Thursday, March 28, 2024

Study Claims This ‘Anti-COVID’ Pill May Actually Be Driving New Variants.

Molnupiravir, the oral pill for COVID-19, may actually be driving the emergence of new, potentially harmful, variants of the virus, according to a Wellcome Trust-funded study at the pre-print stage. The news may come as a blow for Merck, the drug’s manufacturer, which reported massive revenues over the last year, and for the US government, which heavily subsidised the drug’s production and distribution. It will be vindication – albeit unwanted – for those who warned the drug was dangerous and should not be given emergency-use authorization by the FDA.

Merck’s antiviral drug works by causing specific kinds of mutation in the virus, the theory being that the virus will literally “mutate itself to death”, as Dr Harvey Risch, an emeritus professor from the Yale School of Public Health, explained.

Problems could potentially arise if patients treated with the drug do not fully clear an infection, and a drug-mutated strain escapes and infects other people. That this is now happening – if the new paper is correct – is “not a surprise”, Risch adds.

A team of researchers from the US and UK used global databases of SARS-COV-2 sequences to search for mutations that were characteristic of the changes Molnupiravir makes to the viral genome. They found noticeable increases in such changes in the database beginning from when the drug was first marketed. Importantly, the increases took place in those countries where the drug was used.

The initial inspiration for the study came from author Ryan Hisner, an Indiana middle-school teacher, who noticed that a significant number of new variants of COVID-19 emerged after the widespread distribution of Molnupiravir started to take place. He then teamed up with lead author Theo Sanderson, of the Francis Crick Institute in London, and researchers from Imperial College and the Universities of Liverpool and Cambridge to investigate further. The multinational research team is now awaiting the peer-review process for their paper.

Not Quite the Magic Pill?

In 2022, sales of Molnupiravir, which is marketed as Lagevrio, reached nearly $5.7 billion, with a particularly strong showing in Asia in the fourth quarter of the year.

Production and distribution of the drug was heavily subsidized by the US government. In June 2021, months before the drug had even completed clinical trials, the federal government signed a $1.2 billion contract with Merck for 1.7 million full courses of the drug, costing roughly $712 per patient. One analysis suggests this was effectively a 4000 percent markup on the actual cost of producing the drug.

Molnupiravir was granted emergency-use authorisation by the FDA on December 23, 2021, one day after Pfizer’s new antiviral, Paxlovid, was approved.

In February 2022, the federal government then purchased 3.1 million full courses of Molnupiravir, with the option to purchase more. One month later, the drug was included in President Biden’s “Test to Treat” program, in which anybody who tested positive for COVID-19 could obtain free antivirals at a pharmacy.

There were worries about Molnupiravir and Paxlovid from the moment they were announced; although the worries about Merck’s drug were more acute, because of the way that it works. Molnupiravir acts directly to induce mutations in the virus’s RNA genome, while Paxlovid doesn’t. Instead Paxlovid simply increases the virus’s lifetime within the human body, giving it more time to mutate naturally. This is also something the vaccines do.

Dr James Hildreth, a member of President Biden’s COVID-19 Health Equity Task Force, expressed his concerns about Molnupiravir to an FDA advisory panel in December 2021, before the emergency-use authorisation was granted. He stated that, “Even if the probability is very low, one in 10,000 or 100,000, that this drug would induce an escape mutant from which the vaccines we have do not cover, that could be catastrophic for the whole world actually.”

These worries were brushed away by a Merck representative at the time as “an interesting hypothetical concern”. Merck was warned repeatedly, from the beginning, by scientists of the potential dangers of the drug, but “decided to blow off any concerns and put Lagevrio… on the market anyway”. Other recent studies have also questioned the safety and efficacy of Merck’s drug.

Another pre-print study, from a group of Australian researchers, shows that Molnupiravir can “supercharge” the evolution of COVID-19 in the bodies of immunocompromised patients, again potentially leading to the creation of new variants. A study published in the Lancet in January came to the conclusion that Molnupiravir had little effect when it came to reducing “the frequency of COVID-19-associated hospitalizations or death among high-risk vaccinated adults in the community”.

There is some good news about this latest discovery. None of the variants identified as being potentially caused by Molnupiravair have proved to be more deadly or able to evade the body’s defences than any other COVID-19 variants we know about. Whether this remains true, though, is anybody’s guess.

Foreseeable?

In a very real sense, the case of Molnupiravir, and its potential consequences, is emblematic of everything that has been wrong with the official response to COVID-19 over the last three years. The idea that an experimental drug that behaves this way would be widely distributed strikes many as inadvisable. The truth is, the COVID response has been an iatrogenic nightmare. “Iatrogenesis” meaning “medically caused harm”.

Recently, we reported that Gen Z is suffering massive pandemic-induced depression. Forty-two percent of ‘Zoomers’ surveyed said they were suffering with a diagnosed mental-health problem, with 25 percent saying their diagnosis took place during the pandemic. Anxiety, depression, attention-deficit/hyperactivity disorder (ADHD), post-traumatic stress disorder (PTSD), and bulimia were just some of the conditions the respondents reported. Nearly 70 percent said they felt the pandemic had negatively impacted their mental health.

This is just the tip of the iatrogenic iceberg. In addition to all of the mental and developmental harms caused especially to the young by the prolonged social distancing requirements – which include record depression and anxiety, reduced activity levels and increased obesity, and even gestational effects on babies in the womb – we have to reckon with myriad economic, social, physical and mental harms, ranging from vaccine side effects and the suppression of cheap therapeutics, to the destruction of small businesses and rises in domestic violence and substance abuse. While some of these harms, arguably, might not have been foreseen, a great many could – indeed should – have.

Molnupiravir and its unwelcome side effects were foreseen, yet production and distribution continued all the same. A quick consideration of the history of the drug’s development – including, of course, the US government’s purchase history – should give us pause to think about the kind of entrenched interests that have made such a counterproductive intervention possible. Indeed, about the entrenched interests that have made other counterproductive interventions possible too.

At the moment, we can be thankful for small mercies. Molnupiravir has not created a monster. But if that does happen, what will be the response? Will the drug be pulled? Will corporate and governmental heads roll? Or will there be yet more obfuscation – more denials and more insistence that things are actually going totally to plan?

With billions of dollars and the credibility of the US government at stake, I think the answer should be obvious.

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