Last week’s issue of The Cancer Letter featured great news and terrible news.
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On the one hand, Anthony G. Letai, the new director of the National Cancer Institute who has been regarded as a great choice for the position by oncology leaders, has stepped into the public sphere and has been spreading a message of stability and continuity.
On the other hand, Richard Pazdur retired from his position as director of FDA’s Center for Drugs Evaluation and Research after a nearly three-decade career shaping the regulatory landscape of oncology.
Pazdur retired from the agency after Vinay Prasad, director of FDA’s Center for Biologics Evaluation and Research, initiated a new vaccine policy framework, which Prasad described in a memo that announced that FDA had found itself culpable in the deaths of at least 10 children who had received the COVID-19 vaccine.
“He couldn’t stop what really needed to be stopped, which was this effort, this reexamination of deaths from the adverse events reporting system that Prasad ran and other anti-vaxxers that purportedly found,” Paul said. “And by the way, there’s no data. This is all evidence-free, that a bunch of kids died of COVID shots. So, we killed a bunch of children, which is… And FDA, of course, issued this mea culpa finding, and they want to rechange everything and change the way vaccines are approved. And now this is based on no data, based on no outside advisory committees, none of that.”
Pazdur could not support this move by Prasad.
Said Paul:
These adverse events, reporting systems, they’re going to find that terrible things happen to people, but attribution is not possible using that data. So, give it to somebody whose basically goal is to show that vaccinations do more harm than good and give them power to bypass normal scientific inquiry that would withstand… It’s about the soul of American medicine.
And in fact, a group of former FDA commissioners, the people who have run FDA over the course of 35 years wrote an editorial to The New England Journal of Medicine saying, “This is really dangerous. That path the FDA is taking.
And so, basically Pazdur was led up to the point where he had to either sign off on this or slam the door, leave and slam the door. So, he had to leave and slam the door because you do not want to be a part of essentially the destruction of the American medical system.
Stories mentioned in this podcast include:
- Anthony Letai pledges to ensure stability for extramural and intramural cancer science
- In first NCAB director’s report, Anthony Letai focuses on centralized grant review, budget outlook
- Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”
- Mail-out colorectal cancer screening programs extend, rather than replace, clinical care
- Pediatric cancer five-year survival rate has increased dramatically, AACR says in inaugural Pediatric Cancer Progress Report
This episode was transcribed using AI 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: He was refreshing to hear somebody who is on the same wavelength as his advisors.
Jacquelyn Cobb: Absolutely. Absolutely. Love it. Should we switch over to Pazdur?
Paul Goldberg: Yeah, speaking of people who are not on the same wavelength with colleagues.
Jacquelyn Cobb: Yeah, let’s go to the other side of the spectrum.
Paul Goldberg: Yeah, it’s really interesting because you have really great news on one end and really horrific news on the other.
Jacquelyn Cobb: So sad, so sad.
Paul Goldberg: Yeah.
Jacquelyn Cobb: Hello, Paul. How’s it going?
Paul Goldberg: Hi, Jacquelyn. Another week.
Jacquelyn Cobb: Another week. It’s been a while since just you and I have been on the podcast, I feel. It’s been a couple weeks at least; right?
Paul Goldberg: Yeah, I missed it terribly.
Jacquelyn Cobb: I know. Missed it terribly. We have a lot to talk about this week, so I’m going to take us right through the headlines because there’s, yeah, a lot of meat in last week’s issue. I made this joke because I was writing up my intro. I said, I think last week’s issue was the Anthony Letai issue. We had two pretty huge stories about him. But of course, this day and age, there’s a lot more to the issue as well. So, our cover story was an exclusive interview with Dr. Letai and Paul, that’s really what we’re going to be talking about today. And we’ll get into the nitty-gritty and the details. And Letai also addressed the National Cancer Advisory Board for the first time on Dec. 3.
