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Daniel O'Day, CEO of Gillead Sciences Inc., speaks during a meeting with President Donald Trump in the Oval Office of the White House, Friday, Alex Brandon/PA

US regulators approve use of experimental drug to treat coronavirus patients

The Food and Drug Administration acted after preliminary results from a government-sponsored study of remdesivir.

US REGULATORS HAVE approved emergency use of an experimental drug that appears to help some coronavirus patients recover faster.

It is the first drug shown to help fight Covid-19, which has killed more than 230,000 people worldwide.

The Food and Drug Administration (FDA) acted after preliminary results from a government-sponsored study showed that Gilead Sciences’ remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalised Covid-19 patients.

The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir’s effects could be rigorously evaluated.

President Donald Trump announced the FDA’s action at the White House.

Those given the drug were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug also might be reducing deaths, although that is not certain from the partial results revealed so far.

The National Institutes of Health’s Dr Anthony Fauci said the drug would become a new standard of care for severely ill Covid-19 patients like those in this study.

The drug has not been tested on people with milder illness, and currently is given through an IV in a hospital.

The FDA said the intravenous drug would be specifically for hospitalised patients with “severe disease,” such as those experiencing breathing problems requiring supplemental oxygen or ventilators.

Early days 

FDA commissioner Stephen Hahn said “this was lightning speed in terms of getting something approved”, calling the drug “an important clinical advance”.

Dr Sameer Khanijo, a critical care specialist, said he wants to see additional studies to clarify the drug’s benefit.

“I don’t think this is a cure yet, but I think it’s starting to point us in the right direction,” said Dr Khanijo of North Shore University Hospital in New York. “As a society it’s nice to have something that will help stem the tide of this disease.”

The FDA said preliminary results for federal researchers warranted Friday’s decision, though regulators acknowledged “there is limited information known about the safety and effectiveness of using remdesivir”.

The drug’s side effects include potential inflammation of the liver and problems related to its infusion, which could lead to nausea, vomiting, sweating and low blood pressure. Information about dosing and potential safety issues will be provided to doctors and patients, the FDA said.

The drug, which blocks an enzyme the virus uses to copy its genetic material, has not been tested on people with milder illness.

The FDA authorised the drug under its emergency powers to quickly speed experimental drugs, tests and other medical products to patients during public health crises.

In normal times the FDA requires “substantial evidence” of a drug’s safety and effectiveness, usually through one or more large, rigorously controlled patient studies.

But during public health emergencies, the agency can waive those standards and require only that an experimental drug’s potential benefits outweigh its risks.

Gilead has said it would donate its currently available stock of the drug and is ramping up production to make more. It said the US government would coordinate distribution of remdesivir to places most in need of it.

No drugs are approved now for treating the coronavirus, and remdesivir will still need formal approval.

The FDA can convert the drug’s status to full approval if Gilead or other researchers provide additional data of remdesivir’s safety and effectiveness.

“This is a very, very early stage so you wouldn’t expect to have any sort of full approval at this point,” said Cathy Burgess, an attorney specialising in FDA issues. “But obviously they want to get this out to patients as quickly as possible.”

The FDA previously allowed narrow use of a malaria drug, hydroxychloroquine, for hospitalised patients who were unable to take part in ongoing studies of the medication.

Trump repeatedly promoted it as a possible Covid-19 treatment, but no large high-quality studies have shown the drug works for that and it has significant safety concerns.

The FDA warned doctors late last month against prescribing the drug outside of hospital or research settings, due to risks of sometimes fatal heart side effects.

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    Mute Thomas Harrington
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    Apr 20th 2021, 7:51 PM

    1) Cops only go after the easy stops
    2) students need to grow a pair

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    Mute Big Smokey
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    Apr 20th 2021, 8:12 PM

    @Thomas Harrington: honestly have never seen students complaining. Only people complaining about students.

    Also I don’t see how it’s acceptable to say “grow a pair” when students are getting regular fines of €75 when they don’t have any income.

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    Mute Brian Lyons
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    Apr 20th 2021, 8:46 PM

    @Thomas Harrington: if they only go after the easy stops who is filling the jail’s with the terrorists, murderers, organised gangs ?

    69
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    Mute Pat Casey
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    Apr 20th 2021, 8:04 PM

    If those little scrotes weren’t having house parties and super spreader get togethers they would have no problems with the guards.

