Those days are gone. So when a group of scientists applied for an EUA for fluvoxamine, what did the FDA do? You can help by bringing this document to your doctor's attention. Doctors who have used fluvoxamine in the US and other countries swear by it. Fluoxetine is just as effective. If you take fluvoxamine, please avoid caffeine while on the drug. 90,000 people will die in the next 3 weeks alone if we continue to ignore this drug that has caused no harm. Some countries dont have fluvoxamine so this is the alternative. The board members I spoke to say they refused to publicly promote any drugs for off-label use and tried to explain to Kirsch that its incredibly common for exciting results from small trials to disappear in larger ones. But they will refuse to give it to you even after being proven in a Phase 3 trial that was approved by the WHO. Instead, it erodes confidence in our government to provide timely advice that is in the public interest. He told me that while he and his family got vaccinated as soon as they were eligible, he got the idea that vaccines are dangerous from a man he hired to clean his carpets, who got very sick after receiving the vaccine. Molnupiravir followed patients for only 30 days because they know the drug is dangerous. You can experience serious side effects if you do not pay attention to interactions such as if you are currently on another SSRI of a different type. The alarming article cited the claims of two anti-vaxxers, Steve Kirsch and Dr. Robert Malone. Flavio Cadegiani and Steve Kirsch's studies didn't make the cut. People are dying because of physician fear of a new treatment with a 100% success rate and a solid mechanism of action. We don't know why the NIH panel is ignoring fluvoxamine and we aren't allowed to find out. The medical community did nothing (with a few exceptions like Dr. Seftel). 4000fluvoxamine750 His latest startup, M10, is a spin-off of a spin-off that sells a blockchain for banks. The NIH never did a risk benefit analysis of this drug. Steve calls himself a "medical philanthropist" who says "the most important thing to me is saving lives." In . Please. If you start 5 days after symptoms, all bets are off. It used to be that a Phase 3 study would do it. Compulsive hand washing? My publicly shared concerns regarding the safety of the COVID-19 vaccines may have had a negative impact on my company, M10. I also think it makes a lot of sense to look for pre-existing drugs that can help treat covid symptoms. The premise made sense: Most experts were predicting vaccines would take years, while finding helpful drugs with known safety profiles could shortcut the approval process. The WashU Phase 3 study hasnt been disclosed yet, but they had compliance problems with their patients this time around (phase 2 was local so the patients got the drug early and also were very compliant and the placebo group was truly taking nothing). Ms Tech | Pexels (hands); Kirsch (skirsch.com), Ivermectin has been falsely promoted as a covid treatmentbut for those who use the drug legitimately, seeing it become a piece of anti-vaccine misinformation is disconcerting, supports Technology Review's reporting on covid, anti-covid-vaccine, pro-ivermectin pundit, Roomba testers feel misled after intimate images ended up on Facebook, How Rust went from a side project to the worlds most-loved programming language. There were IRB rules that required the 65 patients to be listed in the diagrams and charts. . Yeah, its possible, he told mehe also says that he has regularly seen Kirsch manipulate evidence so that it seems to support claims that are, in reality, baseless. Get your prescription in advance of getting COVID. If you are experiencing any odd adverse reactions, youll need to consult with your doctor ASAP. The drug was widely prescribed as a covid treatment for much of 2020, based on anecdotes and flawed studies. How covid-19 conspiracy videos keep getting millions of views. Steve put in $1MM of his own money and . My favorite dosage is 50mg twice a day for 14 days. Although there is evidence that fluvoxamine can prevent clinical worsening and the need for hospitalizations in outpatients with early covid-19, I have seen no good evidence that fluvoxamine is useful as a substitute for the vaccines, co-investigator Angela Reiersen wrote to me. One user reported dilated pupils and increased heart rate (which could be nerves about the dilated pupils). He is very smart, and he knows that he is very smart, and hesometimes he behaves like he thinks hes the smartest guy in the room, whether he is or isnt, he told me. Steve Kirsch reported that doctors commonly say (of fluvoxamine), "This is the most powerful drug in my arsenal. has tons of info on fluvoxamine with all the links. The documents in the data room discuss