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The Highwire with Del Bigtree

WILLFUL IGNORANCE ON DISPLAY AT THE FDA?

The Highwire with Del Bigtree

The Highwire with Del Bigtree

News, Society & Culture, Health & Fitness

4.93.4K Ratings

🗓️ 10 November 2020

⏱️ 10 minutes

🧾️ Download transcript

Summary

Did the FDA ignore the WHO’s damaging megastudy on Remdesivir to push through their full approval of the antiviral drug? Dr. Eric Topol, Founder and Director of the Scripps Research Institute and Professor of Molecular Medicine, thinks the expensive drug isn’t that effective at all. Are safety and efficacy really the FDA’s top concerns, or is there something else going on?

Transcript

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0:00.0

Science Mag reported that this was about two weeks ago, we reported on this as

0:06.2

well that science mag wrote that WHO's solidarity trial for Remdesivir. This is

0:11.7

the anti-viral that was repurposed for COVID-19 false flat. So they released

0:15.9

their their data and this is the biggest study in the world and it showed that it

0:20.4

basically had little little effect and so the FDA approved this drug and did they

0:26.8

look at the WHO study, the biggest study in the world. Don't take it for me, take

0:32.7

it from Chief Scientist at WHO's is Dr. Swamin Yatin. Take a look at this.

0:38.2

Okay. What we understand from the FDA decision yesterday was based on data

0:42.4

submitted to them from Gilead which did not include the solidarity trial

0:47.1

results. We have submitted the solidarity trial results to Gilead. They first

0:53.1

saw the results on the 23rd of September and then saw the full manuscript on

0:59.0

the 28th of September. So they did have the results even before they were made

1:04.7

public through Medarkiv because we give them give it to them 10 days in advance.

1:10.3

So it appears that the solidarity results were not considered, were not

1:14.2

provided to the FDA. We believe that this it is the largest trial in the world,

1:20.2

globally, 5000 patients were randomized to either endesphere or standard of care.

1:26.7

We looked at very important endpoints in hospital mortality, no difference.

1:32.7

92% of people who entered this trial were randomized to this trial were not on

1:37.8

mechanical ventilation. So we looked at how many of those progressed to need

1:42.2

ventilation, exactly similar numbers in the remdesivir and the control arm.

1:47.2

It's outrageous. I remember when we were reporting on this just a couple of weeks ago

1:51.0

and it's, I mean this huge study shows this remdesivir does not really

...

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