So, we had a story about that. We covered his remarks and also the questions NCAB had for him as well, which I think were really informative just considering the time that we are in. We also had major news that somehow was not the cover story in any other normal world, this would be the cover story. But Richard Pazdur, after his 25 plus year long career at FDA, announced his retirement from the agency. The retirement followed a 3-week stint. Is that right, Paul? Three weeks? Three or four?
Paul Goldberg: Something like that.
Jacquelyn Cobb: Yeah, I think three weeks in…
Paul Goldberg: About three. Around two full weeks worth of…
Jacquelyn Cobb: Got it. Worth of being the director of the Center for Drug Evaluation and Research at the agency, which I think we can probably also touch on later in the podcast.
Paul Goldberg: Oh my God. Yes, we should.
Jacquelyn Cobb: Probably.
Paul Goldberg: It’s probably the most important news.
Jacquelyn Cobb: I know.
Paul Goldberg: It’s as important as Letai.
Jacquelyn Cobb: Absolutely. And then just to round off that part of it is we had a guest editorial from Exact Sciences, Paul Limburg, about mail out colorectal cancer screening, plus a pretty exhaustive cancer policy section last week, including findings from ACR’s inaugural pediatric cancer progress report and some other things that are definitely worth checking out. Okay. So, Paul, let’s start with Letai, just start with, I guess, the good news. Can you take me through what your conversation was like, what his attitude means for the field?
Paul Goldberg: Yeah, yeah. It was interesting because it was actually my first real conversation with him. I didn’t know him amazingly until now. He’s really serious about sending out the message that things are going to be stable. And that is not the message the cancer world has been getting for a very, very long time.
Jacquelyn Cobb: Just about nine months.
Paul Goldberg: So, stability, stability, stability. He is not going to be really very different from three of his predecessors. One of them was a Republican appointee at Sharpless. Then of course, Monica Bertagnolli is a Biden appointee and as was Kim Rathmel. I mean, but these are really top-notch heavy duty cancer people and he is one of them and he’s not going to do it differently. I mean, he understands the structures, he understands the cancer centers. I don’t know how he’s going to get it done, but he’s going to stabilize this thing. And it’s not that unstable actually when you think about it.
But one of the things that’s a work in progress for him is, and I’m saying this as a consumer of information, is to explain how the new method for funding grants is going to work. I don’t know. I don’t understand it yet. How it will work is probably different from how it was designed that things always are, but I don’t even understand how it was designed or why. But it’s not accusatory. I just don’t understand it. It’s just being honest. I don’t get it.
Jacquelyn Cobb: I mean, to speak frankly, and I think that this change in policy, it’s centralizing the peer review for the grant review process, right? So, it’s going out to NIH. And also basically we’re done with pay lines. There’s still going to be a score and it’s…
Paul Goldberg: That’s the part. That’s the part. Yeah.
Jacquelyn Cobb: Yeah, yeah. And that is, I think, really weird even just for me. I mean, I feel more secure in my understanding of the field now, but still, I mean, I’ve only been here for three years, but still I think that pay lines are… We write about them every single year. They always are really important to our readers. And so, it feels a little destabilizing to just not have them. And I think when we were covering it before Dr. Letai was announced, and we have Trump and Kennedy and Makary and Prasad, all of these actors who don’t necessarily seem to have the oncology’s world best interest in mind, or at least in our view.
And I think that’s what’s nice is that the opening of the gray space is I think actually what he said, right? He said there’s going to be more gray area, which I guess from my understanding, there was already a gray area, right? It’s not just going to be a pay line, but I think that the concern for us was when we have these people in power that we don’t necessarily have the same trust in, that we do with Dr. Letai, right? He has all of these credentials, he’s trusted by the community, and now he’s the top decision maker in this process where there’s more gray area and more trust is required. So, I think that the change…
Paul Goldberg: More trust is required. Right.
Jacquelyn Cobb: Yeah, the change is a little unsettling. We don’t love the idea of moving away from four percentile pay line, period. And we just know that it’s scientific rigor, that’s it. And when Trump says it’s more aligned with institute priorities. That’s a little scary, I think, as information consumers, as you’re saying, Paul. But thankfully now we have Letai in charge and he seems to be very trustworthy. And so, hopefully I think what he’s trying to say is that these things are different or these processes are changing, but hopefully in actuality, not a lot will change. And I think that’s what I’m hoping for as a naive optimist.
