Hydroxychloroquine: the world has lost the sense of risk and benefit
I will return again to the taboo subject. But this time it will all be different. Today I will accept everything that is being presented to me as science, without disputing anything.
Every time I write about hydroxychloroquine as a possible treatment for COVID-19, my texts are charged with being against what has been presented to all of us as science.
I don't need to make any hard-hitting statements or give strong opinions to generate controversy. The mere sequence of facts is enough. However, even if I put just facts, people don't believe me. They think, at first, that I am omitting part of the events to reach some conclusion that I want. In other words, people believe that I am being dishonest, that I am showing the facts that favor my argument and ignoring the others.
Furthermore, whenever I write about hydroxychloroquine and inevitably come to a contesting tone, someone comes along and asks what my qualifications are for daring to question "the science". I understand those who think this way. It is reasonable. After all, I am not a scientist or a doctor. I am just an aerobatic pilot and I am, at most, if I contract the virus, a patient.
After almost two years of pandemic, we all know one thing: the mere name of the medicine arouses uncontrollable emotions. This happens in Brazil and in several countries around the world. And exactly because I see these childish reactions, including from scientists, I will try, again, to bring rationality to the debate.
Yes, we need rationality when talking about COVID treatments. I think people should stop with mass hysterics each time this subject is brought up.
And exactly to avoid these reactions, today's article will have a different tone. To keep people's emotional balance, my approach here will be different. I will not dispute anything! This time I will accept everything that is being presented to me as science during the pandemic.
I understand people reacting emotionally when someone says hydroxychloroquine works
You have been locked up at home for almost two years. You don't receive any friends. You avoid visiting your parents as much as possible, making them depressed. When you leave your house an inch, you put on a mask to protect yourself. You carry a bottle of alcohol gel and rub it on your hands every five minutes.
At the same time you open the newspaper and there it says: "Hydroxychloroquine is not scientifically proven". You turn on the television and see smiling experts saying the same thing. You consult the WHO - World Health Organization, and read that they do not recommend the drug. The famous medical association? They don't recommend it. The important, reference hospital in your region? They don't use it.
In this situation there are two possible situations: The first is that a person comes to you and repeats the statement that it doesn't work. By doing so, this person is saying that, despite the pandemic, the world is in a normal situation. It does not create any kind of disturbance.
But there is a second situation: it is a person coming to you and claiming that hydroxychloroquine works against COVID-19. In this case, it is perfectly human to have an emotional response. It's completely understandable.
Think along with me. On the off chance that the cheap, generic drug available on any corner is working, there are a lot of people, including governments, doing the evil thing of suppressing it from the population, leaving millions to die alone, breathless, intubated. It would be an action of official misinformation generating a legion of orphaned children, helpless grandchildren, and grieving families. Someone claiming that it works, therefore, represents something disturbing. It would be a horror story.
It is not difficult to understand. This person, by claiming efficacy, is saying that the WHO - World Health Organization, the NIH - National Institute of Health, the FDA - Food and Drug Administration, among several governments, are acting against their populations. At the same time, this person is saying that there are scientists working to sabotage, deceive, and defame the cure, and that doctors are letting patients die unnecessarily.
In other words, this person is saying that mankind is garbage, and that you, on top of everything else, are naive for having faith in human goodness, and that you have been made a fool of for almost two years, putting your life at risk. Maybe you lost your mother, your father, a relative or a friend and didn't even have the opportunity to say goodbye with a decent burial.
It is very heavy. To shake people's faith in human benevolence is deeply uncomfortable. It is perfectly understandable that there are jokes, sarcasm, or insults in response to those who say that COVID-19 has effective treatment. It's not hard to understand those who interrupt, most of the time in a rude way, people who dare to talk about the subject. I fully understand everyone who reacts in this way.
But if even the WHO recommends against HCQ, why does the supposed controversy still persist?
The WHO has already given its verdict: it is against prescribing these drugs. This matter was supposed to be over and done with.
However, many scientists around the world, including some with a distinguished history in science, continue to insist that the drug works and that lives are being needlessly lost. Why?
Let me explain. Today, October 24, 2021, there are almost three hundred clinical studies with hydroxychloroquine. Among them, 32 were done on a specific condition: early treatment. That is, with initiation of medication within the first five days of symptoms. In an overall analysis, among all of these in early treatment, the results, for those treated, are strong and consistent.
Among the 32 studies in early treatment, 13 evaluated an important outcome that cannot be disguised or negotiated: mortality. Here is the list of the 13 studies with this analysis.
All observational studies on early treatment of HCQ that measure mortality as an endpoint show positive results
In the first column, on the left, are the names of the principal investigators of each study. In the second column, how much the reduction in mortality was in percentages. Each study was done in different places, by different researchers, on different dates. All, as the graph shows, have very close results of effectiveness. The benefit is unanimous.
In the overall results, among the 18,434 patients who took hydroxychloroquine, only 81 died. And among the 32,194 untreated, for comparison, 836 died. This represents a 75% reduction in mortality.
From all of them, I will explain some details of three, so that everyone understands what observational studies are.
The observational study by Dr Zelenko, Dr Denwand and Dr Scholz
A first example is the study by Dr Zelenko, who treated patients in a city near New York. He used hydroxychloroquine, azithromycin, and zinc. He started the triple therapy in patients with an average of four days of symptoms. To publish the study, he partnered with two other German scientists, Roland Derwand and Martin Scholz.
They treated 141 outpatients with an average age of 58. To compare the result, they took reference data from 377 untreated patients from the same community where Dr Zelenko treated his patients. Among those treated, 2.8% were hospitalized. Among the untreated, 15.5% were hospitalized. An 85% reduction in the hospitalization rate. There was only one death among the 141 treated. Among the 377 untreated, there were 13. A 79% reduction in mortality.
This is a cheap kind of study to do. It was just a matter of comparing the results of treated patients with the results of untreated patients.
The observational study of Hackensack University Medical Center
Led by scientist Andrew Ip, it is a study that took place at 13 hospitals in the Hackensack Meridian Health network in New Jersey, USA. It involved an analysis on 1,067 patients in the network confirmed with COVID, where 97 took hydroxychloroquine as monotherapy in the first few days of symptoms, and 970 received no medication. There was a 37% reduction in the need for hospitalization among those treated. Ultimately, of the 97 treated, two died, and among the 970 untreated, 44 died. A decrease in mortality of 55%.
