others previously had plans to leave or cited their own health issues.

But Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials, said the majority of what she calls an “alarming” exodus resulted from increasing pressure as states reopen. Three of those 27 were members of her board and well known in the public health community — Rio Grande County’s Brown; Detroit’s senior public health adviser, Dr. Kanzoni Asabigi; and the head of North Carolina’s Gaston County Department of Health and Human Services, Chris Dobbins.

Asabigi’s sudden retirement, considering his stature in the public health community, shocked Freeman. She also was upset to hear about the departure of Dobbins, who was chosen as health director of the year for North Carolina in 2017. Asabigi and Dobbins did not reply to requests for comment.

“They just don’t leave like that,” Freeman said.

Public health officials are “really getting tired of the ongoing pressures and the blame game,” Freeman said. She warned that more departures could be expected in the coming days and weeks as political pressure trickles down from the federal to the state to the local level.

From the beginning of the coronavirus pandemic, federal public health officials have complained of being sidelined or politicized. The Centers for Disease Control and Prevention has been marginalized; a government whistleblower said he faced retaliation because he opposed a White House directive to allow widespread access to the malaria drug hydroxychloroquine as a COVID-19 treatment.

In Hawaii, U.S. Rep. Tulsi Gabbard called on the governor to fire his top public health officials, saying she believed they were too slow on testing, contact tracing and travel restrictions. In Wisconsin, several Republican lawmakers have repeatedly demanded that the state’s health services secretary resign, and the state’s conservative Supreme Court ruled 4-3 that she had exceeded her authority by extending a stay-at-home order.

With the increased public scrutiny, security details — like those seen on a federal level for Dr. Anthony Fauci, the top infectious disease expert — have been assigned to state health leaders, including Georgia’s Dr. Kathleen Toomey after she was threatened. Ohio’s Dr. Amy Acton, who also had a security detail assigned after armed protesters showed up at her home, resigned Thursday.

In Orange County, in late May, nearly a hundred people attended a county supervisors meeting, waiting hours to speak against an order requiring face coverings. One person suggested that the order might make it necessary to invoke Second Amendment rights to bear arms, while another read aloud the home address of the order’s author — the county’s chief health officer, Dr. Nichole Quick — as well as the name of her boyfriend.

Quick, attending by phone, left the meeting. In a statement, the sheriff’s office later said Quick had expressed concern for her safety following “several threatening statements both in public comment and online.” She was given personal protection by the sheriff.

But Monday, after yet another public meeting that included criticism from members of the board of supervisors, Quick resigned. She could not be reached for comment. Earlier, the county’s deputy director of public health services, David Souleles, retired abruptly.

An official in another California county also has been given a security detail, said Kat DeBurgh, the executive director of the Health Officers Association of California, declining to name the county or official because the threats have not been made public.

DeBurgh is worried about the impact these events will have on recruiting people into public health leadership.

“It’s disheartening to see people who disagree with the order go from attacking the order to attacking the officer to questioning their motivation, expertise and patriotism,” said DeBurgh. “That’s not something that should ever happen.”

Many local health leaders, accustomed to relative anonymity as they work to protect the public’s health, have been shocked by the growing threats, said Theresa Anselmo, the executive director of the Colorado Association of Local Public Health Officials.

After polling local health directors across the state at a meeting last month, Anselmo found about 80% said they or their personal property had been threatened since the pandemic began. About 80% also said they’d encountered threats to pull funding from their department or other forms of political pressure.

To Anselmo, the ugly politics and threats are a result of the politicization of the pandemic from the start. So far in Colorado, six top local health officials have retired, resigned or been fired. A handful of state and local health department staff members have left as well, she said.

“It’s just appalling that in this country that spends as much as we do on health care that we’re facing these really difficult ethical dilemmas: Do I stay in my job and risk threats, or do I leave because it’s not worth it?” Anselmo asked.

Some of the online abuse has been going on for years, said Bill Snook, a spokesperson for the health department in Kansas City, Missouri. He has seen instances in which people took a health inspector’s name and made a meme out of it, or said a health worker should be strung up or killed. He said opponents of vaccinations, known as anti-vaxxers, have called staffers “baby killers.”

The pandemic, though, has brought such behavior to another level.