Paul Goldberg: Well, as a naive optimist, it looks like the cancer centers are doing pretty well with CCSG review process acting working out pretty well. And he’s talking about making things simpler for redesignation, renewing designations of cancer centers that is Letai is… I’m eager to find out what he thinks about the new criteria for designation. He said that he’s got more to say later, which is great. We’ll be there. Yeah, it’s also interesting to see what he said about helping NCI make its case.
Jacquelyn Cobb: Yeah. That was definitely in the NCAB Q and A session. And I would say that that might’ve been the tensest moment. It was not very tense and that’s so refreshing to have just a nice meeting to cover, no tension, whatever. But the most maybe high stakes moment was, I think, a conversation about this push that Letai is going for, and it’s an awesome idea. Well, do you want to explain exactly what it is?
Paul Goldberg: Yeah. Well, he’s talking about showing to the American public that their money has been spent really well-
Jacquelyn Cobb: Exactly.
Paul Goldberg: … which is drugs came about that are direct outcomes of the NCI funded grants. So, it’s not a drug that’s brought to you by AstraZeneca or Pfizer or whoever. It’s a drug that was brought to you by the American taxpayers and then-
Jacquelyn Cobb: Developed.
Paul Goldberg: … turned, developed by a pharma company. So, that’s been the case and it should continue to be the case. And that’s what he’s trying to show. Well, the part that’s controversial is that right before… Well, somewhat before he came in, right after the administration came in, they got rid of the NCI communications team entirely almost. So, they didn’t just transfer it over to NIH. No, no, no, no, no. They riffed it. And Dr. Letai basically is saying here is that he wants to rebuild this capacity and power to him if he wants to do it.
Jacquelyn Cobb: Yeah. I mean, and I could be misunderstanding this. We can fact check me, but my understanding was, and again, that was exactly what that exchange was at the NCAB meeting, was one of the NCAB members brought up this concern of this is a great idea. Having these vignettes of patients who’ve been helped by NCI, excuse me, taxpayer money, all of these things, such a good idea because it is true. Nobody outside of the world, not nobody, but not many people outside of the world of oncology understand the role of NCI in actually progressing cancer treatment. I think that is definitely a room for growth in the communications.
But my understanding was that I think Dr. Letai was saying that they currently have the capacity to do that even with the smaller communications budget. I could be wrong about that. Do you remember, Paul?
Paul Goldberg: I don’t know. No, that is exactly what the discussion was, but I don’t know what’s the best communication strategy would be, and that’s not what people pay us, is to determine what’s the best communications strategy. I’ve seen NCI spend money well on communications, and I’ve seen it absolutely do horrific things, but I suspect he’s going to come up with something good. I don’t know about you, but I miss PDQ, which was most of the NCI communications that I hope they restarted. The money is really coming because it’s just levels of evidence is something that’s more important than what they call gold standard science these days, whatever that is. But you know what? I mean, that’s just all the semantics stuff.
Who cares? What we care about is that they do good policy and that NCI does make its case for what it does.
Jacquelyn Cobb: Yeah. Well, that’s what I was saying. It was like a positive thing, considering all the turmoil, Letai is really giving out, like you said, this confident statement that things are fine, things will be fine, period.
Paul Goldberg: And they aren’t not fine yet. They may remain fine. Some parts of medicine things aren’t fine. Some parts of NCI things aren’t fine, but mostly the rumors of the demise of the national cancer programs have been overstated greatly. So, we were going back and forth on this Mark Twain quote in our conversation, which was a lot of fun, but it shows you that he’s got a sense of humor about the whole thing and his planning is in the right place, presumably as his heart is in the right place. So, it was refreshing to hear somebody who is on the same wavelength as his advisors.
Jacquelyn Cobb: Absolutely. Absolutely. Love it. Should we switch over to Pazdur?