The average age of the patients analyzed was 54 for the untreated and 57 for the treated.
The Iranian study with 28,759 patients
The lead scientist for the study is Majid Mokhtari from Shahid Beheshti University of Medical Sciences in Tehran. The research involved a network of 5500 Comprehensive Health Centers (CHC) throughout Iran. First, there was a 35% reduction in the need for hospitalization among those treated, similar to Hackensack. And of the 7,295 patients who received early treatment hydroxychloroquine monotherapy, 27 died. Among the 21,464 patients who did not receive the drug, 287 died. A 70% reduction in mortality. The average age of the patients was 43 years.
"Serious HCQ adverse drug reactions were not reported in any of the age groups with or without comorbidities", the Iranian scientists concluded.
"Observational has no power to determine effectiveness of therapy"
This is the statement they give us all the time. It is repeated by many people, like the Brazilian author José Alencar, who wrote the book "Manual of Evidence-Based Medicine". The people who disqualify observational studies say that only the "gold standard" studies, the randomized and placebo-controlled ones, are able to measure drug efficacy.
I could dispute that by citing the scientific paper by Andrew Anglemeyer, an epidemiologist from the University of Otago in New Zealand. His peer-reviewed study, published in 2014 at the Cochrane Library, concluded that there are no significant differences in outcomes between observational studies and the "gold standard," especially when efficacy is greater than 8%, as are all the studies of hydroxychloroquine in early treatment. In other words, the study states that observational studies do prove efficacy.
But today I will accept that only the "gold standard" studies attest to efficacy.
I could argue along the same lines with another study, by Kjell Benson, published in 2000 in the New England Journal of Medicine, where the author reached the same conclusions. "We found little evidence that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or qualitatively different from those obtained in randomized, controlled trials," the scientist concluded.
But to avoid triggering mass hysteria, today I will also ignore this study and agree with the celebrity scientists who appear on the news.
I could say that never in the history of medicine 13 observational studies with an average of 75% effectiveness have had their results reversed in "gold standard" studies. But today I accept the current statement and will not do so.
It would not be difficult to challenge with one question: to ask if insulin for diabetics or the tetanus vaccine are effective, because no "gold standard" studies have ever been done with these interventions. But today I accept everything and dispute nothing.
It would not be difficult to confront these experts stating that 86% of infectious disease treatments and 89% of cardiology treatments do not have the maximum level of evidence, and that therefore, especially during a pandemic, we should never wait for the maximum evidence to treat patients. But today I am not pointing out inconsistencies. It's all good.
Another way that media specialists use to criticize the observational studies of hydroxychloroquine is to accuse them of being published in scientific journals with a low or medium impact factor, which is true.
Today, among hundreds, the most prestigious medical journals are the New England Journal of Medicine, the Lancet, Jama, the British Medical Journal, JAMA Internal Medicine, the Annals of Internal Medicine, and the American Journal of Preventive Medicine.
The NEJM, for example, has an impact factor of 91,245. The Iranian study is published in a journal with an impact factor of 4,932. The Hackensack University study is in a journal ranked 3,090 and Dr Zelenko's study is in a journal with only 5,283. Numbers much lower than the New England Journal of Medicine.
I could countersay this by quoting Richard Smith, who was editor of the British Medical Journal for 25 years and wrote an article with the following title: "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies."
In his article, Smith quoted a sentence from Richard Horton, editor-in-chief of the Lancet, who in March 2004, said, "Journals have devolved into information laundering operations for the pharmaceutical industry."
Based on this, I could argue that it is the data from the studies that are important and that high impact factor journals would never publish positive studies of generic, cheap, off-patent drugs for outpatient treatment of COVID, for the simple fact that it is not in the interest of the big industries and they determine what these journals publish. But I won't do that. I'll take it. Fine.
So you, reader, along with me, are going to ignore all these observational studies. You will, from now on, consider them as incapable of determining the efficacy of a therapy. Forget all the efficacy data. Understand them only as "unconfirmed hypotheses", as the media experts explain.
What do the "gold standard" studies say about hydroxychloroquine in early treatment?
After a year and a half, almost everybody knows what a gold standard study is. It is what all the "science reporters" are explaining almost every week: The patients are drawn in an equal way, reducing confounding factors, so that two "arms" are formed. One group receives the drug, and the other receives a placebo. The factors that influence the draw are: age, pre-existing diseases, COVID risk factors, and gender.
In addition, it is not only the patients who do not know who received the active drug or the placebo. The doctors who are treating them don't know either. This is the "double blind".
What do the "gold standard" studies of hydroxychloroquine in early outpatient treatment, peer-reviewed and published in high-impact journals, say? These journals are, to the "defenders of science", the only ones that publish reliable studies.
We have only one. The study by Caleb Skipper of the University of Minnesota, USA, published in the Annals of Internal Medicine, a journal with an impact factor of 25,391, the sixth highest in the world.
It was conducted between March 22 and May 20, 2020. They enrolled participants through web-based surveys in the United States and the Canadian provinces of Quebec, Manitoba, and Alberta. In total, data from 423 participants were analyzed, where 212 received hydroxychloroquine and 211 received placebo.
I, of course, in order not to cause emotional reactions, and because I am just a stunt pilot, will not dispute anything in the study, even though my observations have nothing to do with science or clinical trials. I will accept the data exactly as it is published.
But what does the study say anyway?
You opened the study, read it, and came back here, right? As predicted, the result of the randomized, double-blind, placebo-controlled study matches the results of the observational studies.
In the placebo group, 10 people ended up being hospitalized, but two were unrelated to the disease, says the study. So there were eight COVID hospitalizations in the placebo. In the treatment group, in contrast, only four patients needed to be hospitalized.
In other words, there were 50% fewer hospitalizations among those treated. Those who took hydroxychloroquine did better when we talk about the need for hospitalization due to worsening of the disease. This was close to the 37% reduction in hospitalizations in the Hackensack University study, and the 35% reduction in the Iranian study.
What about deaths? Among the 211 who received placebo, one person died. And among those who received HCQ, one person also died, but in this case without being hospitalized. And there is no detailed explanation about that. And I wonder: how does someone die of COVID without going to the hospital in the richest country in the world? We are not talking about Afghanistan, Guinea-Bissau or Haiti. We are talking about the USA and Canada.
