American Thought Leaders - How Numbers Can Lie in Scientific Research: Dr. Lynn Fynn

Episode Date: May 30, 2025

Dr. Lynn Fynn is a clinical research scientist and a retired infectious disease specialist. We sat down together to discuss issues she sees plaguing medical research, including the misallocation of funds, a broken peer review process, and major conflicts of interest.”Any time you incentivize something, you’re creating a bias. And when you create a bias, there’s an element of truth that’s removed from the equation,” says Dr. Fynn.“When a pharmaceutical company gets to pour money into a program, the curriculum is going to reflect what they want it to reflect, to make it a profitable transaction for them. It’s a return on investment.”What practical steps are needed to restore public trust in science and medicine?“Where there’s transparency, there’s trust. It’s really that simple,” says Dr. Fynn. “Oftentimes, [in] what used to be the scientific method, the process gets reversed. They look at the conclusion that is agreeable or preferred, and then they start working backwards. How can we prove this conclusion?”Views expressed in this video are opinions of the host and the guest, and do not necessarily reflect the views of The Epoch Times.

Oftentimes, the scientific method, the process, gets reversed. They look at the conclusion that is agreeable or preferred, and then they start working backwards. How can we prove this conclusion? Dr. Lin-Fin is a clinical research scientist and a retired infectious disease specialist. We sat down to discuss issues she sees plaguing medical research, from the misallocation of funds to problematic peer review processes

to major conflicts of interest. When a pharmaceutical company gets to pour money into a program, the curriculum is going to reflect what they want it to reflect to make it a profitable transaction for them. It's a return on investment. What practical steps are needed to restore public trust in science and medicine? Where there's transparency, there's trust. It's really that simple.

This is American Thought Leaders, and I'm Jan Jekielek. Lin Fin, such a pleasure to have you on American Thought Leaders. Thank you so much, Jan. Thanks for having me. So what is the big issue with clinical scientific research today? That's a really good question. First of all, understand that scientific publications are kind of the backbone of decision making in medicine and science as a whole. When you hear things like evidence-based medicine, it started out with good intentions, but it took a left turn. The journals going through a peer review process have become the basis of what they do now,

which is protocols, flow charts, and guidances. And these tools that are used for clinicians basically draw upon the integrity of those publications. So when the publications themselves and the research itself becomes compromised, your foundation is quite shaky. When you have a shaky foundation, what happens? Your whole building is based on a shaky foundation, it falls.

And I think we're all experiencing that to some degree presently with the advent of the Bayh-Dole Act, with incentives to universities to pump out publications, with the government on one end and pharma on the other end basically bringing in the funds to come up with a certain conclusion or idea, and then pharma comes in and co-ops that, then the taxpayer gets left out of the equation altogether. For the longest time, the NIAID, one person had quite a lot of control on where that money went. And with that, the taxpayer funds would make advances that could lead to a commercialized product or to a patent, but reap none of the rewards of that.

And pharma would co-opt it, and they would reap all the rewards, along with the university. So there are so many things at play, and agencies with foundations attached to them where Pharma money would come in, that when looking at these scientific publications as the gold standard for how to base an opinion,

you have to also understand that so much of it now is conflicted. There are conflicts of interest on every level. So then you start to wonder, how much of this can I take as fact, because the peer review process has changed dramatically throughout the years. You've painted a very broad picture here. Let's break this down a little bit. First of all, the legislation that you discussed.

The Bayh-Dole Act basically gave the universities the right to participate in the financial rewards of, say, a patent granted to that university. Years ago when I was in undergrad I worked in a lab and I made a new discovery and they gave me a dollar for it because that's how they did things back then. They gave you a dollar, okay, and sign this and it now belongs to the university. They're not going to be compensated for it in any way because it wasn't declared that they could, but it would be part of the university

and part of innovation. That isn't done anymore. Now they take part in the funds that are received from leasing the patent or using the patent. And if that product goes to commercialization, they take part in some of the profits. The Bayh-Dole Act allowed that to happen. And in doing so, it also allowed for mountains of publications and scientific research to be published that may not be as robust or have the integrity that we all would want. Explain to me why this legislation would cause that to happen. Well, the incentive is for money. And it's a numbers game.

