7 ms·
Large Ivermectin Study Retracted
- kaminar 5y ago1 study, foreign...falsity is nothing new here...in a recent HN article, it was shown that the majority of some foreign health studies were fake or seriously wrong... Aside from that, ivermectin is a proven therapy for Sars related cases. There is no question, only political and media combat with physicians.
- ekianjo 5y ago> "Phase 3 double-blind randomized clinical trials are needed to provide definitive data." Let me LOL at this statement. If you think Phase 3 studies can't be hacked in one way or another, well please meet the Pharma industry with its hordes of 1) cherry picking patients for phase 3 recruitment, 2) cherry picking patients who should be removed from the analysis as "dropouts", 3) p-hacking and multiple other practices well known under the sun. Believing that randomized Phase 3s remove all bias is incredibly naive.
- gumby 5y agoBased on my experience (I designed pharmaceutical clinical trials in an earlier life) this is much harder todo than it sounds. You have to start early (Phase 1) and what you end up with goes on your label (basically the package insert). You don’t always end up where you want to. The real shenanigans appear once your drug is approved.
- ekianjo 5y ago> this is much harder todo than it sounds. Cherry picking patients is not hard, since this is entirely up to the trial's recruitment criteria. This is also what makes comparing drugs virtually impossible since no 2 drugs in the same market apply the same recruitment criteria. This is how manufacturers invite the discussion about "superiority" while competitive drugs are almost never compared directly in the same trials.
- srean 5y agoI wonder if there are cryptography based secure protocols that can ensure that the studies have been carried out the proper way. Given your experience would love to hear your thoughts. My second question to you is to understand what apart from deep pockets prevent a trial to be repeated until an outcome favorable to the drug company is obtained. I understand pharma companies are encouraged to make all their trials public, but to me that seems like a generic guidance with no teeth.
- gumby 5y ago> I wonder if there are cryptography based secure protocols that can ensure that the studies have been carried out the proper way. Given your experience would love to hear your thoughts. Cryptographic methods would be overkill and yet couldn't be applied to the places where such fraud might occur. When you submit trial results the documentation is immense -- you submit pretty much everything. There is a long, highly documented chain of custody and a lot of people (and independent entities) involved so it would be very difficult to pull off a conspiracy. That's not where the problems lie. For example if the agency thinks something is irregular they can go back and look at the underling data and the instructions on how those data were collected. The amount of data supplied is so large that before the days of electronic filing every drug company had a group whose job was simply to manage the logistics of organizing the trucks needed to transport a single submission! That sounds therefore like there would be a needle-in-a-haystack problem, and of course there always is, but you'd be surprised by the tiny details you get asked about as someone sees something they don't understand or are suspicious about and just follow the trail backwards. > My second question to you is to understand what apart from deep pockets prevent a trial to be repeated until an outcome favorable to the drug company is obtained. I understand pharma companies are encouraged to make all their trials public, but to me that seems like a generic guidance with no teeth. So this is the place to look: at a high level. However what you ask is hard. You can't legally give humans unapproved drugs (the agency doesn't give you permission to do so; they say "you proposed to use X on people who meet criteria C, following a specify procedure P, in order to answer questions Q, R and S. As long as you do precisely as you asked, only on the population C and on no more people than discussed, we will not prosecute you for using an unlicensed drug". And you submit an enormous amount of data you have already collected that explains why it's worth giving it a try and why it isn't a risk to human life. So you do specific pre-clinical (animal) work just to get it into humans at all (phase 1), then use the safety data you collected to justify some kind of limited study of efficacy (Phase 2) and based on that you do a large, representative (of the people in the US who might need this drug) population of subjects. If you tried to repeat a trial the agency would say "but you already did this and didn't like the results, so no". And in fast why would you? You'd be desperately trying to figure out why it failed and try to do something different.
