Veklury (remdesivir) was approved by the FDA for the treatment of Covid-19 in hospitalized individuals on October 22, 2020. This was a full approval, not an emergency use application: https://www.fda.gov/media/137574/download
We've continued using the vaccines under the existing EUAs even after a treatment was approved.
The FDA has granted additional EUAs for other treatments, even after that date: four more, not counting a sedative agent, per https://www.fda.gov/emergency-preparedness-and-response/mcm-... .
In fact, the FDA has even granted an EUA for a vaccine after approving Veklury: the Janssen/J&J vaccine received its first EUA on February 27, 2021. https://www.fda.gov/media/146303/download
Even if ivermectin was a perfect treatment for Covid, and even if an approved treatment would pull all the vaccines off the market -- despite that not happening after the FDA approved Veklury -- by the time ivermectin made its way through the approval pipeline to be labelled for this indication, the Pfizer and Moderna vaccines would very likely have received approval as well. So there's no "billions of vaccinations" at risk should another treatment be found to be effective and approved.
When people who are credible scientists (like many of his guests) get censored it can reasonably look suspicious.
I'm not saying he's correct, I'm just saying the right answer is debate.
A person who is willing to have a calm, 3 hour discussion on a topic is not the kind of person who needs to be censored.
And isn’t it valuable to have someone respond? Isn’t there value in educating the public so conspiracy theories don’t spread? (And preventing the theories from being discussed just makes them more firmly held, whereas debate doesn’t have that effect.)
Per the FDA: ""Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.""
And that falls apart under some scrutiny... it says "adequate, approved, and available alternatives." "adequate" being efficacious which is debatable without testing. "approved" which that drug is absolutely not approved for covid use. "available" being enough supply which is debatable if it turns out to be effective and widely used. I see no reason why the EUA for the vaccines would be threatened by this drug also being used in an EUA fashion. if they are going for actual approval for that drug it would take as long as the vaccine to get.
> When you look at the amount of money these companies stand to make from producing billions of vaccinations, you should not be surprised.
I think that when you look at everything through the conspiratorial lens... all you see are conspiracies.
They both are used for the same disease but in different ways. They are only alternatives in a very broad sense.
Even if it fit all those criteria for being an alternative it's not like it's some kind of thing that couldn't be amended if they really needed/wanted to. saddens me how reactionary everyone is.
Edit: also I forgot to make the point in my replay above... it's not like having three vaccines under is preventing another vaccine from getting EUA so even under this logic framework it is nonsense. are they hinging it on the fact that it's an approved drug for some other disease?
Literally? Everyone? LOL this is why there are so many normal people in this thread saying "at least let's have a discussion!"
Your sentiment is the reason (imo) that these discussions are so hard to have, no offense.
nowhere did I say that this treatment couldn't be effective and no where did I say that they shouldn't look into it as an alternative because I think all tools should be on the table. I am simply saying the part about the EUA thing being pushed by antivaxxers and other conspiracy theorists.
We need effective vaccines and therapeutics. I don’t understand this push to discredit any therapeutic before reasonable research has even been conducted.
No such thing exists. There are literally dozens of therapeutics in trials , and a few actually approved and in non-trial general use (dexamethasone, remdesevir, and favilavir, in various jurisdictions) — for both, see [0] — the ones that tend to get strongly negative treatment are hydroxychloroquine (not actually in trials) and ivermectin (in Phase 2/3 trials), both on the basis of unsupported scams around both earlier in the pandemic, not any general aversion to therapeutics.
[0] https://www.raps.org/news-and-articles/news-articles/2020/3/...
It’s simple. Money. Companies like it and want more of it.
This paper by Pierre Kory has graphs that clearly show the evolution of Covid cases and deaths across different states in Peru.
https://covid19criticalcare.com/wp-content/uploads/2020/11/F...
It isn't like the vaccines are pure profit. The pharma companies have to develop them, they have to produce them, they have to distribute them, and if they charge too much they get into massive political trouble. It seems like it is basically a giant marketing effort for pharma companies where everybody in the world is benefiting.
1: For example, from Feb 1st, 20 to today, Pfizer is up 10% and the Vanguard total stock index VTI is up 35%
Did the patent issues get resolved? Last I heard, the drug companies didn't want to share because of reasons.
