with Paulina Firozi
There was only patchy evidence for using the anti-malaria drugs much touted by President Trump to treat covid-19 when the Food and Drug Administration authorized their use on an emergency basis last month.
There’s now better evidence for using remdesivir, a treatment originally developed for Ebola and expected to get emergency use authorization by the FDA. It’s no miracle cure, but some preliminary studies suggest it could help moderately ill coronavirus patients recover sooner.
Trump and members of his coronavirus task force just announced hopeful results from a rigorous clinical trial by the National Institutes of Health.
As U.S. deaths from novel coronavirus passed 60,000 yesterday, the trial found that remdesivir accelerated the recovery time of infected patients by 31 percent.
The median recovery time for covid-19 patients given the drug was 11 days, compared with 15 days for patients given a placebo.
“The data shows that remdesivir has a clear-cut, significant positive effect in diminishing the time to recover,” said Anthony Fauci, head of infectious disease at the National Institutes of Health and a key figure on the task force.
Yet for weeks Trump repeatedly praised hydroxychloroquine, despite sparse evidence of its effectiveness.
Trump said hydroxychloroquine and azithromycin, “taken together, have a real chance to be one of the biggest game changers in the history of medicine.” He had millions of doses of the drug added to the National Strategic Stockpile and pressed recovered covid-19 patients on whether they had used it. He said he'd consider taking it himself as a preventative measure.
He has now toned that back, after a study released earlier this month linked use of the drug to higher rates of death among Veterans Affairs patients hospitalized with covid-19. Our colleague Philip Bump has the timeline of Trump's 40 days of “promotion, hype and eventual retreat.”
That arc underscores why scientists have stressed the importance of waiting until clinical trials show how the drugs play out with covid-19 patients.
Experts say remdesivir could be another weapon in the nation's fight against the virus.
While the drug, unfortunately, didn’t appear to significantly lower death rates, it could prove helpful as the administration and state governors seek pathways to reopen the economy without waiting many months for a vaccine to finally be ready.
Former FDA commissioner Scott Gottlieb:
The drug isn't a home run but will probably benefit some patients, especially when used early in disease course for patients at higher risk of bad outcomes. It’s the beginning of a better toolbox, especially as covid collides with flu in Fall and we face significant new risks 2/— Scott Gottlieb, MD (@ScottGottliebMD) April 29, 2020
Andy Slavitt, former head of the Centers for Medicare and Medicaid Services:
NEWS: FDA to make new therapy available based on early trial results.— Andy Slavitt @ 🏡 (@ASlavitt) April 29, 2020
Hopeful. More hopeful would be enough testing to get people therapies early. https://t.co/lZtqXNZJ73
An Emory University professor:
At most a "solid hit" but certainly not a "home run". Not a "game changer" I am afraid but reminds me of the first AZT vs placebo study published in 1987. That was the beginning of the long road to develop a treatment for HIV. The "home run" did not happen until 1996 with PIs https://t.co/3xU6WmoZ4w— Carlos del Rio (@CarlosdelRio7) April 29, 2020
Next month, Japan is planning to try remdesivir on covid-19 patients. The country is initiating a similar fast-track approval process for the drug, Japanese Prime Minister Shinzo Abe told the country’s parliament this week.
“The NIAID study is the most rigorous test to date of the potential treatment because it is a double-blind, placebo-controlled trial, the gold standard for seeing if a drug is safe and effective,” my colleagues Christopher Rowland and Laurie McGinley report.
“A cohort of patients receive a dummy treatment instead of the real drug, without patients and treating doctors knowing which one the patients are getting,” they write. “It provides the best comparison of how people treated with the drug fared in relation to those who did not get the drug.”
The study involved 1,000 patients at 68 sites in the United States and around the world. Researchers launched it in February, just as the coronavirus was expanding into a huge, global concern. The first patient had been among infected passengers evacuated from the cruise ship Diamond Princess, Chris and Laurie report.
The drug’s maker, Gilead Sciences, also says it has found remdesivir is effective.
The company’s own, much less rigorous study suggests that severely ill patients had similar results whether they received five days of remdesivir versus 10 days. But the study didn’t include a control group of patients given a placebo, and the treatment had to be discontinued for some patients who experienced serious side effects.
And then there’s a study conducted in China and published yesterday in the Lancet medical journal — one that sheds doubt on the usefulness of the drug. The incomplete trial, which ran out of patients to enroll, found “remdesivir was not associated with statistically significant clinical benefits.”
