
Data on 53 Patients Treated With Investigational Antiviral Remdesivir - wyxuan
https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/data-on-53-patients-treated-with-investigational-antiviral-remdesivir-through-the-compassionate-use-program-published-in-new-england-journal-of-medici
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vikramkr
Same comment I posted on the other thread relevant here:

Very promising early results. The caveats for non scientists to be aware of is
that these are not randomized trials with a placebo and all - this is just
through a mechanism called "compassionate use" that allows Gilead to give
people the drug. Also, 68% of patients improved, the title implies that
patients say a 68% improvement in their symptoms which is not the case, the
68% is the number of patients improved divided by total number of patients. To
get a good picture of how much the drug improves outcomes compared to not
having the drug administered, we need large placebo controlled randomized
trials so we can get the statistical signal to see if it works and how well it
works. As the paper states, those trials are underway.

~~~
hilbertseries
> More than half of patients on mechanical ventilation were extubated (57
> percent, n=17/30) and nearly half of all patients (47 percent, n=25/53) were
> discharged from the hospital following treatment with remdesivir.

Death rate for patients on ventilators has been something like 80 percent.

~~~
numbsafari
But, given that this was not a randomized trial, and was given on a
compassionate use basis, we don't know whether...

A) This is better than expected because doctors and families only elected to
use this for patients who were otherwise MORE likely to die.

B) This is worse than expected because doctors and families only elected to
use this for patients who more likely than not to survive.

C) This result is meaningless because there's too much noise in who was given
the drug and who was not.

~~~
vikramkr
It's a nice signal, but yeah, theres a reason they're running a large
randomized controlled trial right now for FDA approval - they arent likely to
get approval just based on this.

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hprotagonist
They changed their endpoints, too, i think.

 _The primary endpoint of the trial of moderate COVID-19 patients originally
looked at the proportion of patients discharged by day 14. The trial of severe
patients was assessing the normalization of fever and oxygen saturation
through day 14.

Now, Gilead has changed all of those details. The trial of patients with
severe COVID-19 has swelled in size from 400 subjects to 2,400 participants.
Gilead dialed the enrollment target in the clinical trial of moderate COVID-19
patients up from 600 to 1,600.

The trials have new primary endpoints, too. In each case, Gilead has changed
the primary endpoint to focus on the odds of improvement on a seven-point
scale that runs from death to not hospitalized._

[https://www.fiercebiotech.com/biotech/gilead-supersizes-
remd...](https://www.fiercebiotech.com/biotech/gilead-supersizes-remdesivir-
trials-changes-primary-endpoint)

~~~
tpm
That's for a different study though, no?

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hprotagonist
i’m not sure

~~~
vikramkr
Its definitely a different study, this one has nowhere near thousands of
patients...

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hcknwscommenter
As my advisor always used to say. If you didn't include a control, you didn't
do an experiment. It's that simple. THe results are promising, but you have to
keep in mind what that really means. It means, we haven't proven that it
doesn't work. SO there is a chance that it works and we don't know how big
that chance is. It also means that we haven't proven that it causes more harm
than good. So there is a chance that it does indeed do more harm than good.

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svara
No randomized control group. Without one all that these findings mean is "go
get more data".

~~~
Frost1x
They also mean "advertising opportunity in the face of ignorance."

Due to general systemic issues of incentives and disincentives to research
(especially tied to profit driven entities but its everywhere) that are
growing ever more problematic, successes are often painted more vibrant and
failures toned down, usually through loose/generalized language in summaries
or by adding so many quantifiable qualifiers to the situation/experiment at
hand, the results become nearly useless.

Research is not incentivized to give unbiased truth of failures the way
science should be. They focus on optimistic results and try to gloss over
negative results (have to pay rent and keep eating).

The truth usually requires reading through a full paper because while forming
narratives is commonplace, pure academic dishonesty is not. Research results
_typically_ do not forge or falsify results.

Even in a humanitarian perfect situation where Gilead is pushing the supply of
this out for free, I can assure you managers and purse holders want to see
positive results. If you're a research scientist working at Gilead, I highly
suspect you're going to be encouraged to show positive optimistic results, not
problems/shortcomings (as in most business environments). If you do show
negative results, they won't see the light of day if they're even read by
management.

~~~
vikramkr
It's not like you can go buy the drug on the open market. The fda are the
gatekeepers, and as gilead states in the press release, they are currently
running a large phase 3 study with a control group etc to confirm these
results

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jstewartmobile
So many gilead/remdesivir posts here... of no better quality than the whole
chloroquine controversy...

Ctrl+F Gilead:

[https://www.ycombinator.com/people/](https://www.ycombinator.com/people/)

~~~
wyxuan
False equivocation. Remdesivir has been actively going through the drug
approval process. P2 results for remdesivir indicate that side effects include
liver issues. Contrast that with chloroquine which is nowhere near as studied
(in context of covid) and is significantly more dangerous. There's a reason
why the WHO put remdesivir as the most promising drug.

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cameldrv
My question is why, three months in, we don't have data from even a small RCT
of Remdesivir?

~~~
vikramkr
They usually have predetermined readout dates since p values can fluctuate
throught data collection and prospectively defining those dates prevents you
from being able to just pick the best time for a readout and skew results

~~~
tristanz
Somewhat counterintuitively to frequentists, this is not a problem if they did
Bayesian analysis. Many new trails for COVID19 therapeutics are actually
reporting realtime Bayesian estimates of efficacy.

[https://www.pwc.com/us/en/industries/health-
industries/libra...](https://www.pwc.com/us/en/industries/health-
industries/library/coronavirus-who-master-clinical-protocol.html)

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tgafpc2
TL/DR: Treatment before intubation.

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ttul
This press release has no medical significance. It is borderline irresponsible
for Gilead to release such information, albeit they seem to have carefully
qualified everything they say so as to avoid liability.

~~~
vikramkr
Irresponsible to who? This doesnt get the drug approved. They're running large
phase 3s and all, which is what let's them put the drug on the market. In the
mean time compassionate use data is useful to know.