all eight (you'll need access to the restricted area to see the presentation on all 8). In it, he claimed mRNA vaccines kill one in 5,000 recipients and dramatically increase the rate of miscarriages. . See more below. The paramedics will think you are on drugs. The 50mg BID dose was quite effective, but it has to be started early (as soon as symptoms start). This is quite stunning because the PK of the drug done at the Gates Foundation shows it only reaches 50% of the final concentration after 3 days. Fluvoxamine is a very safe drug on market for 37 years, tens of millions of people have taken it, no record in scientific literature of anyone dying on overdose, and according to doctors that know the drug the best, about as dangerous as taking a Tylenol. See my article on treatments. Here is what, e) which concluded: Under a variety of assumptions, fluvoxamine shows a high probability of preventing hospitalization in outpatients with COVID-19., For more about fluvoxamine (and other SSRIs that work), see, fluvoxamine completed a Phase 3 study showing it works that was published in the Lancet Global Health, NIH basically dismissed the fluvoxamine study as I predicted they would, few people werent afraid of expressing their displeasure, the highly acclaimed Bangladesh mask study showed, Johns Hopkins has incorporated fluvoxamine in their treatment guidelines, Ontario has become the first province to list fluvoxamine as a treatment doctors can consider for patients. After I ended the Zoom meeting, Satterfield called me to apologize for cutting us off. The antidepressant fluvoxamine, which is generic, but sometimes sold under the brand name Luvox, is a member of the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). . In some cases, youd want to taper down the dosage. Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI), a class of anti-depressants, mostly prescribed for people suffering from an obsessive-compulsive disorder. If it isn't fluvoxamine preventing hospitalization and long-haul COVID, then if you find what it is, you win. I asked to give a talk about COVID at MIT, but they couldn't find a faculty member to sponsor it. Nobody who took the drug got sick at all, most all wanted to return to work within 3 days after starting treatment. Here's why. As trial results rolled in, that mismatch began to put a strain on Kirschs relationship with the funds advisory board. . I fully expected both organizations to do absolutely nothing. Last Checked: 03/02/2023. Expect similar things to happen when Eiger applies for an EUA for interferon lambda, a drug with a 89% efficacy in phase 3 trials. She understands complex, politicized pandemicsshe was one of the first clinicians to specialize in HIV/AIDS, and she sat on the FDA advisory panel that approved the first antiretroviral drug. He is very smart, and knows that he is very smart, and sometimes he behaves like he thinks he's the smartest guy in the room, whether he is or isn't., Kirschs response was to take his name off articles hed written about vaccine deaths, changing the authorship to VaccineTruth., On July 1, he tweeted from his personal account, My publicly shared concerns regarding the safety of the COVID-19 vaccines may have had a negative impact on my company, M10. The anecdotal data of 100% success rates is further icing on the cake. [https://www.quora.com/What-is-the-current-treatment-for-Covid-19/answer/, The most urgent need in the country right now is to reduce. of the 'intellectual dark web '" and allowed him to access a "large and receptive audience to his claims about a fluvoxamine conspiracy". Once the Phase 2 result came out, it should have been embraced by doctors. Nobody who took the drug got sick at all, most all wanted to return to work within 3 days after starting treatment. But the confusion provided a fertile breeding ground for skeptics. From the French observational data (see the very last page), it appears that the biggest effect is limiting serotonin release (any SSRI will do that). Its motivated out of his sense of keeping people safe and advancing health care.. So it was both obvious and convincing the difference between the groups to the workers and the track management. Thanks to the volumes of data and information provided by pharmaceutical companies and regulators, as well as large numbers of trials from independently funded research groups around the world, I now trust that theyre safe for the vast majority of adults. The Wall Street Journal thinks it should be used (and that the NIH is wrong for waiting for more clinical trials). Compulsive fiddling with your mask? I didnt intend to spend a lot of time on Steve in particular, but that video was so influential.. Fluvoxamine public data repository - Google Drive, On Cytokines, Fluvoxamine and