From the lack of explanation, it could be anything. From a slip in the bathroom by someone with COVID, a bicycle accident by someone infected, or it could have been someone killed with a cop's knee to the neck, like George Floyd, who had COVID and died during the study's follow-up period, right in Minnesota, the city where the research originated.
Among those who were assigned to take hydroxychloroquine, 25% of them did not take all doses or stopped taking the drug, the study says. It is not reported whether this may have been the case for the dead person in the hydroxychloroquine arm.
In any case, the obvious point is that the lower your chance of being hospitalized for the severity of a disease, the lower your chance of dying from the severity of the same disease.
And now you, the reader, are standing there, stunned to see that hydroxychloroquine has a "gold standard" peer-reviewed study published in a high impact journal, in which the treatment group did much better than the placebo group. Now you are wondering why neither the authorities, nor the experts on television, are recommending the treatment.
I'll explain. Because there were only a little more than 200 people per arm, the positive result of 50% fewer hospitalizations is not statistically significant. There is a measure called p-value, the probability value. In the case of this study, for need hospitalization, the value is P = 0.29.
This means that the result of this study has a 29% chance of having occurred by chance. The convention of medical science is that a study only demonstrates something if the possibility of chance is at most 5%. In other words, the HCQ patients did in fact do better than the placebo patients, but it may just have been due to luck of the drug.
I could argue that the average age of the patients in this study was 40 years. With this average age, and not a study in patients in the risk group, most of them recover without assistance. This reduces the scope for a treatment to produce improvements and generate contrast between the treatment and placebo groups. But I accept, without contesting, what has been published, so that no one feels offended.
In fact, with just over 400 patients at an average age of 40, that is, outside the risk group, it is impossible to generate a statistically significant result, even if the efficacy is 50%. But all right, I accept that it was a positive result by chance.
I could complain that to date no one has done a study with a large enough sample size to point to significant efficacy in early treatment of hydroxychloroquine, and that therefore there is this requirement, but no one has ever wanted to do that study, but I won't do that.
All people have faith in human goodness and believe that scientists are really interested in looking for a cure for two years. So I accept that we only have one single study, with a positive result, but by luck.
And one more detail in this research: at some point they decided that they would include 750 patients in each arm. This is reported in the study itself. But they didn't do that. So it is a partial result, from a study less than a third the size. In other words, the hydroxychloroquine vs. placebo game was stopped when hydroxychloroquine was winning.
A pause for a mathematical curiosity about the p-value, the probability value
In the Skipper study, 212 received HCQ and 211 received placebo. There were 50% fewer hospitalizations among those treated. But the p-value is 0.29. So it indicates that there is a 29% chance that the result was random.
I asked Daniel Tausk, PhD in mathematics, a professor at USP, one of the most prestigious universities in Brazil, to do a calculation: how much would the value of "chance" be if the study had been complete, with 1500 patients in total, as was conceived by the researchers themselves, following the same 50% reduction in hospitalizations among those treated, as indicated in the partial result.
"If there were 1500 patients in total, 750 in each arm, keeping the same proportions, we would have 28 of 750 in the placebo and 14 of 750 in the treated," Tausk said.
With the larger sample, keeping the same proportion, "the p-value would drop to 0.04 and be significant", Tausk calculated. In other words, the chance of the result being random, with a full study, would be 4 percent.
A word of caution from me: no one should follow me or use my perception as a reference, it may be distorted
There are two ways of looking at early treatment of COVID with hydroxychloroquine. The first is with the science from before the pandemic, where the "gold standard" study reporting reduced hospitalizations merely confirmed the results of the observational studies.
According to the science said by the experts heard by the newspapers today, the chance of the study result being random at 29%, and not less than 5%, qualifies the treatment as not valid. Therefore, this possibility of treatment, according to their opinion, should not even be taken into consideration. Quite the contrary: it should be opposed.
In this article, I am not disputing the experts who speak on television. And I am therefore dismissing the first possibility, that the "gold standard" study only confirmed the efficacy. There is therefore a one in three chance that the result of the study, which is positive, was the work of chance. From this point on, it is necessary to put the risks and benefits into the balance.
The drug is 70 years old and has been thoroughly tested. It is extremely safe. For some diseases, such as lupus and rheumatoid arthritis, people take HCQ daily, for years. The daily doses for both these diseases and for COVID are about the same, but for COVID people only take it for five days.
Basically, the side-effect risk of using hydroxychloroquine in a COVID treatment is to have a chance of about 15% of getting mild diarrhea. Nothing more than that has been reported.
Let's suppose that today I have symptoms of COVID. There is a treatment that reduces by half the chance that my disease will get worse and I will end up in hospital, but the chance that the result of this study was random is 29%. On the other hand, if I take the medicine, I have a very low chance of getting simple diarrhea.
My Decision? One of the safest drugs in the world? I take it. Even if it was a 100% chance of getting diarrhea. But don't follow me, I am not a reference and I don't want to influence anyone. You need to know one thing: I am used to taking risks.
I perform acrobatic presentations at low altitude. For every maneuver, I need to make a quick risk-benefit calculation. Any small mistake I make, or if a possible technical problem happens, there is a strong side effect. This is when a presentation of aerial acrobatics becomes something else: a spectacle of sound, light, and heat.
In many years practicing the activity, I have been to several funerals of fellow pilots and I continue to fly.
Acrobatics were in fact invented during the First World War. They were used to escape enemy gunfire or to shoot at them. We have kept up the activity until today just for fun and aeronautical tradition, besides Nietzsche's probable concept of living dangerously. But now only with the risk, without the need to use the maneuvers to survive in a war.
Anyone who is willing to take these risks has no hesitation, in case of being infected with Covid, in taking hydroxychloroquine for five days, even though this drug is one of the safest in the world, for just a good chance of not being hospitalized. But this decision is in my nature and I don't want to influence anyone.
However, you, the reader, who also has to make a decision about what to do if you contract the virus, are being influenced by the risk-benefit calculation for which category of people?
"Did you know that the effectiveness of the condom is only 90%?"
You go to a bar and take your nerdy friend who is always bullied by everyone. He is a guy who walks funny and laughs weird. His favorite subjects are dinosaurs, black holes, and time travel, all of which he watches on youtube. In addition, he has collections of Star Wars trinkets, loves video games, and reads superhero comic books.
