The Legal Impact: Research Controversy at Stanford University

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Professor Stan Kowalski discusses Stanford’s President Marc Tessier-Lavigne stepping down and whether we can trust research data. Produced and Hosted by A. J. Kierstead

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Legal topics include research, technology, transfer, intellectual property, academia, education, ethics

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A. J. Kierstead:

This is the Legal Impact. Podcast presented by the University of New Hampshire Franklin Pierce School of Law. Now, accepting applications for JD, and graduate programs. Learn more, and apply at law.unh.edu.

Opinions discussed, are solely the opinion of the faculty, or host, and do not cost you legal advice, or necessarily represents official views of the University of New Hampshire, and UNH Franklin Pierce School of Law.

I'm your host, A. J. Kierstead, and today I'm joined by Prof. Stan Kowalski, director of the International Technology Transfer Institute, also known as ITTI. Welcome back to the show.

Stan Kowalski:

Oh, thank you, A. J. It's great to see you again, and work with you.

A. J. Kierstead:

So in a recent article in Nature, they covered the work of John Carlisle, who is part of Great Britain's NHS, which is their government health institute. He looked at the topic of fake and flawed research data in the journal, Anesthesia.

This is a quote from nature, "For more than 150 trials, Carlisle got access to anonymized individual participant data, by studying the IPD spreadsheets. He judged that 44% of these trials contained at least some flawed data. Impossible statistics, incorrect calculations were duplicated numbers, or figures, for instance. And 26% of the papers had problems that were so widespread, that the trial was impossible to trust, he judged. Either, because the authors were incompetent, or, because they had faked their data."

And then, adding into this Stanford's president, Marc Tessier-Lavigne, is stepping down on August 31st. It was unveiled, he had decades of research that he refused to correct.

I'll post a link to both the Stanford Dailies article covering that, and as well as the nature article in the episode description at law.unh.edu/podcast.

I mean, Stan, overall, when you look at research as a whole, how much of a problem is flawed data appearing in these final products that are ending up in journals, libraries, and everything like that?

Stan Kowalski:

I don't think it's an overwhelming problem. I think it is a problem in some areas of research, and I read the article in the Stanford Daily about President Tessier-Lavigne, I think his name is, and the problems he's having.

Now, when you look at that article, you'll note that his research was in the cutting edge area of Alzheimer's disease, and the neurological basis of Alzheimer's disease.

Now, think about it, that's highly cutting edge research, it's highly topical, it makes him into a quasi celebrity at least, or a celebrity, so you see all these factors come together. And what that does, then, is creates a high pressure atmosphere in the laboratories to generate the data which support that proposition.

So in other words, it's like the reverse of the scientific process where we do experiments in order to make a determination, and then, we make a conclusion from the experimental research.

This is almost like, "I have reached a conclusion. Do experiments to verify my conclusion, in order for me to become famous." And you'll note too, that the articles published in Nature and Science, which are the highest ranked journals in the entire field.

So I don't believe this is anything new, because this had been going on when I first started doing research, and biochemistry that were stories. There was a scandal, which came out of Cornell, in the early eighties, similar to this. It wasn't a prominent scientist, but it was a postdoc, or a graduate student. Activities were uncovered in terms of fraud.

So it is a problem, but I think overall the scientific endeavor is sound, but still, in all, it can be a problem.

A. J. Kierstead:

Do you think this is more of a problem at the journal level, where many people have brought up the issues when it comes to how these science journals operate? I'm not going to dive into that can of worms right now, but the desire to be published, and needing to have the right headline, and things like that, maybe, could have an impact?

Stan Kowalski:

Yes, and there's multiple factors working here. Once again, let's go back to the drama coming out of Stanford as example. You have high impact research, which could have significant potential, both in terms of the ego of the principal investigator, who I presume this was President Marc Tessier-Lavigne from Stanford. And so, the idea, the problem is that, then they want to publish in high impact journals such as science, or nature, which increases the pressure to generate results, which will verify their theory. For example, the neurological basis of Alzheimer's disease, which would be a fantastic scientific breakthrough.