Paul Goldberg: Yeah, speaking of people who are not on the same wavelength with colleagues.
Jacquelyn Cobb: Yeah, let’s go to the other side of the spectrum.
Paul Goldberg: Yeah. It’s really interesting because you have really great news on one end and really horrific news on the other.
Jacquelyn Cobb: So sad, so sad.
Paul Goldberg: Yeah. Let’s first talk about what Pazdur stands for.
Jacquelyn Cobb: Yeah, please go ahead. You wrote that story. That story was incredible. Please, please share.
Paul Goldberg: Oh, thanks. Well, what Pazdur stands for is regulatory science that’s rigorous. People talked about it as being the need for rigorous regulatory science before it could be done. And he has demonstrated it could be done and made it happen. So, he deserves medals for this. In fact, we’re going to have one made.
Jacquelyn Cobb: Are we? This is news. I would love to do that. He’d probably be like, “What is this?” We should do it though. I’m in for that.
Paul Goldberg: Oh, yeah. Let’s design the….
Jacquelyn Cobb: The Cancer Letter honors you.
Paul Goldberg: Yes, The Cancer Letter medal of honor or whatever you could call.
Jacquelyn Cobb: We can make it a thing.
Paul Goldberg: But really, he deserves it, whatever it is, even the jest. So, he received a battlefield promotion when George Tidmarsh got canned, deservedly so, to become director of Center for Drugs Evaluation Research, which is arguably one of the hardest jobs in the U.S. government, by the way. And Pazdur was up to it, and to some extent, Pazdur had a good reason to do it, which is in part to protect oncology, the things he built in oncology. But did that guarantee that these guys won’t come for that? No. And he basically couldn’t stay. He wasn’t up for it.
And also, he couldn’t stop what really needed to be stopped, which was this effort, this reexamination of deaths from the adverse events reporting system that Prasad ran and other anti-vaxxers that purportedly found… And by the way, there’s no data. This is all evidence free that a bunch of kids died of COVID shots. So, we killed a bunch of children, which is… And FDA, of course, issued this mea culpa finding, and they want to rechange everything and change the way vaccines are approved. And now this is based on no data, based on no outside advisory committees, none of that.
Plus, there’s this voucher program that the FDA commissioner has put together, and that voucher program is a parallel drug approval system. So, how do you get drugs approved? Now, what Pazdur has always stood for is bring a bunch of academics, have them sit down without preconceived notions and kick this thing around in a public fashion because he thinks rigorously. When you have somebody who thinks rigorously, they will be able to withstand a bunch of academics hashing things out in the public forum. And if you don’t know what you’re doing or if you have a secret agenda, you’re going to be finding all manner of stuff.
Now, what this means is that… Think about it, these adverse events, reporting systems, they’re going to find that terrible things happen to people, but attribution is not possible using that data. So, give it to somebody whose basically goal is to show that vaccinations do more harm than good and give them power to bypass normal scientific inquiry that would withstand… It’s about the soul of American medicine. And in fact, a group of former FDA commissioners, the people who have run FDA over the course of 35 years wrote an editorial to the New England Journal saying, “This is really dangerous. That path of FDA is taking.”
And so, basically Pazdur was led up to the point where he had to either sign off on this or slam the door, leave and slam the door. So, he had to leave and slam the door because you do not want to be a part of essentially destruction of the American medical system. So, what does that mean? I don’t know. What it means for oncology almost certainly is that anybody who hasn’t tried leaving yet should really, is probably trying right now to get the heck out of there because they’re coming for you. That’s really what it is. And it’s also, there’s no mystery about what Vinay Prasad wants to do next because we’ve just seen it with vaccines.
So, he’s going to show using FDA’s own data, and some of this was hinted at by Tidmarsh before his ouster, that they will use FDA’s own data to show that there’s no overall survival based on accelerated approvals based on surrogate endpoints. So, they’re not used as surrogate endpoints. It’s basically looking at Pazdur’s whole worldview around which he built the whole system, engineered it, and gained trust from academic oncology. And you take somebody who is essentially a Gadfly, Vinay Prasad, who has made a career of Pazdur bashing and bashing of accelerated approval and put him in charge. So, they’re coming from oncology and what will that mean? God only knows.
