The Cancer Letter

On Dec. 19, the Mikaela Naylon Give Kids a Chance Act was blocked in the Senate by Sen. Bernie Sanders (I-VT) after receiving unanimous approval from the U.S. House of Representatives Dec. 1. On this episode of The Cancer Letter Podcast, Nancy Goodman, founder and executive director of Kids v. Cancer, joins Jacquelyn Cobb, associate editor with The Cancer Letter, and Claire Marie Porter, reporter. Goodman walks Jacquelyn and Claire through the emotional highs and lows that have characterized the legislative story of the bill, which is aimed at accelerating pediatric cancer treatments and expanding access to life-saving therapies for children battling rare diseases. The legislation was named in memory of Mikaela Naylon, a 16-year-old with osteosarcoma who had advocated for the Give Kids a Chance Act and who had spent her last weeks asking Congress to pass it.The bill’s failure in the Senate was a total shock to Goodman and the other pediatric cancer advocates involved.“When the House had their vote, we brought a whole slew of kids who had cancer or who were bereaved siblings or parents and Mikaela's parents and her brother came and we all watched together. And it was just one of the most moving moments you can imagine. People were crying and just it was like this moment where we felt like Congress really cared and Congress was working and Mikaela's family felt like her death was not for nothing. And we came back to my house and celebrated,” Goodman said. “It was just this awesome party, this beautiful moment. We were just so happy. We couldn't believe it. And Senator Mullin's staff was saying they're going to have a vote soon. And we thought, ‘Oh my gosh, this can happen before Christmas. This is going to be our Christmas gift.’ So, we were just ecstatic. We thought it was going to happen.”But Sen. Sanders blocked the small Mikaela Naylon Give Kids a Chance Act in favor of pushing a larger, billion-dollar spending bill, Goodman said. “What he said was he doesn't object to the bill, but he said that he has other priorities,” Goodman explained. “He has this huge set of priorities…And he said, ‘Look, [the 2024 CR] was a bipartisan agreement. There are over a billion dollars worth of bipartisan priorities. Before we give the Republicans any opportunity to cherry-pick what they care about…let's pass the whole package.’"Sen. Sanders’s larger bill was struck down by Sen. Markwayne Mullin (R-OK), leaving the Mikaela Naylon Give Kids a Chance Act without support in the Senate.“I just wonder, Senator Sanders says he cares about kids with cancer,” Goodman said. “And I'm just asking him to show us: How does he care? Where is it?”Stories mentioned in this podcast include: Mikaela Naylon Give Kids a Chance Act nixed by Senate House passes Mikaela Naylon Give Kids a Chance Act—next step, the SenatePediatric cancer research cut from spending legislation at last minuteA transcript of this podcast is available: https://cancerletter.com/podcastc/20260107-goodman/ 

In a year that brought us new KRAS-inhibiting drugs, deepened our understanding of HER2 in breast cancer, and highlighted new potential for mRNA vaccines, the cancer field was also rocked by uncertainty of the future of research funding, equity in cancer delivery, and the integrity of review at FDA. In a lively conversation with The Cancer Letter’s Paul Goldberg, Brawley, who is the Bloomberg Distinguished Professor of Oncology and Epidemiology at Johns Hopkins University and co-editor of the Cancer History Project, started off on a positive note, highlighting several major discoveries made in 2025. “Let me talk about some of the science that excites me. In the last year, we've known for years that KRAS is important. There are a whole bunch of tumors, be it lung cancer, colon cancer, some of the brain tumors, neuroblastoma, where KRAS is an important gene,” Brawley said. “Well, this year we got inhibitors of KRAS G12D, G12V, and G12R. So, all of a sudden we have drugs that truly have the potential of inhibiting KRAS and positively affecting a whole bunch of tumors. And so to me, this is one of the things that really excites me.”Despite these great breakthroughs happening in oncology, cures and treatments are not being delivered equally in the U.S., Brawley said.This numbered among his concerns for the field, which included the loss of Rick Pazdur at FDA as well as talented young investigators choosing alternate career paths. “I think we've lost some of our young good investigators,” Brawley said. “A lot of the training grants are not being funded. I know several young, talented people who are looking to Europe. I know several young, talented people who are looking to Wall Street, go tell investment banking firms where to put their money as opposed to doing the science to develop the new drug or to develop the new understanding of cancer. So we have been harmed.”Many of the established systems that have shaped the field of oncology in the U.S. have faced a shakeup this year. Brawley and Paul agree it is time to talk about rebuilding. “We do need to talk about rebuilding,” Brawley said. “Part of the rebuilding is how do we finance it? Part of the rebuilding is how do we organize it?”Stories mentioned in this podcast include: Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulationsAs cancer scientists, we must change how we engage with the public on the impact of NIH cuts What the scientific method obscures, by George Weiner and Elizabeth JaffeeKay Dickersin: How NBCC started Project LEAD to teach science to breast cancer patients A transcript of this podcast is available: https://cancerletter.com/podcastc/20251231-brawley/ 