The more you put out there, the more you publish, the more chances that you're going to reach a commercialized product or an idea or have pharma come in and co-opt it with you. By co-opt it, do you mean buy it? They buy it, they co-license it. There are multiple ways that a pharmaceutical company can get involved in the discovery of a product. They can co-license it with you where they work out a deal, where they get royalties, or they pay an upfront price to be able to get it

on the back end or a percentage of return goes to them. They get to put their labeling on it or whatever, or they could buy it outright and develop the rest of it on their own. Some people would say this is the industry supporting academia, right? I mean, probably that is what a lot of people say. It very much is. It very much is on both the undergrad and applied science level, all the way through medical schools. But what I mean is they would see that as a good thing.

I find anytime you incentivize something, you're creating a bias. And when you create a bias, there's an element of truth that's removed from the equation. And when a pharmaceutical company gets to pour money into a program, the curriculum is going to reflect what they want it to reflect to make it a profitable transaction for them. It's a return on investment. Say a university is working on a study and they come out with a very interesting point and then they further develop it. This is all in taxpayer dollars and they file a patent, patent's granted. patents granted, it hits the radar of industry, and industry contacts them and says, you have

this patent, we'd like to further develop it. And they start pouring money into more research for that university and start shaping the conclusions to be made. And by that I mean, okay, they say, let's start looking for a specific endpoint here. The endpoint may or may not be relevant to what they're trying to treat, but it doesn't matter because they can make it a marketable product. And in doing so they start negotiating, you know, patent rights, they start negotiating return on investment if they commercialize the product, they may put more money in there to take it through the FDA process since

the universe and take it from there since the university wouldn't do that. And they actually become partners in the deal. Then you have the conflict of a big pharmaceutical company paying into a government agency and getting more of a green light than say a small boutique group would or a small group of innovators. You have the name behind you to push it through. A good example would be an Alzheimer's drug that was approved and actually I looked at all of the data and it did not show benefit whatsoever, but it was approved. And it was approved mainly because the behemoth behind it

was the one pushing it through, not the scientists at the university. And they ended up taking it off the market because they couldn't show post-marketing benefit and only adverse events. But these sorts of things happen regularly. Our government is another component of that because with the example of Moderna, they partnered with the NIH.

So what a lot of people don't know is the revenue with the mRNA vaccines for COVID is split in a way that 40% of it goes to the NIH. Now does the taxpayer get any of that? No. The NIH does. The other 60% goes to Moderna so they can develop another version of it. But it's almost like what started off as maybe a good idea has introduced so much conflict that biases enter in a stepwise manner along the way to your finished product. It's a bit of a complex system, actually. It is very complex.

For me to understand. But basically, just the fact that you know money's coming in from someone with deep pockets, who's looking for a particular outcome, right? It makes you much more predisposed to find that outcome, even if the evidence is not very strong, basically. You're brilliant. But yes, that's exactly it. No, I mean, it's important. And even if you're not doing it consciously, I suppose,

right? You may not be doing it consciously. But the bias enters the picture when deep pockets are behind it and they have a vested interest in a specific outcome. And 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, what used to be the scientific method, the process gets reversed. 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.

I was just about to say that because in my underground work, one of the things I love to do was experimental design as a budding biologist. I discovered very quickly that based on the design, I could favor a particular conclusion quite easily. Of course, in certain situations, that's impossible. And there's these dramatic, dramatic outcomes. But a lot of the time, you could do that. And I found that actually, frankly, really disturbing, because you would have to assume the best absolute faith of the 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 the head of a lab or head of a research group that's hobnobbing with Big Pharma and a lot of money, then a new bias enters the picture. I'm gonna make my name, I'm gonna put 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. So I mean, really, this is almost like an intractable problem that you're painting. I'd love to hear what you think. 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, whatever that is, that influences the outcome dramatically. I think it does.

What do we do? that influences the outcome dramatically. I think it does. So what do we do? There are several ways to approach this. 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 blinded, 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 can 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 that 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 could be actually made up. 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 is to comply with all things regulatory.

And it's very, very cut and dry. There is some sort of check and balance to make sure that this is real and done properly. 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 more into. 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 can take this paper, and I can go 2,000 miles away in a lab and say, reproduce this. 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. Any time you turn it into a behemoth that is centralized and just like a certain group at the NIH decided where all of the tax money went for grants, when a certain group decides what can be published and what cannot be published, at what point does it become power review instead of peer

review? 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 has integrity? 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 come together and start attacking the journal to have it retracted.

