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Bad Remdesivir news - Printable Version

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RE: Bad Remdesivir news - oregontim - 04-30-2020

(04-29-2020, 07:18 AM)stupac2 Wrote:  
(04-29-2020, 06:43 AM)OutsiderFan Wrote:  So how come I see all this "Remdesivir is a Covid-19 cure" this morning?

Hope is powerful, biology is complicated.

How much if any additional credibility for the remsdivir hopes when we have Dr. Fauci publicly optimistic about it, on the record, in the White House? I'm layman on this, but tending to believe Fauci. Is this just more politics? The quote here is from an NBC report yesterday morning:

Quote:
"'The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,' Fauci said at the White House on Wednesday. The data he referred to is from a large study more than 1,000 patients from multiple sites around the world. Patients either received the drug, called remdesivir, or a placebo."


RE: Bad Remdesivir news - oldalum - 04-30-2020

BC is correct about potential reasons for well-intentioned and executed mid-course changes, but it should be realized that there is a history in medical research of such changes being made improperly, compromising the integrity of the study. In general they should be infrequent, justified by changes in scientific knowledge outside of the trial, independent of knowledge or analysis of interim trial data, determined by an independent data monitoring committee, and clearly and publicly specified. See, e.g., article. There are good reasons why the data to be collected and a detailed analysis plan are required to be specified before a trial starts. If the changes are needed to salvage the chance to produce generalizable knowledge from a trial, pitfalls must be avoided and the changes and their justification should be clearly published.

RE: Bad Remdesivir news - Snorlax94 - 04-30-2020

A summary of some current treatments by Arun Jose, Assf Prof, U of Cincinnati

https://lookaside.fbsbx.com/file/COVID%20Updates%20Jose%2029APR2020%20Distributable.pdf?token=AWxEqKYUcfYB48v8EuhgnBe6IcQvAGBYwZima2CXeRO0NgR5Dxm3ZpTbiooQa842oOX7q25R03iA3FwlCpbB_uXf1pnsDnU6xr650v1mPwDHoFwmTgSDvHhJzikx1LSIVwUH9tSGnc4K7rwAxNUuROGsGJ4AF0_UAppyRmkZso_eHx68W01MiAXyezdd3caW2eraiM3x_IjvcGhuKQz1yjAE

RE: Bad Remdesivir news - BostonCard - 04-30-2020

(04-30-2020, 10:13 AM)2006alum Wrote:  Excellent and helpful analysis, BC, thank you. One quick follow-up: the pros and cons of an 8-point ordinal rating scale vs. days to recovery would presumably have been known to the researchers prior to launching the study, so do you have any insights as to why they would change midway through? I suppose my skepticism is that if it doesn't change outcomes but reduces recovery time for those who fully recover, then changing the primary endpoint would yield a more straightforward benefit from remdesivir. That's not nothing, but it does strike me as somewhat strange to change horses mid-race when the pros and cons of those horses were known out of the starting gate.

It's a WAG on my part, but here goes:
The ordinal scale generally has more power than looking at any single dichotomous outcome or time to event analyses, because every patient is potentially informative (in time to event analyses, only patients who have the event are informative).  So, two possibilities.  The first and obvious one is that the trial was oversubscribed (I think I saw that the actual recruitment was on the order of 1000), so they had more power to detect an effect in time to recovery.  The second is that a larger share of patients reached the event than they expected because recovery was generally faster in the blinded data than they had figured when they made the initial power calculation.  Note also that power calculations for ordinal endpoints are very hard because they require guessing the distribution of outcomes in the placebo group.

BC

RE: Bad Remdesivir news - dabigv13 - 05-01-2020

https://www.statnews.com/2020/05/01/fda-to-allow-emergency-use-of-gileads-covid-19-drug/

Remdesivir gets emergency FDA approval. May affect US trials since itll be hard to recruit a control group now. Gilead execs must be very happy though. Hopefully the stuff works. Does seem more likely to be helpful and less likely to be harmful than plaquenil which already got FDA emergency approval for covid, seemingly based purely on POTUS influence.