A year like 2025 has demanded a lot from all of us, between the Trump administration’s flooding of the zone, the impact of DOGE and MAHA initiatives on the National Cancer Program, and the personal toll of living amidst uncertainty. In many ways, 2025 was a test. Did the field of oncology pass? Did The Cancer Letter? Reflecting on a year of cancer news coverage and our readers’ most-read stories, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, talk about how this year of change has impacted how The Cancer Letter serves the oncology community.“You had to stay calm because that kind of was the whole purpose of the exercise, is for people to not be calm,” Paul said. “And catastrophizing was easy, but I think all of us tried to keep catastrophizing to a personal level.”A legacy publication from 1973, this year has demanded The Cancer Letter step into the new century. Between launching this podcast, a new Cancer Policy section, and “The Directors” monthly series, The Cancer Letter has expanded.“You had been thinking about the idea for ‘The Directors’ for a while,” Jacquelyn said, “but I think that was definitely kind of a kick in the butt to get it going—where we have sort of a leadership vacuum at NCI once Kimryn Rathmell stepped down.”Hearing from the leaders in the field has a stabilizing impact, and many of these podcast episodes appear among the top stories of the year.“Stability. That's what we were bringing to this thing all through the year, because instead of catastrophizing, suddenly you could see once a month, two directors of cancer centers who are really leaders of the National Cancer Program saying, ‘Okay, we're doing this. Okay, here's what I'm worried about. But this is what I'm doing.’ Basically, two leaders of this field practice psychiatry without a license. That's really what it's about.”The field of oncology changed this year. So did we. “In the mess, there is movement,” Paul said. Jacquelyn agreed. “That really shifted my perspective when all of this started.” Stories mentioned in this podcast include: The Cancer Letter’s most-read stories of 2025The Directors, a monthly podcast series featuring two cancer center directors in conversation about what’s keeping them up at night17 and Onward, a series of guest editorials by former NCI Director Kimryn RathmellA transcript of this podcast is available: https://cancerletter.com/podcastc/20251224-year-in-review/ 

As trust in scientific and regulatory institutions frays and the meaning of “gold standard science” is increasingly contested, cancer research faces a credibility test of its own. “Cancer research is apolitical,” Joann Sweasy, director of the Fred & Pamela Buffett Cancer Center, and president of the Association of American Cancer Institutes, said. “Everyone is impacted by cancer. I don't know any family that's not impacted by cancer.”Sweasy said since the Trump administration took over federal health agencies, cancer center directors have had a lot of “strategic discussions.”“We had a lot of open discussion, which was great, but it wasn't reactive discussion,” she said. “We weren't approaching people on the Hill, our delegations, reacting to things. It allowed us time to get our facts together. So, I think it was a very strategic approach. I really do.”Those closest to this work now have an even greater responsibility to make the case for its value to the public that funds it.“We need to be also accountable and responsible for how we communicate the good news and the bad to the American public,” said Robert Winn, director of the VCU Massey Comprehensive Cancer Center, and former AACI president.Winn considers this renewed attention to communicating cancer progress a “silver lining” to the past year of instability. “We recognize that we cannot work in a vacuum as much as we had been in the past, that we do need to be also accountable and responsible for how we communicate the good news and the bad to the American public,” Winn said. “So, there's something good that came out of all that craziness.”NCI-designated cancer center directors have the responsibility of being the “north star” of the oncology community, says Sweasy.“I think we've shown that we're able to pivot when we need to pivot and work together,” she said. “ I think each of us as directors and members of our cancer center have the north star as really doing the best we can for cancer patients, cancer survivors, and their families, and to prevent cancer. So I think they're incredibly valuable. We are the national team.”Sweasy and Winn appeared together on The Directors, a monthly series which focuses on the problems that keep directors of cancer centers up at night.A transcript of this episode is available: https://cancerletter.com/podcastc/20251219_1/ 

