The Cancer Letter

In this week’s episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Sara Willa Ernst, reporter, break down HHS’ latest vision for the future: Operation Trailblazer. The report is titled: “HHS Roadmap to Maintaining U.S. Leadership in Early Clinical Research and Development.”“The U.S. is apparently losing its leadership in INDs and early phase research,” Paul said. “Some of it is true and also it does not help that the whole enterprise of cancer research right now is in, if not disarray, then at least a kind of mental and spiritual discombobulation.”Most notable were proposed changes to FDA, including an expedited Investigational New Drug program, which would use expertise outside FDA to help prepare INDs before submission, and a lower threshold—just one high-quality late-stage—for confirmatory evidence, which is already common practice in oncology. Paul checked in with sources about the report after it was released. What he heard with his ear to the ground: It’s unclear whether the plans in the report will amount to policy. “We don't know whether it's going to happen and there is a problem right now in that FDA really took a hit in terms of staffing,” Paul said. “At the moment, there is no permanent FDA commissioner. Having leadership that's deeply destabilizing was really a problem.”“FDA really right now needs to get its house in order or as the industry says, ‘right the ship,’” he continued. “A rudderless FDA for a while there was a step in the wrong direction. So, they're going to have to clean this up and maybe they will. Let's hope they do.“That's what I'm hearing from folks as I call them. But it was important to get [the news] out on paper even though the story certainly has a large number of caveats.”Stories mentioned in this podcast include:The Directors: Directors of two Midwestern cancer centers tell us about the challenging healthcare economics in rural areasTo keep the early clinical trial enterprise in the U.S., HHS pledges to simplify regulatory requirementsJoe Fraumeni, founder of molecular epidemiology, dies at 93Karen Huntsman’s vision gave shape to the Huntsman Cancer InstituteRobert Mayer tells us about pancreatic cancer’s hopeless past as new data shows promiseA transcript of this podcast is available: https://cancerletter.com/podcastc/20260701-operation-trailblazer/

“Institutions are feeling crunched at so many different directions”How’s this for a paradox:The better cancer centers become at keeping patients alive, the more expensive cancer care becomes.This brutal tradeoff hits harder in rural areas, where the cancer burden is higher and the investigator and clinical trial representation is lower. The federal budget introduced last summer dealt Medicaid a mighty blow, which is expected to cause a spike in the number of uninsured Americans over the next decade (The Cancer Letter, July 3, 2025). In the June episode of The Directors, two Midwestern cancer center directors, University of Iowa Holden Comprehensive Cancer Center Director Mark Burkard, and University of Minnesota Masonic Cancer Center Director Jeffrey Miller, discussed the financial and logistical challenges confronting cancer care outside major metropolitan hubs. “We had a Medicaid expansion in Iowa, and that supported what's called the directed payment program (Medicaid State Directed Payments) and that's being phased out over 10 years,” Burkard said. “I think it's going to affect rural hospitals and hospitals in underserved areas even more. And some money was put back into the rural transformation funds of which our state got $209 million. But we're looking at, basically, over the next 10 years, it's a billion-dollar cut from our health system. So, we're trying to figure out how to tighten our belts to make up for that difference as a health system.”Driven by the One Big Beautiful Bill Act and subsequent CMS regulations, these changes cap supplemental payments and are expected to significantly reduce federal Medicaid spending over the next decade.The effect of the financial tightening is systemic. Even the paths taken by junior faculty members are affected.“It used to be that you could creatively dabble as a junior faculty, and then figure out how to develop your career,” Miller said. “But now, they want you to do it in pretty much three years. You get three years of unrestricted time, and then you’ve got to go out into the world and say, ‘How am I going to support my salary?’"