Physician and author Eric Topol:
Results of the 1st published randomized controlled trial of remdesivir for severe #COVID19 shows no benefit https://t.co/WYEjo4UYLN @TheLancet— Eric Topol (@EricTopol) April 29, 2020
"numerical reduction" doesn't cut it pic.twitter.com/UNzQbJXs9p
The takeaway: remdesivir isn’t a magic bullet, but it will probably be commonly used for seriously ill covid-19 patients. “With no approved treatments for covid-19, Fauci said, it will become the standard of care for hospitalized patients and serve as a key building block as clinicians hone their approach,” Chris and Laurie write.
Demand for the drug is likely to ramp up.
Gilead has said it expects to have enough dosages by the end of May to treat more than 140,000 patients.
“Gilead has said it is ramping up production capacity in anticipation of approval and to meet demand in clinical trials and through compassionate use, which allows doctors to apply for the drug for individual patients,” they report.
Director of the World Health Organization's Center on Public Health and Human Rights:
News on #remdesevir is good. But we should be cautiously optimistic. We shouldn't think of it as a #COVID19 cure, but rather a possible specific Rx. We don't know how effective it is, on what pops, & the parameters on when it would be prescribed.— Lawrence Gostin (@LawrenceGostin) April 29, 2020
Ahh, oof and ouch
AHH: The Trump administration is working on a “Manhattan Project-style” effort for a vaccine.
The program, called “Operation Warp Speed,” aims to rush production 300 million doses of a coronavirus vaccine before the end of the year, enough for most Americans, Bloomberg News’s Jennifer Jacobs and Drew Amstrong report.
Private pharmaceutical companies, government agencies and the military will work together to try to slash the time for a vaccine development by as much as eight months. Fauci has repeatedly said a vaccine wouldn’t be ready for a year to a year and half.
“There is no precedent for such rapid development of a vaccine,” Jennifer and Drew write. “A spokesman for the Department of Health and Human Services, Michael Caputo, said the president refused to accept the timeline for standard vaccine development and encouraged a breakthrough process.”
The Operation Warp Speed will cost billions and will “use government resources to quickly test the world’s most promising experimental vaccines in animals, then launch coordinated human clinical trials to winnow down the candidates,” they report.
OOF: Cities and states are seeing mass layoffs nationwide.
The coronavirus-fueled economic havoc is impacting Democratic- and Republican-led cities and states experiencing souring finances and revenue gaps. As states continue lockdowns, local governments have had to lay off thousands of workers, and that may only get worse.
The layoffs are “threatening critical public-sector employees and first responders at a time when many Americans may need their local governments’ help the most,” Tony Romm reports. “… Among municipalities, the new budget cuts could be profound: Between 300,000 and 1 million public-sector workers could soon be out of a job or sent home without pay, according to a new estimate from the National League of Cities. The steep reductions in staffing levels could affect education, sanitation, safety and health, local leaders warn, potentially leaving critical public services in utter disarray.”
Local and state officials have pushed for federal aid but have met resistance from Republicans in Washington.
“The recalcitrance on Capitol Hill and at the White House has sparked a lobbying blitz on the part of local governments, which have had no choice but to make painful cuts as they await action in Washington,” Tony adds.
OUCH: Women's groups and prominent feminists are nearly all silent on sexual misconduct allegations from a former Joe Biden staffer.
“The Daily Beast contacted 10 top national pro-women organizations for this story, including Emily’s List, Planned Parenthood Action Fund, NARAL Pro-Choice America, and the National Organization for Women,” the publication's Scott Bixby writes.
“Most organizations did not respond to a detailed request for comment about the allegation by Tara Reade, a former staff assistant in Biden’s Senate office who has accused the former vice president of forcibly penetrating her with his fingers in the early 1990s. Others replied and did not provide a statement.”
These groups pushed a “believe all women” message in 2018 when Christine Blasey Ford made misconduct allegations against Supreme Court Justice Brett Kavanaugh during his confirmation hearings. Some had also expressed regret for how the Democratic Party handled similar accusations made against President Bill Clinton in the 1990s, Scott writes.
“The collective non-response from mostly Democrat-aligned groups comes as potential female running mates struggle themselves in responding to the Biden allegation, which has the potential to upend his campaign against President Donald Trump, who has been accused of sexual misconduct by dozens of women in alleged incidents spanning decades,” Scott writes. “And it echoes the division among progressives when the #MeToo movement revived scrutiny of Clinton’s own alleged sexual misconduct.”