Last month, FDA withdrew a proposed rule for standardized asbestos testing in talc-based cosmetics. The proposed rule, introduced in Nov. 2024 and withdrawn Nov. 2025, was mandated by the Modernization of Cosmetics Regulation Act of 2022 or MoCRA.Following an open comment period, FDA decided to withdraw the rule—citing significant public opposition and unintended consequences.“When you read the headline: ‘They're withdrawing a proposed rule that would regulate asbestos,’ it's hard to see how that could have maybe a less malicious... or not malicious, but insidious spin,” Jacquelyn said. “But like you said, it's so, so complicated.” Some experts and lobbyists suggested the withdrawal smacks of industry influence. Indeed, even if unintended—some industries will benefit from the rule reprieve. “I think this [rule withdrawal] is enormously valuable for Johnson & Johnson, even if it lasts only for a few weeks. Because at the very least, it sort of muddies the record and helps them clawback credibility,” Gardiner Harris, author of The New York Times bestselling book “No More Tears: The Dark Secrets of Johnson & Johnson,” said to The Cancer Letter.However, some other experts believe that the proposed rule was fundamentally flawed, and that a withdrawal was necessary in order to completely rewrite it, Claire said. “But, nothing has really changed,” Claire said. “It was just a proposed rule, the rule was not finalized.”An HHS spokesperson said to The Cancer Letter that a new, more “comprehensive” rule is forthcoming. Historically, it’s not unusual for FDA to withdraw a rule in order to rewrite it, and then propose it again.“A lot of insiders—FDA watchers—I'll call them, pointed out that FDA is legally required to issue this rule. They are mandated by the Cosmetics Act [MoCRA]. So I mean, that's the good news, is that the administration has to propose another and hopefully better rule,” Claire said. “I guess the concerning news is that there's no timeline for when that's going to happen. So, in the meantime, it's voluntary, and it's up to us to decide what's safe.”Stories mentioned in this podcast include: John Byrd brings blood cancer expertise to solid tumor, immunology powerhouse at UPMCFDA withdraws proposed rule for asbestos testing in talc-based cosmetics. It’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation.ESMO publishes guidances on AI tools for clinicians, patients, and researchers. Says one author: “We think there should be some degree of human oversight, otherwise, they can go completely rogue and nobody notices.”Harvey Risch, critic of COVID-19 response, tapped by White House to serve as chair of the President’s Cancer PanelA transcript of this podcast is available: https://cancerletter.com/podcastc/20251217-talc/  

Last week’s issue of The Cancer Letter featured great news and terrible news. 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. “These adverse events, reporting systems, they're going to find that terrible things happen to people, but attribution is not possible using that data,” Paul said. “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 scienceIn first NCAB director’s report, Anthony Letai focuses on centralized grant review, budget outlookPazdur 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 ReportA transcript of this podcast is available: https://cancerletter.com/podcastc/20251210-pazdur-letai/  

Edward Chu, director of the Montefiore Einstein Comprehensive Cancer Center, died on Nov. 13 from glioblastoma. He was 66.In the most recent issue of The Cancer Letter, Roy S. Herbst, deputy director at Yale Cancer Center, penned an obituary for Chu chronicling the career and impact of the “baritone of reason.” In this week’s episode of The Cancer Letter Podcast, Herbst sat down with Paul Goldberg, editor of The Cancer Letter, and shared stories about meeting Chu on a sailboat in Rhode Island, exploring Athens, Greece while they were both in town for a meeting, and the eulogies he heard at Chu’s funeral. Herbst has known Chu for almost 45 years.“He was just a real amazing human being, scientist, clinical researcher, but also someone who cared about people,” Herbst said on the podcast. “It hit us all very hard. Many of us have known that Eddie's been fighting this illness for a while,” Herbst added. “He's been very much a part of our lives—a friend and mentor to so many. We're all struck by his passing and sad for his family, friends, and the entire community that lost someone who did so much for cancer patients, for students, and fellows. Just a real tragedy.”Stories mentioned in this podcast include: Montefiore Einstein Director Edward Chu dies of glioblastoma at 66A transcript of this podcast is available: https://cancerletter.com/podcastc/20251203-edward-chu/ 

Recently, a wave of new private insurance mandates have swept the nation making fertility preservation a covered benefit for people with cancer in 21 states plus Washington, DC. Mia Sandino, an osteosarcoma survivor, chose not to undergo fertility preservation when she was diagnosed at 19. She didn’t know if she wanted kids, had no guarantee that her insurance would cover the extraordinary costs, and feared postponing treatment would delay her return to "normal life."This episode is available on Spotify, Apple Podcasts, and YouTube.On this week’s episode of The Cancer Letter Podcast, Sara Willa Ernst, a reporter with The Cancer Letter, spoke with Claire Marie Porter, reporter, on the nuances of insurance coverage for oncofertility around the country, and the barriers that persist, especially for young people with cancer.“This is a certain kind of existentialism that a lot of young people are faced with. Add on top of that, a cancer diagnosis,” Sara said on the podcast. “It’s really an unfair position that a lot of young people are put into, especially when it’s not covered by insurance—it’s not a question of ‘Do I want to freeze my eggs or not?’ It's more of a question of ‘Do I even have the choice to?’”The American Society for Clinical Oncology first created a standard-of-care guideline for fertility preservation for cancer patients in 2006, deeming it a medical necessity. “But the reality is that in the U.S., most people just don't have benefits that cover this, and it's extremely cost prohibitive,” Claire said.As the oncofertility conversation becomes normalized, the coverage gaps for cancer patients become more glaring—augmenting the already existing burden of financial toxicity many patients carry.Other stories mentioned in this podcast include: Oncofertility coverage mandates expand to 21 states and DC as political momentum buildsShane Jacobson talks about his to-do list for ACSMikkael Sekeres: My introduction to, and lessons learned from, Rick PazdurMontefiore Einstein Director Edward Chu dies of glioblastoma at 66Arnold D. Kaluzny, longtime adviser to the NCI and health services researcher, dies at 87Meeting the moment: ASCO GI Cancers Symposium delivers insights and collaborationA transcript of this episode is available: https://cancerletter.com/podcastc/20251126-oncofertility/ 

Last week, Richard Pazdur was named to the position of director of FDA’s Center for Drug Evaluation and Research. Much has been written about how Pazdur, with nearly a three-decade long career at the agency, represents a stabilizing choice for FDA as it faces inner and outer turmoil.Indeed, on this week’s episode of In the Headlines, we bring you the full audio of a conversation originally published in print in last week’s issue of The Cancer Letter between Ellen Sigal, chair and founder of Friends of Cancer Research, and Karen Knudsen, CEO of the Parker Institute for Immunotherapy, about how Pazdur is a great choice for the position—and the agency.“We're not gushers,” Sigal said. “That’s what’s so funny about this. All of us can be quite critical.” “Now we know, the three of us can gush. We've proven ourselves capable,” Knudsen said. An important piece of this conversation that has not been highlighted elsewhere is the role of Pazdur’s late wife, Mary, in his personal and professional success.“She was his rock. She was his conscience, she was able to work with him, understand him, guide him, and for sure tell him when he was wrong,” Sigal said. “That ability to have someone you trust that isn't just admiring you, that is your partner and your best friend and the trust that he had, and Mary would always speak her mind. “I admired that woman so much. She was just a gift from heaven. I don't know how, tears come to my eyes when I think of her right now. She was extraordinary, and I think she helped him, and we need to give her the credit for what Rick became.”In death, Mary Pazdur continued to inform Rick’s work as a patient-oriented regulator.“He knows personal loss. He knows what it means. He's very empathetic to patients and the real-world patient that is struggling every single day,” Sigal said. “Every decision is never going to be exact, and he has to be able to take risks, and he understands those that are important to patients. We can't ever forget in the back of his mind—not only what he went through, but he understands this instinctively—that he's protecting and helping patients.”Stories mentioned in this podcast include: Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER directorRick Pazdur’s CDER appointment comes at exactly the right moment for FDAFDA to remove black box warnings on hormone therapy for menopauseSmoldering multiple myeloma: Rethinking the waiting gameA transcript of this podcast is available: https://cancerletter.com/podcastc/20251119-pazdur/ 

Richard Pazdur, founding director of FDA’s Oncology Center of Excellence and long-time FDA visionary, has accepted the top job at FDA’s Center for Drug Evaluation and Research following George F. Tidmarsh’s dramatic ouster from the position.  “This is big. Because, you know, the whole field of oncology over the past 25 years—and [Pazdur has] run the oncology division and decided which drugs would get on the market, which drugs won't get on the market. Everybody is speaking ‘Pazdurese,’” said Paul Goldberg, editor and publisher of The Cancer Letter. “Even if you don't like Pazdur, you are speaking Pazdurese if you're doing oncology. And he's shaped it. “I don't think anybody has had more impact on this field than he has,” Paul said. “So, now, here he is, and I suspect there's some people who are unhappy, but I think there's, what I'm sensing is a lot of dancing in the streets.”In this episode of The Cancer Letter Podcast, Paul, Jacquelyn Cobb, associate editor of The Cancer Letter, and Claire Marie Porter, reporter, talk about the details of Tidmarsh’s departure and how Pazdur’s leadership may change FDA.Tidmarsh resigned from his position Nov. 2 following a lawsuit by a former associate and a probe into what an HHS spokesperson described as “serious concerns about his personal conduct.” "FDA is important to the industry,” Paul said. “The industry makes money by having a solid FDA, where people are competent, where decisions are made in a way that is at least explainable."Solid FDA leadership is central to the success of the field of oncology.“This is just as important as the fact that you know, the administration's plans to change over NIH and really gut it has been stopped,” Paul said. “This is as important as the fact that Tony [Anthony] Letai is now the NCI director. Stories mentioned in this podcast include: The Directors: Ruben Mesa and Kunle Odunsi on how immigration and diversity accelerate discoveryCDER Director Tidmarsh quits amid inspector general probe of his “personal conduct” Cancer advocates express concern about comments that signal trouble for accelerated approvalHow George Tidmarsh crossed the FDA-industry RubiconHow next generation sequencing is powering the shift to more accessible—and comprehensive—cancer careCity of Hope’s leadership in lung cancer: Precision, innovation, and a vision for cure A transcript of this podcast is available: https://cancerletter.com/podcastc/20251112-tidmarsh/ 