- missedthecue 5y agoPerhaps phase 3s aren't perfectly free of bias, but they are essentially impossible to effectively manipulate by the drugmaker. Even if we assume all the physicians involved in the trial are willing to be bribed, the pharma company doesn't know which ones are handing out placebos.
- ekianjo 5y ago> Perhaps phase 3s aren't perfectly free of bias, but they are essentially impossible to effectively manipulate by the drugmaker. Not completely accurate. Studies with negative outcomes are not required to be published by the drug maker. You can virtually keep trying the same drug and "get lucky" with a single trial, and just register that one with the authorities since the standards for replication are still very low.
- kuhewa 5y agoNo because you have to preregister all of them.
- ekianjo 5y agoPreregistering does not mean anything about sharing actual results. the large majority of negative outcomes are NEVER published. Please don't spread misinformation.
- kuhewa 5y agoPretty sure FDAAA has mandated reporting results for a while now (although some sponsors choose to break the law). Do you have an example of your scenario of an approved drug with many phase 3 trials pre-registered but only one with reported results?
- forcry 5y ago> pharma company doesn't know which ones are handing out placebos.. Not sure I get you. If all the physicians are bribed, then why would the company need to know anything? Everyone can cook up some data and go along with the result that the company needs, right? Also, about this >If all the physicians are bribed I think you should assume that any physician that ends up in a trial is there because they are known to be complaisant. Same as politicians and authority figures are often planted by powerful people with vested interests.
- unishark 5y agoBy phase 3 they should have to preregister the study and identify the outcomes they will measure. There isn't much room for p-hacking at this point. There will certainly always be bias, but it's still a gold standard for good reasons.
- forcry 5y ago>a gold standard for good reasons. What does this mean exactly? Is it the best possible? Or the best available? If it is the latter, then it does not mean much. If it is the former, then your statement is not true.
- unishark 5y agoI mean "good reasons" as in objectively good reasons. It's not a comparison. Preregistration is one of those reasons.
- ekianjo 5y ago> By phase 3 they should have to preregister the study and identify the outcomes they will measure. There isn't much room for p-hacking at this point. Not all Phase 3 with negative outcomes are published. It's actually the opposite. Most of them are not. So preregistration achieves nothing in terms of transparency. And p-hacking still happens far more often than you think - I have personally seen trials where they identified "sub-groups" of patients in order to prove that there were patients for which said drugs worked. That's a thing, no matter what you decided to set in the first place as objective. And then there's stuff like Biogen's alzheimer drug for which no efficacy was proven but still received FDA commercialization approval. Everything is working just peachy, right?
- kuhewa 5y agoNecessary but not sufficient. Those are issues that can plague all studies, but at least some sources of bias and error can be mitigated against with randomisation and blinding.
- lettergram 5y agoVideo discussing what this retraction actually means https://odysee.com/@DarkHorsePodcastClips:b/ivermectin-meta-analysis:4 https://odysee.com/@DarkHorsePodcastClips:b/ivermectin-meta-... > One of the virtues of meta-analysis is that it allows conclusions to be adjusted with changing evidence. One Randomized Controlled Trial included in the BIRD Group's meta-analysis of Ivermectin has been challenged in The Guardian. It is unclear if the study in question is fatally flawed. In this clip, Tess Lawrie shows us what happens to the meta-analysis when the suspect study is eliminated. Answer: the estimate of the medication's effectiveness change somewhat (prevention of death drop's from 62% to 49%. Prophylactic effectiveness goes up slightly from 86% to 87%. Confidence intervals become somewhat wider). The conclusion of the analysis remains the same: Ivermectin reduces deaths substantially and is a very effective preventive measure against the contraction of COVID-19. Tess Lawrie is an MD and PHD, external analyst for the World Health Organization, and an expert in analysis of medical evidence.
- kuhewa 5y agoDoesn't bode well for the quality of evidence included in the meta-analysis.