However, it becomes a spiral, and apparently, the laboratory is a pressure cooker, where those with data which support that proposition are favored, and those who do not produce data to support that proposition were favored, according to the Stanford article. So it becomes a cycle, and I believe it's really the principal investigator who has to step forward, and say, "I'm here to do this, to find out what's going on," instead of, "To establish what I want to be the truth." So we find the truth, versus I want this to be the truth, therefore it is the truth.

And the sad thing is eventually somebody finds out, as we saw in this article, that it is non-verifiable data, and that's where this house of cards peak begins to collapse.

A. J., it's almost like a system problem, where there's a system where superstar scientists, pressure people in the lab, who are rewarded when they find the right thing, so that the superstar scientists can publish the science in nature, and then, become somebody who discovers the neurological basis for Alzheimer's disease, and then, they become a great person.

Unfortunately, this is going on for a long time, but an additional caveat to this is nowadays with the whole social media internet world, I believe it may be amplified to a certain extent.

A. J. Kierstead:

Yeah. I mean, the rockstar scientist that's also getting this scientific journal article reshared by the New York Times, Washington Post, USA Today, you start hitting that end of things, I mean, it only makes you look even bigger, and it gets you those high-end, like the Stanford President role, things like that, which are very lucrative, and give you even more respect, which doesn't necessarily shift down the pressures that are required to maintain it.

Stan Kowalski:

Yes, you're right. And it goes to the egos, and when I did 20 years of biochemistry research, and there were people like that, I knew people like that at that time who, and I thought to myself, if you want to be famous here in the wrong business, why aren't you in show business? That's where you get become famous, not science, but still in all they have that mindset.

For example, I had one scientist say to me, "My dream is to have my name in lights in nature, or science." And I thought to myself, that's an odd way of looking at things. But then, that mindset then begins to generate this kind of atmosphere, and the pressure is from the top to bottom, and then, there's additional pressure, because there's funding. In other words, we have to find results to satisfy NIH, or NSF, who's ever funding this research.

And there are shades of data, which are either unreliable, unverifiable, or they may be outright fraud.

So for example, there could be a series of experiments where there's always a question like, this could be A, or B, but we just want it to be B, and we won't test A again, and again, to make sure that we're right. So there's various shades of this kind of problem.

Thankfully, science is to a great extent, it's an iterative process, and also, it's competitive.

So the competition can be good, and bad. In this case, with Stanford, the competition had a bad effect, because I believe the attitude of the president was, "I'm going to beat everybody. I'm going to win." But the competition would be good, because other scientists can say, "Well, let's take a closer look at what you have." That's like a two-sided coin as well.

A. J. Kierstead:

Yeah, this is a legal podcast, so we've been talking about the science end of it, which obviously is a supremely important.

I mean, when it comes to the intellectual property realm, where with your tech transfer institute definitely is extremely important, I mean, what are the downstream impacts of things like this coming to light? I mean, do you think, you said before that it doesn't appear to be as widespread an issue as it looks like in some specific scientific magazines, but how much of an issue is this on the IP realm, when things like this come up?

Stan Kowalski:

The article touches on that, because apparently, the president, and, or some of his colleagues, were also involved in startup companies, which will take an experiment, for example, the presumed neurological basis of Alzheimer's disease, and let's speculate. Let's do what's called a thought experiment in law school. Let's speculate that it's flawed, or it's fraud.

And then, they'd go to the next step, and file patent application on this so-called discovery. And then, it goes a step further to the USPTO, where, now, you're dealing with the United States Patent Trademark Office, with an, "Invention," which may, or may not exist, so that's at another level.

In a legal journal, it's more of an ethical problem, or an employment issue problem, maybe, the legal aspect of it that he's facing employment, or there may be contractual issues with the funding.

But then, when we move to the Patent Office, then it's us, and the Patent Office, which is the government of the United States, and we're saying, "Well, we have an invention. We've reduced it to practice, but it's not real." See what I mean? So we've got problems there.

Well, then it goes the next step. What happens then if the Tech Transfer Office begins to sell equity shares on this? In my mind, it all begins to look a little bit Elizabeth Holmes-ish, if you know what I mean, and that becomes pretty scary in terms of the potential for legal action.