RE: Bad Remdesivir news - dabigv13 - 05-01-2020

More reporting on the mid trial change in primary metric from death, to time to leave hospital. 

https://www.washingtonpost.com/business/2020/05/01/government-researchers-changed-metric-measure-coronavirus-drug-remdesivir-during-clinical-trial/

RE: Bad Remdesivir news - 82lsju - 05-01-2020

(05-01-2020, 01:08 PM)dabigv13 Wrote:  https://www.statnews.com/2020/05/01/fda-to-allow-emergency-use-of-gileads-covid-19-drug/

Remdesivir gets emergency FDA approval. May affect US trials since itll be hard to recruit a control group now. Gilead execs must be very happy though. Hopefully the stuff works. Does seem more likely to be helpful and less likely to be harmful than plaquenil which already got FDA emergency approval for covid, seemingly based purely on POTUS influence.

here's the FDA fact sheet

https://www.fda.gov/media/137565/download
From an interview with Gilead’s CEO
   

Quote:How much are you going to be able to manufacture? How much are you to be able to ramp up supply?


I’m very proud of what the team has done since we became aware of this virus in January, both from a clinical perspective, but equally from a manufacturing perspective. So you know, we had around 5,000 treatment courses in January. Today we have more than 50,000 treatment courses, and that number is going to go up, as I said, 140,000 treatment courses plus between now and July. And then we could ramp up, to the end of the year to multiple millions of treatment courses.

Now, the reason that I’m proud of the team is because this is a complicated chemical process. It’s many, many steps. Initially, in January, it took around 12 months from end-to-end to produce this product. Now, based upon the efforts of the team, really fine-tuning all the manufacturing processes, we have that down to now around six months. And immediately in January, when we knew there was even a possibility this medicine could be effective, long before we had any idea, even before the in vitro data came through, we made the commitment as a company to say, this is too important. We have to make every investment that we can in the event that this works given the human need and the societal need here. So we started ordering new raw materials immediately in January. 

What gets us to the 1.5 million donation of vials is that we had a certain amount of raw materials in the supply chain and we were able to order some immediately to get us to the first half of this year. But what allows us to go to an exponential growth in the second half of the year is the actions we took in January to make sure we ordered those long lead-time raw materials, which are just coming in now and six months from now we’ll have end products. So that’s why when you get into the October timeframe, the November timeframe to the December timeframe, you get this very large increase in supply.

 
https://www.statnews.com/2020/04/29/gilead-ceo-were-going-to-make-sure-that-access-is-not-an-issue-with-remdesivir/

RE: Bad Remdesivir news - dabigv13 - 05-07-2020

https://www.washingtonpost.com/business/2020/05/07/remdesivir-hospitals-doctors/

I found this article rather alarming. Considering how this crew has already seemingly allowed politics to dictate distribution of ventilators, realizing they are also in charge of distributing the only known medication for covid19 was scary. I'm not sure what our access to this medication is in our hospital right now; I know several patients have received it in prior weeks prior to FDA emergency approval, I think on research protocol or compassionate use.

RE: Bad Remdesivir news - Griffins78 - 05-07-2020

(05-07-2020, 08:00 PM)dabigv13 Wrote:  https://www.washingtonpost.com/business/2020/05/07/remdesivir-hospitals-doctors/

I found this article rather alarming. Considering how this crew has already seemingly allowed politics to dictate distribution of ventilators, realizing they are also in charge of distributing the only known medication for covid19 was scary. I'm not sure what our access to this medication is in our hospital right now; I know several patients have received it in prior weeks prior to FDA emergency approval, I think on research protocol or compassionate use.
Saw initials reports yesterday on this and it confirmed by what I expected they would continue to do. One thing to be inept. Another when it is for ulterior motives.