Trial Site News, Steve Kirsh, May 16, 2021

Executive Summary

This is the first in a series of articles arguing that obeisance to constrictive evidence-based medicine (EBM) treatment protocols in a pandemic is causing an unnecessary loss of hundreds of thousands of lives.

If, instead of exclusively relying on EBM for developing treatment recommendations, we made medical decisions based on looking at all the available evidence and 1) made recommendations, which are most consistent with the evidence to date, 2) made recommendations that are more likely than not to save the most lives, and 3) considered the costs of being wrong (death vs. minor temporary side effects), then we would arrive at a completely different set of recommendations. We would not be afraid to make mistakes because we would be seeking to minimize the loss of life.

There is abundant evidence that COVID is best treated as early as possible with a cocktail of drugs, two of the most effective and safest being fluvoxamine and ivermectin. Doctors uniformly report that the earlier a patient is treated, the better the outcomes. I have yet to hear of a case where a patient who was treated within 24 hours of first symptoms with those two drugs needed to be hospitalized or developed any long-haul COVID symptoms.

I believe that a major reason why we have so many hospitalized COVID patients is that patients are told to do exactly the opposite of what they should be doing: if they don’t qualify for the monoclonal antibodies, we tell them to stay home and do nothing unless they get really sick. When patients present late, they are much more difficult to treat and the outcomes are never as good. If there is a fire in the kitchen, would you wait until your whole house is on fire before you called the fire department? Sadly, this is exactly what many patients are doing in India right now, waiting as many as 9 days after first symptoms before seeking treatment.

And when a patient finally presents for treatment, doctors have been reluctant to prescribe the two most effective drugs because current recommendations of the NIH and WHO for these drugs are either neutral or negative and these recommendations strongly influence their local guidelines.

The NIH and WHO recommendations are made by evaluating clinical studies, but they fail to take into account the costs of being wrong. If a drug has little to no side effects, and consistent evidence of a lifesaving benefit, why not give that drug the benefit of the doubt even if the evidence quality is low? If we are wrong, there is no harm. If we are right, we can save an enormous number of lives.

This article examines the evidence for three drugs in detail: hydroxychloroquine, ivermectin, and fluvoxamine. In every case when these drugs are used early in the disease, all the evidence (studies as well as results in clinical practice) is consistently positive, yet the official recommendations are either NEUTRAL or AGAINST their use. If the drugs don’t work, how do they explain all the evidence? They don’t. It is a mystery left for the reader to solve.

Fluvoxamine has shown 100% effect sizes in two very high quality randomized trials (one a DB-RCT, the other real-world quasi-randomized), both published in top peer reviewed journals. If fluvoxamine doesn’t work then why were none of the 77 patients in the Seftel study who opted for the drug hospitalized (vs. 12.5% of the no treatment group). Why did none of the treated patients develop long haul COVID compared to a 60% long-haul rate in the healthier group that declined treatment? Not only are these agencies unable to tell us the true cause of these important observations, they appear to have no interest at all in finding out what the actual cause was; they simply assumed it must have been experimental bias or a confounder or two. I offered $1M to anyone who could explain the observed outcome if it wasn’t due to the drug and nobody took my money. So the only explanation left is that the drug actually works really well when it is given sufficiently early. At no time was I ever worried I’d lose the challenge. For fluvoxamine there is only 1 chance in 1e14 that the long-haul effects observed could have happened by chance (10 orders of magnitude more certain than the vaccine).

On January 22, 2021, a key opinion leader panel of 30 experts from the CDC, NIH, and top US academic centers met to review the evidence and recommended by more than a 2:1 ratio that doctors talk to their patients about fluvoxamine for COVID. That expert advice is mostly ignored by doctors; clearly the NIH guidelines trump expert opinion.

Sadly, many doctors don’t like to use drugs that are still in clinical trials, so they will wait another 6 months to a year or more for the trials to finish just to be sure, even if there are no other drugs available. Patients will die, but the physician doesn’t want to make a wrong decision, even if there is minimal downside if they are wrong.

There are 29 studies of HCQ (six of them RCT) and all are positive, yet somehow this results in an AGAINST recommendation from both organizations.

