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Pfizer isn't emergency use
Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
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Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#82So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now?
> So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now? No. They don't have full approval, and aren't likely to get it in the next few months. From the article: > Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible Emergency Use Authorization is not full approval, and obviously comes with oversight and data gathering. "as soon as Possible" i…
Was using "approval" colloquially, I understand the distinction between that and "authorized." However I have seen many larger trials for other repurposed drugs being tried in early treatment dumped on as "underpowered" so it's just odd that that criticism is nowhere to be found in this case. There were 7 people hospitalized in the trial group and 14 in the placebo.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#83https://www.nytimes.com/2021/10/01/us/merck-antiviral-pill-c... The NYTimes article sort of came off as suggesting this is a cheaper, easier to administer alternative to monoclonal antibodies. So I wonder what the overall effect will be on the number of deaths going forward. It’s definitely phenomenal science though, and hopefully we can use this to keep people out of the hospital!
the interview i heard this morning indivcated that there's also a big unknown around whether it can induce genetic mutation (presumably in gametes). (male) participants were advised against (unprotected?) sex during the trials to prevent potential future problems with progeny.
Male and female participants were required to abstain from unprotected sex.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#84Earlier quoted context omitted.
No. Studies on ivermectin are mixed, and it seems like the ones that showed positive effects had falsified data[1]. Additionally, this trial does not demonstrate that Molnupiravir is ineffective after hospitalization. [1]: https://www.theguardian.com/science/2021/jul/16/huge-study-s...
No, one of the positive studies about ivermectin had questionable data. There are dozens of studies with positive results. This post and the article you linked are misinformation. Edit: I don't normally comment on downvotes but the sentiment expressed by the silent downvoters in this thread is pretty gross. We're trying to have a discussion here, but clearly certain perspectives are not allowed, even if supported by…
At least two pro-ivermectin studies have been retracted. The remaining evidence is weak. I don't think your claim of misinformation is well supported.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#85So an abbreviated trial in 775 people is considered sufficient to move forward with drug approval now?
I guess you are wondering why this is better than Ivermectin. From the article:
> The MOVe-OUT trial (MK-4482-002) (NCT04575597) was a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study [...]
If you go to https://ivmmeta.com/ you will see:
* Most of the studies have not placebo, they just compare a group of people with another unrelated group of people. It's very difficult to be sure there are no unexpected differences.
* If you filter only the RCT, most of them are not statistically significant. That is a problem because if the drug has no effect, the reporting/publishing/selection bias will cause barely significant studies to accumulate.
* There are only 6 that RCT that are statistically significant. Have you read them? Some have very weird things that are very big red flags.
If Ivermectin has no effect, I expect like 2 of the RCT that are statistically significant to be caused by flukes. Can you pick your favorite 3?
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#86Phase 3 trial was stopped on a positive interim analysis by DSMB and in consultation with FDA Interim analysis was performed on approximately half of the total enrolled patients (775 of the 1550). Trial included many delta and other variant patients ————— Efficacy • ~50% reduction in hospitalization (14.1% PBO vs 7.3% drug) • 100% reduction in deaths (8 PBO vs 0 drug) ————— Safety • fewer adverse reactions in the dru…
Is 40% adverse reaction to a placebo typical? Really makes me wonder how many "side effects" are in our heads..
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#87Earlier quoted context omitted.
The vaccine maximalists ridicule "horse paste" because many people are literally buying and ingesting products intended for livestock.
In his Nobel-prize lecture, the Merck scientist William Campbell, talks about how Ivermectin was always intended to be used in humans. Two relevant quotes from his speech are, "I had always insisted that our written departmental objectives would include the development of new drugs for control of parasites in humans" and "The end of ivermectin is nowhere in sight." Check it out: https://www.nobelprize.org/prizes/medi…
Ivermectin is useful for control of parasites in humans (1) and other animals such as horses, but the grandparent is also correct, people are "literally buying and ingesting products intended for livestock" - from the veterinary aisle (2), and self-administering random doses not safe for humans, with bad consequences (3). It's sheer lunacy to do that. If it was effective for COVID-19 (a virus, not parasite), then medical staff would be administering correct doses.
1) https://www.who.int/tdr/news/2018/moxidectin-approved-as-tre...
2) https://www.iflscience.com/health-and-medicine/store-only-le...
3) https://www.npr.org/sections/coronavirus-live-updates/2021/0...
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#88Hospitalization from COVID-19
I had to check the title to make sure it is not there. I totally read "from COVID-19" in my mind.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#89I enjoyed this article explaining in more detail how the drug works, though much of it goes over my head: https://www.nature.com/articles/s41594-021-00657-8 Briefly, it causes the copying process of viral RNA to go wrong by increasing the number of G-to-A and C-to-U mutations. A potential worry is that such mutations will also increase in places where we don't want them, such as in host DNA, but apparently at least f…
> A potential worry is that such mutations will also increase in places where we don't want them Can anyone speak to how the drug avoids this? I've tried reading the literature, such as the Nature link above, and have failed to see what makes the drug specific to the virus.
Nature link says the drug targets RdRp specifically which is a type of RNA copying mechanism (mostly?) confined to viruses. Wikipedia says about RdRp:
> RdRps can be used as drug targets for viral pathogens as their function is not necessary for eukaryotic survival. By inhibiting RNA-dependent RNA polymerase function, new RNAs cannot be replicated from an RNA template strand, however, DNA-dependent RNA polymerase will remain functional.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#90I enjoyed this article explaining in more detail how the drug works, though much of it goes over my head: https://www.nature.com/articles/s41594-021-00657-8 Briefly, it causes the copying process of viral RNA to go wrong by increasing the number of G-to-A and C-to-U mutations. A potential worry is that such mutations will also increase in places where we don't want them, such as in host DNA, but apparently at least f…
> A potential worry is that such mutations will also increase in places where we don't want them Can anyone speak to how the drug avoids this? I've tried reading the literature, such as the Nature link above, and have failed to see what makes the drug specific to the virus.
Well one possibility is that, like chemotherapy or radiation vs. cancer, it's worth the risk. The body has DNA-repair mechanisms that could clean up the mess, if you're only taking the pill for a short time. The virus does not. Just a guess.