Doctor Submits Fluvoxamine EUA Application to FDA: Group of physician-scientists believes data support authorization for treating COVID-19

Florida is way ahead of this.

See here:
https://www.brudirect.com/news.php?id=134985

Dr. Joseph Ladapo, Florida surgeon general and secretary of the Florida Department of Health, issued a statewide public service announcement supporting commonsense Wuhan coronavirus (COVID-19) prevention strategies, including optimizing vitamin D levels, staying active, eating nutrient-dense food and boosting the immune system with supplements.

Florida’s Health Department also highlighted emerging treatments for COVID, such as fluvoxamine and inhaled budesonide. Fluvoxamine is an antidepressant pill, while inhaled budesonide is commonly used for asthma patients.

The department stated that physicians should now use their clinical judgment when recommending treatment options for patients’ health care needs, and may include emerging treatment options so long as there is appropriate informed consent of patients.

The evidence of vitamin D against COVID satisfies the criteria for causality in a biological system, with dozens of studies having been demonstrated that it helps reduce all risks associated with the disease.

The HealthierYouFL.org website has been urging Floridians to talk to their health care providers about how certain supplements or foods containing vitamins and minerals might help boost the immune system. These vitamins and minerals include zinc, vitamin D, vitamin C and quercetin, which are all known to have shown a positive impact on mitigating COVID-19 risks.

Vitamin D important for immune function

As early as September 2020, data from 14 observational studies showed that vitamin D blood levels are inversely correlated with the incidence or severity of COVID.

The body is well-equipped to handle infections, provided the immune system is working properly. Vitamin D receptors are found in large numbers of different tissues and cells, including immune cells. Meaning, vitamin D plays an important role in immune function.

Why couldn’t an enterprising Doctor do the same for Ivermectin?

Explain to me if there is an approved treatment why do we need a EUA?

Will never get it. Pfizer won’t allow it.

RE: Explain to me if there is an approved treatment why do we need a EUA?

Hydroxychloroquine, Ivermectin and Fluvoxamine are all APPROVED drugs by the FDA.... BUT NOT FOR COVID.

Old drug fluvoxamine, new hope for COVID-19

The coronavirus disease 2019 (COVID-19) is an acute respiratory disease caused by the novel coronavirus SARS-CoV-2. Despite the second vaccination for SARS-CoV-2, the number of individuals infected with SARS-CoV-2 variants (i.e., delta and lambda) has markedly increased worldwide. Although approximately 80% of individuals infected with SARS-CoV-2 is mild to moderate, a part of them may convert to severe clinical stages in about 1 week, ultimately resulting in the intubation or death. Using drug repurposing, it is, therefore, necessary to discover drugs that can prevent clinical deterioration [1]. Here, we discuss the emergent use of the old antidepressant fluvoxamine which may block clinical deterioration in mild to moderate patients infected with SARS-CoV-2.

In November 2020, Dr. Lenze and his colleagues reported that fluvoxamine could prevent clinical deterioration in adult outpatients infected with SARS-CoV-2. In the study, clinical deterioration occurred in 0 of the fluvoxamine group (n = 80) and in 6 of placebo group (n = 72) [2]. Although sample size of this study was small, this study strongly encouraged further trials using a large sample size. In February 2021, Dr. Seftel and his colleague reported a prospective, non-randomized observational cohort study of fluvoxamine in outpatients (n = 113) infected with SARS-CoV-2 at the Golden Gate Fields horse racing track in Berkeley, California [3]. Incidence of hospitalization was 0 of the fluvoxamine-treated group (n = 65) and 6 of the observation alone group (n = 48). Two patients required intensive care unit stay with mechanical ventilation, one of them died. On April 23, 2021, fluvoxamine was added in the US National Institutes of Health (NIH) COVID-19 Guidelines Panel although there is insufficient evidence for the efficacy of fluvoxamine.

On August 6, 2021, the interim results of TOGETHER trial ( SEE HERE ) by a multinational group in Canada and Brazil were presented at the NIH symposium. They compared three compounds, fluvoxamine, the antidiabetic drug metformin, and the antiparasitic drug ivermectin. Although metformin and ivermectin did not show beneficial effects, fluvoxamine was much more promising. Among the randomized participants (n = 1,480), fluvoxamine significantly reduced the risk of disease progression by 29% (95% confidence interval 0.54–0.93) [4].

Detailed mechanisms of action of fluvoxamine for COVID-19 are currently unknown. In 1996, we reported that fluvoxamine binds to endoplasmic reticulum (ER) protein sigma-1 receptor with high affinity, suggesting a role of sigma-1 receptor in the mechanisms of its action [5]. Subsequent studies suggest that fluvoxamine is a potent agonist at sigma-1 receptor which plays a key role in inflammation [1, 5, 6]. Among the antidepressants, fluvoxamine was the most potent at sigma-1 receptor [1, 5, 6]. Furthermore, fluvoxamine has several beneficial effects, including reduction in platelet aggregation by serotonin transporter inhibition, decreased mast cell degranulation, interference with lysosomal trafficking of virus, inhibition of acid sphingomyelinase (ASM), and increased levels of metatonin by cytochrome P450 inhibition [7].

In October 2020, Gordon et al. [8] identified the sigma-1 receptor (encoded by SIGMAR1) as a functional host-dependency factor for SARS-CoV-2. Knockout or knockdown of SIGMAR1 produced robust reductions in SARS-CoV-2 replication, indicating a key role of the sigma-1 receptor in SARS-CoV-2 replication (Fig. 1). In 2019, Rosen et al. [9] demonstrated that the sigma-1 receptor is essential for the cytokine production in a mouse model of septic shock, and that fluvoxamine could protect against inflammatory response and lethal septic shock. Taken together, it is likely that the potent sigma-1 receptor agonists, such as fluvoxamine, might ameliorate inflammatory events (i.e., cytokine storm) associated with ER stress due to SARS-CoV-2 replication.

