Amazing and important presentation by dr. Pierre Kory: "Since its f...

Amazing and important presentation by dr. Pierre Kory:
"Since its founding, the FDA has approved approximately 32,000 medicines for practically every condition known to medical science. This massive library of treatments is actually a gift to humanity. But like all libraries, it also contains secrets.

We are only now beginning to understand that many long-established drugs have multiple mechanisms and can be used to effectively treat diseases with either similar or even different pathophysiologies. Further, the longer they've been in use, the more well-known is their safety profile.

Thus, there's an enormous potential for repurposing this massive sort of back catalog of well-known drugs that the FDA has already deemed safe. So why on earth aren't we systematically testing them for potential new uses? The ugly truth, as Dr. Hazan and others have referred to, is that it's not profitable to do so.

Big Pharma makes money on complicated new drugs, and it effectively controls numerous levers of power. Nearly half of FDA's budget is bankrolled by the drug industry, and its tentacles are deep in media, academia, medicine, and other regulatory agencies like the NIH. And for decades, it has waged war on safe, effective, off-patent treatments for numerous diseases.

And I would argue none more damaging than its decades-long war on vitamin D. Big Pharma's main tactic is valuing randomized controlled trials as the infallible gold standard, while dismissing positive results of other kinds of studies, such as observational studies or smaller randomized controlled trials.

But here's the unfortunate reality. These large randomized controlled trials, that's the only currency now to get approval, well, they are not objective. And they're not without bias, because they cannot overcome the bias of the massive funders that are bankrolling these trials. I would argue that the only thing controlled about them is their results, as we saw numerous times in the pandemic.

Meanwhile, observational studies, which are far simpler and cheaper to perform, they can be done by independent investigators, nights and weekends, just doing chart reviews. Well, little known fact is that those kind of trial designs actually produce results that are completely consistent with randomized control trials.

This is well known now from a meta-analysis published in the Cochrane Library in 2014 where they compared 10,000 randomized control trials and observational trials and they looked at their results and they concluded, on average, there is little evidence for significant effect estimate differences between observational studies and randomized control trials. Can you show my first slide? And I would argue that this belief, this heralding of the randomized controlled trial, is largely the result of massive disinformation.

I always remind my readers, I wrote a book called The War on Ivermectin, which is literally a case study in these modern wars on repurposed drugs. And they do that using disinformation. And I would invite the audience or listeners to read this article. It's not a long article, but it details the numerous tactics. And I would say the most damaging is the one I have on the screen. It's called the FAKE.

And it consists of three different actions that they take. One is that they design and conduct trials with predetermined results. They did that repeatedly in the pandemic, particularly negative studies to show that hydroxychloroquine or ivermectin didn't work. And then they only they selectively publish only those negative studies and they censor positive studies. This cynical manipulation of evidence-based medicine is not a secret.

As far back as 2009, Dr. Marsha Angel, the longtime editor of the New England issued this prescient warning. "It's simply no longer possible to believe much of the clinical research that is published or to rely on the judgment of trusted physicians or authoritative medical guidelines. No one knows the total amount of money provided by drug companies to physicians, but I estimate from the annual reports of the top nine US-based drug companies that it comes to tens of billions of dollars a year in North America."

This creeping decades-long war on off-patent drugs went into overdrive during the pandemic when Big Pharma turned its guns against early treatments for COVID. Using their control over the high-impact medical journals, they consistently published studies designed to show predetermined negative results.

With the size of these studies and the control of the journals, they managed to convince the world of a lack of efficacy using only a handful of studies, despite hundreds of others concluding efficacy. Further, these studies numerous fatal flaws were ignored. For example, to prove a medicine didn't work, they consistently used the lowest doses for the shortest courses while enrolling patients as late as possible into the disease while including only the mildest cases.

They did the exact opposite actions when they were trying to prove something was effective, like Paxlovid. Those trial designs were mirror images of each other. They were opposites. Can you show the next slide, please? This is what's called the Forrest plot that shows 43 effective medicines in COVID. I've circled the only ones that were approved for use in the United States. And actually, the circles are off, but if you look, you probably can't see it.

But if you look at the costs, the only things approved in the United States, all cost in the many hundreds, if not thousands of dollars. Every $1, $2, $5 medicine was completely ignored and never would reach regulatory approval. Further, when they did not get the result they wanted, in several instances they were forced to change the original endpoint, a supposed never event in research science.

And despite these manipulations, each of these studies' publications launched massive negative PR campaigns and recommendations from health agencies against the use of these inexpensive, safe, repurposed drugs. Last slide. If you look, this is just a little summary of the evidence base as we sit here today. As of today, there have been 420 controlled trials studying hydroxychloroquine in COVID that includes over half a million patients.

With ivermectin, there have been 100 controlled trials with over 125,000 patients. And summary analyses of these evidence bases all show large magnitudes, statistically significant benefits and all important outcomes. Yet, in this country, ivermectin is considered an ineffective horse dewormer and the drug of fringe quack right-wing anti-vaxxers.

So what's the way forward from here? We need to create a framework to test off-patent and off-label drugs and model their clinical benefits and cost savings. A public-private partnership of diverse, independent, un-conflicted stakeholders accountable to Congress could conduct sustained, independent, systematic studies of repurposed drugs that would complement FDA review, clinical practice, and the role of natural immunity and health.

It won't be easy, but if physicians, healthcare leaders, and politicians unite behind this call to action, system towards greater accountability and help more people in the process. Thank you."