At the bar, he takes pictures with a beer in his hand and posts them on the Internet to show other nerds that he is cool and that he usually leaves the house. You are there with him, drinking beer and being entertained by stories about tyrannosaurus rex and meteors. Soon you notice a very beautiful woman exchanging glances, leave your friend aside and decide to invest. After a pleasant conversation, the girl invites you to her apartment. "Did you know that the condom is only 90% effective?", your friend asks. You laugh at his face.
At the high level of "science decisions," if any treatment had been approved by the bureaucrats, vaccines could not gain emergency use status. That is the law in the USA. And in fact, with COVID patients being treated, vaccines would not be needed. Meanwhile, off-patent drugs have no owner and no lobby.
For big financial decisions, "evidence-based medicine" is set up to approve lucrative drugs, and randomized studies are extremely expensive. Thus, these studies serve as a barrier to what there is no commercial interest in. They are only done if they are funded by big industry or governments.
This is exactly why all the "experts" run and refuse to discuss the Anglemeyer study, which shows that cheap, observational studies also testify to efficacy.
In real life, 50% of the funding of the WHO - World Health Organization, comes from vaccine manufacturers. In the business world, the pharmaceutical industry spends three times more on lobbying than the oil industry, which creates wars all over the world.
In the world as it is, vaccine investors make the Forbes list. And among the experts who have to make decisions during the pandemic, the more they receive from the pharmaceutical industry, the more they take a stand against hydroxychloroquine.
In the world of medical science, the more the expert got from the pharmaceutical industries, the more he produced negative studies of hydroxychloroquine versus COVID. All this is what occurs in the big castles. It is not and never was a discussion about risks, benefits and scientific evidence.
On the other hand, with the arrival of the pandemic, the nerds who produced scientific content about dinosaurs and fought homeric wars against the horoscope's lack of scientific evidence, but who had thousands of followers on youtube, became heard references because they were already known "science communicators".
Moreover, TVs catapulted these fearful geeks to the status of sub-celebrities. One of the reasons is that with everyone at home, they already knew how to broadcast lives with good images and well-captured sounds, necessary for television. And they came with a further benefit: they agree with the decisions of the important organizations.
In other words, a kind of people who have no notion of risk and benefit have imposed their worldview on everyone.
This is a CDC (Center for Disease Control and Prevention) document about hydroxychloroquine. It is a guide. It was done before the pandemic.
It says that hydroxychloroquine can be prescribed for adults and children of all ages. It is safe for use during pregnancy and safe for breastfeeding mothers. Only a few drugs have had this safety profile. In addition, it can be prescribed preventively. But for the producers of dinosaur videos, it suddenly became deadly poison.
While at the top of the decision chain the issue involves a lot of money. Down here, these useful innocents really believe it is not worth it. To them, it is too much risk and too little benefit to recommend hydroxychloroquine for COVID patients if the chance of a positive trial result is credited to chance at 29%, not 5%, on an incredibly safe drug.
What's more, these clueless idiots enjoy being elevated to sudden fame. Stuck at home, they watch their numbers of followers on social networks grow to hundreds of thousands. In the end, it is as if these imbeciles, by imposing their limited views of the world, are taking revenge for all the bullying they have received all their lives for being the way they are.
In the past, the faces of people who supported crimes against humanity were the guards of concentration camps or the torturers of Latin American dictatorships. Today the faces have changed: they are fossil-loving youtubers, or science communicators who make fun of astrologers.
If they had normal notions of risk and benefit, it would be easy to overturn the lucrative "no treatment" narrative imposed by the powerful. But no. Empowered by likes and feeling smart, they think they have the right to offend, defame, and disparage doctors and scientists who have intact notions of risks and benefits.
Mass Hysteria and war against all treatments
The HCQ "gold standard" randomized trial story is interesting for a couple of reasons. The first is to explain the issue of the probabilities of positive study results being the result of chance. The second is to show how hydroxychloroquine was killed in front of everyone.
Are you afraid to recommend the "dangerous" hydroxychloroquine because of the 29% chance that study efficacy is random? Your problems are over. There are other options.
The "gold standard" study on propolis had a positive result
It is a gold standard study: randomized and controlled. It was done by Brazilian scientists, including scientists from USP, one of the most prestigious universities in Latin America. It was published in the scientific journal Biomedicine & Pharmacotherapy, with impact factor 6529, and showed the efficacy of Brazilian green propolis in hospitalized patients.
There were 124 patients randomized into three groups. One control with 42, another with 40 on a low dose, and a third with 42 patients on a higher dose of propolis. The average age of the patients was 50 years. "Adjunct treatment with propolis anticipated hospital release by five to six days," the scientists concluded.
The start of the study was in COVID-infected patients who were already hospitalized. On average, patients in the control group were hospitalized for 12 days. Among patients who took the normal dose of propolis, the average hospital stay was only six days. The patients with the lowest dose, seven days.
In other words, with propolis alone you can reduce the occupation of hospitals by half. Want more good news? COVID itself causes kidney damage. Using propolis reduced this damage. It was 4.8% among those who took propolis vs 23.8% in the control group. Therefore, propolis still reduces the sequelae of the disease.
It is a "gold standard" study with statistical significance. Do you know what the chance is that the positive result of the higher dose study, regarding the reduction of the length of hospital stay by half, is random? It is a measly 1%.
Yes. Propolis. Are you afraid of the side effect of propolis? It is a product that is sold in health food stores, does not need a prescription, and is extremely cheap. It is a product that grandparents prescribe for their grandchildren, not doctors.
I even understand people who are afraid to give hydroxychloroquine to their patients. But in a normal world, where there is no mass hysteria going on, where people can think and analyze risk and benefit, there is not a single rational reason why propolis is not being used to empty every hospital in the world.
However, we are on a planet where people accumulate toilet paper to the point of creating a global shortage. A world where people wear masks even when they drive their cars alone. And where anyone who laughs at this is wrong, of course.
Mouthwash worked, according to "gold standard" study
It is a randomized, blind, placebo-controlled study. Carried out by Brazilian scientists, it was published in the Scientifc Reports journal, linked to Nature magazine, with an impact factor of 4,379. It evaluated the efficacy of a mouthwash in 41 patients hospitalized with COVID-19.