A. J. Kierstead:

How do ethics work when it comes to these? Because most major universities, and University of New Hampshire included, has as research, as part of what they do, especially on the STEM side of things. How are ethics managed when it comes to the sale of the IP that comes up from these research projects?

Stan Kowalski:

I think the Technology Transfer Office is not really able to evaluate the scientific integrity of a lot of the intellectual property it comes across. So I think a lot of it has to do with the integrity, and the reputation of laboratory that generating the results.

And this becomes established over time. This business in Stanford appears to have been 20 years in the making, off, and on, from a practical standpoint. Our Technology Transfer Office is well-advised to talk to people in laboratories who are not the principal investigator, in order to get a feel for what's really going on in here.

Because if you read this article from the Stanford Daily, they were people in the lab accusing each other of this type of activity, and the principal investigator was President Marc, was apparently not there, or he didn't want to know, so selective ignorance, so that's the problem.

So the management of the intellectual assets by the TTO means that, well, let's just have a chit-chat with people in the lab, and then, a good business man, a good TTO manager, will begin to say, "Okay, what's going on?" It's just a matter of being a good listener. I mean, that's practical advice on how to begin to sort this out.

And I think that the labs which have integrity, and are trustworthy, which are most of them, actually, will be identified. Just with the thought experiment, I'm speculating like a worst case scenario, where let's just imagine once again, Elizabeth Holmes, if she's scientist. She wasn't. I think she had, maybe, a college degree, maybe, she didn't, but if she was an investigator, her, "Invention," if it went all the way through to a patent, and to a license, and to equity, then you can imagine, it could be quite a series of lawsuits, and I don't know who would be on the hook in that type of problem.

So I think the TTO, the Technology Transfer Office, as a manager, would have a role in managing these intellectual assets to determine the integrity of them, based on a number of factors, including having someone in there who's a very savvy business person running the Technology Transfer Office. This is what business people do. They size people up.

A. J. Kierstead:

And going off your thought experiment also, I would imagine it gets more and more difficult to confirm the research for some of these more, let's just call them, sketchy labs that aren't necessarily doing what they're supposed to.

When you're talking, especially with Alzheimer's research, where you're talking something over decades when it comes to seeing whether the treatments do anything, and then, you're talking, there's a drug that was, I believe, brought to market just a month, or two ago where it gave a three to 10% chance of improving your odds of encountering Alzheimer's disease, or the symptoms of it. It must be very hard to make sure that things are on the up and up with these less-than-savory organizations.

Stan Kowalski:

Well, yeah. One cannot prevent every problem with any kind of fraudulent data, or not only fraudulent data, data that is more questionable, it can't be prevented. But once again, science, it is competitive, both in a good, and the bad sense of the word. In a bad sense of the word, as I said, egotistical principal investigators may wish to become rock stars, and celebrities, which is a problem, but on the other hand is competitive, because there are labs who compete against them who want to win.

And eventually who wins will be the one with the data that can be substantiated. And if industry gets involved, you can be really quite sure that industry is once solid data, because it's a different game they're playing there with investors, and the bottom line.

So the system works itself out. So this article in Stanford, in a way, is troubling, but also, it's encouraging, because this has come out, and it's being investigated, and dealt with, as other instances have as well, in the past. It's the system, but it's not a perfect system as all systems are.

Well, I just want to mention that you had asked with international development, and research, this type of work would have very little impact on international development, and science, because the types of innovations that developing countries are looking for are really established products, and innovations, which have gone through multiple testing research, so that this type of thing would not have much of an impact on technology transfer of innovation to developing countries.

This appears to be more really cutting edge, new research, which has the potential to make somebody famous, or maybe, rich, and rich and famous feed an ego, so it's not a mundane.

Just as a caveat, there's probably always someone in a lab somewhere who just thinks, "Well, I'll just make it up, and get by."

The principal investigator is always to keep a close eye on people, and make sure that there's integrity, and replicability in the data.

A. J. Kierstead:

Prof. Stan Kowalski, thanks so much for joining me.

Stan Kowalski:

Oh, you're welcome.

A. J. Kierstead:

Thanks for listening to The Legal Impact, presented by UNH Franklin Pierce School of Law.

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