The UK Approves Usage of Molnupiravir Against COVID-19

What does this mean for the rest of the world?

Imagine my (lack of) shock that the UK has just approved usage of Molnupiravir, which may begin being administered by mid-November.

It seems as if the UK’s National Health Services (NHS), the national healthcare program for the UK, used the interim data from Merck’s MOVe-OUT trial to justify its usage.

Once again, I am frustrated at the lack of concern and hesitancy with the usage of the drug.

As I have indicated just this week, there are a few concerns with the way these clinical studies were conducted, and there plenty of concern about the lack of rigorous mutagenic studies, particularly ones that examine long-term mutagenic effects.

But once again, look at how Molnupiravir is presented in the media, and see if there is any information about its mechanism of action.

Here’s The Guardian:

Molnupiravir interferes with the virus’s ability to replicate, meaning it is less able to multiply and reach high enough levels in the respiratory system to cause severe disease. Because the drug is most effective when given in the early stages of infection, the MHRA recommends it is used as soon as possible after a positive test for Covid and within five days of symptoms appearing.

Here’s The Courier:

The treatment works by interfering with the virus’s ability to replicate itself in the body.

It stops the virus from multiplying, reducing the severity of the disease and limiting its effects.

Here’s from Forbes key facts:

The pill, known as molnupiravir, “interferes with the virus’ replication,” which prevents the virus from growing, ultimately reducing the severity of Covid-19, the Medicines and Healthcare products Regulatory Agency (MHRA) said.

There’s plenty more you can look up (and here’s a recent Forbes article that actually raised concerns), but the point I am making here is that the news outlets who provide information to an overwhelming number of people could not even be bothered to indicate what the hell the drug actually does aside from ending “viral replication”! If not indicated by independent sources, I doubt people would be aware of how Molnupiravir actually works.

It is the job of the media, whose sole purpose is to relay information to the masses, to make sure that they present as much of the information that they can. Unfortunately, it is quite apparent that many people who have reported on anything surrounding COVID tend to not be able to discern any of the information for themselves.

What’s even more astonishing is that the clinical trials, which may be considered underpowered (~ 1,400 participants) have not even been completed! The results for the last 40% of data is still unaccounted for, and so once again it is quite shocking that the clinical trials have not even concluded. Remember that this happened to Remdesivir, with Dr. Fauci even commenting that it would be unconscionable to not offer Remdesivir with such good clinical trials, which lead to their abrupt end.

Look, the importance for at home therapies against COVID are extremely important, and I won’t argue about the efficacies of Hydroxychloroquine or Ivermectin here. Instead, the need for at-home therapies should not supersede the concerns about possible toxic side effects. Unfortunately, it seems as if the ability to be administered at home is the biggest driving force for pushing for Molnupiravir.

We need more evidence and more testing, even if they prove fruitless in the long term and we find that Molnupiravir is absolutely safe and effective. But as it stands right now the approval does little to assuage any concerns, concerns which have been increasing since the beginning of the pandemic, that many of our regulatory and federal institutions are more concerned with exterminating COVID than to be concerned about other nuanced positions.

This is even more concerning when one of the members of the FDA Advisory Committee that approved use of vaccines in children aged 5-11, indicated that they will not know of possible side effects until they start giving the vaccines to children. In this sense, would anyone who is administered a new, experimental treatment not see themselves as anything more than acting as guinea pigs for fast tracked therapeutics?

The Zhou et. al. 2021 study was an in vitro study, so it’s hard to argue that its results translate well into clinical trials and human models, especially since the dosage was much higher and was administered for much longer than would be expected.

However, something I forgot to highlight, is that the study also examined 2 mutagenic drugs as well: Ribavirin and Favipiravir. It would make sense, then, that much higher and longer doses of these drugs should possibly elicit mutagenic properties as well. Instead, we see the opposite; both Ribavirin and Favipiravir seemed to elicit no mutagenic effects.

Taken from Zhou et. al. 2021. The usage of Favipiravir (green bar) and Ribavirin (red bar) indicate no mutagenic effects, while Molnupiravir (NHC - dark blue bar) shows high levels of mutagenicity. It’s important to note that the lower dosage (light blue) does not indicate the same level of mutagenicity, indicating a dose dependency that may not occur in human trials.

The mechanisms of action could be different, but this points to something important about the way these drugs are used. Both Ribavirin and Favipiravir have very narrow window of usage, and both indicate that they should not be used when pregnant or becoming pregnant. How then, can two well-established mutagens that have been to market for some time, who have a very narrow window of usage, have a greater number of safety warnings than this new, highly experimental therapeutic?

Fortunately, it does seem that the drug will be reserved for the elderly and those with comorbidities, but the widespread usage, especially in the young and those hoping to become pregnant, should still be seen with high skepticism.

Hopefully new data will support its safety and usage, but we will have to wait. Until then, the UK may serve as a model for what is to come throughout the world. I hope that this drug proves beneficial, but not at the cost of possible toxicities down the line.

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