In this week's episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher, and Sara Willa Ernst, reporter, go on a trip into the world of federal health policy surrounding psychedelic medicine. In April, FDA issued National Priority Vouchers to three companies conducting clinical trials of psilocybin for treatment-resistant depression and major depressive disorder, and methylone for PTSD, as well as an IND to study ibogaine for treatment of alcohol use disorder. This came after the president issued an executive order vowing to accelerate drug approvals of psychedelic drugs. “One thing that they seem to want to do is reverse Nixon's War on Drugs, which stopped all of the psychedelic drugs research in its tracks in the '70s,” Paul said. Some oncologists are not opposed to this reversal, particularly as clinical trials evaluating psilocybin as a treatment for cancer-related anxiety, depression, demoralization, fear of recurrence, and other psychological conditions have been ongoing since 2008. But the story behind the policy change is cause for concern. At a press conference in the Oval Office, President Donald Trump sat next to Joe Rogan, comedian and host of “The Joe Rogan Experience" podcast. Just two and half weeks before, Rogan published a two-hour long interview on ibogaine. Rogan texted Trump about the psychadelic’s promise as a treatment for drug addiction, brain trauma, and cognitive decline. “The text message came back: ‘Sounds great, do you want FDA approval?’ It was literally that quick,” Rogan said at a subsequent press conference with Trump in the Oval Office. “This is a very unscientific way to roll back the scientific kibosh,” Paul said. The policy change didn’t appear to come from scientific consensus by an expert panel brought together by FDA or NIH. “When the President of the United States can text you saying, ‘Would you like an FDA approval?’ I worry about prescribing, but especially off label,” said Paul, editor and publisher of The Cancer Letter. “This thing is not approved, by the way, to give credit to FDA right now.”Stories mentioned in this podcast include:Is psilocybin heading to a cancer clinic near you?What NHS-Galleri taught us—and what it didn’tThe NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studiesFDA clears a way for dramatic reduction in animal toxicology studies in cancerProposed OMB rule aims at the heart of the U.S. research enterprise—and scientists are fighting back

This Pride Month, Peter F. Garrett appeared on The Cancer Letter Podcast to talk about what his experience during the HIV/Aids crisis has taught him about effective healthcare communication and advocacy.Garrett spoke with Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor. In the 1980s, Garrett was a closeted gay man in his twenties. He met his now-husband, Ken, who was open, and through him was introduced to a network of people who were openly gay. They became Garrett’s “instant-friends.”“All of a sudden I knew all these great people,” Garrett said on this week’s episode of In the Headlines. “But they then were also dying.”That time period was characterized by an “overwhelming sense of fear and constant anxiety,” Garrett said.“It was so mysterious at first. Nobody knew what was going on. They didn't know if it was an infectious thing, if it was a cancer related to poppers, or some sort of environmental thing,” Garrett said. “So, it was just this very scary feeling that you never knew what a phone call was going to be. Phone calls—I remember being kind of terrifying, (these would've been landline phones, obviously) because it just seemed like bad news was coming in, and so forget about doctor's appointments… Right now, everybody's getting hay fever and allergies. That terrified you. If you had a sore throat, colds, anything with a fever, you just assumed you had HIV/AIDS.”This experience was formative for Garrett, who later became the director of External Affairs at NCI. Garrett has since founded Patient Action for Cancer Research, an advocacy organization that aims to organize and amplify patient voices in an effort to protect life-saving health research.“It was really, really scary. I found myself at the epicenter of something that was happening very quickly to a certain population but was really being talked about broadly, and that very much framed the way I think about disease in general,” Garrett said. “This is really about a pandemic, a disease like cancer that, unlike cancer, which has been around forever, was all of a sudden there, but like cancer in many ways, it had a stigma. And I think that stigma associated with disease is something that is part of what you have to think about when you're talking with patients about what they've experienced in their cancer journey.”Garrett had a message for people with cancer: Stories have power.“It's about people coming to the table and realizing that their story, should they decide to tell it, has a lot of power,” Garrett said. “Whether they tell it to their neighbor or their church community or their local reporter or The New York Times or whomever or a member of Congress, I think it's all powerful. Because it just reminds us that this is not just about science. Science is cool, but this is about being healthier.”Stories mentioned in this podcast include:Proposed OMB rule aims at the heart of the US research enterprise—and scientists are fighting backHouse bill gives NCI $7.4 billion in FY 2027—$110 million above current budget As his Senate testimony alleged danger from mRNA COVID vaccine, El-Deiry had an offer to run NCI Frederick labLessons from the AIDS Quilt: what the cancer world can learn from AIDS advocacy Former NCI official's nonprofit seeks to tell the stories of cancer patients A transcript of this podcast is available: https://cancerletter.com/podcastc/20260617-petergarrett/

