We could have saved a lot of lives. So instead of this paper being treated as confirming an earlier hypothesis, it was treated as generating a novel hypothesis. 1:49 Compulsive hand washing? [4] Steve Kirsch - Silicon Valley Philanthropist Shares Review of CDC Data: COVID-19 Vaccine Associated with 100X Deaths Compared to Influenzas [5] Steve Kirsch - FOIA Document for Vaccine Discussion as to mRNA-based Vaccine Safety Signals Added 12th August 2021: 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. Medium revoked my account for life. I didnt intend to spend a lot of time on Steve in particular, but that video was so influential.. How can the FDA say a drug which meets the gold standard of evidence has insufficient evidence? In California, Silicon Valley tech entrepreneur Steve Kirsch was also thinking about the pandemic. After I ended the Zoom meeting, Satterfield called me to apologize for cutting us off. The track management was so impressed, they asked for prescriptions. Doctors who are most familiar with the drug would prescribe it to their patients. Steve Kirsch said scientists and clinicians are studying a host of drugs and therapeutics to create a new line of defence against the virus but clinical trials are yet to lead to conclusive. Some people report mild nausea while on the drug (stops when stop the drug). Or just depression about the vaccine mandates? In fact, he was unwittingly the source for one of Kirschs figures. ALWAYS check with your doctor and report any medications you are taking before or plan to take after you start taking fluvoxamine. See my article on treatments. These people never called the researchers whose trials they claimed showed no effect. . Saving the world has been a theme of Kirschs life for years. If you cant get a prescription for COVID, then perhaps you have OCD? Boulware disputes that, and says that although Kirschs funding was important, his statements about drugs and vaccines have proven problematic. In September, he resigned as CEO and gave up his board seat. It will be months before enrollments are complete. Early research suggests that fluvoxamine, an FDA approved medication for depression and obsessive compulsive disorder, can be an effective early treatment for COVID-19. Other SSRIs work as well, but fluvoxamine activates the Sigma-1 receptor the most of the SSRIs which is why it was chosen. You can use fluoxetine as well (aka Prozac). We have a bounty of vaccines and more on the way, but drugs that treat the disease are vital too if we want to keep people alive and bring the pandemic under control. I mean, he really, truly has a heart of gold, Char told me. As of November 13, fluvoxamine has been proven to work in every trial that has published results, including outpatient and inpatient studies. With covid, 80% of your patient population does just peachy with no treatment at all, just a little bed rest and fluid. Some countries dont have fluvoxamine so this is the alternative. I asked to give a talk about COVID at MIT, but they couldn't find a faculty member to sponsor it. Please, As of November 13, fluvoxamine has been proven to work in every trial that has published results, including, studies. Kirsch said that his attempts to promote fluvoxamine are being curtailed. Think about it Molnupiravir has a 50% risk reduction whereas fluvxoamine is over 90%. Flavio Cadegiani and Steve Kirsch's studies didn't make the cut. As noted before, the repository has a link to the 1 hour serotonin lecture. According to its founder, serial tech entrepreneur Steve Kirsch, CETF was started in April 2020 in order to fund. Every year, we pick the 10 technologies that matter the most right now. If you cant lay off the java, then try fluoxetine (Prozac). The only way to do that is to treat them as early as possible with a drug that prevents hospitalization and death. 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. 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. just like ivermectin). There is no evidence fluvoxamine is harmful and led to a worse outcome. The next major effect is that that fluvoxamine activates the sigma-1 receptor. Both drugs have compelling data that is hard to explain if the drug doesn't work. In three phone conversations, as well as dozens of emails, his responses to questions about claims in this story were imprecise or constantly changing. Last Checked: 03/02/2023. 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). I've asked people, "there's a lot of evidence here it's not just a small phase 2 RCT. 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). Compulsive hand washing? CETF funded David Boulware's trials on hydroxychloroquine and the Phase 2 and Phase 3 fluvoxamine trials, among many other research projects. 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). And FrameMaker is still a niche product. And not zero., Kirsch immediately forwarded the exchange to me and, I suspect, other journalists. 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. During our first conversation, which turned into a multi-hour Zoom session, Kirsch paced through the rooms of his cavernous house with his phone held at chest level, rarely looking down at the camera. I have all of these on hand and I load up on vitamin D3 every day. What happens when your prescription drug becomes the center of covid misinformation. People are dying because of physician fear of a new treatment with a 100% success rate and a solid mechanism of action. Zero. Note that some of these articles are inaccurate. ICER Publishes Final Evidence Report and Policy Recommendations on Outpatient Treatments for COVID-19 - ICER. It was completed in August. 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 . 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. While YouTube has repeatedly taken down the full video of the DarkHorse episode, various clips have been watched over 4 million times, and the full audio remains available on Spotify. 