Twenty inpatients had mouthwash with the active product. The other 21 with a fake one. Gargling occurred five times a day, for one minute each time, until they were discharged from the hospital. Because the randomization is small, there was an age difference in the placebo and treatment groups, where the treatment group tended to do worse. They were an average of 10 years older, as well as having more comorbidities and being sick for more days.
Even though the treatment group tended to go worse naturally, no one among those treated needed to go from inpatient to ICU. Meanwhile, in the untreated group, six people required intensive care. The same occurred with deaths. In the placebo group, three people died. In the group of those who used the real mouthwash, no one died.
The study has the statistical significance to be "good" for science. As for the benefit of avoiding ICU, the result has only a 2% chance of being random.
So, are you afraid of the side effect of gargling? Do you need to be a low-flying aerobatics pilot to believe that the risk-benefit balance is valid? You see, you don't have to drink mouthwash. It is only for gargling. It is a product that is sold over-the-counter in pharmacies. Moreover, it is cheap, leaves good breath and prevents cavities, like all mouth rinses.
In a normal world, where all people can rationalize, there is no rational argument for this not being used on all the infected people in the world. Even before they are hospitalized. Even before people have their PCR tests confirming COVID, being only suspected of the disease.
But we are in a world of mass hysteria and Canada, not Honduras or Myanmar, has become a dictatorship. There the police entered a house, broke up a party of seven people, and arrested two. And Australia? I, a Brazilian, for the first time in my life, celebrate the good fortune of not having been born Australian. There, they already make concentration camps to arrest people trying to deal with COVID.
And reading this study on mouthwash, a thought came to me. I am not a doctor, but I suspect that there is nothing wrong with taking propolis and gargling for cavities right afterwards. Possibly I have just invented a COVID treatment cocktail, which is able to make the world go back to normal.
Why hospitals prefer to let people die
Let's suppose I own a hospital. Soon I see studies like this on propolis, hydroxychloroquine or mouthwash. I decide, by rational risk-benefit analysis, to start treating all my COVID patients with these drugs.
I see the results and start telling everyone to start using it. I record videos and put them on youtube. I warn all my patients to go to the hospital at the first symptoms of the disease.
Shortly after that a story comes out in the newspaper made by the scientific journalists with no notion of risk and benefit, but that behind them, empowering them, there is a lack of action by the FDA and the WHO. "Hospital gives drugs without scientific proof". The one thing I don't want, for my hospital, is for the press to say that I am a science denier, quack, or that I am providing false hope for a cure.
I, the owner of the hospital, prefer to treat my friends, my relatives, but asking them to be silent. For all the others, I prefer to let them die. If I prescribe for more patients, the photos of the prescriptions go to social media, where there are thousands of shares, soon going to the press.
Every hospital that has tried something different has failed in its goal of treatment.
In the US, the Henry Ford Institute gave hydroxychloroquine to its patients. They saw a positive result, but since the study is not "gold standard," this represents a mortal sin. "FDA denied Henry Ford's request to continue using hydroxychloroquine for COVID-19 patients after hospital released controversial study" the Detroit newspaper MetroTimes reported.
In Brazil, the health group Prevent Senior decided to treat its patients. There were good numbers, like the Henry Ford, like the Iran studies, like the Skipper study, and the Hackensack study, from New Jersey. In The Intercept, the headline is this: "With the consent of the CFM, Prevent Senior transformed Brazilians into human guinea pigs".
No one can take a step back. The FDA denied Henry Ford Hospital's request and still offended them, as if they don't know how to do science. If efficacy is recognized months later, the FDA let thousands die.
In Brazil, Prevent Senior, a cheaper health plan, is the only big hospital that treats, or used to treat covid patients from the first symptoms. The other hospitals, considered more state-of-the-art, such as Albert Einstein or Sírio Libabês, of the economic, artistic and political elites, do not treat. If months or a year later, the efficacy is recognized, the hospitals that let them die are the cutting edge ones, not the middle class ones. This would cause a reputational rupture.
As long as no treatment is recommended by WHO, recommended by FDA, recommended by NIH, and by all medical societies, no hospital will start treating, publicly, out of fear.
That is why there are so many cases of specialists speaking out against treatments publicly and caught red-handed prescribing them for themselves when infected.
This is the case of physician David Uip, former executive director of the São Paulo Heart Institute (Incor), the University of São Paulo School of Medicine, and the Emílio Ribas Institute of Infectology, the three most highly regarded institutions in Latin America. Uip is considered one of the greatest specialists in infectious diseases in Brazil.
The news published on the site Migalhas, which covers the legal area, informs that Uip sued the pharmacist who leaked the prescription for chloroquine that he gave himself. In public he does not defend the treatments.
At Prevent Senior, doctors publicly denounced that the health plan recommended treating patients with drugs "without scientific evidence," treating this as a public health scandal, however, the whistleblowers themselves prescribed the drugs for themselves and their families when infected, reports the Folha de São Paulo.
The three halted HCQ studies and the smoking gun
Not only is Skipper's study from the University of Minnesota the only game where the hydroxychloroquine team was winning and the game was stopped before halftime.
There are two other interrupted games where the hydroxychloroquine team was dominating the match.
In France, two trials have been stopped: Hycovid and Discovery. The cause of the suspension was a fraudulent study published by the Lancet. It is the Surgisphere case. The fraud defamed the drug by indicating that patients treated with hydroxychloroquine died more than untreated patients.
After making headlines in every newspaper in the world, warning that HCQ was a poison, less than two weeks later, the Lancet removed the study from its website. Meanwhile, Hycovid and Discovery have not been taken up.
The "gold standard" Hycovid study showed 46% fewer deaths for the treatment group when the game was stopped.
You don't need to be a scientist, a PhD in something, to ask two critical questions.
The first question is: if the partial result was positive, why were the studies stopped?
The second question is: after the fraud was revealed, why were the studies not resumed?
You see a body on the ground riddled with gunfire. Next to the body you see a person with a gun in his hand and the smoking gun. It is reasonable to conclude that the person with the gun in his hand shot the corpse.
Do you want some curiosities about this? In Brazil, journalist Paula Schmitt called the Surgisphere case what it should be called: fraud. Daniel Bramatti, a journalist who is proud to say that he is a former president of the Brazilian Association of Investigative Journalism, and today is a coordinator in the country in fact-checking efforts, being director of "Estadão Verifica", where he says he is qualified to classify what is truth or lies, reacted: "What Lancet fraud?" he asked. "Fraud involves intent."
