This seems to be one of the many hopeless (because too small for significance) studies that will show that the effect of this potential vaccine competitor is not significant.
Achieved thanks to financial contributions from, among others: Sanofi Pasteur (vaccine manufacturer), GlaxoSmithKline (vaccine manufacturer) and Janssen (vaccine manufacturer), Merck Sharp & Dohme (producer Janssen Vaccin). There were also payments from Gilead (vaccing giant) and Tecnoquímicas, but they were not related to this project (as stated neatly in the "Declaration of Interests"). Of course, they had no influence on the design or on the research. You don't have to if you set it up so small, then it doesn't show that Ivermectin works anyway. Which is usually reversed to shows that it doesn't work.
The ideal medicine for a contagious disease like Covid-19: you go through the real disease so you build up perfect immunity – and then you get better again. Ivermectin, a cheap drug against scabies and river blindness, seems to prevent death and serious symptoms in corona. The drug, applauded by a fanatical constituency who see Ivermectin as the alternative to vaccines, seems to be effective in those areas that affect the vulnerable and allows the others to experience the disease. This is evident from thefirst large, thorough study of the drug, Thursday in doctors' magazineJAMA. (Maarten Keulemans gives a dead link in the VK, I have replaced it here with a working link.)
The main bright spots from the study
- Of the 275 persons who Ivermectin Got no one died.
In the control group of 198 people, on the other hand, were there one death to be regretted.
This difference (in favor of Ivermectin) could be due to coincidence. - Most patients in the placebo group had 20% more time needed to fully recover compared to the Ivermectin users.
This difference (in favor of Ivermectin) could be due to coincidence. - The original objective: a decent severity of the disease, expressed as a 2-point relapse on an 8-point scale, was only achieved by 2% in the Ivermectin group and 3.5% in the placebo group. This means that the control group more than one and a half times as often showed the expected relapse (175%).
These differences (in favor of Ivermectin) could be due to chance. - Some patients required more intensive care during the study. 2% of the Ivermectin group, 5% of placebos. Without Ivermectin, they would therefore need "escalation of care" 2.5 times as often.
These differences (in favor of Ivermectin) could be due to chance. - The placebo group showed more serious side effects than Ivermectin in several respects: headache, diarrhea, skin rash, abdominal pain, vomiting. You might even suspect that Ivermectin helps against this (nonsense of course). It just shows how big the variance is in such a small group.
These differences (in favor of Ivermectin) could be due to chance.
EDIT: 10 days later it came to light that ivermectin was also used in the control group. ( the link no longer works: https://zelfzorgcovid19.nl/werkt-ivermectine-nu-wel-of-niet/) Ivermectin is for sale in Colombia. No wonder that the effectiveness compared to the placebo group was not spectacular enough for significance and that the side effects did not differ much from each other.
It is also striking to see how sales increased (table, see the right column) and how often ivermectina is suddenly googled in the region at the start of the trial: the blue line in the graph.
The link to the tables in the study doesn't work anymore either, that was: https://cdn.jamanetwork.com/ama/content_public/journal/jama/0/joi210022supp2_prod_1614808764.79557.pdf
Setbacks
Mistake thanks
During this scientifically acclaimed study, all subjects were given Ivermectin for only a short period of two weeks, including those who should have received a placebo. Mistake, thanks, but still nice that the pharmacist reported that. At least if it was indeed only about that period. That group of incorrectly served test subjects was then followed but no longer included in the research results. However, it is still mentioned here and there that this group achieved the same results as the Ivermectin group. How you can judge that without significant results is a mystery to me. At most, you can say that neither of them showed any significant differences, but if it was about significance, you wouldn't have had to do the whole study.
Too little sick...
The study was designed to measure on a scale of 0 to 8 which patients would deteriorate 2 points or more. Based on the literature, the experts had calculated that this would be about 18% of the test subjects. That share turned out to be substantially lower (How is that possible? Are basic assumptions wrong?) And so low that that group would become far too small to be able to say anything meaningful about it. Actually, the disease turned out not to be serious enough. The research design was then adjusted. After all, non-significant results can be used well, for example for vaccine propaganda.
