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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 The Divils Avocado
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    Mar 30th 2021, 6:24 AM

    No smoke without fire. An eradication of morale would fit with the recent reports on banning its members from partaking in a dance that every other emergency and voluntary rescue service in the country took part in. Publicising the organisation for all the wrong reasons. I don’t think I’d have much confidence in the management.

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    Mute David Corrigan
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    Mar 30th 2021, 6:17 AM

    “The official ‘Great Place to Work’ survey, commissioned by the Irish Coast Guard…”

    One would have to wonder if there are any connections between management and the company behind their own survey.

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    Mute Anto Curran
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    Mar 30th 2021, 6:56 AM

    @David Corrigan: wow that’s a fairly baseless accusation, one would have to wonder if there’s any connections between yourself and the unofficial survey that has no accountability or transparency (see I can do it too)

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    Mute David Corrigan
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    Mar 30th 2021, 7:02 AM

    @Anto Curran: Their own commissioned survey paints them in good light while the “unofficial” survey says that things are not so good within camp. Couple this to the fact that there is plenty of evidence of underhanded behaviour in this country means that there will always be suspicions around internally driven surveys.
    It’s not that hard to understand Anto is it?

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    Mute Madra
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    Mar 30th 2021, 7:21 AM

    @David Corrigan: those ‘Great places to work’ are a joke. A company I worked for won it once. They had more staff out on mental health issues due to senior directors and bully boy tactics.

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    Mute David Corrigan
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    Mar 30th 2021, 7:34 AM

    @Madra: Stone cold. There are a lot of people in this country who refuse to believe that kind of thing. It just couldn’t be true they say!!!

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    Mute Petulant mcbarity
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    Mar 30th 2021, 10:41 AM

    @David Corrigan: An unofficial survey might easily have a bias, being started by and forwarded to people with a grudge already.

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    Mute patrick boland
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    Mar 30th 2021, 12:48 PM

    @Madra: but it’s a great place to shop??

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    Mute Fintan Keating
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    Mar 30th 2021, 8:30 AM

    Why use a picture of RNLI boat and crew? Very different organisations.

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    Mute Mick McGuinness
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    Mar 30th 2021, 6:40 AM

    How many people actually use or know about the Coast Guard. Very few I’d imagine they do a great job when needed.

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    Mute flexfinn
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    Mar 30th 2021, 7:15 AM

    @Mick McGuinness: tbh here, everybody knows how good a job the coast guard and their volunteers do and luckily not many need to use their services

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    Mute Pat O'Leary
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    Mar 30th 2021, 10:21 AM

    Just as an aside, any sign of the official report on R116 crash in March 2017 (that would be fully 4 years ago) ever being published?? Not aware of any equivalent accident where within a couple of days they had the wreckage + a rough idea of what had happened, yet four years on people still waiting for the official accident report.

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    Mute Gavin Tobin
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    Mar 30th 2021, 10:17 AM

    Ask the right question, get the right answer?

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