Two observational studies, both carried out in New York (Carlucci et al. and Derwan et al.), appear to show promising results in patients treated with a combination of hydroxychloroquine, zinc, and azithromycin. The first, involving 932 paitents, showed a 55% reduction in relative risk of death among those getting zinc in addition to hydroxychloroquine and azithromycin, as compared with those just getting hydroxychloroquine and azithromycin. The second, involving 518 patients, showed an 80% reduction in relative risk of death among those getting the full triple therapy, when compared with a reference sample that didn’t get any of the drugs.
That seems impressive. However, these are low quality observational studies that are seriously limited by the methodology used. The scope for confounding effects is huge. Therefore, these studies should be considered exploratory and hypothesis generating. They certainly should not be considered evidence of any cause and effect relationship.
>In an interview on Friday, Dr. Zelenko said that he was guilty of nothing more than sloppy wording.
>“I’m a clinician, not a researcher,” he said. “I don’t understand fully the language of clinical research.”
Yet he went on TV and on large podcasts and talked like he was an expert on clinical research.
"Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives."
You should probably drill into this if you are interested, but the phrasing most often referenced by people talking about effective therapeutics and the lack of approval by the FDA is, "there are adequate, approved, and available alternatives."
It'd be like claiming the existence of the iron lung is sufficient to yank the polio vaccine out of production.
For example, Remdesivir is approved, without any sign of that fact jeopardizing the EUA on the vaccines. https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-op...
> FDA has approved one drug, remdesivir (Veklury), for the treatment of COVID-19 in hospitalized patients aged 12 years and older who weigh at least 40 kg.
https://www.fdanews.com/ext/resources/files/archives/e/Emerg...
(PDF warning)(section III, the first list, point #4)
>Source that HCQ and zinc are viable treatments?
Dozens? Hundreds? of doctors speaking out, including videos posted to youtube, that they saw great effectiveness in the trial. The people promoting it weren't a bunch of nobodys, despite what the nightly news told you. There were plenty of frontline workers with actual experience. But that likely won't satisfy your request for a source - which is fine. We all appeal to authority as we see fit. I saw many actual doctors saying "this is effective", and I saw many large corporations working together to shut that conversation down.
Do you have any evidence it's not effective?
Do you have any evidence snake oil isn't effective?
Burden of proof is on the people claiming a magic cure.
Anyway here are a couple of studies that show it's not effective.
https://onlinelibrary.wiley.com/doi/10.1002/jmv.27122
https://jamanetwork.com/journals/jama/fullarticle/2777389
Here's a good take by someone that does research on new medicines.
https://blogs.sciencemag.org/pipeline/archives/2021/06/07/iv...
Your document also doesn't say what you think it does. If it did, we wouldn't be able to have multiple vaccines approved. Is there any evidence that the FDA would interpret a non vaccine as an alternative to a vaccine, when there's no issue with granting EUA to multiple vaccines? I doubt it, but would love to see what you have.
"Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123. opens in new tab.)"
https://www.nejm.org/doi/full/10.1056/NEJMoa2019014
"After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668. opens in new tab.)"
https://www.nejm.org/doi/full/10.1056/NEJMoa2016638
"Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection."
https://www.sciencedirect.com/science/article/pii/S258953702...
"Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care. (Funded by UK Research and Innovation and National Institute for Health Research and others; RECOVERY ISRCTN number, ISRCTN50189673. opens in new tab; ClinicalTrials.gov number, NCT04381936. opens in new tab.)"
https://www.nejm.org/doi/10.1056/NEJMoa2022926
Shall we discuss creationism?
To my understanding, the proponents tend to say that HCQ is effective when administered as soon as first symptoms (day 0 to 3 I believe). There are also dosage issues and combinations with other drugs, and they say that HCQ is ineffective administered late.
In the first paper you propose, patients treated are already hospitalized (day 14 or fewer still probably not day 0 to 3). The fourth paper states (when following the link the to protocol) that hospitalisation is a condition for eligibility. That's not first symptoms.
The third papers talks about "initiated medication a median of 5.9 days after symptom onset". So not 0 to 3 days?
The second paper you propose talks about administering HCQ as post-exposure prophylaxis. It seems outside of the scope to me.
There are other issues on this debate, dosage, drug combinations, I can't talk about that, this website does:
This person resumes the argument this way:
https://roundingtheearth.substack.com/p/how-to-rig-research-...
(Note that the fourth paper on your list is the RECOVERY trial he's no a fan of)
What do you think about this? Also what about intelligent design?
There's both actual conspiracies in this world, and well poisoning to damage the conversations. When you look at the amount of money these companies stand to make from producing billions of vaccinations, you should not be surprised.