Huge COVID study finds remdesivir doesn't work--FDA grants approval anyway

[Klaralven]

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.”

...

But in a press conference Friday, the WHO hit back, arguing that the data was, in fact, more robust that the smaller trials that came before it and should certainly be included in any regulatory or clinical decision.

“It is the largest trial in the world,” WHO’s chief scientist, Soumya Swaminathan noted. And unlike the NIAID study, which used a somewhat subjective clinical scoring system to compare disease progression and a range of definitions for “recovery,” the Solidarity trial compared only clear, indisputable outcomes: mechanical ventilation, discharge from the hospital, and death.

“[Death is] not a soft end point,” Swaminathan said. “You cannot fudge that endpoint.”

Swaminathan also noted that it was clear that the FDA did not have the Solidarity trial data when it made its decision to approve remdesivir. But she emphasized that the WHO had provided that data to Gilead in advance. “They first saw the results on the 23rd of September,” she said, well before it was made public. But “it appears the results were not considered—not provided to the FDA,” she said.

https://arstechnica.com/science/2020/10/fda-approves-remdesivir-for-covid-19-but-global-study-finds-it-doesnt-work/

So besides being extremely expensive, it doesn't work. You could use HCQ or ivermectin instead: they are inexpensive and don't work.

[Ferrets are Cool]

1. All about the profit

[soothsayer]

2. Yeah I was puzzled by that

I mean, except for the obvious greed

[BigmanPigman]

3. When I posted this yesterday a lot of replies discussed this

https://www.democraticunderground.com/10142611274

discrepancy between the WHO and FDA studies, etc.

[Hugin]

5. From this article it claims that the FDA didn't have the WHO study...

I wonder who was responsible for turning that over? Gilead?

[Midnightwalk]

8. Interesting discussion. Thanks. nt

[Hugin]

4. It's good to see some pushback against the Trump FDA.

Sooo much horseshit.

My rule #1 for pandemic survival has become, "Do not get trapped in a country populated by buffoons and subject to politicization of disease." It used to be "Cardio."

[StarryNite]

6. It didn't make sense to me how the week before it was said to be ineffective.

Now, a week later, it's the cure? I really wish it would be. Damn, we need a cure for this killer disease.

[NRaleighLiberal]

7. I worked in Pharma for 25 years - it ends up being all about statistics

as they say, numbers can be manipulated to say anything. I saw so many drugs being approved that the numbers had to be twisted to make look good. I am so glad I am out of it after watching exorbitant prices being charged for medicines that were marginally better, at best, than those on the market....not to mention that any given medicine only works on certain percentages of people (each of us have our own set of genes that impact efficacy).