Two lawsuits filed within days of each other in the U.S. District Court for the Northern District of Illinois claimed that Tempus AI Inc., an AI-driven precision and genomic testing company, had violated the Illinois Genetic Information Privacy Act when it acquired Ambry Genetics and started to integrate its genetics data into its predictive models.
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“Ambry contained genetic information from a lot of people,” Paul Goldberg, editor and publisher of The Cancer Letter, said. “And the question is, were these people consented properly before the data were actually put into the kind of combined—if it was indeed combined with Tempus data—and before it was used, again, if it was indeed used for drug development?”
On this week’s episode, Paul and Jacquelyn Cobb, associate editor of The Cancer Letter, talk about last week’s breaking news regarding two lawsuits being brought against Tempus for potentially violating genetic privacy laws.
“So, it’s all very interesting. It’s also making a lot of people nervous,” Paul said. “I know that at cancer centers, and elsewhere, because of just the way all of this is regulated. But I think the issue that fascinated me was that you can de-identify something—maybe—but is it really de- identifiable with DNA research?”
Researchers say that “deidentified”— a word used often in the context of germline data in order to ease privacy concerns—doesn’t mean “deidentifiable.”
“It’s just this interesting idea that the idea of de-identified predates our ability to sequence our entire genome,” Jacquelyn said. “The technology outpaced our regulatory frameworks.”
Stories mentioned in this podcast include:
- The Directors: Yolanda Sanchez and Kelvin Lee talk about making cancer centers more resilient
- Joni Nelson tells us how her background led her to pursue research that meets the needs of the community
- After a year, Stephenson institute sees a broader role in funding pancreatic cancer research, fostering collaborations
- When radiology fails to fix clinical trial imaging workflow at sites…
This episode was transcribed using transcription services. It has been reviewed by our editorial staff, but the transcript may be imperfect.
The following is a transcript of this week’s In the Headlines, a weekly series on The Cancer Letter Podcast:
Jacquelyn Cobb: This week on the Cancer Letter Podcast…
Paul Goldberg: One of my stories actually, I’m going to brag a little bit, led to a Supreme Court case. And that was about class action and certification. It was the Amgen Securities litigation. So, the question was, how do you certify something as class action suit? I had no idea this was happening while it was happening. I also didn’t really care. Once it came out and the case was remanded and then it led to all kinds of other stuff that I couldn’t ignore because it involved me as potentially somebody who was subpoenaed to testify and I didn’t want to do it. It was a big to- do. But really the whole thing was about certification. It wasn’t about the merits of the case. It had nothing to do with the case. And I didn’t know anything about certification. I don’t really particularly care. I was really surprised that the story we broke in The Cancer Letter ended up in the Supreme Court.
Jacquelyn Cobb: That’s awesome.
Paul Goldberg: This was some years ago, and then it was all about certification, which is a subject I really don’t care about. You’re listening to the Cancer Letter Podcast. The Cancer Letter is a weekly independent magazine covering oncology since 1973. I’m your host, Paul Goldberg, editor and publisher of the Cancer Letter.
Jacquelyn Cobb: And I’m your host, Jacquelyn Cobb, associate editor of The Cancer Letter. We’ll be bringing you the latest stories, groundbreaking research and critical conversations shaping oncology.
Paul Goldberg: So let’s get going.
Jacquelyn Cobb: Hello, Paul. How’s it going?
Paul Goldberg: Hi, Jacquelyn. How are you?
Jacquelyn Cobb: I am good. I’m good. For the listeners, we just had a classic Paul-Jacquelyn-ramble going on, and Paul brought us back on topic, which was incredible. So now we’re doing the podcast.
Paul Goldberg: It can happen. It doesn’t usually, but it can.
Jacquelyn Cobb: It was humbling this morning, truly. But no, we were talking about Stowe. I went back to Stowe this weekend, so that’s always fun. Wow. Paul, I love your sweater. Not to go off topic here. But I really, really like … I think I have a new obsession with buttons, so I got the glimpse of the button and I-
Paul Goldberg: Buttons are important.
Jacquelyn Cobb: Yes, true. I’m going to walk us through last week’s headlines because clearly I’m in sort of a rambly mood before I take us fully off the topic.
Paul Goldberg: Looking forward to rambling.
Jacquelyn Cobb: Yeah.
Paul Goldberg: That’s the genre.
