Merck's Molnupiravir - The First Covid-19 Pill (maybe)

[northland10]

I thought that I was jumping on TFB bandwagon by coining a cutesy word that might find it working its way into the mainstream lexicon on here.

I've seen teh for the; elk for ilk; deninned (or thereabouts) for denied; likely a handful of others that escape my memory. That is why I wrote Goggled instead of Googled. I do not use auto-correct, Safari or Edge. Firefox sans autocorrect.

If I missed your attempt at playful humor, that's on me!

I was being silly and snarky. It gave me an opportunity to bring up Orly's "Google my Yahoo" thing which the 12-year-old in me is compelled to do. We could serious use some new terms here. With Ed Hale moving on to swamp cooler in the sky and Bob no longer running to Orly's webstye (along with a lack of Orly filings) we are really lacking new vocabs. Go for it.

[AndyinPA]

https://www.theguardian.com/commentisfr ... big-pharma

Last week, we learned that Merck is planning to charge Americans 40 times its cost for a Covid drug whose development was subsidized by the American government. The situation spotlights two sets of facts that have gone largely unmentioned in the legislative debate over whether to let Medicare negotiate for lower drug prices.

Fact one: Americans are facing not merely expensive drugs but prices that are examples of outright profiteering.

Fact two: in many cases, the medicines we are being gouged on are those that we the public already paid for.

These facts show us that pharma-bankrolled Democrats trying to kill drug pricing measures aren’t just bought and paid for in this particular skirmish – they are foot soldiers in the pharmaceutical industry’s larger multi-decade campaign to seal off and rig America’s alleged “free market”.

[Sam the Centipede]

For context on the opinion piece quoted by AndyInPA (thank you!): the author is described thus:

David Sirota is a Guardian US columnist and an award-winning investigative journalist. He is an editor-at-large at Jacobin, and the founder of the Daily Poster. He served as Bernie Sanders’ presidential campaign speechwriter.

I am NOT disagreeing with the content of the article and its general message that drug companies have bought off the US government, but I thought the background of the author was interesting and relevant.

[pipistrelle]

For context on the opinion piece quoted by AndyInPA (thank you!): the author is described thus:

David Sirota is a Guardian US columnist and an award-winning investigative journalist. He is an editor-at-large at Jacobin, and the founder of the Daily Poster. He served as Bernie Sanders’ presidential campaign speechwriter.

I am NOT disagreeing with the content of the article and its general message that drug companies have bought off the US government, but I thought the background of the author was interesting and relevant.

Didn’t read it but why bought off Democrats specifically in the quotation?

[Notaperson]

For context on the opinion piece quoted by AndyInPA (thank you!): the author is described thus:

David Sirota is a Guardian US columnist and an award-winning investigative journalist. He is an editor-at-large at Jacobin, and the founder of the Daily Poster. He served as Bernie Sanders’ presidential campaign speechwriter.

I am NOT disagreeing with the content of the article and its general message that drug companies have bought off the US government, but I thought the background of the author was interesting and relevant.

Didn’t read it but why bought off Democrats specifically in the quotation?

Probably a reference to Kyrsten Sinema, who I believe is the only Democrat to come out against the drug price reduction measure in the reconciliation package. She gets a lot of donations from big pharma.

[pipistrelle]

For context on the opinion piece quoted by AndyInPA (thank you!): the author is described thus:

I am NOT disagreeing with the content of the article and its general message that drug companies have bought off the US government, but I thought the background of the author was interesting and relevant.

Didn’t read it but why bought off Democrats specifically in the quotation?

Probably a reference to Kyrsten Sinema, who I believe is the only Democrat to come out against the drug price reduction measure in the reconciliation package. She gets a lot of donations from big pharma.

pharma-bankrolled Democrats

That’s not honest reporting if so.

[Sam the Centipede]

Vincent Raccaniello (Higgins Professor of Microbiology and Immunology at Columbia University) has written a post about Molnuprravir and a conjectured side-effect: Molnupiravir, a SARS-CoV-2 antiviral drug, is mutagenic in cells

I am posting the link partly because it describes the action of the drug succinctly (for those of a curious bent). Prof. Raccaniello then describes the possible mutagenic mechanism: our cells might metabolize the Molnuprravir molecules to a form which could be used when one of our cells copies its DNA during replication, messing up the fidelity of the copying process, possibly causing defects in the new cell's DNA (its chromosomes).

Should we be worried? As the post says, presumably nothing bad enough was found to block Emergency Use Authorization, and Merck will be required to do more detailed investigations before getting full authorization.

The protease inhibitor I described upthread would not interfere with our own cells' genetic machinery, but that doesn't guarantee it won't affect some other systems. Few drugs are without side-effects, and the harder researchers look for them, the more they will find them.

[northland10]

Not Merck, but Pfizer recently announced they are seeking Emergency Use Authorization for PAXLOVID.

PFIZER SEEKS EMERGENCY USE AUTHORIZATION FOR NOVEL COVID-19 ORAL ANTIVIRAL CANDIDATE

Tuesday, November 16, 2021 - 02:00pm

• If approved or authorized, PAXLOVID™ (PF-07321332; ritonavir) would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2
• EUA submission includes clinical data from an interim analysis of the Phase 2/3 EPIC-HR study, which demonstrated an 89% reduction in risk of COVID-19-related hospitalization or death compared to placebo in non-hospitalized high-risk adults with COVID-19
• Rolling submissions have commenced in several countries including in the United Kingdom, Australia, New Zealand and South Korea, with planned submissions to other regulatory agencies around the world

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. today announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. This submission to the U.S. Food and Drug Administration (FDA) includes clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis. Rolling submission of non-clinical data for PAXLOVID was initiated with the U.S. FDA in October 2021.

If authorized or approved, PAXLOVID would be the first oral antiviral of its kind, a 3CL protease inhibitor specifically designed to combat SARS-CoV-2 that could be prescribed as an at-home treatment to high-risk patients at the first sign of infection, potentially helping patients avoid severe illness which can lead to hospitalization and death.

PFIZER’S NOVEL COVID-19 ORAL ANTIVIRAL TREATMENT CANDIDATE REDUCED RISK OF HOSPITALIZATION OR DEATH BY 89% IN INTERIM ANALYSIS OF PHASE 2/3 EPIC-HR STUDY

Friday, November 05, 2021 - 06:45am

• PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
• In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
• Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible

Of course, for the right, EUA means it is experimental, unlike usable drugs with no FDA authorization for COVID which are "proven" to work, like horse paste.

[zekeb]

Like Tamiflu and other post-infection remedies, few will receive the drug early enough to have it do much good. It's another excuse for the unvaccinated to justify not getting vaccinated.

[Sam the Centipede]

Like Tamiflu and other post-infection remedies, few will receive the drug early enough to have it do much good. It's another excuse for the unvaccinated to justify not getting vaccinated.

Not disagreeing, but I think the utility of these drugs is for those who are vulnerable (even after vaccination, such as immuno-compromised folk) so they can take the drug as soon as there is any concern about possible/probable infection.

For the general population, not so much. It's expensive and the probable dangers from an infection are relatively low.