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. are all super cheap, effective, and available without a prescription. Some are views most scientists think are wrong. This document is a collection of evidence that highlights the glaring errors in our pandemic response. 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 also made several videos and podcasts with Vladimir Zelenko, the conspiracy theorist doctor who convinced Trump to take hydroxychloroquine. If you take fluvoxamine, please avoid caffeine while on the drug. The Lancet paper showed that if you were treated early enough and took the drug as prescribed (it only works if you take it), it was shown to reduce your chance of death by 12X making it far more effective than any other drug for COVID. Steve put in $1MM of his own money and . 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. 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. But they dont want their names used. Weve known it works since August 24, 2020. Everyone is stunned, but nobody is surprised. We asked Steve to tone it down. The drug was FDA-approved more than 65 years ago. Compulsive fiddling with your mask? If the drug is started right after symptoms, weve seen 100% prevention in hospitalization. No more. 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. Generally, at 50mg BID x 14, it is very tolerable as long as the patient is instructed to lay off the caffeine. Fluvoxamine (Luvox) is a Selective Serotonin Receptor Inhibitor (SSRI) that is clinically indicated for OCD in children, and can be used off label for depression. 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). So check the side-effects list to be familiar with which side-effects are associated with which drug so if you have a side-effect, youll know which drug to reduce or eliminate. He is the inventor of the optical mouse and one of the first Internet search engines, Infoseek. This advice is now outdated. So it was both obvious and convincing the difference between the groups to the workers and the track management. Steve Kirsch's Newsletter ^ | 02/26/22 | Steve Kirsch. If you start later, doctors use higher dosages and compliance becomes a bigger problem. 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). The rest of the board soon followed. Dr. Eric Lenze: So the results were really pretty. 33. Waiting months for the phase 3 trial to complete is nuts. The study was also featured on 60 Minutes. Silence from the medical community. While Kirsch had the final say in who received grants, no one I spoke with expressed concerns about what projects had been funded, or why. He retired at the largest pension in federal history. Hes now outlived his initial prognosis by several years. Online. Generally, at 50mg BID x 14, it is very tolerable as long as the patient is instructed to lay off the caffeine. The reason is pure corruption. Entrepreneur Steve Kirsch who holds an early patent for the optical mouse decided to get involved in treating Covid. Why not fluvoxamine? The medical community did nothing (with a few exceptions like Dr. Seftel). Instead, it erodes confidence in our government to provide timely advice that is in the public interest. Also, this drug is only prescribed by psychiatrists so most doctors have no experience whatsoever with the drug. After boosting unproven covid drugs and campaigning against vaccines, Steve Kirsch was abandoned by his team of scientific advisersand left out of a job. Steve Kirsch is an inventor of the optimal mouse, a Silicon Valley millionaire, and an MIT alum (Class of '80). This story is part of the Pandemic Technology Project, supported by The Rockefeller Foundation. He pushes fluvoxamine, an anti-depression drug which despite doing very well in covid treatment studies has been strangely neglected. So you can address your OCD and if you get COVID, youll can up the dose. There were no studies reported out so far where fluvoxamine made things worse or neutral. 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. A video presentation by Steve Kirsch, Executive Director of the Covid-19 Early Treatment Fund. Now weve lost the high ground, Morris told me. We could have saved a lot of lives. Hes refused to accept the results of a hydroxychloroquine trial that showed the drug had no value in treating covid, for instance, instead blaming investigators for poor study design and statistical errors. The NIH wrote a bullshit rejection because the FDA told them not to approve it. . Thats why they didnt change their recommendation when the Phase 3 trial was published in Lancet. They immediately ruled out the vaccine, because the vaccine is, quote, safe.. of the 'intellectual dark web '" and allowed him to access a "large and receptive audience to his claims about a fluvoxamine conspiracy". Here are my answers. It is an amazing drug and is a very simple safe way to avoid long-haul COVID symptoms. In November, CETF gave the group an additional $500,000 for a phase 3 clinical trial that might show conclusive proof of efficacy. 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. ). If you are experiencing any odd adverse reactions, youll need to consult with your doctor ASAP. I am not aware of a single case where taking the made things worse, e.g., person was doing fine BEFORE the drug and symptoms worsened after taking the drug. I will . Some countries dont have fluvoxamine so this is the alternative. Other drugs in this class include Prozac (fluoxetine), Zoloft (sertraline) and Paxil (paroxetine). That was a lie. They left their recommendation of fluvoxamine at NEUTRAL. All the medical journals refused to publish the meeting notes (rejected by 6 journals). We should not wait for the Phase 3 RCT. That was a lie. How covid-19 conspiracy videos keep getting millions of views. 