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The NIH Guidelines committee is being very slow to react (we have no idea if they are even considering the drug because nobody is allowed to know that because all their deliberations are kept secret). Saving the world has been a theme of Kirschs life for years. 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). So it was both obvious and convincing the difference between the groups to the workers and the track management. are all super cheap, effective, and available without a prescription. Note that some of these articles are inaccurate. You can use fluoxetine as well (aka Prozac). 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. Steven Todd Kirsch is an American entrepreneur. The NIH picks the drug that makes the most money for the drug companies regardless of long-term safety Molnupiravir! Fluvoxamine for COVID-19 summary Steve Kirsch Executive Director COVID-19 Early Treatment Fund stk@treatearly.org 650-279-1008 Google Docs This is a more comprehensive look at the key evidence supporting fluvoxamine: Fluvoxamine for COVID-19 Medicine isnt about saving lives anymore. It is currently approved for treatment of depression and obsessive compulsive disorder (OCD). I have all of these on hand and I load up on vitamin D3 every day. What's even worse is that a third of recovered patients from COVID will return to the hospital within 5 months and 1 in 8 die. Its not about the science. His latest startup, M10, is a spin-off of a spin-off that sells a blockchain for banks. Medicine has been transformed to doing whatever the NIH/FDA says, regardless of how many lives will be lost. sorry about that. 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. No one has been able to come up with an example where phase 2 + this level of evidence resulted in a failure of Phase 3. This suggests that a 50mg BID loading dose for day one, followed by 50mg QD dose for the following 13 days should also be quite effective. Fluoxetine is just as effective. The web price charge of skirsch.io . Its all about NIH saying it is OK. Medicine today is driven by government opinion, not science. So take the lowest likely effect size * 60% success rate and you are looking at an expected 45% reduction in death which is clearly better than a 0% reduction. Drug researchers at Washington University in St. Louis reached out to Kirsch looking for $67,000 to finish a very smallbut placebo-controlledtrial. Jeffrey Glenn, an infectious disease professor at Stanford University, calls the inaction on the current evidence on the table "criminal.". Fluvoxamine is a well-tolerated, widely available, inexpensive selective serotonin reuptake inhibitor that has been shown in a small, double-blind, placebo-controlled, randomized study to prevent clinical deterioration of patients with mild coronavirus disease 2019 (COVID-19). Dosing. Kirsch: Yes, but you could easily watch that 60 Minutes story and believe that we need more data before people should start using fluvoxamine. Hes now outlived his initial prognosis by several years. All this was known back in January 2021 when a key opinion leader panel of experts from NIH, CDC, FDA, academia, and journal editors voted by over 2:1 to recommend that fluvoxamine be recommended to physicians to discuss with patients. Those days are gone. NIH is still unsure whether fluvoxamine should be used to treat COVID. David Boulware, a researcher at the University of Minnesota, received $125,000 to test the drug against covid. FDA official fluvoxamine rejection. Where did it go wrong. It was recommended back in January 2021 by a key opinion leader (KOL) panel to be used, but it took a year for, because they were rejected by 10 journals. The ICER independent review showed fluvoxamine is more effective than Molnupiravir: Read this article I wrote about using fluvoxamine correctly for COVID. Steve Kirsch is looking for an explanation for 171,000 excess deaths. Try refreshing this page and updating them one Mouse Systems is not a household word, he told the journalist. But not 150K. An MIT Technology Review investigation recently revealed how images of a minor and a tester on the toilet ended up on social media. That receptor also helps regulate the body's . Kirsch said that his attempts to promote fluvoxamine are being curtailed. The choice couldn't be more clear cut. Dr. Seftel's paper has been accepted for publication and will appear in OFID in early February. The NIH wrote a bullshit rejection because the FDA told them not to approve it. Steve Kirsch Nov 5, 2021 145 92 Here are the key things you should know about fluvoxamine for COVID: It works. JAMA systematic review and meta analysis It doesnt get any better than this. 