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[RUSH TRANSCRIPT BELOW] 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 NTD.

RUSH TRANSCRIPT
Jan Jekielek:

Dr. Lynn Fynn, such a pleasure to have you on American Thought Leaders.

Thank you so much, Jan. Thanks for having me.

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 guidance, these tools that are used for clinicians basically draw upon the integrity of those publications.

So when the publications themselves and the research itself become 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 conclusions or ideas, and then pharma comes in and co-opts that; then the taxpayer gets left out of the equation altogether.

For the longest time, the NIAID [National Institute of Allergy and Infectious Diseases], one person had quite a lot of control over 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, you know, 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 signed 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.

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? Probably that is what a lot of people say, right?

It very much is, both the undergrad and applied science level, all the way through medical schools. But what I mean is they would say 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. It’s granted; it hits the radar of, 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. 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.

In doing so, they start negotiating 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 [U.S. Food & Drug Administration] process 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. 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 benefits 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 [National Institutes of Health]. 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.

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 look much more predisposed to find that outcome even if the evidence is not very strong, basically. It’s important, and even if you’re not doing it consciously, I suppose, right?

Yes, that’s exactly it. 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.

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 undergraduate 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 outcomes, right? But a lot of the time, you could do that, and I found that actually, frankly, really disturbing because you have to assume the best absolute faith of the researcher, truly looking impartially.

Another variable to throw in, a monkey wrench to throw in this whole thing, is ego. So when you have a head of a lab or a 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 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. Let’s face it. With intelligent people, there’s a huge ego, and that’s another monkey wrench.

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, whatever that is, 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 is 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 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 from a nobody that really has promise 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 the data can be corrupted as well.

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 [Contract Research Organization], which is an approved place of study. It’s not a university setting, it’s a CRO. It’s a commercial 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 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 could 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 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 a pal 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 came together and started attacking the journal to have it retracted.

I’ve seen a couple of attempts at 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? 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. 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. The taxpayer dollars for innovation go. That is a problem, and it has happened for almost 45 years. That can never happen again. There has to be panels; there has to be a more even distribution of where deciding where this money goes and what it’s going for.

Have you thought about how to enact that in the current period of change in HHS right now?

That’s right. 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. When someone says, when you attack me, you’re attacking the science, in a way, that is true, because he gets to decide. 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.

You should create a panel. You create a committee within our HHS system that serves to put a board together, like an IRB [Institutional Review Board]. IRBs consist of people of all walks of life, a scientist, a clergyman, a teacher. Institutional 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 worthy of a taxpayer-funded grant?

Are you imagining multiple ones of these in different areas of research?

Yes, 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 has 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.

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 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 a fellowship in that.

Then I ended up doing some tropical medicine in West Africa for several years, which was fascinating. And from there, I had mounting debt, as anybody coming out of medical school does. And I found myself discovered at a craps table to go into finance. As crazy as that sounds, someone approached me and said, your very unique way, your mind works in a very unique way to control your purse while you’re gambling. I just liked to play craps. But it ended up that they supported me and put backing for me to get all of my licenses to trade on Wall Street; series seven, series 63, series 55, and a 24 for a registered principal. 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. In clinical research, I worked on several very successful drug development processes. 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 didn’t want to be part of a hospital system. They can get a vending machine to do that. 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, and am 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 several patents in the U.S., one in Israel, I’m pending in Europe, and I’m pending throughout the world, Australia, I skipped India and China; they just steal your stuff anyway, and now I’m working on the final pivotal trials for this therapeutic.

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