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 so many,

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. Well, that needs to happen in science. And we have to come up with ways to have this done, starting with not having a single entity decide where all the taxpayer dollars for innovation goes.

That is a problem and it happened for almost 45 years. That can never happen again. There has to be panels, there has to be a more even distribution of deciding where this money goes and what it's going for. Have you thought about how to enact that in the current... There's a current period of change in HHS right now, right? Well, first and foremost, the head of a division in one of our scientific agencies should not decide where all of the money goes. That's almost a totalitarian view of science. And when someone says, when you attack me, you're attacking the science. In

a way, that was true, because he gets to decide, and I know you're like, he who, but this person gets to decide where all the grant money goes and what he wishes to champion, what ideas he wishes to champion, what conclusions he would like to see, that puts too much power in one person. And that should never have been create a panel. You create a committee within our HHS system that serves to put a board together like an IRB. IRBs consist of people of all walks of life, a scientist, a clergyman, a teacher. Independent review boards decide

if you can go on with your study. if you're doing a scientific study or you're trying to achieve something of that nature before you can go to the CRO that I mentioned to start dosing in human subjects. It has to pass an IRB. In universities, a lot of these IRBs are university IRBs. Is there a bias there? Maybe. But in the private sector, it's truly an IRB of peers. Not just scientific peers, citizens, teachers, clergy,

like I said. And they get together and they look at all the pros and cons, because they all have a different life view. And then they decide, yes, let's move forward. I think we should kind of attack this in the same way, almost like an IRB. With no one that's conflicted or no one that's involved in the government or has a specific desire for an outcome, that board gets together and decides, is this study here

of a taxpayer-funded grant? Are you imagining multiple ones of these in different areas of research? Yeah, yeah. Absolutely. So these are your policy recommendations, blinded submissions, so you don't know if it's big money or little money or whatever that's coming in that's been where it's been adjudicated. The data's been sort of verified by an independent party as being good. And then through these IRBs, the independent review boards have the different funding in different areas with appropriate groups

to kind of do the decision making around that. I think that would improve things quite dramatically. It certainly wouldn't make things worse. Well, so tell me a little bit about your background. How is it that you got into working on all this? Well, I started off on the bench in microbiology. Undergrad, I did a lot of microbiological work. I witnessed the AIDS, the whole AIDS debacle. And it was a very big learning experience for me. From undergrad, I went to medical school.

I really had an affinity for, because of my microbiology background, I had an affinity for pathogens, pathogenic bacteriology, virology. So I went on and did fellowship in that. Then I ended up doing some tropical medicine in West Africa for several years, which was fascinating. From there, I had mounting debt, as anybodyps table to go into finance. As crazy as that sounds, someone approached me and said, your mind works in a very unique way to control your purse while you're gambling.

You know, and I just like to play craps, but it ended up, they supported me and put backing for me to get all of my licenses to trade on Wall Street. So Series 7, Series 63, Series 55, and a 24 for a registered principal. And I did that for a few years and paid off my student loans.

During medical school, I moonlighted in clinical research. And that was my second love. And in clinical research, I worked on several very successful drug development processes. And I knew at some point I was going to go back to it. And when I saw medicine becoming so corporatized, it just wasn't for me at that point. I don't want to be part of a hospital system. They can get a vending machine to do that.

Well, now they have AI. They can get anybody to do that. I didn't want to be part of a hospital system because I really like to think outside the box. So I went back to clinical research and I worked on several drugs with several small, small companies. Worked on five drug approvals.

Currently working with my own company on a new drug, that will be quite interesting. And I can't say too much about it, other than the current therapy for this has been on the market for decades, and I've proven with multiple reproducibility in humans that it really doesn't work. And I've developed something that does. So it's very exciting. We're in the efficacy, pivotal efficacy trial stage of this drug and I'm

truly excited to bring it to market because it's going to change a lot of lives for the better. Both financially, physically and all around. I did get a patent, several patents in the US, one in Israel, I'm pending in Europe, I'm pending throughout the world, Australia, I skipped India and China, you can just steal your stuff anyway, and now I'm working on the final pivotal trials for this therapeutic. Well, this helps explain your thinking, both from the business side and the research side. How is it for you working with the FDA? Well, I'm a small fish. My company has four partners. We all wear very different hats.

