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May 30, 2025 - Epoch Times
09:35
Clinical Research Scientist Calls for Blinded Drug Application Submissions to the FDA
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Over the last 40 years, the ones holding the purse strings in our government agencies have made it clear that there could be deep pockets from the government if you come up with an outcome that fits the puzzle.
and therein lies the issue with bias from the scientists, from the research group, or whatever.
And oftentimes...
They look at the conclusion that is agreeable or preferred, and then they start working backwards.
How can we prove this conclusion?
I mean, statistics, you can prove with anything.
Statistics are a very interesting thing because you can use statistics.
To prove that saline cures cancer.
You can use statistics in any way, shape, or form.
You can use study design to do the same thing.
You know, I was just about to say that because in my underground work, one of the things I loved to do was experimental design as a budding biologist.
And I discovered very quickly that based on the design, I could favor a particular conclusion quite easily.
I mean, of course, in certain situations, that's impossible.
And there's these dramatic...
But a lot of the time you could do that.
And I found that actually, frankly, really disturbing.
Because you'd have to assume the best absolute faith of a researcher truly looking impartially.
And another variable to throw in, a monkey wrench to throw in this whole thing, add ego to it.
So when you have a head of a lab or a head of a research group that's hobnobbing with...
Then a new bias enters the picture.
I'm going to make my name.
I'm going to put this university on the map or I'm going to put my research team on the map.
And this is going to be a famous publication that's going to be cited everywhere.
I mean, let's face it.
With intelligent people, there's huge ego.
And that's another monkey wrench.
I mean, really, this is almost like an intractable problem that you're painting, or at least I'd love to hear what you think you solve it.
But basically you're saying if there's money coming from industry or money coming from government or money coming from foundations or wherever that has a particular interest, you know, whatever that is, that influences the outcome dramatically.
I think it does.
So what do we do?
So there are several ways to...
If everything that went into the FDA was blinded, just think about it.
You mean if every product that's coming out of a pharma company was, what does blinded mean?
That means the data is uploaded in the system and the IND, which is the Investigational New Drug Application.
If all of that was blinded as to what company or who did it, And the data is uploaded, just the data, and it has to be looked at objectively by the team.
It could change a lot of things.
It could change the speed of an approval.
It could change the approval itself.
It could take something that really has promise from a nobody and bring it to the forefront.
To me, that's pure innovation.
That's unbiased innovation.
There's no name behind it.
You don't know whether there are billions of dollars behind it, or if it's a ragtag group of five scientists that left pharma and formed their own group.
You know nothing about it.
You have an electronic file with all of the data there, and you have no idea where it came from, but it's following the regulatory process.
And the review period and the review process is such that it's objective and you're just looking at the data and you're just giving guidelines based on that.
That could solve a lot of issues.
But you say that data can be corrupted as well.
Okay, well, it can be.
And we learned in the last few years that papers are starting to get retracted because the data That isn't necessarily done when small groups upload data to the IND because usually they're done at a CRO, which is an approved place of study.
It's not a university setting.
it's a CRO, it's a commercial, say phase one unit or phase two unit where their job There is some sort of check and balance to make sure that this is real and done properly.
Well, say on the university level they published a paper that was like the beginning of a commercialized product because it came up with a conclusion that is quite interesting and something to look at.
Something as a bioactive property that can help with a potential disease, for example.
Say that happens, and they want to publish it.
In the past, it would go through a peer review process, and that peer review process would have all data, all supplemental data, the entire methodology.
And the whole point of peer review would be, I could take this paper and I can go And they can get a group together on the bench, they can do the study, they get the same answers.
The reproducibility of science is a form of proof.
That ended because they felt that that peer review process was not efficient.
It took too much time.
It was not efficient.
They needed more product to publish.
So it became more of what I call pal review.
When you centralize science, you can corrupt science.
When you centralize the economy, you can corrupt the economy.
Anytime you turn it into a behemoth that is centralized and Are they looking into the study?
Are they on the bench trying to reproduce part of it?
Are they doing anything, checks and balances or quality control wise to say this is They're not.
They're saying, oh, that's Professor so-and-so.
He does great work.
The whole idea of review is review, right?
Exactly.
And it's actually been weaponized to a point because now you have groups that may be funded by, who knows, a government or a company, but you have groups that will gang up on a previous publication.
Because of an inconvenient conclusion and find ways to have it retracted.
I've seen it happen to several colleagues of mine that had wonderful studies, some even observational studies, which aren't making claims.
they're a stepping stone to look into something further.
But it was such an inconvenient conclusion that these inorganic groups And I've seen a couple of attempts of retracting good papers for no reason.
And that pattern kind of tipped me off as to what the motivation was for it.
And I have my own opinions that are anecdotal or not proven.
Are they manipulating the stock price?
Is this some sort of gaming the finances?
Or are they trying to remove inconvenient conclusions from the world's databases where AI would draw from so it's not even mentioned?
There are a lot of great innovations out there that are exciting, but in the wrong hands, they're not.
And we need these checks and balances.
We need blinded submissions.
Like in law, liberty, justice is supposed to be blind.
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