Meanwhile, months earlier, Richard Horton, the editor-in-chief of the Lancet, called the Surgisphere case a "monumental fraud," according to the New York Times.
In another situation about the same case, the researcher Marcio Bittencourt, who boasts the pompous title of Master in Public Health from Harvard University, when writing about hydroxychloroquine in Folha de S. Paulo, one of the most influential newspapers in Brazil, when trying to explain why the hydroxychloroquine controversy remains, incredibly inverted the result of the fraud in the Lancet. He claimed that the Surgisphere study "suggested that chloroquine had positive effects."
"There are people who embarrass themselves in public and there are the authors of this article in Folha de São Paulo for which we need to create a whole new category. They wrote an article putting themselves in the position of great serious scientists teaching how science is done to the ignorant people who defend the use of hydroxychloroquine for treating covid and committed an unbelievable gaffe," wrote Daniel Tausk, PhD.
I tried to suggest to "Estadão Verifica" to check Bittencourt's article. "Verifica" is led by Bramatti and has the power of censorship in social networks. Bramatti refused.
Perhaps the lack of action on this checking has an explanation: "Verifica" has banner ads for Janssen, a vaccine against COVID, and Johnson, its manufacturer. That's right, those who check the "truth" and censor stories about the vaccines' cheap competitors are sponsored by the vaccine manufacturers.
Do you want a randomized, "gold standard" study against COVID, published in high impact factor journals, with positive results and statistical significance? They exist.
"Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness," said Richard Horton, editor of the Lancet, in 2015.
Now, during the pandemic, after the Surgisphere case, it seems, the Lancet may be trying to apologize to society. They published two "gold standard" studies, with a relocated, old, off-patent drug: budesonide. Moreover, they are studies done in the West, in first-world countries and in the supposedly most prestigious scientific centers.
The first is about inhaled budesonide in early treatment. It is a drug used for asthma, safe, inexpensive, widely available, and has been tested against COVID-19. This study was published in Lancet Respiratory Medicine, a journal with an impact factor of 30,700. It was done in England, at Oxford University.
The result was so high that the study didn't even have to go all the way. It reached statistical significance quickly. It did not need to continue after an independent statistical review concluded that the result would not change with the enrollment of new participants.
Among the 70 patients who used the medication, only one needed to be hospitalized. Among the 69 without early treatment, 10 needed to be hospitalized. A 90% reduction in the need for hospitalization. The probability that the outcome of the study was by chance is less than 1%.
A second study with budesonide has been done. It is also the "gold standard". This one on later treatment, not early, with an average of 6 days after the onset of symptoms. It was published in the leading Lancet, the second highest impact factor journal in the world, with 79,311. It was also done at Oxford University.
Among all items evaluated, the risk of ICU admission among the treated patients was 50% lower. The risk of death was 39% lower, and the recovery time was 17% lower, the last item being statistically significant.
All peer-reviewed. All in high impact journals. And very few people using it. Just like propolis and mouthwash, this should be protocol in every hospital in the world.
However, we are in a hysterical world where, last year, people from their windows cheered health professionals, but today, a large part of the population sees them as enemies and doesn't care about them anymore.
They were heroes in the past, but with an expiration date set. Today, the more than 82,000 health care workers in NY who refuse to take the vaccine will be destined to be fired.
Just history repeating itself
At the beginning of this article I talked about faith in humanity. I explained how difficult it is to renounce these values where it is believed that the vast majority of people are good and would never do evil for money. I explained that questioning this belief generates, in most people, emotional reactions. However, everything that happens in the world today is nothing but a repetition of previous events.
The pharmaceutical giant Bayer, owner of the Cutter laboratory, was manufacturing, based on science, during the 1980s, a product called Factor VIII. It was used to treat hemophilia. It was from blood plasma. However, the product was infected with HIV, the AIDS virus. The company knew about the contamination. U.S. government officials also knew about the contamination. Everyone decided to cover up the crime and the drug continued to be exported. Thousands died. This is the story told in 2003 by the New York Times.
After all, the stock of the product, approved by scientific studies, was large and the company was aiming for profit. What's wrong with a lot of people dying of AIDS when it makes money? Isn't that right?
Bayer ended up paying some compensation. "The Guinness of Shame record is held by Pfizer, which paid out a whopping US$2.3 billion in 2009 for fraudulent marketing," said journalist Paula Schmitt. The conviction is published on the US Government's website.
You, reader, who often see doctors and scientists being accused of being science deniers for talking about Covid-19 treatments, may have a clue to what is going on with the story of Merck and the Vioxx drug, reported on the CBS News website. According to the story, Merck made a target list of doctors who criticized Vioxx. The list contained the names of dissident doctors with the labels "destroy," "neutralize," or "discredit."
Vioxx even became one of the scientific sales champions of the pharmaceutical industry. It was a product duly approved with seals and stamps, by all scientific agencies. In 2005, after much struggle, the drug was taken out of circulation. In one projection, 27,785 heart attacks could have been prevented if the drug had not been consumed between 1999 and 2003. According to the CBS report, Merck even created a fake scientific journal to publish studies of Vioxx.
And has hiding, scientifically, positive results from unprofitable drugs ever occurred? Yes, according to a report published in the Washington Post two years ago. The company involved in this? Pfizer. "Enbrel could potentially safely prevent, treat and slow progression of Alzheimer’s disease,'' said an internal document. However, the company has not published its data. The reason? ''Enbrel has reached the end of its patent life. Profits are dwindling as generic competition emerges,'' the Post explained.
Has it ever occurred to claim that effective medicines don't work, while expensive ones are promoted? Yes, that's what Sean Strub reports in a story in the Huffington Post: "Dr. Anthony Fauci is rewriting history. He is doing so to disguise his shameful role in delaying promotion of an AIDS treatment that would have prevented tens of thousands of deaths in the first years of the epidemic." Strub wrote.
Fauci, in office to this day, did not listen in 1987 to the front-line doctors who were successfully treating patients. They begged Fauci to recommend the use of bactrim, a cheap, generic, off-patent drug. "Fauci refused to acknowledge the evidence and, according to one account, even encouraged people with AIDS to stop taking treatments, like Bactrim," reports the article, which gives a figure: 17,000 lives lost by 1989, when the recommendation finally occurred after much pressure.
