We don't know why the NIH panel is ignoring fluvoxamine and we aren't allowed to find out. Fluvoxamine, COVID, pandemic, . Hilary Grant-Valdez Operations Manager Tom Brunner 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). Jeffrey Morris, director of biostatistics at the University of Pennsylvania Perelman School of Medicine, has made debunking Kirschs claims something of a hobby. In three phone conversations, as well as dozens of emails, his responses to questions about claims in this story were imprecise or constantly changing. 707. Enter the email address you signed up with and we'll email you a reset link. His appearance on an episode of anti-covid-vaccine, pro-ivermectin pundit Bret Weinsteins DarkHorse podcast, alongside Robert Malone, a prominent source of vaccine misinformation, introduced Kirsch to followers of the intellectual dark web, who have since embraced him as a fellow truth-teller. 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). 36m "We found Fauci was the most highly compensated federal employee. The medical community did nothing (with a few exceptions like Dr. Seftel). Doctors who have used fluvoxamine in the US and other countries swear by it. 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. This drug can save your life but you have to ask for it! Fluvoxamine has at least a 30% hospitalization and death benefit. We report a real-world experience using fluvoxamine for coronavirus disease 19 (COVID-19) in a prospective cohort in the setting of a mass outbreak. At that dose, no side effects were reported for his patients (I know of only one person who had mild nausea at that dose) and everyone reversed out their symptoms in an average of 3 days. Nov 12: Steve Kirsch gives talk on CETF to HarvardBusiness School hosted by Dr. Seftel Nov 13:Mass COVID outbreak at GGF is now publiclyknown Nov 16: Seftel, the track physician at GGF, startsFLV . 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. 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. 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. (One of them, Eric Lenze, was in fact giving a presentation on fluvoxamine to the National Institutes of Health the next day.) Three of the four outpatient trials have been reported out: all were successful. All have had a 100% success record in keeping their patients out of the hospital. It could do nothing. That is when the phase 2 results were published. Medicine has been transformed to doing whatever the NIH/FDA says, regardless of how many lives will be lost. Decreasing the dosage or stopping the medication will mitigate symptoms within hours. Its not about the science. Fluvoxamine is way better than Molnupiravir, but the NIH doesnt approve drugs on effectiveness. It is very safe: There is no evidence fluvoxamine is harmful and led to a worse outcome. For decades, coders wrote critical systems in C and C++. The NIH never did a risk benefit analysis of this drug. Is that really true? Nobody who took the drug got sick at all, most all wanted to return to work within 3 days after starting treatment. Medicine isnt about saving lives anymore. There is an executive summary below, but the most important thing is that top infectious disease docs who have looked at all the evidence (including the two clinical trial results) believe the effect size is 75% or more in reducing the hospitalization rate. This is the gold standard of evidence based medicine, Article about the fluvoxamine rejection (The Verge). And FrameMaker is still a niche product. They were all given the drug soon after symptoms and the placebo group was pure in that they were not taking any COVID drugs. This looks ominous, but it harmless. Earlier that month, Seftel had heard about fluvoxamine during a presentation by tech entrepreneur Steve Kirsch, whose COVID-19 Early Treatment Fund supports research on existing drugs that could . 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. 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. FDA official fluvoxamine rejection. All the supporting observational studies were positive as well. Today, if we follow the CDC advice, nearly 100,000 people a month will die from COVID. Unfortunately, as Jeffrey Morris at UPenn points out, public health officials and scientists have done plenty to undermine their own authority, like claiming masks dont work, downplaying the natural immunity conveyed by previous covid infections, and not doing enough public communication about vaccine safety surveillance systems. Elsewhere he has said he began questioning vaccine safety after an unnamed Twitter follower told him several family members died after getting their shots. By the beginning of September, he was no longer the companys CEO, replaced by his co-founder, Marten Nelson. So why would we wait when lives are being lost? Steve Kirsch Nov 5, 2021 145 92 Here are the key things you should know about fluvoxamine for COVID: It works. Dosage there is 30mg once a day. Less than a week later, David Seftel read about the Lenze trial, and ignored the JAMA advice. But how many did it help? We should not wait for the Phase 3 RCT. Summarizes the 5 observational studies, RCT, RWE, and some of the more interesting anecdotal data. The NIH picks the drug that makes the most money