We don't know why the NIH panel is ignoring fluvoxamine and we aren't allowed to find out. Sadly, doctors and public health officials refuse to instruct patients to seek early treatment. They never make things worse so are safe to try. Steve Kirsch reported that doctors commonly say (of fluvoxamine), "This is the most powerful drug in my arsenal. Kirsch, though, often relies on the heartstrings to smooth over a lack of data. I fixed the link to the fluvoxamine article. The race to find covid-19 drug treatments that actually work, The antimalarial drug Trump took for covid might actually be dangerous. 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. After I ended the Zoom meeting, Satterfield called me to apologize for cutting us off. Long haul. I only know of a few doctors who prescribe this off-label, all with 100% success rates. My website www.skirsch.io has tons of info on fluvoxamine with all the links. Compulsive hand washing? 47).. 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. JAMA systematic review and meta analysis It doesnt get any better than this. Dosage there is 30mg once a day. 21. 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. ). Steve Kirsch is an inventor of the optimal mouse, a Silicon Valley millionaire, and an MIT alum (Class of '80). Silence from the medical community. I took it myself at that dosage and noticed zero side effects. There were IRB rules that required the 65 patients to be listed in the diagrams and charts. My favorite dosage is 50mg twice a day for 14 days. Dosage there is 30mg once a day. We need to keep people out of the hospital in the first place. It was tested in. Kirsch did a lot of things right when he set up CETF. [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. 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. The study was also featured on 60 Minutes. 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. The differences are obvious to untrained eyes. All the medical journals refused to publish the meeting notes (rejected by 6 journals). . Note: normally I have lots of hyperlinks to all the sources, but Im pressed for time. Its not about the science. 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. Today, we are letting people drown and we are not even telling them there is a life preserver they can ask for today with compelling evidence that is under consideration by the life preserver safety group. It is perhaps the greatest unnecessary loss of life in American history. Every earlier study of fluvoxamine (such as observational studies) showed it work and the mechanism had been shown. . Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI), a class of anti-depressants, mostly prescribed for people suffering from an obsessive-compulsive disorder. But while this effort was praiseworthy, Kirsch's predilection for oversimplifying and exaggerating led him to mislead. His foundation shifted focus to one goalcuring Steve Kirschby supporting one of the few scientists looking at the disease. Most recent articles first. CETF funded David Boulware's trials on hydroxychloroquine and the Phase 2 and Phase 3 fluvoxamine trials, among many other research projects. By March 2020, hed settled on the idea of searching for covid treatments in the pre-existing pharmacopeia. An MIT Technology Review investigation recently revealed how images of a minor and a tester on the toilet ended up on social media. It is about following orders and making money for the drug companies and protecting the doctor from liability and losing his medical license. He has been a medical philanthropist for more than 20 years. Three of the four outpatient trials have been reported out: all were successful. The alarming article cited the claims of two anti-vaxxers, Steve Kirsch and Dr. Robert Malone. If the drug is started right after symptoms, weve seen 100% prevention in hospitalization. I have all of these on hand and I load up on vitamin D3 every day. . (The ivermectin data are trash, Feinberg told me. Or just depression about the vaccine mandates? In three phone conversations, as well as dozens of emails, his responses to questions about claims in this story were imprecise or constantly changing. , a non-profit known as the nations drug pricing watchdog, did a review of the evidence and determined that fluvoxamine evidence is superior to Molnupiravir. S1R can essentially turn off IRE1, so IRE1 will not activate XBP1, so that the cytokine production will decrease. 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. Food/drugs to avoid while on fluvoxamine. In May, all 12 members of CETFs scientific advisory board resigned, citing his alarming dangerous claims and erratic behavior. If you continue to get this message, The NIH wrote a bullshit rejection because the FDA told them not to approve it. Refresh. Decreasing the dosage or stopping the medication will mitigate symptoms within hours. 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). Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI), a class of anti-depressants, mostly prescribed for people suffering from an obsessive-compulsive disorder. Paper reviewing the evidence and mechanisms of action for fluvoxamine: Lenze Phase 2 RCT published Nov 12, 2020: Seftel RWE trial that confirmed the Phase 2 trial published Feb 1, 2021. The NIH never did a risk benefit analysis of this drug. For decades, coders wrote critical systems in C and C++. We should not wait for the Phase 3 RCT. Its the gold standard of medical evidence. Early treatment with existing drugs is the fastest, most effective, and lowest. This document is a collection of evidence that highlights the glaring errors in our pandemic response. If you wanna find someone to debate me for ten thousand dollars, or a thousand dollars, Im happy to do that, just for your benefit.. My website. As Kirsch has gone deeper into the anti-vaccine scene, many professional associates have increasingly distanced themselves from him. He considers himself an expert in something that he doesnt have training or experience in, and hes not following scientific methods to assess data.. So why would we wait when lives are being lost? CETF founder Steve Kirsch accepted an invitation to discuss the findings on a weekly . of the 'intellectual dark web '" and allowed him to access a "large and receptive audience to his claims about a fluvoxamine conspiracy". just like ivermectin). 