The focus seemed to be elsewhere, AZT, the most expensive drug in history: "Fauci's close colleague, Dr. Samuel Broder, who was head of the National Cancer Institute, even suggested -- in the absence of any evidence at all -- that the newly introduced antiretroviral, AZT, would make prophylaxis against PCP redundant!" says Straub.
In 1988, Larry Kramer, an author and playwright known for AIDS activism, wrote an open letter to Dr Anthony Fauci. In one part of the letter, Krammer states, "drugs we have been begging that you test remain untested. The list of promising untested drugs is now so endless and the pipeline so clogged with NIH and FDA bureaucratic lies that there is no Roto-Rooter service in All God’s Christendom that will ever muck it out."
In the letter, Kramer reports that the agency headed by Fauci placed 80% of the focus only on patented AZT, not on cheap repurposed drugs. Soon the author compared Fauci to Adolph Eichmann, a Nazi bureaucrat who during World War II made the concentration camps run like an industry.
The letter went on to plead for clinical trials, which were not occurring. "The cries of genocide from this Cassandra will continue to remain unheard," the author states near the end of the text.
By coincidence, now, during the current pandemic, while the expensive and useless Remdesivir was being celebrated, the only large, "gold standard" trial of hydroxychloroquine (with azithromycin), involving 2000 patients, in other words, large enough to have statistical power, was cancelled by the NIH, where Fauci is director.
Given the facts presented, I personally suggest not having so much faith in human kindness, especially when it involves power or profit.
In addition to the WHO, the FDA is financed by industry
According to the University of Connecticut's website, the FDA has almost half of its budget funded by the pharmaceutical industries. The same thing happens with several other health-related agencies. At the same time, the mainstream media leaves out some voices in the debate about pandemic treatments.
Maybe the explanation for this can be found in a 2016 article published in Scientific American. "How the FDA manipulates the media" is the title. "The U.S. Food and Drug Administration has been arm-twisting journalists into relinquishing their reportorial independence, our investigation reveals. Other institutions are following suit."
The report explains how the FDA dictates to reporters who can and cannot be interviewed. It also reveals how the agency takes control of journalists who should be keeping an eye on these institutions. "The watchdogs are being turned into lapdogs," stated the report.
The report calls this control a "disturbing picture." "It is an increasingly important tool used by scientific and government agencies to control the behavior of the science press" It further reported that the FDA deceives with half-truths to prevent reporters from going after a story.
"In that situation, the journalist is allowing his or her reporting hands to be tied in a way that they're not going to be anything, ultimately, other than a stenographer.”
According to another report, from 2015, from Slate magazine, "The FDA buries evidence of fraud in medical trials" This happens when they decide if a new patented drug should be allowed on the market or not.
At the same time, it is impossible to imagine a global conspiracy theory of scientists from all over the world, from various countries, including those with no diplomatic relationship with the US, such as Iran, producing 32 positive studies on early treatment with hydroxychloroquine, a drug with no lobby, cheap, generic and no patents. Just as in the case of ivermectin, with its 63 clinical studies, also generic, cheap, and without patents.
Science explains: mass hysterias are common and contagious. And during hysterias, there is no rational dialogue
Apparently, during this pandemic, it is allowed to offend doctors who talk about treatments, interrupt them, and not listen to them. Like the case of Francisco Cardoso and Ricardo Zimmerman, who went to the Senate of Brazil to make a presentation about all the treatment possibilities.
Some of the senators left, saying they did not wish to listen to those who "deny science. The press also decided to ignore. The sessions, which were broadcast on television, stopped being transmitted on this day.
At the same time, those who speak against medicine have their voices amplified. As when, in Brazil's senate itself, a doctor, who apparently has not treated patients of COVID, said that discussing possibilities of treating COVID is like discussing the edge of the flat earth. Her statement was echoed in all the newspapers and TV programs.
And this is not just a Brazilian hysteria. The censorship, since these self-imposed, of people refusing to listen or read, has extended to the social networks and even reached important people. As an iconic example, there is the case of Japanese Nobel Medicine Prize winner Satoshi Omura. A video where he discussed the use of ivermectin against COVID was censored on youtube. He was talking about his peer-reviewed scientific paper published in the highly regarded scientific journal The Japanese Journal of Antibiotics.
There is an explanation for everything. According to the scientific paper led by Philip Bagus of Rey Juan Carlos University in Madrid, Spain, along with two other scientists, diseases are an ideal breeding ground for the development of mass hysteria.
The scientists commented on some cases, such as a hysteria that happened even with a non-existent disease. "Another interesting, more recent case are the effects of an episode of the Portuguese TV show Strawberries with Sugar. In the show, the characters got infected with a life-threatening virus. After the episode had been broadcasted, more than three hundred Portuguese students fell ill. They reported symptoms similar to the ones that the TV show characters had experienced. Among these symptoms were rashes and difficulties to breathe. As a result of these symptoms, several schools in Portugal actually closed. However, an investigation of the Portuguese National Institute for Medical Emergency concluded that the virus did not exist in reality and that the symptoms were caused by the anxiety watching the show, i.e., the symptoms were caused by mass hysteria."
"There is another recent case of mass hysteria connected to a virus. On the Emirates flight 203 in September 2018, some passengers were showing flu-like symptoms. When other passengers observed these symptoms, they started to feel sick as well, and a panic broke out. The panic reached such an extent that the whole flight was quarantined once it had reached New York. The investigation after the incident showed that only a few passengers actually had seasonal flu or a common cold. Indeed, diseases are an ideal ground for mass hysteria to develop.".
In the same article, the scientists explain the conformity issue. When due to a majority of hysterics, without rational thought, it causes the few who can still reflect to stop having critical thinking. "Once anxiety has spread and the majority of a group behaves in a certain way, there is the phenomenon of conformity, i.e., social pressure makes individuals behave in the same way as other members of the group. In the end, there may be a phenomenon that has been called emergent norms: when a group establishes a norm, everyone ends up following that norm."
Early treatment: 489 COVID patients and only one death
This is one of the studies that I like the most. What is striking is its simplicity and the reflection it produces. It is a peer-reviewed study published in a journal with an impact factor of 2,930.
It tells the story about the patients of Dr Brian Procter, an American physician. It involves a total of 489 patients with COVID that he treated. In his arsenal of medications were hydroxychloroquine, ivermectin, inhaled budesonide, antibiotics, zinc, and vitamins.