Vaccine vs medication
The side effects of Ivermectin include: tremors, swelling, skin discoloration. Itching too. All temporary and also here the differences (to the disadvantage of Ivermectin) may be due to chance. In the Volkskrant, the comparison is made between vaccine and Ivermectin. What is usually not mentioned is that with medication you can adjust the dosage to the sensitivity of the patient. You can also stop the treatment. That is a major advantage of medicinal treatments. In that respect, a vaccine is binary: on or off. Once there is an injection in your system, it never goes out. Medication is prescribed to people who need it, with vaccination campaigns everyone is at risk of side effects, even healthy people who could do without it.
Why hopeful
The study is designed in a way that guarantees non-significant results. So it leaves a lot of room for interpretation. Why is that?
The average age of most subjects was around 37 years. In this age group, the symptoms after a SARS-CoV-2 infection are minimal. The researchers apparently did not know this: the vast majority of people resist the disease and recover before serious symptoms appear. You immunize (that's what we call 'being sick') and after a week or so, almost everyone is better – and immune. So also immune to the majority of mutants that will not be recognized by a vaccine immunization. Even immune to mutants that in some cases can lead to worse symptoms due to the vaccination. These things are not taken into account when determining the 'efficacy' of a vaccine.
Due to low SARS immunity, many of our immune systems have been overtaken by this new mutant of SARS. In the age group of the test subjects (most of them around 37 years), about 0.1% die from an infection with SARS-Cov-2. That is one per thousand infected people. Let's say for arguments sake: 0.2%: one in 500.
In what Maarten Keulemans calls "a large, thorough study", of about 400 people in total, you could therefore expect one covid death. Or maybe two or three if you are really unlucky. In this case, the deaths occurred not with the Ivermectin swallowers. The research is set up in such a way that no interesting result can come out of it anyway. Whatever you want to show about Ivermectin or Covid-19: the result will never be significant with this number of subjects.
The main claim 'Treatment with Ivermectin reduces the mortality rate' has therefore NOT been investigated here.
The fact that no one died in the Ivermectin customers and did in the placebo group may therefore also be a coincidence. I therefore wonder why this study was done if it doesn't even mean anything when someone dies. You know in advance that nothing significant can come out of it. And that the Volkskrant will then shout that Ivermectin "does nothing".
A better article on news-24.fr
It can also be very easily done differently in terms of reporting: just read the headline below.
Dutch versions of the original french article:
Ivermectin does not relieve mild symptoms of Covid-19, study finds
Robinette Girard8 hours ago 18
Ivermectin, a controversial antiparasitic drug touted as a potential Covid-19 treatment, does not speed recovery in people with mild cases of the disease, according toa randomised controlled trialpublished Thursday in the journal JAMA.
Ivermectin is mostly used to treat parasitic worms in humans and animals, but the scientific evidence for its effectiveness against the coronavirus is poor. Some studies have shown that the drug can prevent various viruses from multiplying in cells. And last yearAustralian researchers discoveredthat high doses of ivermectin suppressed SARS-CoV-2, the virus responsible for Covid-19, in cell cultures.
Such findings have spurred the use of the drug Covid-19, especially in Latin America.
"Ivermectin is currently widely used," said Dr. Eduardo López-Medina, a physician and researcher at the Center for Pediatric Infectious Diseases in Cali, Colombia, who led the new study. "In many countries in America and other parts of the world, this is part of the national guidelines for treating Covid."
But drugs have also proven to be divisive. While some scientists see potential, others suspect that effective inhibition of the coronavirus may require extremely high and potentially dangerous doses. Health officials are also concerned that people desperate for coronavirus treatments may use versions of the drug developed for pets. (It's often used to prevent heartworms in dogs.)
"There are a lot of conflicting views on this, sometimes very conflicting views," says Dr. Carlos Chaccour, a researcher at the Barcelona Institute for Global Health who was not involved in the new study. 'I think it has become another hydroxychloroquine.'