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. Generally, at 50mg BID x 14, it is very tolerable as long as the patient is instructed to lay off the caffeine. Dr. Seftel is an NIH-funded researcher and an NIH reviewer. Doctors wait for government permission (EUA or added to the NIH guidelines) before using a drug. They knew in advance it was coming and on the day the paper was published they ignored it entirely. As noted before, the repository has a link to the 1 hour serotonin lecture. The drug was widely prescribed as a covid treatment for much of 2020, based on anecdotes and flawed studies. Its all about NIH saying it is OK. Medicine today is driven by government opinion, not science. There are at least eight mechanisms of action that we think contribute to the effectiveness of this drug. At the end of May this year, Siliciano emailed the other advisors to say that Kirsch had gone off the deep end and he was cutting ties. But thats not a surprise, according to researchers who conducted them: the vast majority of trials for any drug end in failure. The rest of the board soon followed. 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. 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. I think so. There were no studies reported out so far where fluvoxamine made things worse or neutral. An approach that promised to democratize design may have done the opposite. To protect M10 from my COVID-19 vaccination opinions, I will no longer post about my vaccination concerns here. All can merit a fluvoxamine prescription based on traditional diagnoses. . On his blog, Covid-19 Data Science, he has extensivelyand mercilesslyunpacked Kirschs evidence for the vaccine death claims. Stopping the meds will return you to your normal self. This advice is now outdated. It cant be more clear than this. In fact, he was unwittingly the source for one of Kirschs figures. This story is part of the Pandemic Technology Project, supported by The Rockefeller Foundation. 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). If you are experiencing any odd adverse reactions, youll need to consult with your doctor ASAP. But they dont want their names used. I learned this the hard way. Today, if we follow the CDC advice, nearly 100,000 people a month will die from COVID. . My experience is very typical. (Clayton Fox, Marty Makary, and Jeffrey Klausner). Steve Kirsch: Vaccine Killing Millions, Treatments, VAERS, 5-Month Death Signal, Mystery Clots Embed 1.15K 'This Has Cost Millions of Lives': Steve Kirsch on Suppression of Repurposed Drugs and a Spike in Deaths 5 Months After Vaccine Rollout American Thought Leaders AMERICAN THOUGHT LEADERS JAN JEKIELEK Show more Loading comments. It is very important to educate doctors because most people rely on their doctors for advice. We should be making decisions now based on the evidence on the table today. Completely avoid caffeine, alcohol, tylenol, and benadryl. In some cases, youd want to taper down the dosage. These people never called the researchers whose trials they claimed showed no effect. That covers almost 150,000 of them, which happened before vaccinations began. We don't know why the NIH panel is ignoring fluvoxamine and we aren't allowed to find out. As of November 13, fluvoxamine has been proven to work in every trial that has published results, including outpatient and inpatient studies. are all super cheap, effective, and available without a prescription. After one or two conversations like that, I got tired of arguing, so I started avoiding his calls.. 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. Here's why. Added to FLCCC protocols and Fareed-Tyson protocol among others. This should be top news, but the press is ignoring this and attempt to write stories about it are killed by the editors. ALWAYS check with your doctor and report any medications you are taking before or plan to take after you start taking fluvoxamine. Article about the rejection (Stat News) Article about the fluvoxamine rejection (The Verge) NIH is still unsure whether fluvoxamine should be used to treat COVID (article I did after the TOGETHER trial). Ive talked to doctors who are extremely familiar with the drug and all the trial results and they would prescribe it to their patients. The. 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. . ICER Publishes Final Evidence Report and Policy Recommendations on Outpatient Treatments for COVID-19 - ICER. How covid-19 conspiracy videos keep getting millions of views. I fully expected both organizations to do absolutely nothing. That is when the phase 2 results were published. The effect size is huge if the drug is given early right after symptoms start. $1M reward: Do we need more data re: Fluvoxamine for COVID-19? (article I did after the TOGETHER trial). Note that some of these articles are inaccurate. 