Will the White House step in and this? God only knows. It was really interesting that Bio actually issued a very strong statement saying, “Hey, this is time to write the ship.” Because if you’re developing drugs, you want there to be predictability of the system. I mean, there is a way to get a drug approved, possibly. I don’t know how you get a drug on the commissioner’s voucher program list, what it takes. I have no idea. I don’t think it’s transparent. With Pazdur things, we’re always transparent. I mean, you could like him, you could hate him. I’ve heard people say, “He killed a bunch of my drugs, but hey, I don’t want him to see him go, because you know why he killed your drugs.
Jacquelyn Cobb: Yeah, exactly.
Paul Goldberg: And this is not going to be a system where you will know anything or that could be run by anybody because that whole layer of people who could run FDA after or oncology division after Pazdur leaves doesn’t exist anymore. They’ve already left. They got really nice offers, I hope, I hope. And left. So, you have a bunch of younger people who are probably very good too, but need a little bit of time, but so it’s a nightmare scenario and it’s taking place. They’re under attack and there’s no way they can withstand the attack.
Jacquelyn Cobb: Yeah. It’s terrifying.
Paul Goldberg: It is terrifying. And people who are terrified, the only good news on this, I’m going to be on brand as an optimist. It’s my new brand. I’m an optimist.
Jacquelyn Cobb: Oh, love that.
Paul Goldberg: Yeah. Yeah, right. Is that pharma and biotech and not maybe the associations, but mostly companies themselves are going to let the White House really make the White House understand what slaughter is taking place. One of the things that came through in this whole debacle is that Marty Makary has more juice politically at the White House than RFK Jr. Because RFK Jr. is the guy who talked Pazdur into taking this job at Cedar. And as Pazdur was leaving, that’s the triumph of Makary and Prasad. Makary believes that Prasad is one of the greatest geniuses of our time. It’s the greatest something. I don’t know if a genius is quite right.
Jacquelyn Cobb: Yeah. Well…
Paul Goldberg: Let’s fill in the blank.
Jacquelyn Cobb: Yeah, I know I can’t let myself fill in the blank here.
Paul Goldberg: Yeah. That’s probably a good move.
Jacquelyn Cobb: Probably for the best. Yeah.
Paul Goldberg: No. I mean, we’ve covered him over and over and over. This is a person who is on record basically opposing next gen sequencing in cancer and basically opposing immuno-oncology, driving out the person, and I’m talking about Prasad, who has made it possible for whole new generations of drugs, precision oncology, drugs, and other drugs such as immuno-oncology to become available.
Jacquelyn Cobb: You’re talking about Pazdur, right?
Paul Goldberg: Yeah.
Jacquelyn Cobb: Yeah, yeah. You said Prasad, so I just want to make sure that…
Paul Goldberg: No, Prasad is the guy who’s opposed to the entire Pazdur point of view and all the technology that it’s based on. So, if I misspoke or was how you say speaking in oblong steroidal…
Jacquelyn Cobb: I don’t know that. What is that?
Paul Goldberg: If I were him.
Jacquelyn Cobb: That’s perfect. Thank you for the definition.
Paul Goldberg: Anytime.
Jacquelyn Cobb: Thank you.
Paul Goldberg: Yeah.
Jacquelyn Cobb: Yeah. I mean, I think there’s a lot of uncertainty to come. We’re going to have to see how this all plays out, but we will be here to cover it.
Paul Goldberg: It’s a great time to be a journalist.
Jacquelyn Cobb: Oh my gosh. Wow. When’s the last time we pulled that out? Love it.
Paul Goldberg: A couple weeks ago.
Jacquelyn Cobb: Love it. Awesome. Well, thank you so much, Paul. I will talk to you next week.
Paul Goldberg: Next week, we’ll all be there here.
Jacquelyn Cobb: 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.