Jacquelyn Cobb: Yes. Yes. Rambling. So our cover story last week was an episode of the directors. This time featuring Yolanda Sanchez and Kelvin Lee. Yolanda Sanchez is director of the University of New Mexico Comprehensive Cancer Center and Kelvin Lee is director of the Indiana University, Simon Comprehensive Cancer Center. And that conversation was really great and wide ranging. Kelvin Lee is incredibly funny. So it has a lot of character, unique character to this story. And it was a really interesting topic as well. I think Claire did a really beautiful job. And Paul, sort of framing the narrative where they focused on how to build and sustain the next generation of scientists and how diversity is fundamental for maintaining a diverse ecosystem. And yeah, I just loved Kelvin Lee’s sort of reference to the fact that that’s a biological fact. I got to love that. Then we put out a second podcast last week, this one, the last in a series celebrating Black History Month.
This episode featured Joni D. Nelson, the assistant director for the Office of Workforce Development at MUSC Hollings Cancer Center, who was interviewed by Robert A. Winn, who is the Cancer Letters guest editor for Black History Month. Then I wrote a story about the Stevenson Global Pancreatic Cancer Research Institute and sort of roughly a year later kind of checking in on what their goals are since last time we wrote about them. They sort of had projected goals and sort of just what are they actually drilling down into now. And we had a guest editorial by Jeff Sorensen, CEO and founder of UNU Inc. About how to modernize clinical trial imaging. That story is very niche, but very interesting and long, so worth actually combing through that one. And then cancer policy, I’m not going to go through them, but this isn’t me just saying it was a very important, dense cancer policy.
So listeners, that’s your homework.
And then of course, story two that I’m circling back to now is Paul’s Thursday scramble. Love it. Love when that happens. You know it’s high drama when that happens. So I’m going to let you sort of give the elevator pitch for your story, Paul. And then I will poke and prod and get more info.
Paul Goldberg: Well, it’s called a news outbreak, It’s actually when something actually happens.
Jacquelyn Cobb: Every Monday meeting we go, “We’re going to wait for a news outbreak as well.” What can I do? Yeah.
Paul Goldberg: Yeah. It’s really kind of fascinating when that happens. But then this was an amazing story. There were these two class action, well, suits that are hoping to be class action against Tempus AI about genetic privacy based on Illinois law that has to do with the acquisition of a genetic testing company called Ambry.
And Ambry contained genetic information from a lot of people. And the question is, were these people consented properly before the data were actually put into the kind of combined, if it was indeed combined with TEMPUS data and before it was used, again, if it was indeed used for drug development. So it’s all very interesting. It’s also making a lot of people nervous. I know that at cancer centers and elsewhere because of just the way all of this is regulated. But I think the issue that fascinated me was that you can de- identify something maybe, but is it really de- identifiable with DNA research? So it’s just a question of a research question or just question.
Jacquelyn Cobb: Yeah.
Paul Goldberg: So, I mean, you see stories about people being found criminals because of their cousins on 23andMe or whatever, family members. So you can actually start narrowing things down with that. And does that violate privacy? Yeah, maybe. But we also really do not know the facts in this case. I mean, what we see is an allegation. And I guess that’s kind of what … It’s interesting because we can talk about it in a podcast, but I wouldn’t quite put it as bluntly as I want to write in a story. It’s kind of like a medium is the message situation. When you think about it, what is a class action suit? A class action suit as a general reposition is an attempt to shake somebody down. Does it have any policy making or guidance or prospective guidance? Does it offer any of that? Not really usually. The law is not clarified because they usually settle the thing. Courts are usually fairly generous in terms of certifying, in terms of certifying a class action. Once it’s certified, the question is whether the thing gets thrown out or settled, but you rarely see any real judgments on this. Yeah. It’s really a bizarre thing. Like one of my stories actually, I’m going to brag a little bit, led to a Supreme Court case, and that was about class action and certification. It was the Amgen Securities litigation. So the question was, how do you certify something as a class action suit? I had no idea this was happening while it was happening. I also didn’t really care. Once it came out and the case was remanded and then it led to all kinds of other stuff that I couldn’t ignore because it involved me as potentially somebody who was subpoenaed to testify and I didn’t want to do it. It was a big to- do. But really the whole thing was about certification.
It wasn’t about the merits of the case. It had nothing to do with the case. And I didn’t know anything about certification. I don’t really particularly care. Yeah. No, I was really surprised that the story we broke in the cancer letter ended up in the Supreme Court and-
Jacquelyn Cobb: That’s awesome.
Paul Goldberg: … some years ago, and then it was all about certification, which is a subject they really don’t care about.
Jacquelyn Cobb: But now you’re the expert.
Paul Goldberg: But here it is. There will be no guidance issued, but the way the US laws are set up, a lot of the privacy laws seem to be written by state legislatures, which is what is the case with what the case is with Illinois. And will we learn something from it? I don’t know. This is a subject on which I think we all have to become experts. Absolutely. And I think it’s something that we will be covering. I’m hoping that we’ll have a guest editorial about this maybe this week, ideally this week, because I really went after that. But yeah, we definitely need to become experts on this subject.