for the drug companies regardless of long-term safety Molnupiravir! [NIH] doesnt want any of these treatments. I think so. It is about following orders and making money for the drug companies and protecting the doctor from liability and losing his medical license. You will be wired for 24 hours if you dont heed my advice. This site requires JavaScript to run correctly. Twenty-four years ago, . There were IRB rules that required the 65 patients to be listed in the diagrams and charts. Molnupiravir followed patients for only 30 days because they know the drug is dangerous. The medical community did nothing (with a few exceptions like Dr. Seftel). Di scl ai mer: T he vi ews expressed i n t hi s art i cl e are my own personal opi ni on based on my 1, 000+ hour st udy of cut t i ng edge . Vaccine waitlist Dr. B collected data from millions. That was a lie. While combining the results of several well-designed trials can strengthen an argument or unearth patterns unseen in smaller samples, a meta-analysis is just the sum of its parts; any single well-done experiment is more useful than combining the results of several poorly done ones. Reached by email, the two fluvoxamine investigators denied that there was any effort to suppress their research, and they were cautiously optimistic about their continued study. Now they turn to Rust. A video presentation by Steve Kirsch, Executive Director of the Covid-19 Early Treatment Fund. He has been a medical philanthropist for more than 20 years. And he wont talk to you either if you ask nosy questions like Cliff, my risk benefit analysis shows you should be rushing to recommend this drug. If you continue to get this message, Some are views most scientists think are wrong. 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). But they will refuse to give it to you even after being proven in a Phase 3 trial that was approved by the WHO. CETF funded David Boulware's trials on hydroxychloroquine and the Phase 2 and Phase 3 fluvoxamine trials, among many other research projects. This is a more comprehensive look at the key evidence supporting fluvoxamine: Hear from the doctors who did the studies directly as well as the Dean of Medicine at Emory University: List of the best evidence-based COVID treatment options. It should be crystal clear to everyone that the current CDC guidelines for treating COVID aren't working. Zero. . My favorite dosage is 50mg twice a day for 14 days. It was not compatible with his position as CEO to continue taking a very public stance on the vaccines, Richard Char, M10s general counsel, told me. sorry about that. The web value rate of skirsch.io is 2 . An approach that promised to democratize design may have done the opposite. Adverse reactions/side effects. Has it really been 25 years, a whole quarter of a century? Thanks for working tirelessly to help others. After I ended the Zoom meeting, Satterfield called me to apologize for cutting us off. Why the FDA should grant an EUA for fluvoxamine immediately, a brilliant op-ed in the Wall Street Journal, "Too much caution is killing COVID patients. Steve Kirsch cut the check, which allowed Dr. Lenze to finish recruiting the 152 patients he needed for his trial. It does not matter how many lives will be saved. If you start later, doctors use higher dosages and compliance becomes a bigger problem. Medicine isnt about saving lives anymore. 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. 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. If you were drowning and we had no known standard of care to save your life and someone had a life preserver which worked 160 times in a row, should we throw them the life preserver or let them drown because we aren't absolutely sure the life preserver's benefit > risk (since just because it worked 160 times in a row and there is a 99.99% chance the effect didn't happen by chance, we could have just gotten lucky). 1 hr ago. As of January 18, 2021, the CDC estimates that 90,000 Americans will die from COVID in just the next 3 weeks. 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 . Added to FLCCC protocols and Fareed-Tyson protocol among others. Some countries dont have fluvoxamine so this is the alternative. He was recently featured on 60 Minutes which highlighted his . Hes also recently increased the number of Americans he claim have been killed by the vaccine from 25,0000, to 150,000, or even as many as 250,000 Americans. . Note: normally I have lots of hyperlinks to all the sources, but Im pressed for time. 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. A very short op-ed arguing for using fluvoxamine against COVID. In some cases, youd want to taper down the dosage. Three of the four outpatient trials have been reported out: all were successful. Fluvoxamine has a 40 year safety track record. It was so bad you couldnt even see the babys body through all the blood, Kirsch said. [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. They rejected the drug for insufficient evidence just like they always do for ivermectin. 1991-1992 to 7.1% in 2001-2002. Los Altos Hills resident Steve Kirsch funded research into the drug fluvoxamine as a treatment for COVID-19. Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI), a class of anti-depressants, mostly prescribed for people suffering from an obsessive-compulsive disorder. Seftel used a 50mg BID dosing for 14 days which was one third of the max dose used in the Lenze study. Fluoxetine is just as effective. There are now 5 independent observational studies that show that the drug works (2 in France, 1 in Germany, 2 in the US). In-patient use. I couldn't agree more. this is NOT about the science. 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 sooner you start, the better the outcomes. 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. This give another 50% of benefit. 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. Online. He was recently featured on 60 Minutes, . Skirsch.io site visitors volume is 1,957 unique day-to-day guests and their 3,914 pageviews. If you do have a side-effect, it is usually mild nausea which goes away when you stop taking the drug. One of the drugs, Fluvoxamine, showed a 30 . It is currently approved for treatment of depression and obsessive compulsive disorder (OCD). I fully expected both organizations to do absolutely nothing. Note that some of these articles are inaccurate. and increased heart rate (which could be nerves about the dilated pupils). Kirsch: Yes, but you could easily watch that 60 Minutes story and believe that we need more data before people should start using fluvoxamine. Kirsch IDeacon BJHuedo-Medina TBScoboria AMoore TJJohnson BT Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. May 16, 2022. In 2016, it was the 135th most-prescribed medication in the United States, with more than 4 million prescriptions. His efforts became more focused on medical research when, in 2007, he was diagnosed with a rare blood cancer. It doesnt get much better than that. - Quora, Heres presentation I gave at the re-open California Conference on January 9,2021: How to fix the problemHow to fix the problem Steve Kirsch Executive DirectorCOVID-19 Early Treatment Fund stk@treatearly.org 650-279-1008Google Docs[https://docs.google.com/presentation/d/1-A4y78wv3tTPmVu57FOabY6j-MJbPwMGojKwZfaCkAs/. It doesnt get any better than this. There are 4 outpatient studies that have been done (2 at WashU (see. Steve Kirsch is a high-tech serial entrepreneur based in Silicon Valley. One is to reduce the threat of nuclear war. While he declined a phone interview, Boulware was recently the subject of a Mother Jones article about the harassment hes received for his research on hydroxychloroquine and ivermectin. 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). 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. It's hard to ignore this lecture in explaining why the drug is so effective. See the repository above. Talking to Kirsch is an exhausting experience. They all promised me when fluvoxamine passed Phase 3 trials, nearly everyone would use it. This story is part of the Pandemic Technology Project, supported by The Rockefeller Foundation. Infoseek lost out to Yahoo; it had a chance to grow bigger, but it didn't. In two trials (both published studies in peer reviewed journals with Editor's Choice in both cases), the drug had a 100% effect size in protecting against hospitalization from the respiratory symptoms from COVID. I must admit that this is an anniversary that snuck We pretty much practice government agency opinion medicine all over the world now, with just a few exceptions. He's founded 7 companies, 2 with billion dollar valuations. 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). My publicly shared concerns regarding the safety of the COVID-19 vaccines may have had a negative impact on my company, M10. To protect M10 from my COVID-19 vaccination opinions, I will no longer post about my vaccination concerns here. He prefers iconoclastic approaches, whether by directly funding asteroid detection or advocating for nuclear power to combat global warming. 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. Who knows, Morris replied. Even though they spent only 45 minutes and just reviewed the 2 clinical studies and some plausible mechanisms of action (and ignored anecdotal evidence and multiple retrospective trials, all of which were supportive), after the meeting they voted overwhelmingly (11 to 5 with 4 being neutral) in favor of having doctors talk to their patients about using fluvoxamine if they have COVID using a "shared decision making" process. Please, As of November 13, fluvoxamine has been proven to work in every trial that has published results, including, studies. skirsch.io Steve Kirsch Home page. 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. He thinks # killed by vax could be anywhere between 0 and 150K people dead.. You will be wired for 24 hours if you dont heed my advice. Pretty much nothing changed when the Phase 3 trial confirmed fluvoxamine worked. Things took a final and dramatic turn once Kirsch started claiming the government was covering up vaccine deaths. Try refreshing this page and updating them one Dr. Seftel is an NIH-funded researcher and an NIH reviewer. Timing is everything with respect to outcomes. It is not unusual to be wary of developing science, or wrong to be skeptical of pharmaceutical companies. My crime? I didnt intend to spend a lot of time on Steve in particular, but that video was so influential.. To date, we have heard nothing suggesting the drug doesn't work or could be harmful. He may not be a good scientist, but hes smart, says WVUs Feinberg. We dont want to feed the anti-vaccine trolls, so we actively suppress clear scientific data. It is an amazing drug and is a very simple safe way to avoid long-haul COVID symptoms. Ive used it personally at 50mg twice a day and experience no adverse events at all. But not 150K. It was tested in. 