Any hat that's required, we wear it. We know how to do everything from soup to nuts. I can go into manufacturing. I can do regulatory. I can do drug development and I can design the study. And everyone in my group can do the same. So we wear a lot of different hats. And I find that the larger the company, the more pigeonholed the scientist becomes. I do believe that Big Pharma as a whole, most of the people that work for Big Pharma,

believe they're doing the right thing. And they are. They're doing the right thing. They're in it because they're making changes in people's lives, they're advancing science, they're doing their job and they're in it for the right reasons. But there are some that aren't and because they're so pigeon-holed in a tiny tiny bit of the entire process, they don't back up to see the full picture. And it's, I believe, by design. Because when you lack the full picture, you can't assess where it could go wrong, unintended

consequences, where is this going. You can't assess any of that because you did your job to perfection. Well in my company we wear all these hats. We know the big picture. We know we're all in it for the same reason. We want to change lives for the better. We don't want it to be cost prohibitive. We believe that everybody can profit without it being egregious or ungodly.

We believe we're doing the right thing and we look at the pros and cons. We look at what could happen. Unintendedly, we poke holes in our own science. That's how it used to be. When you come to a conclusion, now you can't just say, okay, I got my answer, I'm gonna quit here. Just because you get the answer you were trying to get doesn't mean you stop. At that point, you start poking holes,

you start throwing in hypotheticals, you start adding things that would alter that outcome to see if it truly is that outcome, or it may be an artifact artifact or it may be whatever. So we still do that. We still poke holes. We still start over again. If it's wrong, we're not going to double down on something to make it work. We're not going to say, well, we've come this far. we have to take it to market. We'll scrap it.

We'll scrap it and start over. And I think that gives me great gratification, far more than just being an automaton in a hospital. So what is it like working with the FDA? It's changed over the years. I can tell you in previous interactions and meetings with the FDA, it was like a partnership almost, where we would present data and our studies and what we feel is exciting information and innovation, and they would see what we're talking about, want to champion it, want to be a partner in bringing it through the regulatory process.

And it was always a helpful meeting, whether it was a pre-IND, which means before you even put the investigational new drug application in, or whether it was post-IND, pre-NDA, which is a meeting you have with the FDA before the new drug application is submitted for approval. There are different levels of meetings that you would have with the FDA, and sometimes you'd ask for a meeting just to get some more guidance because maybe you've reached an endpoint or learned something that you didn't expect and want to touch base with them to see, okay, how would you proceed?

What would you want to do? Because a lot of times most drugs don't fail. It's the design and the people that fail. And when the FDA is telling you exactly what you need to do to get it approved, don't get cute. Do what they're saying. They used to be very trustworthy in that respect, and it used to be the way things happened.

Over the last 15, 20 years, there's been a shift. There's been a shift. There's been political introduction into the agency itself. you can feel the conflict of interest. And the reason why I say that, I'm not saying that just to point fingers. So in the past you would either request a meeting for written responses or a video response, but even going further back before they even had video responses, we would go to the FDA, we'd sit down at a table when we present data and talk. Nothing beats that. The nuances of trying to present your data and having a dialogue, nothing beats that. However, once COVID hit,

it became an excuse for no one to be in the office. And I know they had whatever their six foot rule was and all that, which was unsubstantiated scientifically. It was made up. But it was a thing. And so everybody worked from home. So the only thing you could ask for at that point was written responses. And written responses came back copy and paste. Literally copy and paste job of bureaucratic nonsense. It was not a dialogue. In one breath they

would say, oh well I see an increase in a ease your dose is too high. In the same sentence they would say, there's not enough drug or PK in your bloodstream. Okay, which is it? Is the dose too high or is there not enough? But it became an issue because you lose so much. Just think when you're texting somebody and they take something wrong. You lose a lot of nuance in a text.

Well, the same thing goes with written responses. So that became a mainstay for FDA throughout the last five years, written responses. I actually had to get a senator involved to request a meeting that was not written response. And they said, fine, we'll do a Zoom. We'll do a Zoom call. And all of us were on the Zoom call

while I presented the data, which was what we know to be groundbreaking. Groundbreaking data and something that was in place for decades, we've shown it to not work and to not be what it was represented with reproducibility. I'm not saying one-shot thing. I'm talking about four human trials and they all could be carbon copies of each other. And we're sitting on this meeting and they all look like deer in headlights.