Jacquelyn Cobb: Yeah. I’m surprised this hasn’t honestly come up sooner. I feel like this is sort of like that … Zoomsday is maybe too strong of a word, but sort of like negative end scenario when people were first talking about gene like 23andMe and DNA testing, consumer DNA testing. And I think that what you’re talking about is a really interesting concept of like the de- identified versus de- identifiable. I mean, de- identified … And please, I did not do the reporting on this, right? I’m coming from this with my bachelor’s in science. Well, I guess also master’s, but I-
Paul Goldberg: I don’t have even that.
Jacquelyn Cobb: Well, but what I’m saying is that I remember in my precision medicine class, for example, we were learning about the regulatory landscape at a very basic level, of course, and that there was sort of like … I thought I remembered that there were federal protections for gene information, but regardless, it’s just this interesting idea that de- identified, the idea of de- identified predates our ability to sequence our entire genome. And so it’s I think just a really interesting … The technology outpaced our regulatory frameworks. Is that a way to think about it?
Paul Goldberg: Yeah. And it’s going to keep doing it. That’s from what I gather because this should … Yeah, I asked a lawyer friend, I should lawyer, family member, and the answer I got was, “Yeah, this should go to the Supreme Court, but it won’t.” Something like this, but not as a class action suit, because who gives that?
Jacquelyn Cobb: Yeah. So what do you think is going to happen in terms of regulation, like formal regulation surrounding this idea?
Paul Goldberg: I don’t know anything, but that doesn’t make me unique.
Jacquelyn Cobb: No, I think you’re probably the most informed person or one of the most informed people.
Paul Goldberg: I’m going to become one, but I’m not yet. This is the first time I looked at this story. I don’t get it. I mean, I do get it actually, but there’s not much to get other than, oh geez, they opened that Pandora’s box. But also to your point that this is how you learned about it in college. College was really a generation ago in terms of generations ago in terms of your college. Forget my college. My college was not even…Stone Age was before that…in terms of the framing of this question.
Jacquelyn Cobb: Well, what do you mean? Do you think that it’s become more loose as the technology has advanced?
Paul Goldberg: The value of your genomic data was not knowable at the time you were in college. Which is not a long time ago, chronologically.
Jacquelyn Cobb: Yeah, yeah, yeah. True.
Paul Goldberg: Yeah.
Jacquelyn Cobb: Technologically it was. Yeah.
Paul Goldberg: Yeah. Yeah. So in a way, and when you’re talking about how it’s amazing that it’s never come up before. Well, Ambry, Tempus bought Ambry a year ago.
Jacquelyn Cobb: Yeah. Valid. Yeah.
Paul Goldberg: So, it takes a while to find the plaintiff. There are two suits there same court filed a couple of days apart. I just haven’t really … Yeah, the systems have not caught up yet, and it’s all changing every hour by the hour.
Jacquelyn Cobb: I know. I said that, and the first thing that came to my mind was that I’ve definitely said this about AI, all of these … I think that’s a fundamental … What is that? Do you know what I’m talking about? Meyers Law or something? It’s not Meyers. I said Meier because it’s reminding me of a Kaplan–Meier curve, but the idea that technology will continuously … Or the development of technology will accelerate exponentially. Have you heard about that?
Paul Goldberg: Sure.
Jacquelyn Cobb: It’s a law will … It’s very important.
Paul Goldberg: Well, it’s happening, but the law cannot really catch up.
Jacquelyn Cobb: Moore’s Law, that’s what it is.
Paul Goldberg: Moore’s.
Jacquelyn Cobb: Moore’s, not Meier’s. Moore’s Law. All right. That was going to just bug me. I’m sorry. I had to find it. Yeah. But yeah, it’s just we’re seeing it happen. We knew it was going to happen and here we are. Yeah. Yeah. What do you … No, go ahead.
Paul Goldberg: I mean, I think we should be covering the story. It’s a priority to cover this story.
Jacquelyn Cobb: Yeah. Well, I guess I think that’s where I was going to go with this too, is I’m surprised it hasn’t come up before and I’m expecting it to be something that we have to deal with a lot just because it’s so sort of at least conceptually, and I would guess, maybe not conventionally, but narratively, it’s so connected to this whole push for precision medicine, right? It’s this hyper-individualized-test everyone. I think there is a nuance here that I’m not really getting into, right? Testing a tumor for somatic data like we were kind of getting at earlier, Paul, before the podcast, versus sort of like a 23andMe Ambry vibe of consumer germline data. It’s sort of a different conversation I think that’s worth mentioning, but still, it is kind of this weird … Yeah, I feel like it’s a problem we have to grapple with in order to move forward with the precision medicine sort of approach that oncology is taking. You know what I’m trying to say?