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. Doctors who have used fluvoxamine in the US and other countries swear by it. You will be wired for 24 hours if you dont heed my advice. No long haul symptoms if you start the drug ASAP after first symptoms. After publication of the recommendation in December 2021, the NIH did absolutely nothing change their recommendation. Dr. Seftel's paper has been accepted for publication and will appear in OFID in early February. Those who know Kirsch say this is a typical tactic. Every earlier study of fluvoxamine (such as observational studies) showed it work and the mechanism had been shown. This looks ominous, but it harmless. There is absolutely no evidence that either one of these claims is true, as Morris has carefully documented. Online. I couldnt tell I was on the drug. . The US government accused Janssen of improperly promoting the antipsychotic drug Risperdal to dementia patients despite the drug increasing deaths in the elderly. Government agencies are ignoring the science. A very short op-ed arguing for using fluvoxamine against COVID. Instead, it erodes confidence in our government to provide timely advice that is in the public interest. It does not matter how many lives will be saved. And FrameMaker is still a niche product. 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. To scientists, giving fluvoxamine a chance means running a large trialnot giving it to individual patients in the clinic, off-label and outside the context of active data collection and analysis. His efforts became more focused on medical research when, in 2007, he was diagnosed with a rare blood cancer. Hes adept at debate, rapidly shifting the premise of a conversation to put the other person on the back foot. In September, he resigned as CEO and gave up his board seat. It was so bad you couldnt even see the babys body through all the blood, Kirsch said. The medical community doesnt care about saving lives. 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. Steve Kirsch is a high-tech serial entrepreneur based in Silicon Valley. Here are the key things you should know about fluvoxamine for COVID: It works. The evidence is solid. Over the next few years, millions of unvaccinated people are going to get covid; its vital to try to mitigate their suffering, as well as lessen pressure on the health care system. Note: normally I have lots of hyperlinks to all the sources, but Im pressed for time. 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. With little government funding available for such work, Kirsch founded the Covid-19 Early Treatment Fund (CETF), putting in $1 million of his own money and bringing in donations from Silicon Valley luminaries: the CETF website lists the foundations of Marc Benioff and Elon Musk as donors. 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. 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? There may be a depression of libido while on drug, but since the drug is taken on acute basis, this is only temporary and it reverses once the drug is stopped. You can use fluoxetine as well (aka Prozac). Kirsch said that his attempts to promote fluvoxamine are being curtailed. Other SSRIs work as well, but fluvoxamine activates the Sigma-1 receptor the most of the SSRIs which is why it was chosen. That was a lie. Over the summer, the conflict reached his most recent startup, M10. Last Checked: 03/03/2023. 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. Steve Kirsch. Thanks for working tirelessly to help others. Ive talked to doctors who are extremely familiar with the drug and all the trial results and they would prescribe it to their patients. While Fauci was crafting national pandemic policies, Fauci's wife [Christine Grady, Chief Bioethicist, NIH] was back stopping [them]." Report coming soon. 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 . While these are stunning results, less than a dozen doctors in the US are prescribing fluvoxamine today. 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). [NIH] doesnt want any of these treatments. Doctors who are most familiar with the drug would prescribe it to their patients. It is an amazing drug and is a very simple safe way to avoid long-haul COVID symptoms. Quick Summary . 95% confidence effect size is 75% or more. They were giving covid patients the antidepressant fluvoxamine as soon as possible after diagnosis, based on anecdotes about the drug limiting the runaway immune response that causes many severe symptoms. Everyone is stunned, but nobody is surprised. He has been a medical philanthropist for more than 20 years. 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. iRobot said it had consent to collect this kind of data from inside homesbut participants say otherwise. 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. We pretty much practice government agency opinion medicine all over the world now, with just a few exceptions. This advice is now outdated. Some countries dont have fluvoxamine so this is the alternative. saying that the per-protocol analysis was arbitrary and other excuses. By Steve Kirsch in fluvoxamine Feb 14, 2021 The case for fluvoxamine for treating COVID-19 A very short op-ed arguing for using fluvoxamine against COVID. Server IP cope with resolved: Yes Http reaction code: 200 Response time: 0.27 sec. Share this post. (One of them, Eric Lenze, was in fact giving a presentation on fluvoxamine to the National Institutes of Health the next day.) Both drugs have compelling data that is hard to explain if the drug doesn't work. Still, in the moment, his question threw me, and I stuttered. . That way you can start immediately. I see it all the time on social media, Morris told me. NIH doesnt want you to get the drug since it would compete with Molnupiravir, so fluvoxamine will never make the NIH guidelines. Drug interactions should be checked for. In California, Silicon Valley tech entrepreneur Steve Kirsch was also thinking about the pandemic. This 1/6 of the dose the FDA has approved for OCD (the labelled indication for fluvoxamine)! But the confusion provided a fertile breeding ground for skeptics. Steve Kirsch is a high-tech serial entrepreneur based in Silicon Valley. 