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    Mute Lily Martin
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    Apr 20th 2021, 9:29 PM

    @Pat Casey: maybe read the article

    46
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    Mute seangolden1978
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    Apr 20th 2021, 7:52 PM

    Policing Authority trying to justify their existence again. I can understand the role of GSOC but the policing authority seems like a complete waste of time

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    Mute O Hiongardail Collie
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    Apr 20th 2021, 8:13 PM

    The policing authority…… They don’t want body cams because that would be spying on the community says it all really

    89
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    Mute Diarmuid O'Braonáin
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    Apr 20th 2021, 8:08 PM

    “People should not be afraid of their government, government should be afraid of their people”

    85
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    Mute merely ed
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    Apr 21st 2021, 12:35 AM

    @Diarmuid O’Braonáin: they are… thats why we have the police. You don’t think they’re there for us, do you?!

    11
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    Mute plug
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    Apr 20th 2021, 7:58 PM

    low hanging fruit is always the tastiest.

    77
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    Mute Garreth mc mahon
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    Apr 20th 2021, 8:00 PM

    @plug: depends on who’s plums you’re tasting

    34
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    Mute merely ed
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    Apr 21st 2021, 12:31 AM

    @plug: True that… sure most garda never even see an actual criminal. It goes…
    Order of engagement:
    Drug users (non supply)
    Low level drug mules/ growers
    Students
    Road users
    Actual criminals (low level)
    White collar
    Government corruption
    Other police (usually abusive partners… although realistically this would be much further down)

    13
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    Mute Darren Carroll
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    Apr 20th 2021, 8:34 PM

    And yet no fines for people attending golfgate

    71
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    Mute OnlyHereForTheComments
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    Apr 21st 2021, 12:14 AM

    @Darren Carroll: bit difficult since fines for breaching travel restrictions only came into effect in January 2021, but hey! Whataboutery, am I right?!

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    Mute merely ed
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    Apr 21st 2021, 12:37 AM

    @OnlyHereForTheComments: well you’re certainly leaning that way…

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    Mute larry bird
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    Apr 20th 2021, 9:34 PM

    if students behaved they wouldn’t have this issue.

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    Mute Jæ Zucula
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    Apr 20th 2021, 10:13 PM

    @larry bird: and for you! What about read the article? I promise you won’t take that long.

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    Mute Honeybee
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    Apr 20th 2021, 10:51 PM

    I do have sympathy for students as depicted in the article and yes the pandemic has introduced a changed interface between the gardai and the public. Some gardai behave in an authoritarian manner arising out of new powers the government sanctioned , for a people who have always known policing by consent, this change in attitude is difficult to take on board, it will be good when sanctions are withdrawn and policing returns to normal, no more heavy handed rules and interrogation of people just trying to live their lives.

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    Mute Tomo
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    Apr 21st 2021, 9:10 AM

    @Honeybee: The Gardai will always feel entitled to interrogate you at any checkpoint from this point onwards, regardless of the law. Sure, I was out walking once in the park a few years ago and they wanted to randomly search my bag, know all my details… I just asked “why?” and they responded “because we’ll arrest you if you don’t tell us”. Gardai are disgusting to deal with as a young person.

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    Mute Tomo
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    Apr 21st 2021, 9:06 AM

    Gardaí will only target those they can pick on. Older people can break the 5km all they like and have far fewer consequences. Students (within their 5km) have been fined so many times (anecdotally). It’s the same with drugs – they’ll pick on harmless people for smoking a joint and won’t go after real drug dealing criminals.

    10
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    Mute Tomo
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    Apr 21st 2021, 9:15 AM

    I really don’t think Irish people fully understand the implications of all these restrictions, having the longest lockdown in the world, and having people in fear of arrest or fine just from seeing a police officer. These have long term consequences down the line. Just one example is, as mentioned in the article, if young people start seeing Gardai as the aggressor, they’re could end up not reporting crime to the Gardai.

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    Mute Mr T
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    Apr 21st 2021, 12:02 AM

    The Garda, not all, are incorrectly perceived as being desk jockeys who turn a blind eye to common dangerous misdemeanors such as cyclists with no lights on their bikes, cyclsts breaking red lights and less dangerous but, just as annoying, dog owners not being fined for not picking up their dog’s excrement (nothing quite beats walking in dog s%it and bringing it home on your shoes).

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    Mute Gavin Tobin
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    Apr 20th 2021, 10:22 PM

    As Alexei Sayle once said “I hate fooking students, even when I was a student I hated fooking students”

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    Mute Jæ Zucula
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    Apr 20th 2021, 10:18 PM

    So there you have! I’m not a student and i can tell that what written in this article doesn’t surprise me at all.
    Anyway, people refuse but the truth of since 2020 “End does justify the means”.

    6
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