Fig. 1

Proposed biological mechanisms of fluvoxamine in the treatment of SARS-CoV-2-infected patients. SARS-CoV-2 binds to ACE2 receptor on the cells, resulting in activation of the acid sphingomyelinase (ASM) which converts sphingomyelin to ceramide. ASM/ceramide system can facilitate viral entry. Antidepressants such as fluvoxamine inhibit ASM and formation of ceramide-enriched membrane domains, resulting in decreased viral entry. Recent study shows that sigma-1-receptor ligands can attenuate SARS-CoV-2 replication [8]. Through sigma-1 receptor chaperone activity [1], the sigma-1-receptor agonist fluvoxamine may attenuate ER stress due to SARS-CoV-2 replication in cells, thus resulting in a blockade against inflammatory events (i.e., cytokine storm). Thus, early intervention using fluvoxamine may block or delay clinical deterioration in individuals with SARS-CoV-2 infection. A slight modification with Fig. 1 in the reference [10] and Fig. 3 in the reference [1]

A recent observational multicenter study (n = 2846) showed association between the use of functional inhibitors of ASM and reduced risk of intubation or death in hospitalized patients with severe COVID-19 [10]. The functional inhibitors of ASM include the antidepressants such as fluvoxamine, fluoxetine, and escitalopram. Interestingly, fluoxetine and escitalopram are also sigma-1 receptor agonists although they are less potent than fluvoxamine [1]. Considering the role of sigma-1 receptor and ASM in biological actions of SARS-CoV-2 in cells (Fig. 1), both fluoxetine and escitalopram may be prophylactic drugs for mild to moderate patients infected with SARS-CoV-2 although further clinical study is needed.

The advantages of fluvoxamine are favorable safety profiles, widespread availability, very low cost, oral administration and use for children and adolescents. If fluvoxamine is used in individuals with COVID-19 as quickly as possible after confirmation of SARS-CoV-2 infection, clinical deterioration might be prevented [1]. Importantly, fluvoxamine could be a prophylactic drug for COVID-19 in countries with low vaccination rates or low health system.

Author contributions

The authors did the reference search and wrote the commentary.

Declarations

Conflict of interest

Dr. Y. Hashimoto and Dr. Suzuki have no conflict of interest. Dr. K. Hashimoto has received speakers’ honoraria from Abbott and Meiji Seika.

References

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In the case of ivermectin, I think doctors are actually forbidden from writing it for Covid. They used to be able to do it as an off-label use, and they can still do that with these other drugs. But Biden and Fauci will probably close those off too.

They want to crush us all.

Ping for your interest

Fluvoxamine for COVID-19: real-time meta analysis of 6 studies

https://c19fluvoxamine.com/meta.html

Why couldn’t an enterprising Doctor do the same for Ivermectin?

Steve Kirsch (rich vaccine resister) tried this. He put up the money for initial studies but his application was rejected without review because he could not find a pharm manufacture to join the application.

So even though IVM has been safely manufactured at-scale for years, the FDA declined to accept the application let alone review it.

RE: his application was rejected without review because he could not find a pharm manufacture to join the application.

Why do you need a pharm manufacturer to join the application? I’m not sure I understand the logic behind this.

Bkmk

Why do you need a pharm manufacturer to join the application? I’m not sure I understand the logic behind this.

FDA wants to review the manufacturing process too. This makes sense for a new drug that is being authorized. But it doesn't make sense for a repurposed drug.

In the posted article it mentions the applicants for Fluvoxamine EUA did have manufacturer lined up as part of the application.

It is not a sensible requirement for re-purposed drugs that are available at-scale and more or less off-the-shelf.

Well it does makes sense if the FDA is trying to protect a critical source of funding (Big Pharma). Also, important if you are an FDA executive/researcher that wants to graduate to private industry.

Note, the FDA is partially (46%) funded by user-fees. Pharma companies pay a lot of fees ($2.8 billion) to the FDA to process/review applications. Link: www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance

I googled it. One page said it’s obsolete and used for compulsive disorders. Wth?

Dr. Joseph Ladapo, Florida surgeon general and secretary of the Florida Department of Health, issued a statewide public service announcement supporting commonsense Wuhan coronavirus (COVID-19) prevention strategies, including optimizing vitamin D levels, staying active, eating nutrient-dense food and boosting the immune system with supplements.

These suggestions for a healthier lifestyle from the Florida surgeon general should’ve been coming from the federal government from day one of Covid. Instead they closed the playgrounds and parks and said stay inside, wear a mask and order your food to be delivered.

It isn’t that hard to get the ivermectin protocol these days.

Pushealth and the Front Line Doctors site will get you in touch with a doc that will help.

If this passes, look for Blackrock, Vanguard, or one of the drug companies to snatch up the company/companies making the stuff and exponentially raising the price.

It’s the hospitals and doctor groups that are bought and paid for that won’t give that stuff to patients. No money in it.

There are numerous stories of folks on their death beds, family wants to try Ivermectin, hospital denies, family sues, patient gets ivermectin and leaves the hospital and is fine. $3 worth of drugs. Or $1000s in hospital charges.

That is true, I’ve used them myself, but that is not the point.

The point is we need a way to overcome the “official” propaganda that Ivermectin does not work and is dangerous so we can do two things:

1. Save more lives.
2. Get rid of the EUAs shielding Big-Pharma from lawsuits.