Huge COVID Study Finds Remdesivir Doesn't Work--FDA Grants Approval Anyway

[jayfish]

Source: Ars Technica

The US Food and Drug Administration on Thursday issued a full approval of the antiviral drug remdesivir for treating COVID-19—just days after a massive global study concluded that the drug provides no benefit.

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Stephen Hahn said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.”

Early results

The FDA made its decision based on three clinical trials on remdesivir, a repurposed experimental antiviral drug brand-named Veklury. One was a randomized, double-blind, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases. It included 1,062 hospitalized COVID-19 patients, 541 of which received remdesivir. The trial concluded that remdesivir shortened the median recovery time from the infection from 15 days to 10 days. The researchers running the trial defined “recovery” of a patient as either a patient being discharged from the hospital—regardless if the patient still had lingering symptoms that limited activities or required supplemental oxygen to be taken at home—or a patient remaining in the hospital but no longer requiring medical care, such as if they were kept in the hospital for infection-control reasons.

The other two trials the FDA considered were conducted by Gilead, the company that makes remdesivir. One trial looked at about 600 people with moderate cases COVID-19. Patients were split into three groups, each about 200 people—a group that got a 10-day course of remdesivir, a group that got a 5-day course, and a control group that got standard treatments. At day 11 of treatments, the group that had the 5-day course of remdesivir showed a statistically significant improvement in symptom scores compared with the control group. The group that got a 10-day course of remdesivir did not have a statistically significant improvement over the control group, though.

Read more: https://arstechnica.com/science/2020/10/fda-approves-remdesivir-for-covid-19-but-global-study-finds-it-doesnt-work/?comments=1

[SunSeeker]

1. Well that's great. Sigh. Whst about Regeneron?

[Sucha NastyWoman]

2. "Repurposed"

A drug didn’t work on its intended disease. Let’s see if we can find something else to sell it for.
If not we’ll make it a supplement (non-regulated).

Is this any way to run a pharma industry?

[melm00se]

9. It's called "off label"

the drug is prescribed for something other than it's stated purpose. An example is Bupropion.

Commonly prescribed to quit smoking but also for weight loss which was one of the side effects.

[ancianita]

3. Yep, that's the kind of government we now have.

Move the product, get it PR'd to death everywhere, charge high prices and pay back its investors like Trump.

[Maxheader]

4. pharmy r&d..

Has made a killing from corona...you betcha....

[Omaha Steve]

5. Kick

[TheRickles]

6. The same Gilead who named Donald Rumsfeld as Chairman in 1997.

Just Google "Rumsfeld, Gilead". Dozens of articles describing crony capitalism at its finest.

[LiberalArkie]

7. But Prozac does

Antidepressant fluoxetine (Prozac) suppresses replication of SARS-CoV-2

A study conducted by researchers at Julius-Maximilians-Universität Würzburg has shown that the antidepressant agent fluoxetine may be an effective drug for the early treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among at-risk groups.

Jochen Bodem and colleagues found that the selective serotonin reuptake inhibitor (SSRI) fluoxetine significantly inhibited viral replication of SARS-CoV-2 and decreased viral protein expression in a specific manner.

The team points out that clinicians started using fluoxetine during the seventies and that the patent expired long ago. This well-studied drug that has been used to treat people for almost four decades is widely available and relatively cheap, they say.

https://www.news-medical.net/news/20200616/Antidepressant-fluoxetine-(Prozac)-suppresses-replication-of-SARS-CoV-2.aspx

[JCMach1]

8. I was going downhill pretty quickly until I started remdesivir

In the Covid ICU... Literally a few hours from requiring a ventilator.

[Scruffy1]

11. I'm glad you survived. n/t.

[oldsoftie]

12. My cousin also said it helped her. She wasnt as bad off as you though.

She also said that Hydroxichloroquine (sp) was stopped after 3 days because it made her feel like shit.

[BlueIdaho]

10. Anything for a Pro-Pharma Buck. nt.

[not_the_one]

13. Because the turd is taking it.

n/t