He uses a cocktail, after all, in virus diseases, the combination of drugs is more effective, like the cocktail against AIDS. Meanwhile, most of the "gold standard" studies against COVID have been on single drugs, in monotherapy.
Of these 489 COVID patients, he had only six hospitalized and a single death, and 320 of them were at risk: they were over 50 or had at least one comorbidity.
Try to put the hysteria aside and let's go for some thoughts.
Is it necessary to do a "gold standard" study of the cocktail, with 489 more patients another placebo arm, see ten, five or two patients die to conclude the efficacy?
With 489 patients and only a single death, we have two possible conclusions. The first is that the pandemic is not serious, after all, almost no one dies. The second is that the cocktail is effective. There are no other options.
As of October 19, 2021, when I write this article, the US has 45,902,575 residents with diagnosed COVID and 746,438 dead from the disease.
If Dr Procter, who knows how to do a risk-benefit account, had attended to all Americans affected by the disease, with only one death for every 489 infected, the US would today have only 93,870 deaths and not nearly 800,000.
But let's be pessimistic and assume that there is underreporting and the infected in the US are twice as many: 90 million. The deaths with this protocol would be only 188,000. Today with 746,000 victims, the lives saved would be 558,000.
Yes, you have been tricked. It's right there in front of you. They put your life at risk. They put the lives of people you care about at risk. They let millions die without assistance. The most accurate count, as of October 19, is 2.8 million. And it keeps rising. It is the biggest crime against humanity since the Second World War, happening right now, in front of your eyes.
At the same time, Dr Procter was banned from twitter for talking about his scoreboard. Something traditional. Every time crimes against humanity have occurred, censorship has occurred at the same time. Also, historically, censorship has always occurred against those who speak the truth, not the lie.
And there is more detail: one of the authors of this study, Dr Peter McCullough, is one of the world's leading cardiologists, with an impeccable record in science. For talking about the results of this study, he is constantly censured, and has been fired where he was a professor of medicine and sued by his employer.
Likewise, in France, Dr Didier Raoult, probably the world's leading expert on communicable diseases, is being vilified, persecuted, and sued for talking about positive results.
In the same way that in Brazil, Dr Flavio Cadegiani, one of the most prominent scientists in the world, who produced research with proxalutamide and had his studies classified as excellent quality in McCaster University, Canada, the birthplace of evidence-based medicine, and praised in Europe's Cochrane, is being persecuted and sued.
They are not the only ones. All over the world, hundreds of people are censured, persecuted and sued for going against the collective hysteria that is taking over the whole society.
"Gotcha. Here's the WHO study. It didn't work," an uninformed person would say.
The WHO Solidarity study, which made headlines in major newspapers around the world, is not early. The start of the drug was at the time of extreme unction, when 64% of the patients were on oxygen or ventilation.
But there are more details. While in Dr Zelenko's study the total treatment dose was 1.6 grams of HCQ, in the Iranian study the dose was 2.0 grams and on Skiper's was 3.2 grams, Solidarity accumulates a dose of 9.6 grams of hydroxychloroquine. That is written in the study itself. So more people died in the treated group. Definitely, there are no amateurs in the business.
I challenge anyone: layman, doctor or scientist
You have come this far in the article and you are scared. You see that it is a story with a beginning, middle and end. Right now, you have questions. You want to know if I have omitted some important fact so that I could come to these conclusions.
I will give you the way to totally dismantle what I have said. I argued, for most of the article, stating that there is no "gold standard" study of hydroxychloroquine in early treatment ( within 5 days of symptoms) large enough to have statistical power, something like 400 or 500 patients in each arm. I claimed that no one has done it. I suggested that the treatment was buried this way.
You can offend me all you want. Just bring up this study and put it in the first line of your comment and then offend me. Look it up. In any scientific journal in the world. But this study does not exist.
Since June of last year, I have been producing articles explaining that as a patient, without any doubt, it is worth seeking immediate treatment in case you are infected with the virus. This has made me tense to see people dying or afraid, me trying to explain, and the victims themselves refusing to hear the good news.
So, today, what fascinates me the most is the mass hysteria that inhibits rational debate. You read this article, found it interesting, saw a challenge, and right now you feel like sending it to doctors, friends, family members, or questioning, through social networks, the experts talking in the media.
The signs of hysteria are easy to see. People may, even with your recommended reading, simply recuse themselves from the subject. That is a sign. There is the possibility that people will start to make a joke. That's another sign of active hysteria. Going on the attack is also common, even if all the information I have given here is accompanied by links to the original sources.
To avoid the attacks, you can do other tests. It is to ask questions. Copying the links from here, from the propolis or mouthwash studies, for example, and sending them with the question, "In your risk-benefit analysis, why isn't this being used worldwide?" Silence is most likely. If he is a specialist, he will possibly talk about impact factor, as if the journals are not good, but they are.
In such a case, if the question is the impact factor of the propolis or mouthwash study, you should ask the same question about the risk and benefit, but sending the budesonide study, published in the Lancet. In the case of a person seized by hysteria, expect no debate, some blunt response, or silence.
As long as hysteria persists, needless deaths will continue to occur and the world will continue to sink.
And I here make only one prediction. I don't know if it will happen in a year, two years, or twenty, as in the case of the AIDS virus in plasma for hemophiliacs. One day, some historian will look at this pandemic, see the "gold standard" study of budesonide in the Lancet, and will ask, "Why hasn't the whole world adopted this treatment?" The possibility of this not happening is null.
Superb, Filipe! The acrobatic pilot is one of the best epidemiologists I know! 👏
You phrase your argument in an interesting way.
Smoking gun
In January, 2020, the CDC recommending treating high risk influenza patients early with antivirals--even before lab results came back.
In February, 2020, the FDA recommended withholding early treatment of the antiviral HCQ from everyone, including high risk covid patients--HCQ was recommended only for hospitalized patients.
This does not compute. Do the CDC and FDA not talk to each other? Why should early treatment with the antiviral HCQ be withheld from high risk patients in the case of covid, but antivirals should not be withheld from high risk patients in the case of influenza? Influenza, which is supposedly far less deadly than covid, was to be treated on suspicion, but covid was NOT to be treated on suspicion???
Where has the FDA ever issued a rationale for this recommendation? And why did the CDC never question the FDA's recommendation?
I agree with you. I don't think that the problem with the public health organizations is incompetence.
pharma $$$