FDA’s Center for Biologics Evaluation and Research Director Vinay Prasad is set to leave the agency for a second time amid controversy. 

In a March 6 post on X, FDA Commissioner Marty Makary suggested that Prasad’s presence at FDA was a “sabbatical” from his academic career and that he would be returning to his job at the University of California, San Francisco.

“Under Richard Pazdur's leadership, FDA was heading in the direction of behaving rationally in the same way as the mainstream of oncology,” Paul Goldberg, editor and publisher of The Cancer Letter, said. “So, then they take someone who is really an outlier in oncology. He really is like an N-of-1, Vinay Prasad, and basically try to integrate him or make him the chief scientific and chief medical officer over a regulatory agency, and that's like sticking a finger in the eye.”

On this week’s episode, Paul and Claire Marie Porter, reporter with The Cancer Letter, talk about Vinay Prasad’s unusual year at FDA, and what led to his second departure from the agency. He’s officially out at the end of the month, following weeks of controversy, specifically criticisms around drug approvals.

“Right now drug companies are mad [at Prasad], rare disease patients and advocates are mad, and now Congress people are mad, which is a lot of mad people,” Claire said. “And I think when you've united pharma, Congress, and patients, that's almost impressive.”

Drug companies and rare disease advocates are frustrated with Prasad because of seemingly arbitrary rejections of some of those drugs that were among the few options patients had. Representative Jake Aushinschloss (D-MA) has called for Makary’s resignation and accused the agency of crossing legal lines by revealing trade secrets after a very public fight over a gene therapy for Huntington’s disease.

At the same time, the agency’s actions seem to be contradictory—rejecting rare drug approvals while simultaneously publicizing a new push to smooth the approval process for sponsors focused on rare diseases.

Stories mentioned in this podcast include:

• Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

• Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology

• As more people are surviving cancer, we must continue funding bold science

• The murder of Alexei Navalny is part of Russia’s macabre fascination with poisons

• HHS postpones third USPSTF meeting in a row

• FDA approves leucovorin for cerebral folate deficiency

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260315-vinay-prasad/

On Feb. 19, GRAIL Inc. announced that its pivotal NHS-Galleri trial failed to meet its primary endpoint of reduction in advanced stage cancers. The media and the market reacted as one would expect: GRAIL’s stock price halved the day after the announcement and at least three law firms said that they are conducting investigations in preparation for filing investor suits.

Despite this, GRAIL has been doggedly positive in its press about the results. 

In this episode of The Cancer Letter Podcast, GRAIL’s vice president of Medical and Corporate Affairs, Megan Hall, says that GRAIL is “really excited about it, despite the missed primary endpoint, and we’re excited enough that we announced publicly that we’re expanding our sales and medical teams in response to this, because we expect that when we’re able to talk about the data much more fulsomely, that there will also be some excitement about this.

“We are confident that [Galleri] is showing clinical benefit,” Hall said. 

The company says it will submit the full data for presentation at ASCO in late May and early June. 

Multi-cancer detection screening has been a hot button topic for the field, and interested readers can dive into a comprehensive story about the trial results in last week's issue. But for this podcast, we decided to feature GRAIL’s perspective directly alongside NCI’s.

First, Megan Hall explains why GRAIL is excited about the results of the negative study. Then, Philip Castle, director of NCI's Division of Cancer Prevention, laments the trial’s unfortunate result. 

This episode of The Cancer Letter Podcast was sponsored by City of Hope. Learn more at http://www.cityofhope.org. 

Stories mentioned in this podcast include: 

• GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study

• GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.” Mainstream epidemiologists beg to differ

• NCI's Philip Castle on NHS-Galleri results: “I'm sorry that it didn't work, but it keeps the national conversation going.”

• Erin Cummings, Cancer Nation advocate, dies of stomach cancer at 68

• Mt. Sinai forms committee to probe Epstein links to breast center founder Eva Dubin, other faculty members 

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260311-nhs-galleri/

Two lawsuits filed within days of each other in the U.S. District Court for the Northern District of Illinois claimed that Tempus AI Inc., an AI-driven precision and genomic testing company, had violated the Illinois Genetic Information Privacy Act when it acquired Ambry Genetics and started to integrate its genetics data into its predictive models.