The oncology community is still riding the high of the success of daraxonrasib—the first drug to show real promise in treating metastatic pancreatic cancer. The drug doubled overall survival for patients in the phase III RASolute-302 trial.At the same time, science continues to become increasingly politicized. The White House Office of Management and Budget released a 412-page proposal May 29 that inserts political appointees into all stages of reviewing and awarding of federal research grants, centralizes OMB control over awarding federal funds, lists “specific principles” that must be applied to review of research programs of all federal entities, including NIH.In this episode of In the Headlines, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, talk about how these two stories are inseparable. Political review could put future breakthroughs like daraxonrasib in jeopardy when politicization of science is rooted in distrust.“I was actually thinking of talking to someone who understands Project 2025 to talk about the roots of this kind of dislike for science, which is…I mean, what's not like? Is a treatment for pancreatic cancer a bad thing?” Paul said.Daraxonrasib’s success is thanks to the decades of basic, translational, and clinical research that preceded it, largely funded by federal research dollars. Indeed, the NCI RAS Initiative jumpstarted the field of RAS in 2013. “To me, the best part of the story, your story, was going back to the link to the NCAB-BSA joint meeting where you could see these guys, with Harold Varmus presiding, deciding what they want to do with the RAS Initiative. By then, you had a pretty good idea that RAS mattered and that it was worth studying. There were already drugs and it was happening.”“It was not a waste of time, but it was also a bet. And it was a smart bet that only NCI could place, and that's why we need to have political appointees—on either party, I don't even care—to look at the entire process, lest those intellectuals get into their idiot heads to cure some other cancer. I mean, my God, that would be awful.”Stories mentioned in this podcast include:Pancreatic cancer finally starts to budge as daraxonrasib doubles overall survivalThe story of daraxonrasib is the ultimate hero’s journey: A narrative curve with twists, turns, intrigue, drama—and a blow to a mighty foe Political appointees to be inserted into all stages of making research funding awards if OMB rule becomes final At Senate hearing, Brown’s El-Deiry and other witnesses say they were targeted for arguing that mRNA vaccine may be linked to cancerEric Small, ASCO's immediate past president, speaks on the toll of toxicity—financial, emotional, physical—in cancerCancer patients could be exempted from Medicaid work requirements if they prove they are “medically frail” Richard Pazdur joins Friends boardA transcript of this podcast is available: https://cancerletter.com/podcastc/20260610-omb/