COVID-19 Part 1, Jon-Emile S. Kenny MD[@heart_lung] You see, we have a kind of allergy to the past; its our national disease, and the very assurance with which you insist that the past is within the present is l, On Cytokines, Fluvoxamine and COVID-19 Part 2, Jon-Emile S. Kenny MD[@heart_lung] Apocalypse is played out now on a personal scale; it is not in the sky above us, but in our bed. -Mark Doty Introduction With a proposed pathway coupling patho, Effect of Fluvoxamine vs Placebo on Clinical Deterioration in Outpatients With Symptomatic COVID-19, This randomized trial compares the effects of fluvoxamine, a selective serotonin reuptake inhibitor with immunomodulatory effects vs placebo on a composite of dyspnea or pneumonia and oxygen desaturation among adult outpatients with polymerase chain reactionconfirmed mild coronavirus disease 2019 (, Prospective cohort of fluvoxamine for early treatment of COVID-19, Abstract. But not 150K. We dont want to feed the anti-vaccine trolls, so we actively suppress clear scientific data. Note: normally I have lots of hyperlinks to all the sources, but Im pressed for time. Theres nothing there.). Steve is a Silicon Valley entrepreneur and philanthropist who founded the COVID-19 Early Treatment Fund (CETF) at the beginning of the pandemic. Eventually, a press representative who was listening in, David Satterfield, unmuted his microphone to suggest we finish our conversation by email. They all promised me when fluvoxamine passed Phase 3 trials, nearly everyone would use it. With covid, 80% of your patient population does just peachy with no treatment at all, just a little bed rest and fluid. If you cant get a prescription for COVID, then perhaps you have OCD? Physicians who use the drug for COVID now swear by it. And while Morris believes that all claims about vaccine safety should be properly vettedIs it possible theres another rare side effect of the vaccines that we havent figured out yet? Hes probably the closest thing Kirsch has to a nemesis, regularly disputing his assertions in blog posts and private email exchanges with Kirsch and his friends. (article I did after the TOGETHER trial). The ongoing battle between social-media companies and covid-19 misinformation pushersincluding US president Donald Trumpstepped up again this week thanks to a new viral video. Fluvoxamine was reportedly added to just 2 practice guidelines (. But as Kirsch has clashed with the experts he initially surrounded himself with, hes grown increasingly close to others who share his perspectives on vaccineswho have, in turn, provided a large and receptive audience to his claims about a fluvoxamine conspiracy. The next major effect is that that fluvoxamine activates the sigma-1 receptor. Steve angrily decried this development as more evidence of FDA corruption. Those who know Kirsch say this is a typical tactic. I mean, he really, truly has a heart of gold, Char told me. The 5 observational studies is icing on the cake. Fluvoxamine is way better than Molnupiravir, but the NIH doesnt approve drugs on effectiveness. Steve Kirsch is an inventor of the optimal mouse, a Silicon Valley millionaire, and an MIT alum (Class of '80). 90,000 Americans will die from COVID in just the next 3 weeks, a third of recovered patients from COVID will return to the hospital within 5 months and 1 in 8 die, Lenze fluvoxamine RCT that was published in JAMA. Fluvoxamine is way better than Molnupiravir, but the NIH doesnt approve drugs on effectiveness. And, according to three members of CETF's scientific advisory board, he put pressure on them to promote fluvoxamine for clinical use without conclusive data that it worked for . The drug was FDA-approved more than 65 years ago. If you start 5 days after symptoms, all bets are off. Steve Kirsch was extremely helpful early on in the pandemic, stepping up to fund early treatment trials when the US government would not fund such studies, Boulware told me in an email. Always be self aware when using fluvoxamine. Read More fluvoxamine The Fluvoxamine FAQ One of the drugs, Fluvoxamine, showed a 30 . The rest of the board soon followed. The. The 50mg BID dose was quite effective, but it has to be started early (as soon as symptoms start). Download Citation | On Mar 1, 2023, Gne Seda Albayrak and others published A Cross-Sectional Study on the Personality Traits of Episodic and Chronic Migraine Patients | Find, read and cite all . If you cant lay off the java, then try fluoxetine (Prozac). We don't know why the NIH panel is ignoring fluvoxamine and we aren't allowed to find out. Steve Kirsch is a high-tech serial entrepreneur based in Silicon Valley. This is what the Seftel trial at Golden Gate fields used. Every earlier study of fluvoxamine (such as observational studies) showed it work and the mechanism