In Ohio, the Delaware General Health District has had two lockdowns since the pandemic began — one after an angry individual came to the health department. Fortunately, the doors were locked, said Dustin Kent, program manager for the department’s residential services unit.

Angry calls over contact tracing continue to pour in, Kent said.

In Colorado, the Tri-County Health Department, which serves Adams, Arapahoe and Douglas counties near Denver, has also been getting hundreds of calls and emails from frustrated citizens, deputy director Jennifer Ludwig said.

Some have been angry their businesses could not open and blamed the health department for depriving them of their livelihood. Others were furious with neighbors who were not wearing masks outside. It’s a constant wave of “confusion and angst and anxiety and anger,” she said.

Then in April and May, rocks were thrown at one of their office’s windows — three separate times. The office was tagged with obscene graffiti. The department also received an email calling members of the department “tyrants,” adding “you’re about to start a hot-shooting … civil war.”  Health department workers decamped to another office.

Although the police determined there was no imminent threat, Ludwig stressed how proud she was of her staff, who weathered the pressure while working round-the-clock.

“It does wear on you, but at the same time we know what we need to do to keep moving to keep our community safe,” she said. “Despite the complaints, the grievances, the threats, the vandalism — the staff have really excelled and stood up.”

The threats didn’t end there, however: Someone asked on the health department’s Facebook page how many people would like to know the home addresses of the Tri-County Health Department leadership. “You want to make this a war??? No problem,” the poster wrote.

Back in Colorado’s Rio Grande County, some members of the community have rallied in support of Brown with public comments and a letter to the editor of a local paper. Meanwhile, COVID-19 case counts have jumped from 14 to 49 as of Wednesday.

Brown is grappling with what she should do next: dive back into another strenuous public health job in a pandemic, or take a moment to recoup?

When she told her 6-year-old son she no longer had a job, he responded: “Good — now you can spend more time with us.”

 

 

 

 

Huge Study Throws Cold Water on Antimalarials for COVID-19

https://www.medpagetoday.com/infectiousdisease/covid19/86642?xid=nl_mpt_DHE_2020-05-23&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-05-23&utm_term=NL_Daily_DHE_dual-gmail-definition

Huge Study Throws Cold Water on Antimalarials for COVID-19 ...

— No support for continued use seen in analysis of 15,000 patients who got controversial drugs

Chloroquine or hydroxychloroquine (HCQ), with or without an antibiotic, in hospitalized COVID-19 patients were associated with increased risk of death in the hospital and higher rates of arrhythmias, analysis of outcomes in nearly 100,000 patients indicated.

The 15,000 patients who received HCQ or chloroquine were about twice as likely to die compared to controls who did not receive these agents after adjusting for covariates (18.o% for hydroxychloroquine and 16% for chloroquine versus 9.3% for controls), reported Mandeep Mehra, MD, of Brigham and Women’s Hospital in Boston, and colleagues.

The drug was also associated with a higher risk of ventricular arrhythmia during hospitalization (6.1% for hydroxychloroquine, 4.3% for chloroquine versus 0.3% for controls), the authors wrote in The Lancet.

Moreover, risks for both in-hospital mortality and ventricular arrhythmia were even higher compared to controls when either drug was combined with a macrolide antibiotic, they noted.

Mehra said in a statement these drugs should not be used as treatments for COVID-19 outside of clinical trials.

“This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with COVID-19,” he said. “Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death. Randomised clinical trials are essential to confirm any harms or benefits associated with these agents.”

Mehra’s group analyzed some 96,000 patients from 671 hospitals on six continents with COVID-19 infection, from Dec. 20 to April 14, all of whom had either died or been discharged from the hospital by April 21.

Overall, 14,888 patients were treated with hydroxychloroquine, chloroquine, hydroxychloroquine with a macrolide antibiotic or chloroquine with an antibiotic, and their results were compared to 81,144 controls who did not receive these drugs.

Authors adjusted for demographic factors, as well as cardiovascular disease, diabetes, lung disease, smoking, immunosuppressed conditions and baseline disease severity.

The estimated excess risk attributable to the drug regimen rather than other factors, such as comorbidities, ranged from 34% to 35%.

