New Drug Slashed Deaths Among Patients With Severe Covid, Maker Claims
An experimental drug halved the death rate among critically ill Covid patients who were receiving supplemental oxygen and were at high risk for serious lung disease and death, the drug’s developer announced on Monday.
There is a pressing need for new treatments for critically ill patients. Drugs like Paxlovid, made by Pfizer, are aimed primarily at patients who have mild or moderate disease. Other treatments administered to hospitalized patients in serious condition have shown limited effectiveness.
The new drug, sabizabulin, reduced deaths among hospitalized Covid-19 patients so drastically in a clinical trial that independent safety monitors recommended stopping it early, officials at Veru Inc., the drug’s maker, said. The trial was halted on Friday.
The results of that trial have not been peer-reviewed or published in a medical journal. Veru announced the findings at an early-morning news conference. The company’s stock soared in trading Monday following the announcement.
About half of the 52 trial participants given a placebo or dummy pill along with regular care died within 60 days, an indicator of how very sick they were. But the death rate was 20 percent among the 98 participants who received sabizabulin, who were just as ill. The drug was given once a day for up to 21 days.
“Sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients,” Dr. Mitchell Steiner, chief executive of Veru, said. “This represents a big step forward.”
Coronavirus Drug and Treatment Tracker
Most Covid restrictions have been lifted in the United States after declining case numbers, but cases, hospitalizations and deaths around the world continue to be high, Dr. Steiner added. New variants are bound to emerge, and surges will follow.
Close to a million Americans have died of Covid, and there are still 570 fatalities every day on average.
The drug was granted so-called fast-track status by the Food and Drug Administration in January, Dr. Steiner said. The designation is intended to prompt faster development and review of new treatments that address unmet medical needs and target serious or life-threatening conditions.
Dr. Steiner said the company plans to meet with the agency later this month and will be applying for emergency-use authorization for sabizabulin. An F.D.A. spokeswoman declined to comment, saying the agency did not confirm, deny or comment on pending applications.
No safety concerns related to the drug were identified in the course of the clinical trial, company officials said.
“Despite it being two and a half years into the battle, we are still working hard to get highly effective drugs into the mix to treat this specific population of patients, and this is a fairly dramatic improvement in 60-day mortality,” said Dr. Michael Gordon, one of the trial investigators and chief medical officer at HonorHealth Research and Innovation Institute in Scottsdale, Ariz.
But Dr. Gordon leavened his optimism with caution, saying he was eager to see more detailed analyses. Additional data were still being analyzed on Monday, including the proportion of treated patients without respiratory failure, the number of days they spent in intensive care, the length of their hospital stay and how long they were on mechanical ventilation.
“No drug works for everybody,” Dr. Gordon said. “The benefit that was seen is mortality — who is living and who is dying — not who is getting off oxygen, though I anticipate we will see improvement in other parameters, too.”
Patients on both arms of the multicenter trial received all standard care and treatment. The participants were in the United States, Brazil, Argentina, Mexico, Colombia and Bulgaria, and they had been infected with both the Delta and Omicron variants. The drug is effective regardless of the variant type, Dr. Gordon and company officials said.
https://www.nytimes.com/2022/04/11/health/covid-sabizabulin-veru.html
*************************************************When will Fauci and liberal leaders apologize for the millions of lives damaged with pointless COVID restrictions?
Fauci finally admitted to the nation this weekend what has been obvious to everyone, except the most hysteria-prone slice of the population, since last summer: that the pandemic is now endemic. That means it’s here to stay, no matter what we do, so let’s learn to live with it. There is no point to the insane restrictions people insist on like latter-day Puritans denouncing each other for failing to carry out the prescribed rites to ward off the Devil.
“This is not going to be eradicated, and it’s not going to be eliminated,” Fauci said on ABC’s “This Week.” “And what’s going to happen is that we’re going to see that each individual is going to have to make their calculation of the amount of risk that they want to take.”
Great! But what has changed? This is exactly the message Fauci needed to deliver to the people . . . approximately a year ago.
Let’s talk next steps. What’s he going to do to make up for all of the needless misery he caused? I’m not asking him to think like his fellow Italian Marc Antony and fall on his sword, so let’s turn our minds to the moderate and reasonable options. How many days is Fauci volunteering to place himself in stocks set up on the National Mall so that we can all pelt him with rotten eggs? One day for every completely wrong thing he ever said would be fair, but then he’d be there all summer. So let’s be charitable and just make it a long holiday weekend.