had been shown. Every year, we pick the 10 technologies that matter the most right now. Los Altos Hills resident Steve Kirsch funded research into the drug fluvoxamine as a treatment for COVID-19. I wanted to get the article out before my flight left. The most stunning study of fluvoxamine ever done was at the Golden Gate Fields racetrack in November 2020, right after the WashU trial was published in JAMA. In fact, he was unwittingly the source for one of Kirschs figures. ICER: There are 4 outpatient studies that have been done (2 at WashU (see Phase 2 trial results published in JAMA), one in Berkeley, CA by David Seftel, one in Brazil published in the Lancet, and one in-patient study done in Croatia. Nobody in the medical community is speaking out about how hypocritical the medical community is for ignoring the positive Phase 3 trial results and instead following whatever the NIH or FDA says. There are 4 outpatient studies that have been done (2 at WashU (see. Government agencies are ignoring the science. Mouse Systems is not a household word, he told the journalist. The other doctors aren't using it either because they don't know about it or fear doing anything not approved by the CDC for treating COVID. Dose escalation studies in lupus patients and in rheumatoid arthritis patients established that 800 mg per day for life and 1,200 mg per day for 6 weeks are extremely well-tolerated. Fluvoxamine, Proxalutamide, and Ivermectin: 100% success I'm very bullish on two drug combos since it is rare for Read More The best COVID treatments for hospitalized patients Seven treatments for hospitalized COVID patients with very high success rates. Boulwares trial was part of a wider movement to bulk up the evidence base underlying standard covid treatments, and one of several trials that found no benefit to using hydroxychloroquine. These people never called the researchers whose trials they claimed showed no effect. Drug interactions should be checked for. That study was featured on 60 Minutes. I couldn't agree more. Fluvoxamine at 50mg twice a day for 14 days is a very well-tolerated drug (as long as you avoid caffeine and alcohol) for the treatment of COVID infections. Get your prescription in advance of getting COVID. Kirsch said that his attempts to promote fluvoxamine are being curtailed. My website www.skirsch.io has tons of info on fluvoxamine with all the links. Summarizes the 5 observational studies, RCT, RWE, and some of the more interesting anecdotal data. We need to keep people out of the hospital in the first place. The findings, published Wednesday in the New England Journal of Medicine, add to a growing body of scientific evidence pushing back against the use of the antiparasitic drug that has been promoted by some prominent voices on social media. Stopping the meds will return you to your normal self. An approach that promised to democratize design may have done the opposite. Note that some of these articles are inaccurate. just like ivermectin). Since FLV is a safe drug, it should have been widely discussed with patients that there is virtually no downside and a huge reduction in hospitalization if the drug is given early. Talking to Kirsch is an exhausting experience. . All can merit a fluvoxamine prescription based on traditional diagnoses. And, according to three members of CETFs scientific advisory board, he put pressure on them to promote fluvoxamine for clinical use without conclusive data that it worked for covid. The ICER independent review showed fluvoxamine is more effective than Molnupiravir: Read this article I wrote about using fluvoxamine correctly for COVID. In 2016, it was the 135th most-prescribed medication in the United States, with more than 4 million prescriptions. Refresh. Other SSRIs work as well, but fluvoxamine activates the Sigma-1 receptor the most of the SSRIs which is why it was chosen. None of this would really matter if Kirschs views on vaccinations were private, or shared with a limited audience. Here are my answers. The man who ran Risperdal sales, Alex Gorsky, is now CEO of Johnson & Johnson. Repurposed drugs are safer and more effective than the current vaccines. On his blog, Covid-19 Data Science, he has extensivelyand mercilesslyunpacked Kirschs evidence for the vaccine death claims. 