But neither supporters nor critics have had much hard data to back up their opinions. There are few well-controlled studies on the drug's efficacy against Covid-19, although more are expected in the coming months. And treatment guidelines from the National Institutes of Health note that there arenot enough evidence torecommending the use of the drug in patients with Covid-19 "for or against".
Actually a bloated rather irrelevant research
What matters with Covid are the serious symptoms and of course above all: the mortality. That's not even what this study is about. It is actually hardly relevant, but De Volkskrant seizes on everything to claim that the vaccine is the only thing that helps us in the fight against this virus. Unfortunately, the infections with this virus have so little impact that it is incredibly difficult to do proper research on it. How do you make a significant difference with something that is almost non-existent? There is only one answer to that: involve the entire world population in the experiment. Then every difference is significant, no matter how small.
There are also many observational studies that leave nothing to be desired in terms of clarity. Unfortunately, that is not enough according to the standards we imposed on ourselves when there was no crisis.
Research by AMA, fighters against quackery
This study was conducted in Cali, Colombia under the auspices of the AMA, the American Medical Association. The longer I look at it, the less solid impression it makes.
So you set up an insignificant research protocol and because the results are insignificant, you conclude "The findings do not support the use of ivermectin for treatment of mild COVID-19"
“The AMA also tried to combat the prevalence of ‘quack’ medicines—potions with secret ingredients of doubtful use or safety, which were widely available before the invention of modern drugs.”
In the Netherlands we also have quackery fighters, the Foundation against quackery, the Skepsis Foundation and probably more. I was always a big fan, member and donor. These Foundations are at the forefront of the fight against medical nonsense claims and harmful malperformance or deception. This fight for sound scientifically based medical treatments was always in line with how the government thought about it. At least I can't remember that the government focused on quackery, apart from subsidies to treatment methods that satisfied patients while there was no evidence of efficacy. Then the Foundations spluttered on parts, but that was it.
Last year I learned that the anti-quacks don't have as open a mind as I always thought. The moment the lack of substantiation comes from the government, they still opt for that official line. Suddenly the critical tone disappears. In fact, the critics are booed and personally attacked (yes, they are a sharp people, for sure). I have previously written about. For me it was a huge deception, also on the forum of Kloptdatwel.nl that I visited in my enthusiastic naivety in search of an open discussion with sensible thinkers. It turned out to be a toxic club, in procession and with great respect in line with the pioneers of the Foundation.
Please note: AMA's studies should certainly be taken seriously. I thought I saw a bias in the conclusions, which in my opinion did not fit in well with the findings – and certainly not the headline of the Volkrant. That's why I created this blog with more or less opposite conclusions. If you are wondering where that bias could come from at the AMA, it is easier to understand from a cramped anti-quack attitude.
Traditionally, the basic stance of anti-quack organizations like AMA has been vehemently against alternative medicines, home remedies, obvious home-grown treatments, even "alternative" use of medicines (repurposing, which is something very different from alternative medicines) – and anything that comes from a different angle than the academic/pharmaceutical one. And especially if they come from alternative quarters, such as the Zelenko protocol (HCQ/Zinc). It is clear that pharmaceutical companies certainly do not benefit from repurposing old drugs.
I would expect such nuance from a quality newspaper as well. But yes. The headline "Acclaimed 'miracle drug' Ivermectin does nothing against corona" says it all. Moreover, it is again a lie, knowingly and knowingly. How do we ever get out of this...
Bonus: Following the Money
The research was partly due to amounts from
- Sanofi Pasteur (see their home page below)
- GlaxoSmithKline – pharmaceutical company with Pfizer shares
- Janssen - From the vaccine (Johnson & Johnson)
- Merck Sharp & Dohme - See their home page below
- Gilead – manufacturer Veklury® (remdesivir)
- Tecnoquímicas – this statement explicitly states that this payment was not related to the research.
Een belangrijk argument tegen ivm was dat de fabrikant van ivermectine, Merck, zelf ook zei dat het middel niet werkte. Het middel was allang patentvrij en Merck had intussen andere belangen:
Naar aanleiding van de zoveelste blunder van Maarten Keulemans:
