In last week’s issue of The Cancer Letter, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, each had a big story: Jacquelyn wrote about the April 30 meeting of the Oncologic Drugs Advisory Committee, and Paul wrote about Vinay Prasad’s inaccurate claims on his CV.
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In this week’s episode of The Cancer Letter Podcast, Jacquelyn and Paul talk more about these stories.
In a document dated June 23, 2023, Prasad, who is described as a social media star, inaccurately claims to have served as a “Member” of “U.S. President’s Cancer Panel” between 2016 and 2017.
“The President’s Cancer Panel is one of those interesting institutions created in the National Cancer Act of 1971, which is, and its function is to inform the president of the United States about barriers towards implementation of the National Cancer Act of 1971 and the National Cancer Program,” Paul said. “And one of the great honors in oncology is to be placed on this panel and it’s had some really illustrious members. The first chair of the president’s cancer panel was none other than Ben Schmidt. I mean, I’m pretty sure that Mrs. Lasker was on it. I mean, this is a big deal—it’s also three members at a time, and they’re actually advising the president of the United States.
“So, when you have three of them, there’s not much room to hide.”
Later in the episode, Jacquelyn and Paul talked about AstraZeneca’s new drug application for camizestrant, a next-generation oral selective estrogen receptor degrader, or SERD, in metastatic breast cancer, appearing before the FDA Oncologic Drugs Advisory Committee.
The application, with a Breakthrough Therapy designation from FDA, an ASCO plenary, and publication in The New England Journal of Medicine under its belt, might have seemed set to sail smoothly through the FDA approval process.
But ultimately, the application got a thumbs down from the committee.
In this disease setting, patients develop resistance to first-line treatment, and “a primary way it develops is through this one mutation called ESR1,” Jacquelyn said.
“Basically, this mutation, we know, is a resistance mutation and it leads to progression. What we don’t know is that between that mutation being acquired and the progression actually happening on scans, or radiographic progression, we don’t know whether it’s better for patients to continue on the aromatase inhibitor or to switch to a new drug.
“So, that’s basically the big question about this trial, about this drug and this approach, this biomarker-driven progression approach. And that’s why this was such a bigger question than just the ODAC. This approach is going to be coming up in other indications. It’s a technological advancement that is coming for the field, whether we’re ready or not.”
Stories mentioned in this podcast include:
- Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC
- Vinay Prasad’s CV inaccurately claims past membership on the President’s Cancer Panel
- J. Craig Venter’s work was foundational to cancer advancement of the past 25 years
- Trump changes pick for Surgeon General, nominating Nicole Saphier
WEB ONLY HERE DOWN —
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: I guess the one thing that is really interesting is the mystery of how his CV ended up in public domain because I asked for it. I asked UCSF for it and they told me that they don’t have it, which is not necessarily true and actually kind of stretches my… I’m not especially gullible, but anyway, they say they don’t have it and they declined to give it to me and declined to comment. And then I asked Dr. Prasad who didn’t respond, but the reason we have his CV is that it was submitted to Wiley & Sons’ medical publishers, and the reason to submit his full CV generally is when you’re applying for a position as a journal editor.
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.
Well, Jacquelyn, welcome to the weekly podcast and I hope you had a great weekend.
Jacquelyn Cobb: Thank you, Paul. Hi, thank you for welcoming me. It was so formal. I liked it.
Paul Goldberg: Very formal.
Jacquelyn Cobb: Yes, yes. The eminent host of the podcast. I love to hear from you. Yes.
Paul Goldberg: Presenter.
Jacquelyn Cobb: The presenter, exactly. Yes. The editor and publisher of the Cancer Letter.
Paul Goldberg: And stuff like that.
Jacquelyn Cobb: Stuff like that. Well, thank you for being with me today, Paul. We have two pretty cool stories to go through, my story and your story from last week. But before I do that, as always every week, I will go through the rest of the headlines, but there’s not too, too many this week. So the main story is basically a longer story of the ODAC, Oncologic Drugs Advisory Committee, meeting that happened April 30th. And we wrote a short story about that for the May 1st issue that was right after the ODAC happened, but this story is just a little bit of a deeper dive just with a little bit more time to write about it.
And then we had our second story was Paul’s story and that is about Vinay Prasad’s CV inaccurately claiming that he was a member of the President’s Cancer Panel from 2016 to 2017. And then finally, our last story from last week was a… It actually wasn’t an obituary. It was a letter to the editor, even though it started out that way and news-wise, J. Craig Venter died. There were many obituaries written about him, but we decided to do this letter to the editor approach instead. And it was really interesting because he is this unique character in the, I guess, oncology world. I guess he was probably just more biomedicine, I feel like, than just our-
Paul Goldberg: Genomics.
Jacquelyn Cobb: Genomics.
Paul Goldberg: Sequencing.
Jacquelyn Cobb: And just an interesting cataloging of this person’s historical context from a younger scientist and how they have experienced the impact of his work. So it was a really interesting story. Short, but very concise and nice. And then we had some sponsored articles and some cancer policies. Trump changed his pick for the Surgeon General. He has now nominated Nicole Saphier. I don’t know if I’m pronouncing her name right. I apologize if I mispronounced.
So, I’m going to stop there. Should we start with Vinay?
Paul Goldberg: Yeah.
Jacquelyn Cobb: You had this crazy story. Do you want to tell us the start of it? I mean I already gave the lead about, he had an inaccurate claim, but if you want to deliver.
Paul Goldberg: I looked at his… We examined his 2023 version of his CV and found a really startling claim that he was a member of the President’s Cancer Panel between 2016 and 2017. And now, the President’s Cancer Panel is one of those interesting institutions created in the National Cancer Act of 1971, and its function is to inform the President of the United States about barriers towards implementation of the National Cancer Act of 1971 and the National Cancer Program. And one of the great honors in oncology is to be placed on this panel, and it’s had some really illustrious members. Like the first chair of the president’s cancer panel was none other than Benoit Schmitt. I mean, I’m pretty sure that Mrs. Lasker was on it. I mean, this is a big deal and it’s also three members at a time and they are actually advising the President of the United States. So, when you have three of them, there’s not much room to hide. And you also cannot be a secret member of the panel. It can’t be in your heart. It has to be visible.
Jacquelyn Cobb: You have to have it actually on the… You have to be on the roster.
Paul Goldberg: You have to be on the roster and it’s three people at a time. So I called the chair of the panel at the time, Barbara Rimer. I emailed her actually. I didn’t call her. And she said, “No.” And the answer was really no. And I knew the answer was no, to be perfectly honest, because I always know who is on that panel. It’s a big deal.
Jacquelyn Cobb: It speaks to how important it is.
Paul Goldberg: Well, you can argue about whether it’s important, but it is definitely prestigious.
And it’s definitely visible to us at least. But I’d say it’s very important. It can be very important. So it writes some important reports and Dr. Prasad did not respond to my questions as is often the case. And UCSF actually just declined to comment, which is really interesting because I guess UCSF… Well, they should care because this was done on their watch when this came up. Of course, we wouldn’t necessarily know right away if they care.
Jacquelyn Cobb: That’s true. That’s true. Still though, I mean, I think my favorite part… Do you mind if I read the-
Paul Goldberg: Yeah, please.
Jacquelyn Cobb: Kaplan quote from the story or at least part of it, or is that giving away too much.
Paul Goldberg: Art Kaplan of NYU, the bioethicist. Go ahead.
Jacquelyn Cobb: He said, “Claiming to be a member of the President’s Cancer Panel because you have presented before it,” which is not quoting, that’s something that Prasad did do, now quoting again, “Is akin to claiming to be a member of the U.S. Supreme Court because you submitted an amicus brief.” That’s the quote that gets me. I mean, he goes on to say, “Stuffing one’s CV is both fraudulent and immoral. No one who deliberately distorts or inflates their academic record ought to hold a leadership position, and to hold any position requires a full explanation and apology for this deception. Science demands trust and trust is corroded by deceit.” That part of the quote, so, so strong and I feel like gives it the weight it deserves. My immature self loves the first part of the quote just because I feel like it puts it into context of what is he actually saying? Why is this so surprising and so odd? That was a really good quote.
Paul Goldberg: Well, he does it in three places on this so-
Jacquelyn Cobb: That’s the other thing, right?
Paul Goldberg: He-
Jacquelyn Cobb: It’s not just a mistake. It literally happens three separate places where he claims he is a member.
Paul Goldberg: He clearly means to. Maybe… I have no idea what the explanation is and I’m obviously hearing that I’m not entitled to an explanation. And maybe I’m not, but I went through that story being totally surprised and really shocked to see that this was there.
Jacquelyn Cobb: Se we’ll see [inaudible 00:09:22].
Paul Goldberg: But it is true that he did speak before the President’s Cancer Panel and took part in the panel of the panel, or not really a panel. He took part in a workshop essentially on the cost of cancer therapies.
Jacquelyn Cobb: Which to be fair was described as a thoughtful participation. It was not… But-
Paul Goldberg: You can submit a very smart amicus brief and still not be a member of the United States Supreme Court as-
Jacquelyn Cobb: Exactly.
Paul Goldberg: Art Kaplan put so-
Jacquelyn Cobb: Exactly.
Paul Goldberg: Brilliantly.
Jacquelyn Cobb: That’s exactly it. I’m just like, “Okay, yeah, that makes sense.”
Paul Goldberg: But Dr. Prasad is back at UCSF and he is educating young minds and molding them and also treating patients at San Francisco General. He’s not a member of the Cancer Center.
Jacquelyn Cobb: Oh, I don’t know if I knew that. That’s interesting.
Paul Goldberg: No, he’s not.
Jacquelyn Cobb: Well, with that, I mean, is there anything else you want to talk about with Prasad? I feel like we just have to follow the story and see what happens, right?
Paul Goldberg: Yeah. I guess the one thing that is really interesting is the mystery of how his CV ended up in public domain because I asked for it. I asked UCSF for it and they told me that they don’t have it, which is not necessarily true and actually stretches my… I’m not especially gullible, but anyway, they say they don’t have it and they declined to give it to me and declined to comment. And then I asked Dr. Prasad who didn’t respond, but the reason we have his CV is that it was submitted to Wiley & Sons’ medical publishers and the reason to submit a full CV generally is when you’re applying for a position as a journal editor in which case this thing does not usually get put out there in public domain, or trying to get an academic book published and then you submit the CV. So I suspect Wiley made a mistake by publishing it. I don’t know it. I don’t know it. It wouldn’t surprise me if that’s a mistake.
Jacquelyn Cobb: Interesting.
Paul Goldberg: So, we weren’t supposed to see this thing.
Jacquelyn Cobb: Which almost makes it worse somehow. It’s like…
Paul Goldberg: It was definitely submitted to Wiley and Wiley published it, whether Wiley intended to publish it or not. And now the nice thing about having it is that if Wiley pulls it off their website, which we will check probably as soon as we finish this podcast, we still have a copy and it’s going to be preserved in the Cancer Letter on the website in perpetuity or as close as we can get to it. So let’s talk about ODAC.
Jacquelyn Cobb: Let’s talk about ODAC. All right. Well, the ODAC was really cool. So it happened on April 30th and we wrote a short story about it for that Friday. And then last week I was able to dive into it a little bit more detail. I really only focused on the first session. So just for a heads-up, there was an afternoon session of the ODAC that I’m not going to dive into here, but the morning session was really interesting because, basically you have this application for this drug that works basically. And this is all going to be podcast lingo, so please take any of this with a grain of salt. I’m hedging all of this. This is very complicated. So anything specific, please go to the story. But basically this drug had a successful trial. It met its primary endpoint of PFS and it had, I think it was directionally optimistic OS trends, but those data were immature and also the trial was empowered for OS.
So PFS is really what this trial was based on and the trial and the application had a lot of fanfare around it. It had a plenary session at ASCO Annual Meeting 2025. They had a simultaneous submission in the New England Journal of Medicine. There was all of this sort of… Oh, and gosh, the most important thing is that FDA granted it breakthrough therapy designation in May 2025. So last year there was all of this fanfare and excitement around this new drug. But the important part about this trial, SERENA-6, is that this PFS endpoint… And again, this is where it gets very complicated, but they measured PFS or they measured progression, I should say, with a new time point assessment. So typically PFS or progression is measured by radiographic progression. So somebody is getting scans or they have a symptom that is clinically presenting and then they go to the doctor and they find out that there’s been a progression.
In this trial, there was a new method of measuring this progression and it was using a biomarker. And this is something I would love to learn more about just as the field progresses… Maybe not progresses is the right word in this case, but moves forward, advances, is that these biomarker… I mean, ctDNA is huge in the field. It is a new-ish thing and its tendrils are everywhere. It’s in diagnostics, it’s in progression assessment, it’s in all of these different things, but specifically with breast cancer, there are so many biomarker-driven treatment approaches. And so the drug was AstraZeneca’s camizestrant That is a next generation oral selective estrogen receptor degrader, or SERD, and it was AstraZeneca applied for the indication of metastatic breast cancer, specifically hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer. Those are always such a mouthful for me to say.
But basically within this specific indication, patients are typically given an aromatase inhibitor. And again, all of this hedging, I’m not familiar with breast cancer treatment plans. It’s very, very complicated, but these particular, this subgroup of people, resistance develops, these are metastatic patients. So the goal of treatment is just to continue to have a longer time of clinically stable of treatment basically or time off treatment. I’m actually, again, not sure about the treatment specifics. But all that to say is that specifically with aromatase inhibitors, resistance develops and a primary way it develops is through this one mutation called ESR1. And basically this mutation we know is a resistance mutation and it leads to progression. What we don’t know is that between that mutation being acquired and the progression actually happening on scans or radiographic progression, we don’t know whether it’s better for patients to continue on the aromatase inhibitor or to switch to a new drug.
And so that’s basically the big question about this trial and unfortunately… Or about this drug and this approach, this biomarker driven progression approach. And that’s why this was such a bigger question than just the ODAC. It was this approach is going to be coming up in other indications. It’s a technological advancement that is coming for the field, whether we’re ready or not, whether FDA keeps up with regulation or not. But this trial, SERENA-6, wasn’t really intended to answer this question, and it doesn’t answer the question really. And so unfortunately FDA and ODAC was in a weird situation where they have this drug that seems to work and like I said, the PFS was met, but progression in that PFS, progression-free survival, that progression, that P is measured with a different time point. We don’t know what to make of it. And that’s what the ODAC members were saying.
But the tricky part about this trial is that, with the breakthrough therapy designation, AstraZeneca, in theory, should have gotten a lot of hands-on help, assistance, guidance from FDA about their trial and their regulatory process for camizestrant. And the way that this happened is a little bit surprising, I think, to the field because really the issue brought to ODAC was one of trial design. And really that is a question that perhaps shouldn’t be brought to an ODAC for a breakthrough design, breakthrough therapy drug. And I say that just because AstraZeneca and FDA both acknowledged that the company had gotten buy-in and go-ahead from FDA throughout the entire process. And again, it’s a very, very complicated setting. Just to give you context, SERDS, so the class of drugs that camizestrant is part of, there were no approved SERDs at all. This class hadn’t even been really developed at all when this trial had been initiated. The field is moving so, so, so fast that it’s really hard to keep up.
And then also just, I feel like the bigger issue is just that AstraZeneca, again in theory, should have gotten guidance that this trial was not going to work before ODAC. Maybe over the course of the regulatory process, sure, maybe it wouldn’t have been the best. They maybe would have started the trial even without FDA’s guidance, but they did. Supposedly they did have FDA’s buy-in. So it was a very interesting I think especially in the backdrop of an unstable FDA that doesn’t have solid expectations for industry. There’s this larger issue of sponsors and industry not knowing what to expect from FDA. And so it was just a really interesting story to dive into, especially because normally ODACs are very contained. They’re very like, “This is the ODAC, this is the application, this is it.” But this story felt a little bit bigger. And like I said, it had its tendrils everywhere.
Paul Goldberg: It’s really an interesting thing because you’re talking about breakthrough therapy designation, which means that all hands on deck at FDA, here comes a very important drug that we better get through the process really fast because it’s so new. So basically, by the time it got to ODAC, there should have been buy-in.