22, 2021, 9:00 a.m. Steve Kirsch , a former tech entrepreneur who earned a fortune worth up to $300 million, has been showcased on TrialSite a few times for his activity supporting the clinical development of repurposed drugs for COVID-19 treatments. One of the first CETF grants was to investigate the antimalarial hydroxychloroquine. Some people are jittery, but usually that is because the doctor either prescribed a dosage higher than 50mg twice a day or didnt notify the patient to completely avoid the list in the previous paragraph, or the patient is simply sensitive to the drug (50mg twice a day can be too much for some people). After publication of the recommendation in December 2021, the NIH did absolutely nothing change their recommendation. It is an amazing drug and is a very simple safe way to avoid long-haul COVID symptoms. As a health care journalist, I started off firmly in the wait-and-see camp on mRNA vaccines. Thats why they didnt change their recommendation when the Phase 3 trial was published in Lancet. MisinformationKills. If there is a better drug on the table today than fluvoxamine, the NIH panel should put that one on the guidelines. Im sorry to sound so cynical. Doctors wait for government permission (EUA or added to the NIH guidelines) before using a drug. Kirsch: Yes, but you could easily watch that 60 Minutes story and believe that we need more data before people should start using fluvoxamine. So it was both obvious and convincing the difference between the groups to the workers and the track management. Steve and CETF funded the research that showed promising results of fluvoxamine as an early treatment of COVID-19. The post read: "I will be featured on 60 Minutes this Sunday talking about fluvoxamine as an effective treatment for COVID-19 to prevent hospitalization and death. more time. After one or two conversations like that, I got tired of arguing, so I started avoiding his calls, she said. In May, all 12 members of CETFs scientific advisory board resigned, citing his alarming dangerous claims and erratic behavior. Added to FLCCC protocols and Fareed-Tyson protocol among others. When I asked him why so many experts in the field disagreed with him, he alleged there were effortseither malicious or negligentto suppress evidence of cheap, effective covid treatments. Since FLV is a safe drug, it should have been widely discussed with patients that there is virtually no downside and a huge reduction in hospitalization if the drug is given early. 707. After two weeks (since it was a tight knit community, everyone could see what was happening to the two groups), every track worker who got sick with COVID, demanded the drug. Other SSRIs work as well, but fluvoxamine activates the Sigma-1 receptor the most of the SSRIs which is why it was chosen. Please, As of November 13, fluvoxamine has been proven to work in every trial that has published results, including, studies. Pretty much nothing changed when the Phase 3 trial confirmed fluvoxamine worked. He pushes fluvoxamine, an anti-depression drug which despite doing very well in covid treatment studies has been strangely neglected. Its really, really common for a small effect, something that looks exciting, to be a statistical fluke when you look at a larger population. That way you can start immediately. He immediately tweeted an offer to give anyone $1 million if they could win a debate with him about vaccine deaths. Flavio Cadegiani and Steve Kirsch's studies didn't make the cut. The track management was so impressed, they asked for prescriptions. He said of his study, This is the most extraordinary effect Ive seen in my 25 years practicing medicine.. Drug researchers at Washington University in St. Louis reached out to Kirsch looking for $67,000 to finish a very smallbut placebo-controlledtrial. Seftel used a 50mg BID dosing for 14 days which was one third of the max dose used in the Lenze study. Three of the four outpatient trials have been reported out: all were successful. We don't know why the NIH panel is ignoring fluvoxamine and we aren't allowed to find out. The infectious disease scientists lied to me. 95% confidence effect size is 75% or more. Waiting months for the phase 3 trial to complete is nuts. The repository goes over the prescribing guidelines, contraindications, and describes the effect on caffeine consumption while on drug (basically you want to avoid caffeine while on the drug). Indeed, some of the most prominent people spreading misinformation about ivermectin and vaccines today began by promoting hydroxychloroquineincluding by claiming to debunk Boulwares data analysis. We are ignoring the advice of the KOL group and doing nothing. The web value rate of skirsch.io is 2 . skirsch.io. Its actually much harder to parse out a signal than if youre treating diabetes or cancer., In addition to the issues with fluvoxamine, advisors grew increasingly uncomfortable with Kirschs posts about ivermectin, which he has repeatedly claimed in blog posts and appearances in alternative media can be used together with fluvoxamine to prevent 100% of covid-19 deaths. He's founded 7 companies, 2 with billion dollar valuations. I believe they made the right decision and we should be rushing to follow their advice.
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