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. It is very safe: There is no evidence fluvoxamine is harmful and led to a worse outcome. You can use fluoxetine as well (aka Prozac). This is the gold standard of evidence based medicine. This story is part of the Pandemic Technology Project, supported by The Rockefeller Foundation. (article I did after the TOGETHER trial). After one or two conversations like that, I got tired of arguing, so I started avoiding his calls, she said. Medium banned him for misinformation. . Here's why. By March 2020, hed settled on the idea of searching for covid treatments in the pre-existing pharmacopeia. If you take fluvoxamine, please avoid caffeine while on the drug. These people never called the researchers whose trials they claimed showed no effect. Skirsch.io traffic volume is 1,957 unique daily visitors and their 3,914 pageviews. They knew in advance it was coming and on the day the paper was published they ignored it entirely. Molnupiravir followed patients for only 30 days because they know the drug is dangerous. Government agencies are ignoring the science. ICER: Flavio Cadegiani and Steve Kirsch's studies didn't make the cut. I couldnt tell I was on the drug. The reason that it isnt used is because the medical community ignores evidence-based medicine principles. We look for advances that will have a big impact on our lives and break down why they matter. Those days are gone. Fluoxetine is just as effective. He considers himself an expert in something that he doesnt have training or experience in, and hes not following scientific methods to assess data.. The agency quickly slapped down the comments from Kirsch, a tech mogul with a fortune once estimated at $230 million, even as the claims triggered a flurry of false social-media posts attributing. Ive used it personally at 50mg twice a day and experience no adverse events at all. Get your prescription in advance of getting COVID. Proxalutamide and fluvoxamine pushers and the early treatment grift. While these are stunning results, less than a dozen doctors in the US are prescribing fluvoxamine today. Telling the truth, he tweeted. Thats what creates some of these heroes.. The drug was FDA-approved more than 65 years ago. NIH doesnt want you to get the drug since it would compete with Molnupiravir, so fluvoxamine will never make the NIH guidelines. The infectious disease scientists lied to me. This was shown to be very tolerable (no side effects in 99% of patients) and extremely effective (no hospitalizations and death if you start it ASAP after first symptoms). But even she was drained by Kirschs constant attempts to override the data. They immediately ruled out the vaccine, because the vaccine is, quote, safe.. My website. That study was featured on 60 Minutes. I have never heard of a case it didn't work. Late in the session, minutes before this impromptu video wrap up, Tip o' Spear Steve Kirsch addressed the panel and revealed that the FDA had just shot down Fluvoxamine as an approved COVID treatment. Waiting months for the phase 3 trial to complete is nuts. Even though an expert panel was overwhelmingly convinced in just one hour, hearing a very small subset of all the supporting evidence, the organizations that they belong to are taking their time. Fluvoxamine works on hospitalized patients too, but no US hospital will let you use it (sound familiar? That was a big mistake because the original paper contained text related to earlier studies and the editors chopped it out. So far, doctors have failed to share his sense of urgency. If the drug is started right after symptoms, weve seen 100% prevention in hospitalization. skirsch.io Steve Kirsch Home page. All the supporting observational studies were positive as well. Soon after his appearance on the DarkHorse podcast, several partners of his most recent startup, M10, expressed concerns about the increasing extremism of Kirschs vaccine views. Now weve lost the high ground, Morris told me. With cases spiking, the Los Angeles area banned gatherings. When was the last time you saw a phase 3 fail where there was a 100% effect size in both an RCT and RWE study along with 4 independent observational trials all showing a positive effect, and there is clear mechanism of action where there is less than a 1% chance that it is not working (the SSRI's ordered their impact based on their Sigma activation which is 1 in 120 options), and where in every single case we are aware of the patient taking the drug reversed to normal in an average of 3 days? 