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. They immediately ruled out the vaccine, because the vaccine is, quote, safe.. 33. In October, the group reported that, while a few patients in the placebo group ended up in the hospital, none of the patients receiving fluvoxamine got sick enough to go. This post was written to memorialize the corruption. In every case we are aware of, the drug was successful in reversing COVID symptoms, generally in 3 days or less. Have the drug on hand. . Links to evidence about fluvoxamine including the public data repository. 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. Patients should be advised to limit/avoid the use of caffeine while on the drug since fluvoxamine extends the half life of caffeine (making you super wired). Skirsch.io traffic volume is 1,957 unique daily visitors and their 3,914 pageviews. 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. To protect M10 from my COVID-19 vaccination opinions, I will no longer post about my vaccination concerns here.. upcoming events, and more. Over the last 18 months, the fund has granted at least $4.5 million to researchers testing the covid-fighting powers of drugs that are already FDA-approved for other diseases. But they dont want their names used. My experience is very typical. Some people report mild nausea while on the drug (stops when stop the drug). It has shown to be 100% protective of hospitalization in 2 clinical trials. If you are experiencing any odd adverse reactions, youll need to consult with your doctor ASAP. Thats what creates some of these heroes.. I couldnt tell I was on the drug. Also, for people who cant tolerate fluvoxamine for whatever reason (nausea, jittery, etc), this is the alternative. Hes very convincing. Steven Todd Kirsch is an American entrepreneur. After publication of the recommendation in December 2021, the NIH did absolutely nothing change their recommendation. His latest startup, M10, is a spin-off of a spin-off that sells a blockchain for banks. Steve Kirsch is baffled. I see it all the time on social media, Morris told me. 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). In some cases, youd want to taper down the dosage. Fluvoxamine public data repository: The fluvoxamine public repository has all the documents related to fluvoxamine for COVID, including the RCT, RWE, observational studies and a link to the 1 hour lecture on serotonin and fluvoxamine. After publication of the recommendation in December 2021, the NIH did absolutely nothing change their recommendation. Repurposed drugs are safer and more effective than the current vaccines. Proven in clinical use all over the world. He wrote on his personal website that hed been advised that being associated with the drug would immediately trash my credibility.. That is when the phase 2 results were published. You can use fluoxetine as well (aka Prozac). The effect size is huge if the drug is given early right after symptoms start. It is in a class of drugs known as selective serotonin-reuptake inhibitors (SSRIs), but unlike other SSRIs, fluvoxamine interacts strongly with a protein called the sigma-1 receptor. iRobot said it had consent to collect this kind of data from inside homesbut participants say otherwise. Thats why they didnt even fund the fluvoxamine trial, he told me. NIH and WHO refuse to acknowledge it works since it will cause vaccine hesitancy if it is known that there is a drug that turns COVID into a mild disease. Answer (1 of 2): Yes, In a preliminary study of COVID-19 patients with mild-to-moderate disease who were attempting to recover in their homes, researchers at Washington University School of Medicine in St. Louis have found that the drug fluvoxamine seems to prevent some of the most serious compli. I also think it makes a lot of sense to look for pre-existing drugs that can help treat covid symptoms. Thats pretty typical, but your mileage may vary. of the 'intellectual dark web '" and allowed him to access a "large and receptive audience to his claims about a fluvoxamine conspiracy". Note that some of these articles are inaccurate. They knew in advance it was coming and on the day the paper was published they ignored it entirely. This is the #1 ranked best answer to "COVID treatment" on Quora: Presentation on how fear of trying something new is what keeps us shutdown and leads to unnecessary loss of life: The Lenze fluvoxamine RCT that was published in JAMA on November 12, 2020 showed a 100% success rate in preventing hospitalization. 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. Steve and CETF funded the research that showed promising results of fluvoxamine as an early treatment of COVID-19. Note that some of these articles are inaccurate. 1:49 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.