At a time when federal immigration policies are becoming stricter, Kunle Odunsi, director of University of Chicago Medicine Comprehensive Cancer Center, reflected on the fact that cancer research is a highly international community.“I was born in Nigeria, I grew up in Nigeria, I went to medical school in Nigeria, and then I did some of my training in England, in the United Kingdom,” Odunsi said. “My residency in obstetrics and gynecology was at Yale School of Medicine, so it was a very welcoming environment. “In fact, many of us in my class, four out of six, were international graduates, because Yale had the philosophy at the time that we’re just going to take the best from wherever, and that was my experience. I felt just as good as anyone else. It was a great time.”Ruben Mesa, president of Advocate Health Center Cancer Service Line, is the child of Cuban refugees and agreed with Odunsi that international collaboration is vital for a healthy research ecosystem.“I trained at Mayo Clinic, and when I was a resident and fellow, I think about some of the extraordinary individuals, folks like Kunle, again, who came and had trained from other countries, but were just exceptional individuals and really moved forward the science and brought tremendous skills also from their medical training,” Mesa said. As part of its crackdown on immigration under the Trump administration, the U.S. Citizen and Immigration Services announced that as of Sept. 21, H-1B visa petitions will require a $100,000 fee in an attempt to “curb abuses and protect American workers.” “For someone like myself, I don’t think Yale would’ve paid $100,000 to get me an H-1B visa at the time, and I’m sure it’s going to be hard,” Odunsi, who is also the director of the Comprehensive Cancer Research Center, the AbbVie Foundation Distinguished Service Professor of Obstetrics and Gynecology, and dean for oncology at University of Chicago Medicine, said. “But as I said, and as you pointed out, we have to keep our eyes on the target, on our target, and that is cancer.”A transcript of this episode is available: https://cancerletter.com/podcastc/20251107_1/ 

One of the first things that happened as part of President Donald Trump’s “flooding of the zone” in January was the disappearance of the site visit as part of the Cancer Center Support Grant review.In last week’s cover story, Paul Goldberg, editor and publisher of The Cancer Letter, wrote about “the high level of consternation over the disappearance of the site visit from the CCSG review” and how cancer centers are adapting to the new, centralized review process. In this episode of The Cancer Letter Podcast, Paul and Jacquelyn Cobb, associate editor of The Cancer Letter, talk about how the oncology community initially expressed a lot of concern about NIH taking over the Cancer Center Support Grant review.“But at the AACI meeting, which was here in town [Washington, DC] Oct. 19 to 21st, there was some really interesting discussion of this and about what actually is happening.”NIH convened a review group that is “pretty spectacular,” Paul said. “I mean, uber-experienced people, focused, who were able to do the reviews, and some actually are saying, ‘You're going to like this more than you like the previous system,’ which runs counter to our expectations. Because we were catastrophizing, and with good reason. I mean, sometimes, you really have to catastrophize if you're realistic. But in this case, what seems to have happened is the cuts did not materialize, thanks to Republicans in Congress and Democrats, as well. It was bipartisan. Support for NIH is still there.”Stories mentioned in this podcast include: Cancer centers adapt to life without site visits as NIH changes CCSG reviewClass action complaint alleging GRAIL insider fraud resubmitted after dismissalFriends publishes three white papers ahead of annual meeting Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studiesHow GLP-1RA drugs are reshaping patient physiology and the future of oncologyA transcript of this podcast is available: https://cancerletter.com/podcastc/20251105-ccsg/

Early endpoints have the potential to get effective drugs to patients faster, but granting approval to drugs—even accelerated approval—comes with the risk that ineffective or even harmful drugs will be given to patients. “If we don't have these intermediate endpoints to get new drugs to patients, we'd have to wait… I think somebody mentioned in one of the conversations I had while I was reporting on this, that the readout would be upwards of 17 years to get information about these new drugs that are being developed if we rely on PFS, overall survival, the sort of traditional clinical endpoints,” Jacqurelyn Cobb, associate editor of The Cancer Letter, said, “So, that's sort of the general push, to make it so effective drugs, can get it to patients faster. Now, with that, of course, comes a lot of risks. And that's the balance, the conversation. That's why this is something that's so fun to cover.”In this episode of In the Headlines, Jacquelyn and Paul Goldberg, editor and publisher of The Cancer Letter, talk about Friends of Cancer Research's ctMoniTR project, a large-scale effort that aims to improve the efficiency of the development of intermediate endpoints. The ctMoniTR project aims to learn and improve upon previous development of early endpoints, such as minimal residual disease, which is now an accepted early endpoint for the accelerated approval multiple myeloma. Jacquelyn and Paul also talk through Paul’s story about the new director of the National Institute of Environmental Health Sciences, and Jacquelyn’s story about the recent results from GRAIL’s PATHFINDER 2 study, which is intended to support an FDA premarket approval application. Stories mentioned in this podcast include: Friends study points to ctDNA’s potential to serve as an intermediate endpoint in NSCLC ctMoniTR project aims to improve efficiency in development of intermediate endpointsDuke brain cancer researcher Kyle Walsh named director of NIEHSGRAIL to use new study results to seek FDA approval of Galleri MCD testOmar Abdel-Wahab, John Byrd, Lieping Chen, Robert Ferris, Wendy Garrett, Victor Velculescu are among new members of National Academy of MedicineExperts warn that loss of carcinogen surveillance threatens to increase cancer incidenceA transcript of this podcast is available: https://cancerletter.com/podcastc/20251029-ctdna/

“Our goal was very clear from the beginning, which was to develop a user-friendly simple chat-like interface that would provide specific high-quality answers to questions that our members would bring, utilizing only our content,” said Clifford A. Hudis, CEO of the American Society of Clinical Oncology and executive vice chair of the Conquer Cancer Foundation.On this week’s episode of The Cancer Letter Podcast, Hudis spoke with Paul Goldberg, publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, about his guest editorial, “ASCO and Google Cloud set forth a vision for using AI to modernize health care and advance oncology.”Hudis co-wrote the article with Thomas Kurian, CEO of Google Cloud.In the episode, Hudis, Jacquelyn, and Paul talk about the collaboration between the American Society of Clinical Oncology and Google Cloud to develop an AI tool to better access ASCO’s guidelines—and how to do so safely and ethically.“This required tuning the AI tool, in this case, to do essentially two things. And I'm sure I'm oversimplifying it, but number one, it restricted its answering to only our source documents. It couldn't look elsewhere,” said Hudis. “Number two, it was tuned towards facts and away from creativity. And there is a lot of technical background to this, but my understanding therefore is that tunes down the likelihood of it inventing an answer and makes it more reliant on facts. And then number three, and the biggest innovation I think for us at the time, was understanding that clinicians ultimately are absolutely responsible for whatever they do to patients.”Hudis said that ultimately, the problem that was solved wasn’t the one he was anticipating. “We thought we were solving this utilitarian access to the data problem,” he said. “But, I think in the end, the problem we're solving is building trust and support in our community to embrace this new technology, which, as I'm sure we'll talk about, I think is going to be ubiquitous, nearly universal.”Other stories mentioned in this podcast include:Under the lens: Taking a close look at the NIH and FDA declarations on animal-based researchHow animal testing became a MAHA political wedge issue: While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enoughStudy finds no correlation between cancer burden in catchment areas and cancer centers’ CCSG fundingA transcript of this podcast is available: https://cancerletter.com/podcastc/20251022-cliffordhudis/ 

In honor of Hispanic Heritage Month, this week’s episode of The Cancer Letter Podcast features three oncology leaders whose research focuses on identifying and solving health disparities specifically in the Latinx community. Ruben A. Mesa, Amelie Ramirez, and Luis Carvajal Carmona spoke about the concrete impact of federal policy stances on cancer outcomes in Latinx patients.Mesa, who is president of the Advocate Health Cancer National Service Line, president of the Atrium Health Levine Cancer, and executive director of the Atrium Health Wake Forest Baptist Comprehensive Cancer Center, said that his mother recently celebrated her 15th anniversary as a breast cancer survivor. “Just fantastic to be able to celebrate with her,” Mesa said. “And I reflected on why was it that I was able to celebrate with her as a survivor and not be here sad that I had lost my mother to breast cancer many years ago?” Mesa identified two key drivers: advances driven from advances in cancer surgery, radiation, and medical therapies, and the fact that his mother’s cancer was caught early. “Cancer was caught early, [which is] such a crucial piece,” Mesa said. “And at the point in her arc, she was already at that point when she had cancer, she was a U.S. citizen. She had insurance. She was employed. But if she had been lacking those things, maybe her cancer would not have been caught early. She could have had a late-stage presentation that she may not have had the other aspects in terms of health that she might've had otherwise.”These challenges are not new. But changes in federal policy after President Donald Trump’s inauguration are exacerbating the problem. “Immigration status had always been a bit of a concern, but it's a much greater concern when there is a fear of a very aggressive stance in terms of trying to find individuals that are undocumented,” Mesa said. Mesa is also the senior vice president of Advocate Health, vice dean for cancer programs and the Charles L. Spurr MD Professor of Medicine at Wake Forest University School of Medicine. Ramirez is the director of the Institute for Health Promotion Research and chair of the Department of Population Health Sciences at UT Health San Antonio. She is also associate director of cancer outreach and engagement at Mays Cancer Center. Carvajal Carmona is associate vice chancellor and professor in the Department of Biochemistry and Molecular Medicine at University of California, Davis. Other stories mentioned in this podcast include: The Directors: Steven Artandi and Eric Winer on how looming policy changes “reverberate” through oncology “Even when funding gets restored and if the H-1B visa threat doesn’t materialize, it creates an environment where especially young people become uncertain.” ASCO and Google Cloud set forth a vision for using AI to modernize health care and advance oncology KRAS pioneer and Stephenson Prize winner Frank McCormick aims to prevent all KRAS cancers with a pillA transcript of this podcast is available: https://cancerletter.com/podcastc/20251015/Hispanic-Heritage-Month/

