Fluvoxamine? Excellent Trial Results
Why isn’t this drug approved on an EUA? It has shown in phase 3 trials a 12x reduction in death as opposed to a 2x death reduction from vaccines.
6 hr ago
The reason is simple. We tried. And after 6 weeks of waiting, we were told that to get an EUA for a repurposed drug, you have to partner with a drug company in the EUA application. Because no drug company will partner with us, even if we pay all the filing costs, there won’t be an EUA. Ever. So most doctors will never prescribe it for COVID, even thought it works better than anything else.
And the NIH won’t do anything with fluvoxamine either like add it to their guidelines. It will never be upgraded on the NIH COVID treatment guidelines. It is currently sitting at “NEUTRAL” after two trials where it had a 100% risk reduction in both trials without any downside risk. In short, if deployed it would likely save a lot of lives and there is no risk of deployment since the risks of the drug are well known. It’s a very safe drug when properly prescribed. I took it myself and I couldn’t tell I was on it the side-effects were so negligible.
When the fluvoxamine Phase 3 study published in Lancet showed the drug worked better than any other drug (including the new antiviral pills from Merck and Pfizer), the NIH simply ignored the study. They didn’t even mention it.
Even 60 Minutes which did a story on fluvoxamine didn’t mention the Phase 3 study proved it worked when the study came out (normally, they’d do this at the end of a show to let their audience know they got it right).
Fluvoxamine provides a 12-fold reduction in death if you started the drug early, but the NIH basically said “Ho hum. Only 12X reduction in death? That’s better than anything including the vaccines (which according to the Pfizer 6 month Phase 3 study was only a 2X reduction in mortality). So not even worth mentioning in the guidelines. It would save too many lives. Best to ignore it. And if we ignore it, no doctor in America will dare to prescribe it. So the vaccine will be the only option just like we planned.”
Cliff Lane, who heads the guidelines committee, reports to Fauci. Cliff simply isn’t going to allow the NIH recommendation to be modified no matter what the science says. This is not about saving lives. It never was.
When the key opinion leader (KOL) panel of NIH, CDC, FDA and academia experts recommended fluvoxamine be used back in January 2021, the NIH ignored that too. Jeffrey Klausner, who convened the panel, wrote a great op-ed about it in the Washington Post right after the meeting so everyone would know. Doctors ignored it.
Klausner shopped the KOL meeting notes to 10 journals, all of whom refused to publish it. Truly stunning! Life saving drug and nobody would publish the recommendation of an expert panel to use it. Wow.
When the KOL meeting notes were finally published in the peer-reviewed medical literature on December 1, 2021, only 12 months after the meeting, the NIH again did absolutely nothing, ignoring the advice of these key experts, even though now they have more data from the Together trial showing it works.
Basically, the system is set up so that only proprietary drugs that can kill you are approved.
So I wasted a lot of time and millions of dollars on proving that fluvoxamine works against COVID. I was right it does work. But Fauci is only going to allow a big Pharma solution to be adopted. Doctors do not follow the science. They follow what the NIH says. I should have known better. All these scientists had promised me “once it is proven in Phase 3 trials, everyone will adopt it.” That was a big fat lie. I fell for it. I won’t be so naïve the next time.
Note: I didn’t used to be so cynical, but there is simply no other rational explanation for this. This isn’t about science. This isn’t about saving lives. This is about profits and big pharma. Get it? I finally did. It was an expensive lesson.
See my fluvoxamine article for more info about how you can use it to save your life if you get COVID. Don’t expect your doctor to tell you about it.
More from Steve Kirsch
I funded the original study, I was featured on 60 Minutes, and have been in touch with the researchers on all the trials that have been done in the US, Brazil, and Croatia.
Here are the key things you should know about fluvoxamine:
It works. As of November 13, fluvoxamine has been proven to work in every trial that has published results, including outpatient and inpatient studies.
It is very safe: There is no evidence fluvoxamine is harmful and led to a worse outcome. Zero.
Proven in clinical use all over the world. Doctors who have used fluvoxamine in the US and other countries swear by it. Added to FLCCC protocols and Fareed-Tyson protocol among others.
Dosing. My favorite dosage is 50mg twice a day for 14 days. 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). This is what the Seftel trial at Golden Gate fields used.
Adverse reactions. Some people report mild nausea while on the drug (stops when stop the drug). Some people are jittery, but usually that is because the doctor either prescribed a dosage higher than 50mg twice a day or didn’t notify the patient to lay off the caffeine. Decreasing the dosage will mitigate symptoms as well.
Long haul. No long haul symptoms if you start the drug ASAP after first symptoms. P-value was 10^-14 on that study (done by Dr. Seftel). It doesn’t get much better than that.