Arrhythmia’s greatest risk was in the group who received hydroxychloroquine and a macrolide antibiotic such as azithromycin (8% versus 0.3% of controls), and this regimen was associated with a more than five-fold risk of developing an arrhythmia while hospitalized, though cause and effect cannot be inferred, the group noted.

“Previous small-scale studies have failed to identify robust evidence of a benefit and larger, randomised controlled trials are not yet completed,” said co-author Frank Ruschitzka, MD, Director of the Heart Center at University Hospital Zurich in a statement. “However, we now know from our study that the chance that these medications improve outcomes in COVID-19 is quite low.”

An accompanying editorial by Christian Funck-Brentano, MD, PhD, and Joe-Elie Salem, MD, PhD, of Sorbonne Université in Paris, noted limitations of the observational data, but said the authors “should be commended for providing results from a well designed and controlled study … in a very large sample of hospitalized patients.”

They also cautioned against attributing the increased risk of hospital deaths to the higher incidence of arrhythmias, noting that “the relationship between death and ventricular tachycardia was not studied and causes of deaths (i.e., arrhythmic vs non-arrhythmic) were not adjudicated.”

The editorialists nevertheless concluded both hydroxychloroquine and chloroquine, with or without azithromycin, “are not useful and could be harmful in hospitalized patients with COVID-19,” and stressed the importance of clinical trials for these drugs.

“The global community awaits the results of ongoing, well powered randomized controlled trials showing the effects of chloroquine and hydroxychloroquine on COVID-19 clinical outcomes,” they wrote.

 

 

 

 

Rick Bright, ousted director of vaccine agency, warns that administration lacks ‘centralized, coordinated plan’

https://www.cnn.com/2020/05/14/politics/coronavirus-whistleblower-testimony/index.html?fbclid=IwAR0KfVp-njw8vqKFdaLbBC4r4NAx3KeS4rFg2vmFbSneW7PcqOwVYult9rc

Virus whistleblower tells lawmakers US lacks vaccine plan | Where ...

Rick Bright, the ousted director of a crucial federal office charged with developing countermeasures to infectious diseases, testified before Congress on Thursday that the US will face an even worse crisis without additional preparations to curb the coronavirus pandemic.