The former Senate aide who accused Joe Biden of sexual assault shared details of the alleged incident in a conversation in the mid-1990s, her former neighbor Lynda LaCasse has confirmed to our colleagues Amber Phillips and Matt Viser.
LaCasse wrote in a text message that while she lived near Tara Reade in 1995 and 1996, Reade told her that “Joe Biden sexually assaulted her.” She didn't offer other details to Amber and Matt, referring them to Business Insider, which published an interview with LaCasse on Monday.
“I am a very strong Democrat, and am supporting Joe Biden during this election,” LaCasse said in the message. “I believed Tara at the time she told me that Mr. Biden assaulted her, and I continue to support her now. I feel that the truth needs to be told.”
There are still things to learn about the coronavirus
There’s a “second-week” crash for some covid-19 patients.
For patients dealing with the most severe coronavirus reactions, the second week can take a turn, with some who seem stable becoming critically ill, Lenny Bernstein and Ariana Eunjung Cha reports.
But it’s not clear why there’s a sudden peril or heightened concern during this time.
“There is little consensus among doctors and experts about why the fifth through 10th days, or thereabouts, seem to be so dangerous for some people with covid-19, the disease caused by the virus. But everyone from critical care specialists to EMTs is aware of this frightening aspect of the disease,” they write.
Some doctors speculated the second-week crash could be in part due to the influence of individual’s genes, the virus’s effect on lung tissue, overactive immune responses, blood clotting and even the impact of the ventilators used to save patients’ lives.
The crash can also happen before or after a patient is hospitalized. “Doctors report seeing patients who wait too long to seek care, including those who do not feel the symptoms of plummeting oxygen levels, such as shortness of breath, until they are in crisis,” they add. “No one is sure why. Many people’s lungs remain flexible for a while, allowing carbon dioxide out and forestalling the sensation that they aren’t getting enough oxygen.”
Peculiar rashes may be another sign of a coronavirus infection.
A curious phenomenon of frostbite-like patches on people’s toes have caught the attention of researchers in coronavirus hot spots around the world.
“But the reports had been mostly limited to individual case studies and first-person observations, making it difficult to determine what these rashes mean, why they are occurring and how they are linked to the virus,” Ariana writes. “Now a U.S.-based group is preparing to publish the first in-depth look at covid-19’s dermatologic effects, based on a registry of nearly 300 patients confirmed or suspected of having the virus. The report, expected out as soon as this week, offers some tantalizing clues about the pathogen and its wildly different effects on different people.”
These toe rashes may be an early sign of covid-19, or could also signal that an individual had the virus but that it has resolved and passed.
The new paper found that most patients with these “covid toes” were asymptomatic or had just mild symptoms.
Esther Freeman, a dermatologist at Massachusetts General Hospital in Boston, told The Post: “My inbox and my telemedicine clinic are full of just toes. It’s all about toes. I have never seen so many toes.”
Here are a few more headlines and developments to catch up on:
The hardest hit:
- In Georgia, more than 80 percent of hospitalized covid-19 patients were black, according to a new study, Rachel Weiner reports.
- Sen. Chris Murphy (D-Conn.) and Rep. Jimmy Panetta (D-Calif.) introduced a bill to expand an underused part of the food stamps program to allow Americans to use their food stamps at restaurants, Tim Carman reports.
- As states begin to reopen, unemployed Americans face a difficult choice of whether to go back to work and risk getting sick or stay home without the support of unemployment aid, Politico’s Megan Cassella and Brianna Ehley report.
Congress on the coronavirus:
- House Speaker Nancy Pelosi (D-Cailf.) appointed seven Democratic lawmakers to a new House coronavirus committee to assess the administration’s pandemic response, Politico’s Kyle Cheney and Sarah Ferris report.
Good to know:
- A University of Pennsylvania research project is looking to determine if dogs can sniff out coronavirus case, Karin Brulliard reports.
- China is signaling that its coronavirus epidemic is under control as it schedules big political meetings for next month, Anna Fifield reports.
The industry impact:
- Health insurer Anthem says it anticipates people will shift toward government-sponsored health-care plans rather than employer-sponsored ones as the pandemic fuels job losses across industries, Reuters’s Manojna Maddipatla and Vishwadha Chander report.
- Some of the nation’s most iconic brands could disappear because of the pandemic, Daniela Santamariña, Abha Bhattarai and Kevin Uhrmacher report.