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 The proposed rule, introduced in Nov. 2024 and withdrawn Nov. 2025, was mandated by the Modernization of Cosmetics Regulation Act of 2022 or MoCRA.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 UPMC

• FDA 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 Panel

A 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 science

• In first NCAB director’s report, Anthony Letai focuses on centralized grant review, budget outlook

• Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

• Mail-out colorectal cancer screening programs extend, rather than replace, clinical care 

• Pediatric cancer five-year survival rate has increased dramatically, AACR says in inaugural Pediatric Cancer Progress Report

A 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 66

A 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 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/