“Our window of opportunity is closing,” Bright said. “Without better planning, 2020 could be the darkest winter in modern history.”
Bright criticized the Trump administration for failing to implement a “standard, centralized, coordinated plan” to combat the virus and questioned its timeline for a vaccine. His testimony came a week after filing a whistleblower complaint alleging he was fired from his job leading the Biomedical Advanced Research and Development Authority for opposing the use of a drug frequently touted by President Donald Trump as a potential coronavirus treatment.
About an hour before Bright’s hearing, Trump tweeted that he had “never met” or “even heard of” Bright, but considers the NIH senior adviser a “disgruntled employee, not liked or respected by people I spoke to and who, with his attitude, should no longer be working for our government!”
Before the House Committee on Energy and Commerce’s health subcommittee, Bright urged the Trump administration to consider a number of actions, including increasing production of essential equipment and establishing both a national test strategy and a national standard of procurement of supplies. He calls on top officials to “lead” through example and wear face coverings and social distance.
Bright claimed that the administration missed “early warning signals” to prevent the spread of the virus. He said that he would “never forget” an email from Mike Bowen, the hearing’s other witness and the vice president of the medical supply company Prestige Ameritech, indicating that the US supply of N95, the respirator masks used by health care professionals, was at a perilous level.
“He said, ‘We’re in deep shit,'” testified Bright. “‘The world is.'”
Bright said he “pushed” that warning “to the highest levels” he could at Health and Human Services but received “no response.”
“From that moment, I knew that we were going to have a crisis for health care workers because we were not taking action,” said Bright. “We were already behind the ball.”
In his written statement, Bright blamed the leadership of HHS for being “dismissive” of his “dire predictions.” Bright wrote that he knew the US had a “critical shortage of necessary supplies” and personal protective equipment during the first three months of the year and prodded HHS to boost production of masks, respirators, syringes and swabs to no avail. He alleged that he faced “hostility and marginalization” from HHS officials after he briefed White House trade adviser Peter Navarro and members of Congress “who better understood the urgency to act.”
And he charged that he was removed from his post at BARDA and transferred to “a more limited and less impactful position” at NIH after he “resisted efforts to promote” the “unproven” drug chloroquine.
A Department of Health and Human Services spokesperson responded that it was “a personnel matter that is currently under review” but said it “strongly disagrees with the allegations and characterizations.”
Bright is seeking to be reinstated to his position as the head of BARDA. The Office of Special Counsel, which is reviewing Bright’s complaint, has determined that was a “substantial likelihood of wrongdoing” in removing him from his post, according to Bright’s attorneys.
Rep. Anna Eshoo, a California Democrat and the panel’s chairwoman, said Bright “was the right person, with the right judgment, at the right time.”
“We can’t have a system where the government fires those who get it right and reward those who get it completely wrong,” added Eshoo.
In his testimony, Bright also cast doubt on the Trump administration’s goal of manufacturing a vaccine in 12 to 18 months as overly optimistic, calling it “an aggressive schedule” and noting that it usually takes up to 10 years to make a vaccine.
“My concern is if we rush too quickly, and consider cutting out critical steps, we may not have a full assessment of the safety of that vaccine,” Bright said. “So, it’s still going to take some time.”
Some Republicans on the subcommittee said that the hearing shouldn’t have been held at all.
Rep. Michael Burgess of Texas, the top Republican on the panel, said “every whistleblower needs to be heard,” but added the hearing was “premature” and a “disservice” to the Special Counsel’s investigation since Bright’s complaint was filed only a week ago.
And Republican Rep. Richard Hudson of North Carolina claimed that the hearing was not about the whistleblower complaint but “undermining the Administration during a national and global crisis.”
Thursday’s subcommittee meeting comes two days after a blockbuster hearing in the Senate that featured Dr. Anthony Fauci, who leads the National Institute of Allergy and Infectious Diseases. Fauci said that access to a vaccine in time for the fall school year would be “a bit of a bridge too far” and warning against some schools opening too soon, which Trump later called “not an acceptable answer.”
Fauci testified from his modified quarantine at home since he had made contact with a White House staffer who tested positive. But Bright appeared masked and in-person for his hearing on Capitol Hill, as did the lawmakers who questioned him. Many members of the House have steered clear of Capitol Hill since the onset of the outbreak, although they are expected to return on Friday to vote on a multi-trillion dollar Democratic bill responding to the crisis.

 

 

Window of Opportunity is Closing for Coronavirus Response

https://www.axios.com/rick-bright-testimony-opening-statement-6817ae7a-5196-4357-b83c-d3ff96990efd.html?stream=health-care&utm_source=alert&utm_medium=email&utm_campaign=alerts_healthcare

Window of opportunity – definition and meaning – Market Business News

A top vaccine doctor who was ousted from his position in April is expected to testify Thursday that the Trump administration was unprepared for the coronavirus, and that the U.S. could face the “darkest winter in modern history” if it doesn’t develop a national coordinated response, according to prepared testimony first obtained by CNN.

The big picture: Rick Bright, the former head of the Biomedical Advanced Research and Development Authority (BARDA), will tell Congress that leadership at the Department of Health and Human Services ignored his warnings in January, February and March about a potential shortage of medical supplies.

  • He will testify that HHS “missed early warning signals” and “forgot important pages from our pandemic playbook” early on — but that “for now, we need to focus on getting things right going forward.”
  • Bright’s testimony also reiterates claims from a whistleblower report he filed last week that alleges he was ousted over his attempts to limit the use of hydroxychloroquine — an unproven drug touted by President Trump — to treat the coronavirus.

What he’s saying: Bright will testify he urged HHS to ramp up production of
masks, respirators and medical supplies as far back as January. Those warnings were dismissed, Bright says, and he was “cut out of key high-level meetings to combat COVID-19.”

  • “I continue to believe that we must act urgently to effectively combat this deadly disease. Our window of opportunity is closing. If we fail to develop a national coordinated response, based in science, I fear the pandemic will get far worse and be prolonged, causing unprecedented illness and fatalities.”

Bright will call for a national strategy to combat the virus, including “tests that are accurate, rapid, easy to use, low cost, and available to everyone who needs them.”

  • “Without clear planning and implementation of the steps that I and other experts have outlined, 2020 will be darkest winter in modern history.”

Read Bright’s prepared statement.