For ivermectin, there are now 6 systematic reviews. Systematic reviews are the highest level of evidence in EBM and all of these reviews recommended FOR ivermectin (5 are published, 1 is awaiting publication). If 6 out of 6 positive systematic reviews are not enough, what is it going to take to get a positive recommendation from these organizations? How high is the bar? To this day, none of us has any clue. They won’t tell us. Were there errors in these systematic reviews? Neither agency has pointed out any such errors.

Recently, fifteen days after Goa India authorized the use of ivermectin, the number of patients needing hospitalization dropped 58%. If the drug doesn’t work (or is as harmful as the WHO claims), then what DID cause the fall in cases there? There are many many more examples.

Ideally, the NIH and WHO recommendations should tell everyone to be treated ASAP after infection with known effective drug combinations and dosages. If there is a better combination than ivermectin and fluvoxamine, these agencies should suggest the better combo. If we made just this one simple change in what we tell patients, hospitals worldwide would empty out.

Both the NIH and WHO have declined to defend their recommendations in a neutral debate. The NIH even refuses to disclose if there was a vote on their ivermectin recommendation.

Does anyone remember what the WHO said on March 13, 2020 about how to treat Ebola? Their advice, delivered by Dr. Michael J. Ryan, was spot on:

“You need to react quickly. Be fast. Have no regrets. You MUST be the first mover”.
“The virus will always get you if you do not move quickly.”
“Everyone is afraid of making a mistake. Everyone is afraid of the consequence of error, BUT THE GREATEST ERROR IS NOT TO MOVE.
Needing more evidence from a large, double-blinded, cumbersome randomized phase 3 trials that will take months, if not years, to finish is inconsistent with the WHO’s original message above. For example, one year later, HCQ, ivermectin, and fluvoxamine are still waiting for their definitive phase 3 trials and outpatient clinical studies of promising drugs such as camostat still haven’t completed enrollment. If only the WHO would heed their own advice from a year ago, we’d have had a completely different outcome today with COVID.

The bottom line is that while both the NIH and WHO have a laudable history of delivering good advice, they aren’t infallible.

The Ebola advice from the WHO was right on point and applicable to COVID: we must treat this virus early and we must not be afraid to use the drugs which today show the best evidence.

Over three million people have lost their lives to COVID, yet the drugs that could have prevented most of those deaths have been sitting on the shelf the entire time. We have been afraid to use them as we await more and more data from trials, all of which are turning out the same way showing these drugs are both extremely safe and effective. We are afraid of making a mistake. To avoid further loss of life, each country should immediately re-examine the evidence and make their own recommendations based on the principle of all the available evidence. That is the best way to minimize the number of lives lost.

India, Brazil, and most other countries all rely on COVID treatment guidance from the two organizations that people most trust for medical advice, the National Institutes of Health (NIH) and the World Health Organization (WHO).

Yet following the COVID guidance of these organizations is failing to prevent the unnecessary death of millions of people worldwide.

Is the guidance provided by these organizations correct? Or is there a possibility it could be harmful to follow their guidance?

This is now a matter of urgent public interest because India recently adopted ivermectin as standard of care for early treatment of COVID, which is exactly opposite to the WHO recommendation.

Is India doing the right thing? Or are they making a huge mistake? It’s important that people around the world hear from experts from both sides so they can decide for themselves.

Individual states in India can issue their own guidance. Goa wants people to take ivermectin, but Tamil Nadu just decided it should not be used. Who is right?

To help resolve this issue, TrialSiteNews has asked the WHO and NIH to provide experts for an open debate with the world experts on these drugs and a mutually agreeable moderator in a live zoom meeting which will be recorded and posted to TrialSiteNews and YouTube for the world to reference.

In the meantime, in this op-ed, I will explain why it is more likely than not that the NIH and WHO have missed the mark on three important drugs: hydroxychloroquine, ivermectin, and fluvoxamine and why world governments should ignore their guidance and independently evaluate the evidence.

This is a long article. Very long. But this is an important topic because over 3M people have lost their lives to COVID so far and the longer we fail to act on the clear evidence in plain sight, the more people will lose their lives unnecessarily. So please bear with me as I tell an important story that needs to be told.

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