I wonder, what could be the potential drawbacks of protease inhibitors taken for long periods for prophylaxis? Aren't some essential processes going to be negatively and unpredictably affected?
Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
141–150 of 294 posts
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#142Earlier quoted context omitted.
> 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.
The criticism is not present because this one wasn't underpowered.
> p=0.0012
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#143Earlier quoted context omitted.
What does "fair" have to do with anything? Are you suggesting that your proposal maximizes the amount of health-improving interventions that society will receive in the future? Do you have any reason to conclude that what you're suggesting will be even a slight improvement?
As a taxpayer / healthcare consumer who is not employed in pharma -- yeah, it would be nice if we (the US) did a little less subsidizing of drug development for the rest of the world. Proportional ownership of sponsored drugs seems like a nicely aligned incentive. What am I missing?
I don't know how the pharma industry decides what to pursue, but it is at least plausible that part of the incentive for what they do depends on being able to price discriminate in sales to other countries. Before suggesting we tear down Chesterton's fence, it seems reasonable that you should have more justification than just that it seems fair to you.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#144Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#145Earlier quoted context omitted.
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. https://www.nature.com/articles/s41591-021-01535-y
The misinformation lies in the implication that we know with certainty that ivermectin is not an effective prophylactic/early stage treatment. We have a large body of mixed results.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#146Earlier quoted context omitted.
> exerts its antiviral action through introduction of copying errors during viral RNA replication How does this target only viral RNA, not the body's own? Copying errors don't sound like something you want in your own RNA. "However, there are inherent risks in this approach. NHC can be metabolized by the host cell to the 20-deoxyribonucleoside form by the ribonucleotide reductase and then incorporated into the host c…
100% agreed on getting vaccinated, but for the elderly or immunocompromised people vaccination isn't enough to necessarily prevent severe outcomes and it might be worth the risk. As a young person, I'd probably stay away, at least in the near term, given how effective vaccines are.
If you're elderly, I suppose it's down to how many years you have left under various outcome scenarios under various risks.
You're not going to reproduce, so reproductive harm isn't an issue.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#147Earlier quoted context omitted.
> Last time I kept up with this, it was some purposeful legal loophole. The drug that got approved, is not yet available. No, that was a maliciously stupid misreading of the FDA's statement. https://www.reuters.com/article/factcheck-fda-pfizer/fact-ch... > The FDA state that Comirnaty has the same formulation as the EUA-approved (Emergency Use Authorization) Pfizer vaccine and is interchangeable (here). Their website…
The language still seems slippery because while the formulation may be the same and interchangeable for providers, the legal process bound to the license could be different for the recipient. If the PREP Act still applies, then there’s less recourse for anyone that may experience an adverse reaction.
No change there. Same recourse for both.
https://www.jdsupra.com/legalnews/fda-approval-of-pfizer-vac...
> Does PREP Act liability protection extend to Comirnaty?
> Yes. The government invoked the PREP Act in response to the COVID-19 pandemic. Under the terms of that act, "covered persons" are granted certain immunity from liability for activities related to "covered countermeasures." Covered persons include essentially all of the entities involved in the manufacture, distribution, and administration of the countermeasure. The term "covered countermeasures" includes both approved COVID-19 products, as well as unapproved products used under an EUA. The Comirnaty approval does not change the status of the vaccine as a covered countermeasure under the PREP Act, and the approved vaccine should receive equal liability protection compared to the version of the vaccine used under the EUA.
https://www.washingtonpost.com/politics/2021/08/30/false-cla...
> “The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,” said Pfizer spokesperson Sharon J. Castillo in an email. “Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.”
> Indeed, contrary to the claims of Malone and others, the Comirnaty vaccine has the same liability protection as the vaccine approved under the EUA. That’s because of a law known as the Public Readiness and Emergency Preparedness Act (PREP Act).
> “The liability protections afforded under the PREP Act are tied to the declared public health emergency and not whether the vaccine is sold under an EUA,” Castillo said. “Therefore, both Comirnaty and the Pfizer-BioNTech covid-19 vaccine receive the same liability protections as medical countermeasures against covid-19.”
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#148Earlier quoted context omitted.
As a taxpayer / healthcare consumer who is not employed in pharma -- yeah, it would be nice if we (the US) did a little less subsidizing of drug development for the rest of the world. Proportional ownership of sponsored drugs seems like a nicely aligned incentive. What am I missing?
I don't know how the pharma industry decides what to pursue, but it is at least plausible that part of the incentive for what they do depends on being able to price discriminate in sales to other countries. Before suggesting we tear down Chesterton's fence, it seems reasonable that you should have more justification than just that it seems fair to you.
I don't understand your concern -- how does proportional ownership eliminate pharma's ability to price discriminate? I just think the US government should receive some prorated portion of profits from drugs they subsidized development of, which can be reinvested into further development.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#149Ivermectin is inexpensive to manufacture, is extremely safe, and is currently being used by many countries to both treat and prevent the spread of covid. Molnupiravir had concerns during its development of the drug having mutagagenic properties. Why not just use the inexpensive, safe, proven effective medication?
Please don't post dangerous disinformation to HN. That drug is not an approved treatment for COVID.
Re: Antiviral Molnupiravir Reduces Risk of Hospitalization/Death by ~50 Percent
#150I think it's disappointing that this thread has devolved into a political discussion that is hardly related to the topic. The scientific/medical achievement here seems significant. As an MD, the difference between calling in a script for a pill and arranging for outpatient infusion therapies is vast.
Thank you for weighing in. I am hugely excited about this and immediately sent a message to all my family. I know people who died because they didn't know that antibody treatments were available and effective when given early enough. I very likely saved my own father's life by helping him to get an antibody treatment when he and his own doctor knew nothing about it at the time. When we're talking about pre-hospitaliz…
Would you mind to share which antibody treatment were you able to get for your father? I would be useful for the rest of us if we ever find ourselves in this situation again.