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. Note that a total of 77 people got the drug, not 65. Its really, really common for a small effect, something that looks exciting, to be a statistical fluke when you look at a larger population. Steve Kirsch is baffled. No more. And not zero., Kirsch immediately forwarded the exchange to me and, I suspect, other journalists. If you have trouble getting a prescription, perhaps you have OCD? One user reported dilated pupils and increased heart rate (which could be nerves about the dilated pupils). So when a group of scientists applied for an EUA for fluvoxamine, what did the FDA do? He felt like he in good conscience had to speak out about covid, and so he made the decision to separate himself from M10, says Char, who has known Kirsch since the 1980s. So instead of this paper being treated as confirming an earlier hypothesis, it was treated as generating a novel hypothesis. Doctors wait for government permission (EUA or added to the NIH guidelines) before using a drug. Can I see your risk-benefit analysis?. The NIH never did a risk benefit analysis of this drug. Summary of key evidence. More recently, hes adopted extremist positions on covid vaccines, which he alleges are toxic. He has claimed that one in 1,000 people who have received mRNA vaccines have died as a result, and even claimed the vaccines kill more people than they save at an FDA public forum, which was first reported by the Daily Beast. 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. As a health care journalist, I started off firmly in the wait-and-see camp on mRNA vaccines. Both of them encouraged anyone reading this article to get vaccinated. If not, they should at least acknowledge that fluvoxamine might be helpful by at least listing it as a possibility. . 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. But not 150K. The anecdotal data of 100% success rates is further icing on the cake. . My publicly shared concerns regarding the safety of the COVID-19 vaccines may have had a negative impact on my company, M10. If you start later, doctors use higher dosages and compliance becomes a bigger problem. All have had a 100% success record in keeping their patients out of the hospital. I've collected fluvoxamine evidence here for convenient access. It does not matter how many lives will be saved. 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. At the dosing for COVID (50mg BID x 14 days), there is a 1% chance of mild-nausea and because the dose is so low and the time it is taken is so short, and there are no psychotropic effects (which require more than 3 weeks of use; the psychotropic effects non-existent if you don't have depression or an anxiety disorder in the first place). The drug was FDA-approved more than 65 years ago. Fluvoxamine - The backstory T he i nsi de st ory behi nd how f l uvoxami ne became a CO V I D t herapy By Steve Kirsch Last updated: June 3, 2021 . Talking to Kirsch is an exhausting experience. How I recommend people treat COVID and the fascinating backstory of how fluvoxamine was discovered. Less than a week later, David Seftel read about the Lenze trial, and ignored the JAMA advice. So much for evidence-based medicine. Another is to identify an asteroid that is going to hit the planet.. It was 25 years ago yesterday that Andrew Wakefield launched the modern iteration of the antivaccine movement.In doing so, he laid down a template that antivax quacks today still follow. The web price charge of skirsch.io . Its motivated out of his sense of keeping people safe and advancing health care.. Summarizes the 5 observational studies, RCT, RWE, and some of the more interesting anecdotal data. Adverse reactions/side effects. 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). Online Status. Medicine isnt about saving lives anymore. All the researchers are convinced the drug works. 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. . But I know something else that few other people know, thanks to a source at the NIH: the NIH was planning to approve fluvoxamine months ago, but they got a call from the FDA telling them not to. 19 In addition, several . Expect similar things to happen when Eiger applies for an EUA for interferon lambda, a drug with a 89% efficacy in phase 3 trials. This drug can save your life but you have to ask for it! Drug researchers at Washington University in St. Louis reached out to Kirsch looking for $67,000 to finish a very smallbut placebo-controlledtrial. There are two ways Ive discovered that I may be able to save the world, he told an IEEE Spectrum reporter in 2000. 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. Los Altos Hills resident Steve Kirsch funded research into the drug fluvoxamine as a treatment for COVID-19. Hes very convincing. That was a big mistake because the original paper contained text related to earlier studies and the editors chopped it out. . The group who declined the drug were very sick with 12.5% requiring hospitalization and one died. In a recent post, discussing claims Kirsch made during a three-minute comment at an FDA public forum, Morris wrote: In spite of many pages of writing and claims of over a dozen independent analyses verifying their results, their evidence falls far short of substantiating these dramatic conclusions, including a claim that vaccines have caused >250K excess deaths in the USA..

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