At the American Society of Clinical Oncology annual meeting, the plenary sessions are one of the main events. A handful of clinical research studies are chosen from the thousands that are presented at the conference to represent the biggest achievements from the field in the last year. This year, results from the phase III RASolute-302 trial were the unequivocal highlight of the plenary hall. With an extended standing ovation, the results showed that patients with metastatic pancreatic cancer who were given daraxonrasib, sponsored by Revolution Medicines, had a median overall survival of 13.2 months compared to a 6.7-month OS for those given chemotherapy.A story about the trial will be in the upcoming issue of The Cancer Letter. But in this week’s In the Headlines, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, talk about the buzz that these results are generating.Paul has seen the prognosis of other cancer types—such as  melanoma and multiple myeloma—completely transform after the development of effective drugs. “I was there when people were saying, ‘Oh, melanoma, forget it.’ But then, suddenly, there was stuff [treatment options]. Melanoma, multiple myeloma—my God, what catastrophe that was. And look at what's happening now. I mean, there's a lot to be said.”Paul said that this is a reminder of the importance of the biomedical research enterprise, and of clinical cancer researchers specifically. In last week’s issue of The Cancer Letter, the cover story was an episode of The Directors, a special segment of The Cancer Letter Podcast, where Paul spoke with two principle investigators of NCI Community Oncology Research Program, or NCORP, sites. “This is the week where we better take a good look at how well we are treating our clinical researchers. And we better keep looking at it… Seriously, these folks are heroes,” Paul said. “They should be treated well and respected and well funded because guess what? You cannot do ... NCORP brings in about a third of the clinical trials participants. You wouldn't be able to answer the questions we're answering and we better come up with more money for them and continue to come up with more money for them.“You can write about all the rogues in the field all you want, but you know what? There are some really great people who are really moving this field forward and we're all lucky to see this and covering this is a privilege,” Paul said.Stories mentioned in this podcast include:The Directors: NCORP PIs discuss workforce shortages, expanding workload, and crushing burden of regulatory oversight When CAM is added to standard therapies, survival rates drop, observational study finds As rural cancer disparities persist, aligning policy with care delivery models can close the gapUK Markey’s Denise Fabian: Theranostics lets us pair a diagnostic with a radioactive therapeutic that target the same molecule A modest proposal from a former FDA commissioner: Add antidepressants to the nation’s water supply Warning: This is not a public health recommendation. Do not implement.A transcript of this podcast is available: https://cancerletter.com/podcastc/20260603-daraxonrasib/

Getting NCI clinical trials to the community has never been a simple matter. Has it been getting simpler or more difficult? How does research get done at the NCI Community Research Program sites? To take the pulse of research in the community, The Directors podcast invited two NCORP principal investigators to ask the questions usually posed to directors of America’s cancer centers: What’s keeping you up at night?NCI Community Oncology Research Program is a national NCI-supported network that brings cancer clinical trials and cancer care delivery research studies to people in their communities.In the May episode of The Directors, we speak with Amarinthia Curtis, the medical director of Gibbs Cancer Center and Research Institute and the PI of Upstate Carolina NCORP, and Jeffrey Berenberg, a co-PI of the Hawaii Minority and Underserved NCORP and the Core Clinical Member for Translational and Clinical Research of the University of Hawaii Cancer Center.In the U.S. cancer enterprise, bureaucracy is increasing, compliance burdens are growing, and clinical research is becoming harder to run efficiently. According to Amarinthia and Curtis, it’s frustrating that each agency has its own rules for what counts as a financial conflict of interest, how researchers must disclose it, how often disclosures must be updated, and what dollar amount triggers concern.“I printed out a graph that showed that 60% of the regulations that we have were created in the past 10 years,” Curtis said on The Directors podcast. “I wasn't aware exactly of that, but my heart, my body can feel that,” Berenberg responded.