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. It does not matter how many lives will be saved. Steve Kirsch reported that doctors commonly say (of fluvoxamine), "This is the most powerful drug in my arsenal. I fully expected both organizations to do absolutely nothing. Months later, the site wont disclose how many doses it helped deliveror what it plans to do with user data. Refresh. Worst case, if we ignore all additional evidence so the average is a 60% pass rate. You cannot get any better than that. Lack of action. The FDA is will take months to deliberate on the fluvoxamine EUA application that we submitted on January 29. For example, tylenol+caffeine+fluvoxamine can lead to serotonin syndrome. Fluvoxamine was reportedly added to just 2 practice guidelines (. Peter Meinke, another former board member, spent nearly three decades in drug discovery at Merck. 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 medical community doesnt care about saving lives. This is the gold standard of evidence based medicine, Article about the fluvoxamine rejection (The Verge). 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? The paramedics will think you are on drugs. I only know of a few doctors who prescribe this off-label, all with 100% success rates. All the researchers are convinced the drug works. But while this effort was praiseworthy, Kirsch's predilection for oversimplifying and exaggerating led him to mislead. Do they sell it anywhere? I disagree with his interpretation of the data regarding several medicines and strongly disagree with his anti-vaccine nonsense, Boulware wrote to me. Ive talked to doctors who are extremely familiar with the drug and all the trial results and they would prescribe it to their patients. Hes also publicly railed against what he claims is a campaign against drugs like fluvoxamine and ivermectin. . 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. We are ignoring the advice of the KOL group and doing nothing. We don't know why the NIH panel is ignoring fluvoxamine and we aren't allowed to find out. It's hard to ignore this lecture in explaining why the drug is so effective. The 50mg BID dose was quite effective, but it has to be started early (as soon as symptoms start). Ivermectin has a very high quality systematic review, the highest possible level in Evidence Based Medicine. My website www.skirsch.io has tons of info on fluvoxamine with all the links. Physicians who use the drug for COVID now swear by it. Steve Kirsch Executive Director at COVID-19 Early Treatment Fund (2020-present) Author has 176 answers and 1.7M answer views Updated 1 y Both. Steve Kirsch Nov 5, 2021 145 92 Here are the key things you should know about fluvoxamine for COVID: It works. In it, he claimed mRNA vaccines kill one in 5,000 recipients and dramatically increase the rate of miscarriages. (The fund borrows its nonprofit status from the 501(c)(3) Rockefeller Philanthropy Advisors, which managed its money until it quit, according to the Daily Beast; neither organization is related to the Rockefeller Foundation, which supports Technology Review's reporting on covid.). But the best way to help people is through rigorous trials that show what drugs help which people, and at what doses and timesnot by basing entire protocols on incredibly limited evidence. [NIH] doesnt want any of these treatments. 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. If you ask your doctor for any evidence that fluvoxamine doesnt work or is harmful (like a DB-RCT which is the only thing they trust), they will show you nothing. An MIT Technology Review investigation recently revealed how images of a minor and a tester on the toilet ended up on social media. Kirsch is a serial entrepreneur who has spent decades pitching the next big thing, whether optical mice (Mouse Systems), document processing (FrameMaker), search engines (Infoseek), digital security (OneID), or e-commerce (Propel Software). In-patient use. We don't know why the NIH panel is ignoring fluvoxamine and we aren't allowed to find out. So when a group of scientists applied for an EUA for fluvoxamine, what did the FDA do? Share this post. . 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? Once the Phase 2 result came out, it should have been embraced by doctors. FDA official fluvoxamine rejection. So there were too few events in the placebo group and they werent recruiting fast enough. So far, doctors have failed to share his sense of urgency. Kirsch told me that meta-analyses are a higher level of evidence than randomized controlled trials. When I responded that meta-analyses are only as good as the data they are based on, he said Id like to understand your source on that, because I cant find a source that says a phase 3 trial is greater evidence than a meta-analysis., When you characterize me, you need to say that Steve Kirsch doesn't go with majority votes on interpreting data.. See this. Server IP cope with resolved: Yes Http reaction code: 200 Response time: 0.27 sec. 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. But they will refuse to give it to you even after being proven in a Phase 3 trial that was approved by the WHO. If you cant lay off the java, then try fluoxetine (Prozac). Doctors wait for government permission (EUA or added to the NIH guidelines) before using a drug. After publication of the recommendation in December 2021, the NIH did absolutely nothing change their recommendation. Don't underestimate the virus. Hes spending his own money to do what he thinks is right. After one or two conversations like that, I got tired of arguing, so I started avoiding his calls.. That way you can start immediately. Theres nothing there.). . And that is what has allowed Kirsch, and people like him, to become so influential. Steve Kirsch is a high-tech serial entrepreneur based in Silicon Valley. It is currently approved for treatment of depression and obsessive compulsive disorder (OCD). Eventually, a press representative who was listening in, David Satterfield, unmuted his microphone to suggest we finish our conversation by email. In 2013, Johnson & Johnson paid $2.2 billion for its own kickback and fraud scandal, including a specific $400 million fine for its subsidiary Janssen, which manufactures the covid vaccine. Less than a week later, David Seftel read about the Lenze trial, and ignored the JAMA advice. The effect size is huge if the drug is given early right after symptoms start. Molnupiravir followed patients for only 30 days because they know the drug is dangerous. He may not be a good scientist, but hes smart, says WVUs Feinberg. But they dont want their names used. 