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 builds

• Shane Jacobson talks about his to-do list for ACS

• Mikkael Sekeres: My introduction to, and lessons learned from, Rick Pazdur

• Montefiore Einstein Director Edward Chu dies of glioblastoma at 66

• Arnold D. Kaluzny, longtime adviser to the NCI and health services researcher, dies at 87

• Meeting the moment: ASCO GI Cancers Symposium delivers insights and collaboration

A 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 director

• Rick Pazdur’s CDER appointment comes at exactly the right moment for FDA

• FDA to remove black box warnings on hormone therapy for menopause

• Smoldering multiple myeloma: Rethinking the waiting game

A 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 discovery

• CDER Director Tidmarsh quits amid inspector general probe of his “personal conduct” Cancer advocates express concern about comments that signal trouble for accelerated approval

• How George Tidmarsh crossed the FDA-industry Rubicon

• How next generation sequencing is powering the shift to more accessible—and comprehensive—cancer care

• City 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 review

• Class action complaint alleging GRAIL insider fraud resubmitted after dismissal

• Friends publishes three white papers ahead of annual meeting Topics: Clinical trials on rare cancers, combination drug trials, multi-regional studies

• How GLP-1RA drugs are reshaping patient physiology and the future of oncology

A 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 endpoints

• Duke brain cancer researcher Kyle Walsh named director of NIEHS

• GRAIL to use new study results to seek FDA approval of Galleri MCD test

• Omar Abdel-Wahab, John Byrd, Lieping Chen, Robert Ferris, Wendy Garrett, Victor Velculescu are among new members of National Academy of Medicine

• Experts warn that loss of carcinogen surveillance threatens to increase cancer incidence

A 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 research

• How 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 enough

• Study finds no correlation between cancer burden in catchment areas and cancer centers’ CCSG funding

A 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 pill

A 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 director

• U.S. government shuts down Impact on NCI uncertain as administration threatens more RIFs

• Sexual 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/