While every agency under HHS, particularly FDA, has seen historic leadership shakeups and massive cuts to personnel and funding over the course of the second Trump administration—NCI has been spared, even getting a small raise, under the direction of NCI Director Anthony Letai.“For some reason the wheels have not come off NCI, the wheels are very much on and it's kind of moving forward,” said Paul Goldberg, editor and publisher of The Cancer Letter.Is it luck?This has happened in previous administrations. Some agencies have done very well, some have not, Paul said. But at a recent Senate hearing with the typical contentious moments between Democrats and Republican agency heads, Letai was spared the drama. He wasn’t asked about vapes—a hot button topic of the last few weeks that led to the resignation of FDA Commissioner Marty Makary—and he wasn’t asked about payout rates.Meanwhile, the word “moonshot” was thrown around at a City of Hope-convened symposium on the microbiome. HHS Secretary Kennedy called for a “moonshot” targeted on the role of the microbiome in cancer, which was unexpected.“When people say, ‘Oh, we're going to do a moonshot,’ what they really want to be saying is something like, ‘We are going to project manage this beast, and we're going to emphasize certain kinds of scientific research,'" said Paul.In this episode of In the Headlines, Paul and Jacquelyn Cobb, associate editor of The Cancer Letter, discuss why NCI seems beyond reproach, the microbiome symposium, and the implications of a new cancer “moonshot.”“To me, the microbiome has been this MAHA-adjacent wellness topic that happens to have a really strong scientific foundation,” Jacquelyn said. “So, to me, this moonshot, whatever you want to call it, but this push for microbiome research feels to me like, ‘Oh, there happens to be this … overlap where this is something that the MAHA, RFK people find interesting and find important and it's preventative. It's almost, not holistic, but it's less pharmaceutical, which is, I think, an important point that you talked about, why NCI has to be involved is that there's not necessarily going to be pharmaceutical products that promise profits afterwards, like the typical cancer drug pipeline.”The overlap between the MAHA agenda and cancer research could be impactful.“So, it's just interesting to me where it almost feels like the field is seeing, "Okay, we have this MAHA leader who wants to focus on this type of stuff, what's the highest return subtopic that will actually help cancer patients?" Jacquelyn said.Stories mentioned in this podcast include:Kennedy calls for a “moonshot” targeted on the role of the microbiome in cancerMarcel van den Brink: Microbiome research is now in “critical phase” where evidence points to therapeutic useNCI’s Letai gets softball questions from Senate appropriators at an otherwise contentious hearingUSPSTF leaders John Wong and Esa Davis fired by Kennedy, leaving the panel rudderlessUMGCCC neuro-oncologist navigates the reality of his father’s pancreatic cancerFDA’s acting drug chief, acting vaccines chief, and chief of staff ousted in the wake of Makary departure

In last week’s issue of The Cancer Letter, the cover story featured something special: The first de novo book published by The Cancer History Project. The book, “Backwater to Blockbuster:  St. Jude Children’s Research Hospital,” co-written by Charles J. Sherr and William E. Evans, chronicles the previously untold story of St. Jude Children’s Research Hospital and its rise to becoming a global leader in pediatric cancer research.In this week’s episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, talked about serving as an editor for the book.“I said, ‘Well, if you want, the Cancer History Project, which publishes books, could make this our first de novo book project,’” Paul said that he told Sherr and Evans at the time. “‘And if you want to work with an editor, I have one for you: Me.”’“And so, in my spare time, I became an editor for this book.”The book is available at no charge on the Cancer History Project website.“And it's fun because it's kind of a story about the time the Giants walked the earth—giants like Chuck and Bill—by the way. And the cool thing is that there's only one way that the Cancer History Project can publish a book, which is to make it free,” Paul said.In other news, FDA has authorized fruit-flavored vaping products while easing enforcement against illicit products awaiting premarket review, a move critics argue opens the door for major tobacco companies to expand into the flavored vape market.This authorization was the final straw for former FDA Commissioner Marty Makary, who resigned as a result.In this week’s episode, Jacquelyn Cobb, associate editor of The Cancer Letter, and Sara Willa Ernst, reporter, join Paul to talk more about these stories.“It was definitely something new, but it wasn't causing too much alarm among the cancer researchers that I was talking to,” Sara said. “But then a few days later, what we thought was a story turned out to be a different story—which, this is our life in the news and working in journalism. But FDA essentially said, ‘Hey, we're taking a different approach when it comes to enforcement. So, we will be cracking down pretty much on the black market, but one subsection of the black market and not another subject section of the black market.’ Particularly, they will no longer be prioritizing enforcement for black market products that have a pending pre-market application. And so, the experts that we talked to, whether that was a legal expert or other kinds of cancer researchers, they were saying that the way that it might shake out is that the major tobacco companies such as JUUL, that pretty much aren't on the market right now, they kind of have a pathway to be able to put their own products on the shelf without FDA giving them a hassle.”Stories mentioned in this podcast include:“Backwater to Blockbuster” chronicles the previously untold story of the explosive growth of St. Jude Children’s Research Hospital. In a conversation with Deborah Doroshow, co-authors Chuck Sherr and Bill Evans discuss their collaborative writing processFDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applicationsAfter a year-long reign over tumult at FDA, Makary heads for the exitA transcript of this podcast is available: https://cancerletter.com/podcastc/20260520-vapes-and-FDA/