With major leadership changes, grant disruptions and terminations, and a stoked distrust in science, Steven Artandi, the director of Stanford Cancer Center, worries that young investigators will feel disenchanted by the U.S. research atmosphere and take their work and study elsewhere. “The uncertainty in the current system is giving some people pause, especially younger people, whether they’re Americans or whether they trained abroad, as to whether the United States is the right place to spend their careers,” said Artandi, who is also the Laurie Kraus Lacob Director of the Stanford Cancer Institute and the Jerome and Daisy Low Gilbert Professor of Medicine and Biochemistry at Stanford University. “So, I am up at night worrying about the future of American leadership in cancer science and in science more broadly.”“And these changes reverberate,” said Eric Winer, director of Yale Cancer Center. “The fact that there’s this threat to scientists from around the world to be able to come to the U.S. is a real turnoff for a lot of people.” There is an existential threat that the U.S. might not be the best place to do cancer research right now, said Winer, who is also president and physician-in-chief of Smilow Cancer Hospital, Yale New Haven Health System.“This is the time where I think all of us in the field want to step hard on the research accelerator, we don’t want to back off,” Winer said. However, Winer pointed out that he will not be the one making scientific discoveries in 10-20 years. It’s the future generations, the very ones who are feeling uncertain about entering into an unstable NIH, that worry him.“And if we lose a generation, or even half a generation of people, it’s a huge problem for cancer medicine and cancer science,” Winer said.Winer and Artandi appeared together on The Directors, a monthly series which focuses on the problems that keep directors of cancer centers up at night. Otis Brawley, the Bloomberg Distinguished Professor of Oncology and Epidemiology at the Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, appeared as a discussant on this episode.A transcript of this episode is available: https://cancerletter.com/podcastc/20251010_1/ 

“Patient stories, as you know, can either make or break a story,” said Laurie McGinley, a former health and science editor at The Washington Post who is now on the board of Patient Action for Cancer Research, or PACR, a new advocacy organization aimed at organizing and amplifying patient voices in an effort to protect life-saving federal health research.In last week’s issue, The Cancer Letter reporter Sara Willa Ernst wrote about how PACR is building a repository of patient stories to better connect policymakers to the people most affected by their decisions. On this week’s episode of The Cancer Letter Podcast, Sara spoke with Jacquelyn Cobb, associate editor of The Cancer Letter, and McGinley.In the episode, affectionately dubbed “the Ladies’ Podcast,” Sara, Jacquelyn, and McGinley talk about Sara’s process of reporting and writing the story, the role of a group like PACR in the current political climate, and how McGinley—who was part of a team at The Wall Street Journal that was awarded the Pulitzer Prize for reporting on AIDS—decided to join the board of PACR. “From a professional standpoint, and I guess this takes us into the wider discussion, it's just so obvious that it's important to have patients and patients stories at the center of this debate, this very difficult debate that's going on now about funding research of all different kinds, especially cancer research,” McGinley said. “And this is not news to anyone in journalism or anyone in the cancer community. We're not trying to preach to the choir, and people already know this, but we're just trying to make it somewhat easier and to augment efforts to do this.”Other stories mentioned in this podcast include: Former NCI official's nonprofit seeks to tell the stories of cancer patients Anthony Letai sworn in as 18th NCI directorU.S. government shuts down Impact on NCI uncertain as administration threatens more RIFsSexual and gender minoritized cancer patients deserve better Seeding NCORPs with academically-focused oncologists can advance the national research agenda A transcript of this podcast is available: https://cancerletter.com/podcastc/20251008-LaurieMcGinley/ 

With little fan fare, Anthony Letai, a highly respected physician-scientist, was sworn in as the 18th director of the National Cancer Institute on Sept. 29. Then, two days later, on Oct. 1, the government shut down.The news of Letai’s apparent appointment was broken last week in the media, with no word from the White House. Although HHS has published a press release announcing Letai’s appointment, the White House is still silent on the matter. Meanwhile, Trump’s FDA initiated an unusual regulatory pathway for leucovorin—asking the drug sponsor to reinstate a 25-year-old drug application—in order to begin the process of approving the drug for autism.This week on The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, discuss the oncology community’s enthusiastic support for Letai’s appointment, the government shut down, and the strange regulatory future of leucovorin.“Here's the issue,” Paul said. “Leucovorin is a branded drug up through about 1997. By 1997, the company asks to just let it go to the generics. ‘The heck with this thing.’ Then, by 1999—GSK is the sponsor—GSK just withdraws from the whole thing, which makes perfect sense. That's what pioneer companies do, because who wants to be updating the label on something you're not selling? Who wants to be responsible for that? So, that's just typical behavior. “So, a quarter of a century ago. Now, fast forward to now and 26 years later, really, and there's this sort of a political push, not necessarily scientific, but maybe a little so, to get this thing approved for autism, for a form of autism. So, the only reason to get that approval is so you can start promoting it.“So, really, probably for the first time in the history of FDA and therefore likely for the first time in human history, the company was allowed, or in this case, really probably prevailed upon, to renew, revive, its NDA, and then seek a supplemental NDA for this indication.”Stories mentioned in this podcast include: Anthony G. Letai to be named NCI director. The Dana-Farber and Harvard physician-scientist is an inspired choice, colleagues say Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism. Experts call the move “extremely premature”Population-based cancer surveillance is a national treasure at risk, by Eric B. Durbin, Karen L. Knight, Betsy Kohler, and Sarah NashCi4CC’s 24th Symposium & Workshop set to focus on precision oncology powered by data intelligence, by Stephen D. NimerEarlier diagnosis, better outcomes: Telemedicine has found a home in oncology, by Hardeep Phull Championing nurse wellbeing as a strategic priority, by Kim Slusser A transcript of this podcast is available: https://cancerletter.com/podcastc/20251001-nci-director/ 