The nation’s 4-year-olds should be allowed to get to the front of the line, if any of them can squeeze in some time between appointments with all of the speech pathologists and psychotherapists they need because of Fauci’s insane policies.
Over the years, Fauci was very adamant about his findings and is sharing a complete different perspective now.
“We’re at that point where, in many respects, that we’re going to have to live with some degree of virus in the community,” Fauci also said Sunday.
COVID doves such as Dr. Monica Gandhi, an infectious disease specialist at the University of San Francisco, saw all of this coming: wearing a rag over your face wasn’t going to stop an incredibly transmissible virus.
“We’re going to get it,” she predicted last September. “Unless you just sit in your room, you’re going to get it in your nose. But at least in this country, it will be manageable.”
“The emergency phase of the disease is over,” Stanford professor and health economist Jay Bhattacharya said last summer. “Now, we need to work very hard to undo the sense of emergency . . . panicking over case numbers is a recipe for continuing unwarranted panic,” because the vaccines provide superb protection against death or hospitalization.
Yet as recently as November, Fauci said, preposterously, that he was going to put off calling the virus endemic until we got the thing cornered: “We want control and I think the confusion is at what level of control are you going to accept it in its endemicity.”
Huh? Asserting “control” has nothing to do with “accepting its endemicity.” When you do the latter, you’re acknowledging the former isn’t possible. COVID is not subtle: ever since we learned in the middle of last year that even vaccinated people can catch it and spread it, it has been flashing a message as unmissable as the American Eagle signage in Times Square: “You can’t control me, bro. I’m coming for everybody. Get vaccinated and you’ll live.”
You may have missed it, but Fauci said something even stupider than “We gotta control this thing before we admit it’s endemic” in the November interview: that we shouldn’t get too excited about the distinction between such COVID outcomes as “getting killed” and “missing a day of work.”
Why did he say something so absurd? Because he’s Larry Lockdown and loves to create confusion and panic. Like another blustering egomaniac, the guy he used to work for, he can’t handle the idea of an America in which everyone isn’t talking about him all the time. In post-COVID America, guess who doesn’t get invited on Colbert and Kimmel and Meet the Press every week?
“I think we better be careful to not make too sharp a distinction between protecting against infection that’s symptomatic versus protection against hospitalization and deaths,” Fauci said in November. “I don’t know of any other vaccine that we only worry about keeping people out of the hospital. I think an important thing is to prevent people from getting symptomatic disease.”
By that reasoning, a head cold and stage-four lymphoma are the same thing. Ladies, and gentlemen, America’s doctor!
Fauci couldn’t grasp that the virus is two different animals depending on whether you’re vaccinated: A jab turns a venomous 100-foot dragon into an ill-tempered dog. For vaccinated and boosted Americans, you are at much higher risk of dying in a car accident than from the virus, yet people choose not to fear the Corolla the way they fear the Corona.
“Get vaccinated, then get on with your life,” should have been Fauci’s message from the start, except for small children, who were never at great risk in the first place and should therefore never have had to deal with idiotic restrictions such as mask mandates.
Vaccinated children are as well protected as vaccinated adults, and yet we continue to torture little kids by making them wear masks in day care, in schools, and on mass transit.
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The replication crisis has spread through science – can it be fixed?
It started in psychology, but now findings in many scientific fields are proving impossible to replicate. Here's what researchers are doing to restore science's reputation
I HAVE a confession to make: some of the articles that have appeared in New Scientist, including ones I have written, are wrong. Not because we deliberately misled you. No, our reports were based on research by respected scientists at top universities, published in peer-reviewed journals. Yet, despite meeting all the normal standards of credibility, some findings turned out to be false.
Science is in the throes of what is sometimes called the replication crisis, so named because a big hint that a scientific study is wrong is when other teams try to repeat it and get a different result. While some fields, such as psychology, initially seemed more liable than others to generate such “fake news”, almost every area of science has since come under suspicion. An entire field of genetics has even turned out to be nothing but a mirage. Of course, we should expect testing to overturn some findings. The replication crisis, though, stems from wholesale flaws baked into the systems and institutions that support scientific research, which not only permit bad scientific practices, but actually encourage them. And, if anything, things have been getting worse over the past few decades.
Yet as awareness of the problem has grown, so have efforts to tackle it. So, how are these opposing forces faring? Will the efforts to combat fake science succeed? And how can you know if the research you read about in New Scientist and elsewhere will ever make it out of the lab and start working in the real world?
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
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