And also the biomarker, just the idea of reliance on biomarkers and studies like these is what’s at stake here. So did they actually need to get the ODAC to be talking around the regulatory issue or talking around a larger theoretical issue, did they need to have an approval question, thumbs up, thumbs down? And in this case, they decided to combine that. There had to be a rationale for that, but-
Jacquelyn Cobb: Well, I just had to think about, my brain immediately went to MRD, minimal residual disease, because they had an ODAC. I believe that there was a vote, but it wasn’t about an application. It was just a discussion-based situation. And that was so helpful because, like you said, it was this moment in the field where this biomarker-y, blood test-y thing, again, don’t want to conflate too much, but was talked around and there was, I think, space for the members to talk about the importance of the potential for technological advancement and advancement in… Weighing the risk of, “Oh, we might not know exactly how this is going to work, or there might be risks we can’t yet foresee, but this is what we do know about the use of this new approach in the treatment.” And it was of multiple myeloma, right, MRD?
Paul Goldberg: Mm-hmm.
Jacquelyn Cobb: So, all that to say is that… And even one of, I think it was the ODAC chair, Neil Vasan, said that he asked FDA directly at this ODAC meeting for a specific application camizestrant, right? He turned to FDA and he was like, “Hey, are we going to get guidance for ctDNA specifically because this… ” I mean, I loved his quote. I thought it was so strong. Did I include it at the end?
It was just about, basically it was that… Here, let me… I have it, so I want to… Since I have it.
“CTDNA is already shaping clinical trials and practice and we need clear guidance on how to act on molecular progression in metastatic cancer because the field has already begun to move.” I thought that really summed it up for me, because it was like this… And that considering that it felt a little odd to have it be this contained just one drug in this one setting approval. And again, not to say that MRD and multiple myeloma felt narrow, but it felt more appropriate to the conversation actually being had.
Paul Goldberg: Well, what makes it so interesting is that here you have a trial based on a novel endpoint.
Jacquelyn Cobb: A novel time point, I would say probably.
Paul Goldberg: Well, a biomarker. The endpoint. Time point, endpoint it’s…
Jacquelyn Cobb: Well, endpoint would be like PFS, right?
Paul Goldberg: Yeah.
Jacquelyn Cobb: PFS is not changing, but it’s the way of measuring.
Paul Goldberg: The way you’re measuring it, yeah. Well, it’s still measured radiographically versus measured based on a biomarker and the biomarker is not validated. So there you have it, and here’s the data involving the… With the patients in this trial, do you presume that the biomarker is validated. That assumption, does that need to be made? Can it be? And that’s really what ODAC was asked to do, to decide on whether this is approvable based on the fact that we really don’t have validation of the biomarker. It would be interesting to see what the solution is. I actually am wondering whether the drug is really not going to be approved because even though it was a six… Was it six to three?
Jacquelyn Cobb: It was three to six.
Paul Goldberg: That’s what I meant.
Jacquelyn Cobb: Well, but I believe that they were not on board. Most people were not…
Paul Goldberg: Right. So it’s a pretty solid, but sometimes the agency bypasses this sort of thing.
Jacquelyn Cobb: It can.
Paul Goldberg: It can.
Jacquelyn Cobb: It’s a weird spot because you have these two statements on either camp. It’s on one hand, the drug and the trial met its primary endpoint that was… There’s that truth of this… In theory, it should have shown clinical benefit. And then on the other side, you have that simple statement that you said of you’re asking this to approve something based on a biomarker that hasn’t been validated yet, period. Both of those things are just hard. They feel like truths. So I’m interested to see what happens and we’ll definitely be reporting about it.
Paul Goldberg: Absolutely. This is a fascinating time to be a journalist.
Jacquelyn Cobb: As always, as always. Well, thank you, Paul. Thanks for listening to me talk about ODAC for 10 minutes, 15 minutes. I appreciate it.
Paul Goldberg: Thank you, Jacquelyn. Thank you for enduring my talking about Dr. Prasad.
Jacquelyn Cobb: We do it for each other. It’s perfect.
Paul Goldberg: And non-membership on the President’s Cancer Panel.
Jacquelyn Cobb: Love it. Love it. We’ll see you next week. And listeners, I will see you next week too.
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.