With the fiscal year drawing to a close, grant funding from NCI is picking up speed, offering a glimmer of hope to cancer researchers who are beginning to feel cautiously optimistic about the road ahead.Following firm bipartisan pushback against the White House’s proposed budget cuts for FY2026, both the House and Senate have reaffirmed their support for biomedical research. At last week’s annual symposium marking the 50th anniversary of UNC Lineberger Comprehensive Cancer Center first securing its designation, former NCI directors Ned Sharpless and Kim Rathmell expressed optimism about the future of cancer research. In the podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Claire Marie Porter, reporter, reflected on the former directors’ sentiments. “It's very interesting to hear this and very reassuring, but also not really that surprising, because Congress, both the House and Senate, are poised to either give NIH a small increase or maybe keep things at flat funding, so that's not the 40% cut that the administration wanted,” Paul said. The Republican party is to thank for saving NIH’s budget, said Paul.“I think we've felt a great sense of urgency, at the same time a lack of agency, since the upheaval began at NIH,” Claire said.“Its not easy, things aren’t great,” Paul said. “What stays, what goes, it’s not really clear. If you were to look at the damage report, there is damage. But it’s not fatal, it’s a bunch of little flesh wounds.” And at the moment, the money is flowing, Paul said. Stories mentioned in this podcast include:NCI is “really, really sturdy” and won’t break, former directors Ned Sharpless and Kim Rathmell say at UNC Lineberger symposiumAACR Cancer Progress Report makes the case for federal investment in cancer researchPaul Thurman: Urgently needed: A funding mechanism to insulate cancer research from political whimsGeorge Weiner: How today’s uncertainty can motivate young investigators to double down on their passionOusted CDC director testifies before Senate HELP Committee CDC’s ACIP makes changes to childhood vaccine recommendations in first meeting since Monarez’s ousterFDA cracks down on direct-to-consumer ads, including the Hims & Hers Superbowl blitz A transcript of this episode is available: https://cancerletter.com/podcastc/20250924-nci/ 

Readers of The Cancer Letter and listeners of The Cancer Letter Podcast are familiar with the impact of President Donald Trump’s first nine months in office on the field of oncology. Now, the threats posed to oncology are being brought to the attention of a general audience—Jonathan Mahler, staff writer for The New York Times Magazine, wrote an in-depth article about how the Trump administration’s actions have brought chaos, uncertainty, and damage to the oncology research community.In this episode of In the Headlines, Mahler spoke with Paul Goldberg, publisher and editor of The Cancer Letter, and Jacquelyn Cobb, associate editor, about becoming immersed in the history of oncology research (going all the way back to Mary Lasker and the National Cancer Act), and the personal and professional impact of the seemingly-beaurocratic policy changes coming down from the White House.Mahler’s article introduces a lay audience to the intricacies of the oncology research enterprise, and how this complex network of actors—including federal agencies, academic and community cancer centers, patient advocacy groups, and professional societies—was necessary to produce the drastic improvements in survival and quality of life outcomes of the last 50 years. Mahler has no qualms describing Trump’s actions as a deliberate attack on biomedical research. “The NIH and NCI, as you guys know better than anyone, are designed to be apolitical institutions,” Mahler said. “They are designed to be insulated from political attack. So, in order to undermine them, to really have to do this kind of damage to their agenda, takes some work and takes some forethought. And I think you see that when you start to look at how all of this unfolded beginning just days after the inauguration, that it was a deliberate strategy. And so, you kind of have to see it that way, and people who are working there certainly saw it that way.”Stories mentioned in this podcast include: The Directors: Ben Ho Park and Suresh Ramalingam discuss tough times, uncertainty, and resilience “If you’re going to be an oncologist, we look at the glass 5% full, not 95% empty.” Reflections of a cancer scientist Maintaining the pace of novel technologies will lead to more efficient and less toxic medicinesNobel laureate David Baltimore dies at 87 Baltimore discovered that genetic material of tumor viruses could make DNA from their RNA genome Harvey Golomb, past chair of UChicago's Department of Medicine, dies at 82Bonnie Addario, lung cancer survivor and advocate, dies at 77 NCAB approves five reissue conceptsAfter stormy Senate hearing, Trump offers tepid support for RFK Jr. while Kennedy family members call for his ouster Vinay Prasad regains role as FDA chief medical and scientific officer A transcript of this podcast is available: https://cancerletter.com/podcastc/20250917-Jonathan-Mahler/