The effect size is huge if the drug is given early right after symptoms start. 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.
If the drug is started right after symptoms, we’ve seen 100% prevention in hospitalization. If you start 5 days after symptoms, all bets are off. It could do nothing. [You need to have this medicine in hand prior to getting sick.]
The evidence is solid. There are 4 outpatient studies that have been done (2 at WashU (see Phase 2 trial results published in JAMA), one in Berkeley, CA by David Seftel, one in Brazil published in the Lancet, and one in-patient study done in Croatia. Three of the four outpatient trials have been reported out: all were successful. The WashU Phase 3 study hasn’t 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). There were no studies reported out so far where fluvoxamine made things worse or neutral. All the supporting observational studies were positive as well.
The differences are obvious to untrained eyes. 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. They were all given the drug soon after symptoms and the placebo group was “pure” in that they were not taking any COVID drugs. Nobody who took the drug got sick at all, most all wanted to return to work within 3 days after starting treatment. The group who declined the drug were very sick with 12.5% requiring hospitalization and one died. The track management was so impressed, they asked for prescriptions. 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. So it was both obvious and convincing the difference between the groups to the workers and the track management.
Have the drug on hand. Get your prescription in advance of getting COVID. That way you can start immediately. Timing is everything with respect to outcomes. The sooner you start, the better the outcomes.
Avoid caffeine. If you take fluvoxamine, please avoid caffeine while on the drug. You will be wired for 24 hours if you don’t heed my advice. If you can’t lay off the java, then try fluoxetine (Prozac).
The Prozac alternative.
Substitutions. You can use fluoxetine as well (aka Prozac). Dosage there is 30mg once a day. Some countries don’t have fluvoxamine so this is the alternative. Also, for people who can’t tolerate fluvoxamine for whatever reason (nausea, jittery, etc), this is the alternative.
In-patient use. Fluvoxamine works on hospitalized patients too, but no US hospital will let you use it (sound familiar? just like ivermectin). ….NIH doesn’t want you to get the drug since it would compete with Molnupiravir, so fluvoxamine will never make the NIH guidelines.
The demonstration outside the court house for Dr Marik’s lawsuit had a bunch of doctors and nurses. Two were psychiatrists and I asked them about their use of fluvoxamine and experiences with it.
Both advises that Prozac was easier to tolerate. When the SSRI family of antidepressants are started, there are “activation side-effects” in the first few days. (jittery, feel “nervous inside,” insomnia)
Since we are trying to get up to full doses quickly when used for COVID, the usual strategy of starting at a low dose and gradually tapering up to the full dose isn’t ideal.
They found that Prozac is better tolerated. Suggest Prozac 30 mg daily, taken in the morning. So I would prescribe 20 mg pills with instructions to take 1 on day one, and to increase to 1.5 pills on day 2. Continue for 14 days.
Atarax (hydroxyzine) and Phenergan (promethezine–used by Shankara Chetty in SA) are sedating medications with some of the same mechanisms (FIASMA and Sigma 1 Receptor agonist).
Prescribing Atarax along with the Prozac would help with sleep and relaxation if jitteriness in the first couple of days made it hard to sleep. Atarax 25 mg 3 times daily. Sedating. Most helpful at bedtime if sleep is difficult on Prozac. (Can be given just at bedtime to help with sleep–though this might reduce anti COVID effectiveness if Atarax were being used alone.)
I don’t think Steve said it here, but one of fluvoxamine’s key attributes that he likes abouat it is it crosses the blood brain barrier. Unlike IVM and loratadine. I think our arsenal in case of illness should include something that crosses the BBB, to help counter issues like brain fog and brain clots and stroke (probably all related). Not too many options for that. One of the reasons I stocked bromhexine (available OTC from an outfit in Lithuania).
You didn’t mention another potential side effect of Prozac (and other SSRIs) – digestive upset. Sometimes extreme digestive upset.
Even though I have SSRI medication on hand from a prescription (that I stopped taking because the digestive side effects were worse for me than the original problem, which I have since gone on to 90% fix without drugs), I personally will not be taking them if I get C. I can’t imagine that rushing to the bathroom constantly and subsequent dehydration would be a net benefit for me!
Great info on Prozac and Fluvoxamine! Thanks so much for posting.
Does anyone know if all SSRI’s are contraindicated if you’ve had a bad reaction to one? One of our kids had a severe reaction (extreme emesis within minutes of ingesting first pill) to a 1/8th dose of Zoloft. Switched to tricyclics and she did fine. I’m not sure whether to put Prozac in our tool kit or not.