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. If you take fluvoxamine, please avoid caffeine while on the drug. Steve calls himself a "medical philanthropist" who says "the most important thing to me is saving lives." In . Thanks for working tirelessly to help others. In every case we are aware of, the drug was successful in reversing COVID symptoms, generally in 3 days or less. At the beginning of the COVID-19 pandemic, Steve Kirsch created the COVID-19 Early Treatment Fund (CETF) to finance trials of off-patent drugs in an attempt to find a potent treatment that had been staring us in the face. 95% confidence effect size is 75% or more. Why fluvoxamine isnt used. The NIH picks the drug that makes the most money for the drug companies regardless of long-term safety Molnupiravir! Don't underestimate the virus. Vaccine waitlist Dr. B collected data from millions. Also, for people who cant tolerate fluvoxamine for whatever reason (nausea, jittery, etc), this is the alternative. P-value was 10^-14 on that study (done by Dr. But the whole process has gone too slowly for Kirsch. And FrameMaker is still a niche product. He has a BS/MS in Electrical Engineering and Computer Science from MIT. I wanted to get the article out before my flight left. It was recommended back in January 2021 by a key opinion leader (KOL) panel to be used, but it took a year for the KOL meeting notes to be published because they were rejected by 10 journals. committee votes 11-2 that the evidence is not adequate to demonstrate a net health benefit for molnupiravir over symptomatic care alone; Paxlovid and fluvoxamine receive more favorable votes, This site requires JavaScript to run correctly. There are now 5 independent observational studies that show that the drug works (2 in France, 1 in Germany, 2 in the US). The anecdotal data of 100% success rates is further icing on the cake. 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. This 1/6 of the dose the FDA has approved for OCD (the labelled indication for fluvoxamine)! They knew in advance it was coming and on the day the paper was published they ignored it entirely. But the confusion provided a fertile breeding ground for skeptics. Im just telling you the truth. This alone will give roughly a 50% effect size and explains why all of the the SSRIs are effective including those that do not activate the Sigma1 receptor (e.g., Paroxetine). @stkirsch. . Quick Summary . Its sad, but its true, he told me. 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. We don't know why the NIH panel is ignoring fluvoxamine and we aren't allowed to find out. Early treatment with existing drugs is the fastest, most effective, and lowest. 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). Doctors wait for government permission (EUA or added to the NIH guidelines) before using a drug. The CDC has advised everyone to wear a mask. He started 7 high tech companies, two with billion dollar market caps. Thirty minutes past the end of our scheduled time, he dropped his phone in the cupholder of his Tesla so that he could keep talking while he ran an errand. Doctors wait for government permission (EUA or added to the NIH guidelines) before using a drug. 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. In the second trial, it was shown to be 100% effective in long-haul COVID symptoms: None of the treated patients had any long-haul symptoms after 2 weeks compared to 60% of untreated patients having 1 or more of the 15 long-haul symptoms after two weeks, and 29% having 4 of more of the long haul symptoms after 2 weeks. The group who declined the drug were very sick with 12.5% requiring hospitalization and one died. Flavio Cadegiani and Steve Kirsch's studies didn't make the cut. The data we have today with just 2 clinical trials (RCT and confirmatory RWE) is compelling. MisinformationKills. Part of TV News Archive. Here is the latest version. In September, he resigned as CEO and gave up his board seat. 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. Peter Meinke, another former board member, spent nearly three decades in drug discovery at Merck. In 2016, it was the 135th most-prescribed medication in the United States, with more than 4 million prescriptions. Consider masks by contrast. Ive talked to doctors who are extremely familiar with the drug and all the trial results and they would prescribe it to their patients. I asked to give a talk about COVID at MIT, but they couldn't find a faculty member to sponsor it. A few months ago, Kirsch suddenly stopped promoting hydroxychloroquineeven scrubbing it from the CETFs official list of trials it has funded. By Steve Kirsch Mar 14, 2021 Fluvoxamine, Proxalutamide, and Ivermectin: 100% success I'm very bullish on two drug combos since it is rare for a single drug to be 100% successful. You see this with people who have a lot of money, who think that reflects their intelligence, Richman told me. Dr. Joe Ladapo wrote a brilliant op-ed in the Wall Street Journal, "Too much caution is killing COVID patients." In November, CETF gave the group an additional $500,000 for a phase 3 clinical trial that might show conclusive proof of efficacy. . Every year, we pick the 10 technologies that matter the most right now. After several failed attempts to stop the progression of his disease, he designed his own protocol for chemotherapy and doctor-shopped to find an oncologist who would give it to him. To date, we have heard nothing suggesting the drug doesn't work or could be harmful. Since making a fortune as the founder of Infoseek, an early search engine that was the Google of its day, Kirsch has spent tens of millions of dollars fighting humanitys biggest threats.