- lettergram 5y agoRecommend watching the full video, basically meta-analysis are only as good as the underlying data. Because these studies test various protocols, it's likely you're going to underestimate the drugs effectiveness. (Later studies are more likely to have better protocols). In this case, the confidence interval drops, but the reduction in deaths and hospitalizations is still a very strong signal. However, the confidence interval has widened (note, the lower bound is still showing positive results).
- bb88 5y agoSure, but it strikes me that people latched on to this drug as a miracle cure since this study stated that chance of dying with ivermectin was 90% less than compared with a placebo. It just strikes me that any subsequent studies should be viewed with the highest amount of skepticism. I think this epidemiologist provides a better argument than I will ever do on an online forum: https://gidmk.medium.com/is-ivermectin-for-covid-19-based-on-fraudulent-research-5cc079278602 https://gidmk.medium.com/is-ivermectin-for-covid-19-based-on... (TL;DR: efficacy goes to 0 when you add in a new study and remove an additional study that shouldn't have been in the meta-analysis) Also, let's not forget recent history: the EUA for Hydroxychloroquine as a treatment for covid got pulled by the FDA even though it was celebrated by many as the miracle cure for covid last year both on this site and in the media. https://www.fda.gov/media/138945/download https://www.fda.gov/media/138945/download
- motohagiography 5y agoAn interesting comment I read somewhere else was that the realpolitik case for discrediting treatments is that deploying the fast tracked vaccines is predicated on a legal emergency measure, for which the key requirement is there are no other viable treatments. I don't think there is serious controversy that the vaccine rollout is being used as leverage for imposing digital identity schemes and for establishing a variety of other ostensibly temporary powers that will not be rolled back, and so it is difficult to "trust the science" on this as the question has become 90%+ political. The consequences of a non-vaccine treatment being available would obviate the need for all the supporting systems for it, and derail a large co-ordinated effort that has been some years in the making. If you know anything about digital identity, you know what's been going on in that space right now and who/what is driving it. Conspiracy theories about mere pharma profits are distracting and don't think nearly big enough. If we really want to get everyone vaccinated for c19, we need to commit to no domestic vaccine passports. If we require the passports, the rollout is going to stall, you're going to mass-disenfranchise 20%+ of the middle class, and when we have to deal with a threat with a more serious fataility rate, there will be no institutional credibility left to respond to it. I'm not sure we should be haggling the details of chemistry and biology we aren't equipped to reason about when the real policy issue of passports is something we all have a stake in.
- GavinMcG 5y ago> I don't think there is serious controversy that the vaccine rollout is being used as leverage for imposing digital identity schemes and for establishing a variety of other ostensibly temporary powers that will not be rolled back Well you're flat wrong about the controversy bit, not even reaching the substance.
- motohagiography 5y agoIt's not seriously controversial. If you work in identity or health, you know what technologies are being used, tech standards are being pushed out via public health networks, (SMARThealth, WHO's covax, etc.) and the massive changes in privacy regulations and information sharing in support of it are unprecedented. There are probably details that are still confidential in government, but that parties are leveraging the pandemic crisis to drive prior agendas is no secret. To deny that is unserious to the point of the very gaslighting that is creating the mistrust that is impacting the rollout. Data on ths subject is so politicized it's not even science anymore, it's scientistic policy activism. Arguing in the ivermectin/HCQ debate isn't going to impact policy or rollouts, but a tangible commitment to not exploiting the crisis to impose centralized identity governance would.
- kuhewa 5y agoMy favourite part of this fraud was: > It appeared that the authors had run entire paragraphs from press releases and websites about ivermectin and Covid-19 through a thesaurus to change key words. “Humorously, this led to them changing ‘severe acute respiratory syndrome’ to ‘extreme intense respiratory syndrome’ on one occasion,”
- me_again 5y agoThe thing I found most interesting was the ungodly mess they found in the spreadsheet of the raw data. I almost never see papers backed by a link to the spreadsheet or other software used to calculate the results, but I feel like that ought to be expected for publication nowadays. I wonder how many other papers would implode if their raw data were easily available for download.