And normally after you present something like that, there's a barrage of questions. And I said, do any of you have any questions? And it was silent. And I noticed that on the call were a lot of junior employees. It wasn't the deputy director which would normally attend a meeting like this or anybody that has any kind of decision making capabilities. It was a lot of junior scientists

and there were no questions. So then I started asking questions and they couldn't answer them. So it was basically a chronologic process where finally somebody went, okay, that's an hour. We're going to conclude our meeting. We'll send you the minutes. So after my team pow-wowed, this gentleman, PhD, said to me, in my 50 years with regulatory bodies, I've never seen anything like what just happened in my life.

Because that was unbelievable. Unbelievable. And I said, should I have done anything differently? And he said, no, absolutely not. They should have done everything differently because I don't know what to think about this. So that's when we decided as a company to go to another country.

So we set up a meeting with another country's regulatory body, which is almost as big as the FDA, if not bigger with its recognition through other countries. And we had the exact same meeting. I presented the exact same data, and it was the same thing, but it was completely different. And the reason why we chose this regulatory body was, it's my PhD who said, I've dealt with them before, they're English speaking, they really are excited about innovation,

what we thought the FDA used to be, because they had been in the past. And we presented it and they couldn't be more helpful. And they gave us guidance and they green lit our pilot study for efficacy. And they said, I want to see this data as soon as it starts coming in. Set up a meeting with us when that data starts rolling in.

We'll have another meeting. We'll do the final touches on the pivotal and we'll get this through. That is exactly what was supposed to happen at home, but it didn't happen. So we're gonna continue the process. We're going to get approved there. And the question is going to be why did an American company have to go all the way here to

get someone to listen and partner with innovation? It's a concern of mine. It's a deep concern of mine. How do we bring back trust into health? Where there's transparency, there's trust. It's really that simple. Every decision in science, every dissemination of funding, all of these things have been behind closed doors from the American public from start to finish.

And it was never an issue. Everybody was fine with that until the past five years. And then FOIAs and then emails. And one email saying, we have to shut down that the fringe epidemiologist. And another email saying, we are not to discuss this severe adverse event that we're seeing prevalent. And when the public starts reading these things, they're like, what is going on here? What is going on here? And when all of the people that were trustworthy in the past turn their backs in a very, very contentious situation, and then these kind of things start getting leaked out, the public starts questioning everybody involved.

They start questioning the agencies, they start questioning their own doctors, they start questioning the pharmaceutical companies that are supposed to help and come up with the saving therapeutic. And in my opinion, the only way to change course is to be fully transparent. There should be no backdoor meetings. In fact, when our agencies are meeting, there should be a C-SPAN kind of situation where it's real time, somebody can tune in. You're saying it should be like a congressional hearing, you should be able to wander in and listen. I think so. I think where this much of our tax dollar

goes, we should be able to hear. Now, I'm not going to say the same thing about the Department of Defense for obvious reasons. You know, Joe and Peoria shouldn't know about, you know, our missile defense system. But when we're talking about our health, when we're talking about what is going into American citizens and what is being funded by

American citizens, they should have transparency. With transparency, then comes trust. Because you start seeing that they're really working for the right reasons, doing the right things, and not trying to hide things. Dr. Pinn, thank you for this conversation. Any final thoughts as we finish up? Dr. Pinn, thank you for this conversation. Any final thoughts as we finish up? Final thoughts? Not all is lost. I hope people realize that. A few tweaks and a few mitigating factors enter the picture and we can turn this around. We can make health and science a real thing.

We can clean up our food supply, make more efficient and cost-effective therapeutics. We could open up preventative medicine, which is what we haven't spoke about for a long time. I mean, it was obvious that vitamin D helped. Why did we quell it? Why did we not say anything about it as a public agency? Why did we not rally behind easy, easy fixes that could have, you know, prevented quite a lot of loss? If we start opening our minds, and I'm very hopeful with the new administration, and if we start doing things ethically, morally, and correctly, we can

turn this around. And I think that's what needs to happen. Well, Dr. Lynne Finn, it's such a pleasure to have had you on. Thank you so much, Jan. I appreciate it. Thank you all for joining Dr. Lynne Finn and me on this episode of American Thought Leaders. I'm your host, Jan Jekielek.