The Molnupiravir Anthology Series Archive
The Molnupiravir Anthology Series Archive
A Collection of my posts on Molnupiravir
Just yesterday an FDA panel narrowly approved of the use of Molnupiravir by a 13-10 vote. It’s a severely narrow margin, and what’s even more shocking is that reports indicate the members were either concerned about approving its usage, and those that did were very lukewarm to its usage.
As it stands the committee approval have raised plenty of concerns:
This is only to be approved for use in people over 18. This could be due to the demographics of the people in the Phase III studies, but it seems like there are also concerns about the drug’s affect on growing children, in particular its effects on children’s growth plates (based on animal studies).
There seems to be large concern around its use in pregnant women. Again, it seems like the recommendation is only in extreme circumstances. But remember that the clinical trials excluded pregnant women, women who are expecting to get pregnant, and that men could not donate sperm for a month after their last dose. People should be reminded of the issue with thalidomide in the 1960s, a drug used to treat morning sickness in pregnant women which scientists later found out was a teratogen and caused many birth defects. It’s because of this that Molnupiravir should not be used under any circumstance in pregnant women with the concern about possible teratogenicity.
Possible mutations may arise with the use of Molnupiravir. Remember, as a mutagen its mechanism of action is to cause mutations within the viral genome that leads to viral catastrophe. However, the mutations are random, and therefore mutations may arise that operate to benefit the virus. If these strains were to escape and infect people who are not being treated the results could lead to an escape variant that may be more dangerous, all due to the use of this mutagen.
Again, it seems like the majority of the panel are either concerned are unenthused by the use of this drug. It speaks well to the concerns of many doctors, and yet for them to reach a marginal approval consensus also speaks to the concern that the precautionary principle is not being used. The cure cannot be worse than the disease, and thus it seems incomprehensible to approve the use of a drug just for the sake of having an at home therapeutic.
I have been writing about Molnupiravir since early September. The first few talks about it as being similar to Ivermectin made me brush it off, but eventually I looked up the structure and information.
Immediately I noticed it was a nucleoside analogue, meaning that it’s molecular structure is similar to that of typical nucleosides. In this case, Molnupiravir looks similar to cytidine.
But looking up information about it quickly brought up something concerning: it operates as a mutagen, and immediately I grew suspicious.
This started my dive into looking up information on Molnupiravir and highlighting my concerns about the drug.
As of now, I am going through the 9 hour meeting. I plan on picking out concerning information as it relates to the evidence. But for now, I would like to indicate all of my previous writings on Molnupiravir. There’s many of them, and I believe it’s important that people get a deeper discussion about Molnupiravir.
This is my first post. I looked at the mechanism of action and highlighted an in vitro study that raised concerns about the possible carcinogenesis of the drug if used in humans.
Here I mentioned concerns about media reporting on the first information coming out of Merck’s Phase III trial. However, I did not dive deep into the information in that study, drawing more concern about the strange reporting in the media that seems to not bring much attention to its mutagenicity.
I actually dive into the clinical studies and examine what I find concerning with the studies, particularly that the phenomenal results of the clinical trials were based on the incomplete interim data, which only contained around 60% of the actual participants at the time. I also examined a paper from 2020 that raised concerns about the drug, noting that there seemed to be misreporting on a prior drug as being similar to Molnupiravir.
Here’s Part I
And here’s Part II
This one, again, argues about more concerns about media reporting and bringing up a bit of information on Molnupiravir following its approved use in the UK.
Lastly, this is the most recent piece. Shockingly, the final results of Merck’s outpatient trial are far worse than they were providing in the interim report. I bring up concerns about why such a discrepancy could occur, and whether there may have been something concerning at play here. Remember that even now people continue to report the remarkable results of the interim study and not the actual final study.
In the meantime I am hoping to get through the entire meeting and provide my remarks on what stands out. Unfortunately, it’s pretty boring. Scientists aren’t well known to be enthusiastic and so this entire 9 hours will become a slog to get through! But hopefully there will be useful information that comes out of it!
Edit: I will include my piece on the FDA Committee Meeting. Frankly, it was quite boring although there were several alarming things that stood out.
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OK this is SUPER late but I linked the wrong post. I linked one post twice instead of the one about the clinical study. Apologies for that, I shouldn't have overlooked that as it's a pretty egregious mistake.