- FriendlyNormie 5y agoEveryone who downvoted you needs to be decapitated with a chainsaw.
- navjack27 5y agoThis related? https://steamtraen.blogspot.com/2021/07/Some-problems-with-the-data-from-a-Covid-study.html?m=1 https://steamtraen.blogspot.com/2021/07/Some-problems-with-t...
- rich_sasha 5y agoWhy do the researchers do this? It doesn’t sound like they are peddling a (cheap, generic, unbranded) drug. Is it literally just to get a name in a journal? If this is the objective, I’m actually surprised at the amateurishness of the fraud. I’d imagine you could cook the data much better.
- jamesblonde 5y agoIvermectin has been know about since April 2020 when the Caly paper showed in-vitro that at high doses, ivermectin had anti-viral properties (sars-cov-2 sends proteins into the cell nucleus to turn off your immune response (interferon)). However, western scientists thought this anti-viral effect was implausible (https://www.microbe.tv/twiv/twiv-599/ https://www.microbe.tv/twiv/twiv-599/) - they were mostly correct as the effect is most likely immunomodulatory (Melo et al). Thus, NO clinicial trials of Ivermectin have been completed in the West (apart from a tiny 20 person trial in Barcelona). In contrast, the developing world has completed 30 randomized controlled trials (RCTs) and 60 trials in total - https://ivmmeta.com/ https://ivmmeta.com/. Ivermectin is safe (a WHO approved essential medicine), so we only care about efficacy. It is safer than paracetamol and has been taken billions of times. No trial completed to date has shown that it does not have a positive effect. Most trials have shown statistically significance on the most important clinical outcomes - hospitalization and death. Ivermectin works best when given early. It is transforming treatment and having incredible success in places like Uttar Pradesh (200+ million inhabitants, with only 38 new cases and 1 death yesterday - https://www.covid19india.org/ https://www.covid19india.org/). So, Ivermectin is an enormous threat to the Pharma industry. Merck (who discovered Ivermectin and help cure river blindness by donating it) are down-talking it, so they can bring Molpuvanir to market (they got a couple of billion from the US govt for this recently). Vaccine manufacturers run negative ads on google against Ivermectin (https://www.biznews.com/thought-leaders/2021/05/12/mailbox-ivermectin https://www.biznews.com/thought-leaders/2021/05/12/mailbox-i...). AND the person who discovered the fake data in the trial linked was supposedly a masters student, but he runs an investigative service and the level of sophistication in finding the data showed higher involvement - https://trialsitenews.com/ivermectin-study-appears-fraudulent-but-not-a-surgisphere-moment/?utm_source=pocket_mylist https://trialsitenews.com/ivermectin-study-appears-fraudulen.... This is like the tobacco industry funding scientific trials. We already had a discredited Jama paper (https://jamaletter.com/ https://jamaletter.com/) on Ivermectin/Covid. So they can do it, but I really hope the truth on Ivermectin - that it is an effective treatment for Covid - comes out. Otherwise, I will despair for society and advocate revolutionary change. However, the 2 big western trials being funded are being funded by the vaccine manufacturers (indirectly, of course), via Macmaster Univ (Gates-funded) and Oxford (Gates funded). RCTs can be designed to not succeed (it can't fail with Ivermectin, only not shown huge effect), and these are designed so - Bill * Caly et al - https://www.sciencedirect.com/science/article/pii/S0166354220302011 https://www.sciencedirect.com/science/article/pii/S016635422... * Melo et al - https://research.pasteur.fr/fr/publication/attenuation-of-clinical-and-immunological-outcomes-during-sars-cov-2-infection-by-ivermectin/ https://research.pasteur.fr/fr/publication/attenuation-of-cl... https://sebastianrushworth.com/2021/05/09/update-on-ivermectin-for-covid-19/ https://sebastianrushworth.com/2021/05/09/update-on-ivermect...