Paul Goldberg: Yeah. Yeah. Yeah. It’s all really going to present more questions than … But one of the answers that seems to be emerging, and again, I’m not smart enough yet to understand it, is the answer is properly constructed federated models for data that maybe is the answer, at least it’s what I hear from the Cancer Center’s Informatics Society. So the data scientists might be able to come up with this. I don’t think the courts are going to come up with anything.
Jacquelyn Cobb: Got it.
Paul Goldberg: But well, maybe. Who knows?
Jacquelyn Cobb: I mean, ideally they would, but it’s just you need such a specific expertise to be able to come up with solutions for these intense problems.
Paul Goldberg: Yeah. And I really do not yet truly understand what the cancer centers are thinking
Jacquelyn Cobb: About. Well, that’s so funny you said that, Paul. Literally, when I said … I was going to say, you mentioned that they were kind of concerned. Can you expand on that? Now I’m wondering whether you can,
Paul Goldberg: Because you just said you don’t know anything. No, I can’t. I can’t. I can’t.
Which is kind of like one of the most amazing things about podcasts as a medium is that you can have this conversation and you say, “I have no idea what I’m talking about. ” Yeah, that’s what I really think is fascinating about podcasts as a medium because if you’re writing a news story, you can’t really say, “I have no idea.” You find nicer ways of saying it, but really the essence is I absolutely have no idea what I’m talking about in this case and very few other people do. And in fact, many of the people who say they do don’t, but this is like a nicer way of saying, “I don’t know. ” And those are sacred words in science journalism.
Jacquelyn Cobb: Oh my gosh.
Paul Goldberg: So I have no clue. Imagine what the world would be like if we didn’t know, if we had no way of saying, I have no clue.
Jacquelyn Cobb: I know, I know.
Paul Goldberg: So, we are going to follow the story until we know more. Until we become experts. I think that’s another thing about the medium, and this is where a story like that is important, is you really have to bring in people who are experts who live and breathe things like federated models, who can actually authoritatively tell you what is happening. But it was really, as I was reporting the story, I was calling friends and most of them were saying, “Oh, I don’t know. ” Finding nice ways of saying it, and people are not ashamed of saying that to me. It’s like … Yeah.
Jacquelyn Cobb: Yeah. Yeah. Which is, I think, kind of telling that if your friends are saying, “I don’t know, ” probably not too many
Paul Goldberg: People- Off the record too.
Jacquelyn Cobb: Yeah, off the record. Yeah. It’s probably unknowable at this moment or just about.
Paul Goldberg: Well, especially when you’re dealing with the intersection of public policy and really nuanced law, and you have a nuanced scientific question, question that is asked and questions that are not asked, like de- identified versus de- identifiable, and there is no such thing as de- identifiable. Gee, that’s not easy. I mean, I’ve never done Ambry, but I did do 23andMe. And you know what I learned?
Jacquelyn Cobb: What?
Paul Goldberg: Oh, is it? I learned that I am Ashkenazi Jewish.
Jacquelyn Cobb: Which you are not, or are you?
Paul Goldberg: Very useful information.
Jacquelyn Cobb: Yes.
Paul Goldberg: I’m something like 98.7% or something like that. And also, I have more Neanderthal variants than something like 85%.
Jacquelyn Cobb: Oh no, I have higher than normal Neanderthal.
Paul Goldberg: Are you also Neanderthal?
Jacquelyn Cobb: I am. I’m like 75, I think. So it makes sense why we get along.
Paul Goldberg: I mean, think of … Yeah, Neanderthals were not treated well by the homo sapiens.
Jacquelyn Cobb: They were not. Yeah. They were not. They really weren’t. Isn’t that true? Didn’t they kill them off?
Paul Goldberg: Yeah. It wasn’t good.
Jacquelyn Cobb: No, no.
Paul Goldberg: Good. I mean, I have some memories of that, but they’re kind of like…
Jacquelyn Cobb: Some ancestral…
Paul Goldberg: Yeah. Anyway, that’s one of the disadvantages of podcasting is that it disintegrates into utter nonsense.
Jacquelyn Cobb: I warned you it was going to be rambly today.
Paul Goldberg: On that note …
Jacquelyn Cobb: Yes. I think we did pretty well, but on that note, thank you, Paul. I will see you next week.
Paul Goldberg: It’s a wonderful time to be a neanderthal.
Jacquelyn Cobb: Yes, it is.
Thank you for joining us on the Cancer Letter Podcast, where we explore the stories shaping the future of oncology. For more in- depth reporting and analysis, visit us at cancerletter.com. With over 200 site license subscriptions, you may already have access through your workplace. If you found this episode valuable, don’t forget to subscribe, rate, and share. Together, we’ll keep the conversation going.
Paul Goldberg: Until next time, stay informed, stay engaged, and thank you for listening.