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.  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 ODACVinay Prasad’s CV inaccurately claims past membership on the President’s Cancer PanelJ. Craig Venter’s work was foundational to cancer advancement of the past 25 yearsTrump changes pick for Surgeon General, nominating Nicole SaphierA transcript of this podcast is available: https://cancerletter.com/podcastc/20260513-prasad-and-odac/

The Cancer Letter’s coverage of HHS-led overhauls of foundational scientific institutions continued last week with two unrelated stories pointing to continued disarray amongst public health leadership.In this week’s In the Headlines, Claire Marie Porter, Sara Willa Ernst, and Jacquelyn Cobb, reporters with The Cancer Letter, talk about 1) HHS Secretary Robert F. Kennedy Jr. promising to reform the U.S. Preventive Services Task Force by replacing medical generalists with medical specialists, and 2) FDA rejected a drug for treating advanced melanoma, RP1 (vusolimogene oderparepvec)—for a second time—on April 10.USPSTF is an independent panel of experts in primary care and prevention that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventive services.“What's at stake is this group kind of quietly shapes a huge part of American healthcare,” said Claire. “Their recommendations determine what happens in your routine doctor visits, so everything from cancer screenings to preventive counseling, and under the ACA, the Affordable Care Act, they decide what insurers have to cover for free.”Experts say Kennedy’s changes would cripple the task force’s ability to apply the principles of evidence-based medicine and undermine the scientific credibility that has made the panel a cornerstone of preventive care in the U.S.“There are 16 members on the panel. Five are rotating out this year, I think they serve a 4-year term, and he wants to replace them with medical specialists, which is a really big shift, because since 1984, the Task Force has been intentionally built around primary care doctors and methodology experts and not disease specialists,” Claire said. “And the idea behind that is that you want people on the panel who can look at the data broadly, not folks who are deep in one lane.”And FDA’s rejection of the melanoma drug, RP1, took the field by surprise.“The data is really robust. So, when you look at the data and you look at some of the comments that they had in the complete response letter, a lot of people were just kind of dumbfounded,” said Sara. “I heard from one oncologist that they were flabbergasted. I talked to a patient advocate that said that there is a lot of disappointment about this rejection. This is a Melanoma Research Foundation, and at least 75 patients have reached out in the few weeks since the rejection saying, ‘Hey, I really oppose this, and I wish it went a different way.’”The concern about FDA’s handling of the Replimune’s drug are a part of broader worries about inconsistency in the agency’s decisions (The Cancer Letter, March 13, 2026). At least nine other companies have reported surprising regulatory decisions from the Center for Biologics Evaluation and Research in recent months, according to The Wall Street Journal. Stories mentioned in this podcast include:By adding specialists to USPSTF, Kennedy would reshape the functioning and decisions of the influential health panelFDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patientsBenjamin Ebert, Amy Gladfelter, Stephen Liberles, and Pardis Sabeti are among new members of the National Academy of SciencesA transcript of this podcast is available: https://cancerletter.com/podcastc/20260506-hhs/