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. With cases spiking, the Los Angeles area banned gatherings. The differences are obvious to untrained eyes. They never make things worse so are safe to try. Those days are gone. The medical community did nothing (with a few exceptions like Dr. Seftel). My favorite dosage is 50mg twice a day for 14 days. Instead, the government prefers to fund and promote new, proprietary drugs and vaccines, he says. 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. NIH doesnt want you to get the drug since it would compete with Molnupiravir, so fluvoxamine will never make the NIH guidelines. It doesnt get much better than that. Personal life. 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. 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). The group who declined the drug were very sick with 12.5% requiring hospitalization and one died. If you have trouble getting a prescription, perhaps you have OCD? Dr. Seftel is an NIH-funded researcher and an NIH reviewer. Almost 2.5 million people signed up to Dr. B with the promise of getting leftover vaccines. The 5 observational studies is icing on the cake. 12:45 AM . . I also think it makes a lot of sense to look for pre-existing drugs that can help treat covid symptoms. It was approved by the FDA in 1994 and has been used in millions of patients worldwide. Immediately after the results of the first fluvoxamine trial were releasedbut before they were published in a peer-reviewed journalhe wrote a post on Medium.com called The Fast, Easy, Safe, Simple, Low-Cost Solution to COVID That Works 100% of the Time That Nobody Wants to Talk About.. Thats pretty typical, but your mileage may vary. Steve Kirsch is baffled. But the whole process has gone too slowly for Kirsch. They all promised me when fluvoxamine passed Phase 3 trials, nearly everyone would use it. Infoseek lost out to Yahoo; it had a chance to grow bigger, but it didn't. Once the Phase 2 result came out, it should have been embraced by doctors. In other cases, stop cold turkey. 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. 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.. No long haul symptoms if you start the drug ASAP after first symptoms. 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. Hilary Grant-Valdez Operations Manager Tom Brunner Nobody who took the drug got sick at all, most all wanted to return to work within 3 days after starting treatment. Fluvoxamine is way better than Molnupiravir, but the NIH doesnt approve drugs on effectiveness. I learned this the hard way. 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. Enter the email address you signed up with and we'll email you a reset link. How I recommend people treat COVID and the fascinating backstory of how fluvoxamine was discovered. Kirsch is a serial entrepreneur who has spent decades pitching the next big thing, whether optical mice (Mouse Systems), document processing (FrameMaker), search engines (Infoseek), digital. It was tested in. Fluvoxamine has a 40 year safety track record. Adverse reactions/side effects. Telling the truth, he tweeted. Theyre finding alternative leaders to follow, Morris said. just like ivermectin). 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. So how did a man once intent on furthering science become a source of misinformation that undermines the very research he funded? Every earlier study of fluvoxamine (such as observational studies) showed it work and the mechanism had been shown. He says that Facebook took down one of his posts announcing his appearance on 60 Minutes. 1. Decreasing the dosage or stopping the medication will mitigate symptoms within hours. He was recently featured on 60 Minutes which highlighted his . Note that a total of 77 people got the drug, not 65. Is that really true? They all promised me when fluvoxamine passed Phase 3 trials, nearly everyone would use it. One user reported dilated pupils and increased heart rate (which could be nerves about the dilated pupils). ALWAYS check with your doctor and report any medications you are taking before or plan to take after you start taking fluvoxamine. It never was. May 16, 2022. Who knows, Morris replied. Fluvoxamine works on hospitalized patients too, but no US hospital will let you use it (sound familiar? Steve Kirsch -Executive Director at COVID-19 Early Treatment Fund Ivermection study - One .2mg/kg dose a week for prevention "100% success rate whereas those doctors taking placebo had a 59%% infection rate not a typo 237 of 400 docs on placebo got infected vs. 800 docs on Ivermectin none got infected" Antivirals The ICER independent review showed fluvoxamine is more effective than Molnupiravir: Read this article I wrote about using fluvoxamine correctly for COVID. There are at least eight mechanisms of action that we think contribute to the effectiveness of this drug. The group who declined the drug were very sick with 12.5% requiring hospitalization and one died. Note that some of these articles are inaccurate. (One of them, Eric Lenze, was in fact giving a presentation on fluvoxamine to the National Institutes of Health the next day.) 19 In addition, several . 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. 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.