Trial Site News knocked it out of the park with their May 22, 2022 article entitled: “Opinion: What have We Learned about Early Treatment During the COVID-19 Pandemic?”
I strongly encourage people to read the full article, but the quoted sections of the article below highlight key points. For the many of articles published by Trial Site News, one needs to register with the organization for viewing. But this is a simple step, and Trial Site really has been a non-biased truth teller for both this pandemic, medicine and for clinical research in general.
The article starts with
Early calls for use of repurposed drugs that appeared to work—at least according to preliminary studies and hundreds to thousands of doctors on the front lines of the pandemic—were mostly ignored by organized medicine. This was primarily because even in pandemic times, organized medicine will not deviate from the existing stringent approaches and protocols to developing medical evidence. They will demonstrate flexibility with well-capitalized, staffed entities with track records, such as key players in the pharmaceutical industry.
Yet during a pandemic, an urgency called for unorthodox approaches, and according to many front-line physicians, that’s their job in the first place—find ways to treat patients that, in the judgment of the physician—work. It is truly unfortunate that a parallel trajectory couldn’t be employed during the pandemic---that is, in parallel organized, methodical evidence inquiries while also supporting bottom-up physician-led efforts to find repurposed therapies that make a difference.
It goes on:
(Physicians) Working to treat thousands of patients around the country, organized medicine launched a vicious attack against physicians simply working to find safe treatments in the real world. Many doctors have lost their well-paid jobs for taking a stand. While hit squads attack them for sacrificing their stable employment for politicized media attention, with a select few at the top of the list-making up for lost income on Substack. But much of the public is starting to see through this unfortunate agenda—vilifying doctors that overwhelmingly sought to help patients before there were any treatments.
While health authorities and organized medicine have opted to ignore the positive ivermectin (and other) studies – out of 82 total ivermectin studies, most of them have some positive results—the establishment rather focuses on a few key studies that failed to show efficacious results such as the TOGETHER study. IN this latter case, critics have emerged highlighting the problems associated with this study. Some have even declared fraudulent intent… TrialSite does suspect the study was underdosed, as compared to regimen used in various countries, including in India.Much of the original awareness of these alternative approaches originated mostly in low-and-middle-income countries (LMICs), and organized medicine in the “First World” frowned at the use of such data to make medical decisions. A sense that a pious medical elite hierarchy exists became apparent to the common folk.
Even a solid investigation in America--the ICON study conducted at Broward County Health early on during the pandemic that demonstrated ivermectin reduced the COVID-19 mortality rate was mostly shunned even though reported in peer-reviewed journal Chest. Because it was a case series and not a sufficiently powered randomized controlled trial, the results wouldn’t matter—unless, of course, you were one of the patients saved thanks to the study led by the husband-wife team of Drs. Jean-Jacques Rajter and Juliana Cepelowicz and team at Broward County Health.
There was also the pharmacist at Adventist health that developed a protocol that was demonstrating success. That program was shut down as, among other things, a contract with Pfizer precluded such hearsay.
One of the key takeaways of the article is the apparent malfeasance of the World Health Organization, governments, Trusted News Initiative (TNI) and old media to silence the successes of Ivermectin in countries like India.
But as stated above, randomized clinical trials that have been underpowered, started late within the disease time course (after viral load is gone already largely cleared- important for an anti-viral drug for instance) and/or under dosed have been rampant. Normally, most drug studies have pre-clinical animal studies and dose escalation studies that significantly address these issues prior to clinical trial start date. But time and again, these types of studies have not been concluded prior to the start of the trial. Instead, intuition and opinion seems to be driving clinical trial study design. There is no “gold standard” in that. Garbage in, garbage out.
How does a randomized clinical trial for an anti-viral set an enrollment initiation date for initial administration of the anti-viral AFTER the known date of viral elimination by the body? Yet, time and again during this pandemic, this is what has happened in these “gold standard” randomized clinical trials!
Studies that are underpowered, started late within the disease time course and/or under dosed seem par for the course from organizations and institutions that know better. Many note that these studies seem “designed to fail.” This is a pretty strong accusation, and yet there does not seem to be any other explanation for some of these clinical trial designs.
Inquiring minds want to know? What Institutional Review Board (IRB) - that determines that a study is appropriated designed, dosed and powered are approving these clinical trials? There needs to be some accountability.
The article goes on:
Groups of physicians around the world have persisted that early treatment with already approved off-label therapies under investigation (e.g., Ivermectin, Fluvoxamine, Famotidine, or Hydroxychloroquine in combination treatments) would have saved many lives during the pandemic.
This presumption was based initially either on lab findings, previous research associated with other viruses, or localized real-world data at first and then case series, observational studies, and some initial randomized controlled studies.
Much of the original awareness of these alternative approaches originated mostly in low-and-middle-income countries (LMICs), and organized medicine in the “First World” frowned at the use of such data to make medical decisions. A sense that a pious medical elite hierarchy exists became apparent to the common folk.
To this day, I personally am convinced that this suppression of the successes of treatment for COVID-19 had more to do with the promotion of the vaccines. Absurdly, early treatment and prophylactic treatments are seen as competition to vaccination.
One would hope if this was truly a catastrophic pandemic, the need for a gold standard randomized clinical trial before recommendation of a repurposed safe and effective drug would not be necessary. One would hope that safe, licensed drugs that showed some efficacy would be promoted and distributed by world health organizations and governments across the world.
But so much of this pandemic of the elderly and immune suppressed has been hyped. Fear porn is still rampant.
The article goes on:
Repurposed approved generic drugs were seemingly used effectively to combat the pandemic, but this is not acknowledged in the West. For example, in select states in India, ivermectin was put to use by state and municipal public health agencies in population-wide treatment cohorts, such as in Uttar Pradesh, India’s most populous state.
While this mainstream media classifies the reporting of the Uttar Pradesh effort as misinformation, the opposite is actually true. This media platform—independent of any corporate advertising or contribution-- tracked these events closely and found the levels of censorship in the West to be, frankly, shocking. In fact, at this time, TrialSite had no revenue and continued to report on these matters based on its founder’s own finances. For most of TrialSite’s short history (since late 2018), the media platform and fledgling social network centering on medical research was completely founder financed.
When other countries authorized ivermectin for emergency use for a period time—such as Slovakia—any attempt by TrialSite to share the public proof of that event was immediately censored on social media, including Facebook, YouTube, and Twitter.
The question remains, why and who is behind the censorship? Who made the decisions that any information on treatment for COVID by countries such as India, Brazil and Mexico have been removed from social media and censored from old media.
Clearly, this has been a coordinated effort.