The intersection of art and education is well established, but its application in oncology remains limited. Last week’s issue of The Cancer Letter featured two stories about the role of art in cancer outreach and education—one about a comic book designed to increase cervical cancer screening and HPV vaccination in Nigeria, the other about a film festival comprised of films directed by cancer survivors.On this week’s episode of In the Headlines, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, discuss their approach to reporting on art in the world of oncology.“The cool thing about this job, which is why it's great to be a journalist here, is that you're doing a police beat, you're doing investigative, you're doing lifestyles, you're doing just pretty much everything. And that's during just any week. Oh, regulatory beat. Just name it all. It's all there,” Paul said. “And art is a big part of our lives, and a big part of how we communicate. And so, whenever somebody gives me an art story, I go nuts.”Dr. Obi Cancer Chronicles, Vol. 1: Cervical Cancer and the HPV Vaccine,” is the first iteration of a series of comic books developed by a nonprofit called Global Oncology that is focused on equitable cancer care in resource-constrained areas. The comic book was disseminated in Nigeria, where cervical cancer is a major public health crisis, and the response has been very positive.Nearly all of the 350,000 cervical cancer deaths in 2022—94%—occured in low- and middle-income countries. “This story in particular was interesting because we had been covering these recent advances in the cervical cancer screening and HPV screening space,” said Jacquelyn. “This is a preventable cancer, like 99% preventable with screening, vaccination, and follow up, and yet people are dying every hour in Nigeria.”Cervical cancer experts insist that outreach and accessibility strategies are the most important lever to improve outcomes. In theory, cervical cancer could be almost entirely eliminated with prevention and screening efforts, thanks to a quirk of the disease’s histology: Virtually all cases are caused by high-risk human papillomavirus, for which there is both a vaccine and an effective screening test.“What I loved about that story was, first of all, there was no way it wasn't going to get done because the art was amazing,” Paul said. “Because comic book art is always amazing. Comic book art and a comic book that is really calibrated to address, to communicate with people in Nigeria is incredible.” According to the book’s afterward, Dr. Obi is modeled on Olufunmilayo I. Olopade, a native of Nigeria and a leader in the global oncology space. Olopade is the Walter L. Palmer Distinguished Service Professor of Medicine and director of the Center for Clinical Cancer Genetics and Global Health at the University of Chicago. She is also a past winner of Global Oncology’s Visionary award.“So, it was just really fun to see that also, the role model of Funmi Olopade. My God, she's awesome,” Paul said. “The really cool thing about this is that we're not bored. I hope our readers aren't bored.”“How can you be bored with Dr. Olopade in comic form?” Jacquelyn said.Stories mentioned in this podcast include:The Directors: UPMC’s Byrd and Jefferson’s Chapman speak about avoiding catastrophism and using bridge funding to keep labs openAt AACR, Letai announces prevention and screening project for southern Appalachia, describes a future without paylinesProblem: Misinformation and stigma prevent uptake of HPV vaccines and screening. Solution: A comic bookDirecting the narrative of your survival: How The Remission Film Festival centers survivorship storiesForty years after Chernobyl: Little evidence to show that radiation released from the accident increased cancers globallyA transcript of this podcast is available: https://cancerletter.com/podcastc/20260429-art/

Getting NCI clinical trials to the community has never been a simple matter. Has it been getting simpler or more difficult? How does research get done at the NCI Community Research Program sites? To take the pulse of research in the community, The Directors podcast invited two NCORP principal investigators to ask the questions usually posed to directors of America’s cancer centers: What’s keeping you up at night?NCI Community Oncology Research Program is a national NCI-supported network that brings cancer clinical trials and cancer care delivery research studies to people in their communities.In the May episode of The Directors, we speak with Amarinthia Curtis, the medical director of Gibbs Cancer Center and Research Institute and the PI of Upstate Carolina NCORP, and Jeffrey Berenberg, a co-PI of the Hawaii Minority and Underserved NCORP and the Core Clinical Member for Translational and Clinical Research of the University of Hawaii Cancer Center.In the U.S. cancer enterprise, bureaucracy is increasing, compliance burdens are growing, and clinical research is becoming harder to run efficiently. According to Amarinthia and Curtis, it’s frustrating that each agency has its own rules for what counts as a financial conflict of interest, how researchers must disclose it, how often disclosures must be updated, and what dollar amount triggers concern.“I printed out a graph that showed that 60% of the regulations that we have were created in the past 10 years,” Curtis said on The Directors podcast. “I wasn't aware exactly of that, but my heart, my body can feel that,” Berenberg responded.