How Bad Incentives Corrupt Scientific Research: Dr. Lynn Fynn
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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...
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 the guidelines.
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 Beidol 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 it.
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.
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 sign this, and it now belongs to the university.
They're not going to, you know, 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.
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.
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.
I mean, some people would say this is the industry supporting academia.
Right?
I mean, probably that is what a lot of people say, right?
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 say that as a good thing.
I find 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.
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.
And this is all in taxpayer dollars.
And they file a patent.
Patent's granted.
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...
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 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 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 NICs 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.