“Ambry contained genetic information from a lot of people,” Paul Goldberg, editor and publisher of The Cancer Letter, said. “And the question is, were these people consented properly before the data were actually put into the kind of combined—if it was indeed combined with Tempus data—and before it was used, again, if it was indeed used for drug development?” 

On this week’s episode, Paul and Jacquelyn Cobb, associate editor of The Cancer Letter, talk about last week’s breaking news regarding two lawsuits being brought against Tempus for potentially violating genetic privacy laws. 

“So, it's all very interesting. It's also making a lot of people nervous,” Paul said.  “I know that at cancer centers, and elsewhere, because of just the way all of this is regulated. But I think the issue that fascinated me was that you can de-identify something—maybe—but is it really de- identifiable with DNA research?”

Researchers say that “deidentified”— a word used often in the context of germline data in order to ease privacy concerns—doesn’t mean “deidentifiable.”

“It's just this interesting idea that the idea of de-identified predates our ability to sequence our entire genome,” Jacquelyn said. “The technology outpaced our regulatory frameworks.”

Stories mentioned in this podcast include: 

• The Directors: Yolanda Sanchez and Kelvin Lee talk about making cancer centers more resilient

• Joni Nelson tells us how her background led her to pursue research that meets the needs of the community

• After a year, Stephenson institute sees a broader role in funding pancreatic cancer research, fostering collaborations

• When radiology fails to fix clinical trial imaging workflow at sites...

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260304-tempus/ 

One of Joni D. Nelson’s biggest influences growing up was her maternal grandmother, or Màma, as Nelson would affectionately call her. Despite a third grade education and limited literacy, Màma showed her “there is an opportunity to change what’s possible” no matter the barriers life sets in front of you.

Now, Nelson is the assistant director for the Office of Workforce Development at The Medical University of South Carolina Hollings Cancer Center. 

Nelson’s mother also helped her find her path. She was a registered nurse who believed in Nelson’s passion for science and medicine.

“I’m standing on the shoulders of two giants,” Nelson said.“One beginning without a degree, focused on contributing to the community here, my mother as a nurse, and then here I come, many decades later, contributing to the field of science and cancer. Those are my influences.”

Nelson dug into her personal history with Robert A. Winn, director and Lipman Chair in Oncology at VCU Massey Comprehensive Cancer Center in honor of Black History Month. 

Winn is The Cancer Letter’s editor for Black History Month. 

In an era of uncertainty around funding for academic research, Yolanda Sanchez and Kelvin Lee are thinking about how to build the next generation of scientists in spite of these challenges. 

“Certainty is not there anymore. So, what do you do?” said Sanchez, director of the University of New Mexico Comprehensive Cancer Center. “Because we’re not stopping. We’re not telling students that they can’t be graduate students, they can’t be postdocs anymore. We are continuing the work. We just have to shift the funds from one place to another.”

A key to resilience is protecting younger investigators and creating a diverse ecosystem of funding sources. 

“We’ve always argued that money comes and goes, but if you lose a generation of scientists—you can’t buy them back,” said Kelvin Lee, director of the Indiana University Simon Comprehensive Cancer Center. 

On this episode of The Directors Podcast, Sanchez and Lee spoke with The Cancer Letter’ Paul Goldberg about what it takes to build a resilient cancer center as the ground beneath their feet is constantly shifting. 

A transcript of this episode is available: https://cancerletter.com/podcastc/20260227_1/

“About a year ago, in January, were these two massive fires in Los Angeles: the Palisades fire, and the Eaton Fire,” Sara Willa Ernst, reporter with The Cancer Letter, said on The Cancer Letter Podcast. On this week's episode, Sara and Jacquelyn Cobb, associate editor with The Cancer Letter, talk about their experience working as writer-and-editor duo on The Cancer Letter’s most recent cover story, which featured emerging data about the toxic exposure and cancer risk caused by the Eaton and Palisades fires—specifically focused on the firefighters who were sent to fight them. 

“I remember watching the TV coverage at the time, and I'm like, ‘Is this real life? This is a huge metropolitan area that is being engulfed by flames.’ And talking to firefighters that were on the front line…Yeah, it was absolutely nuts,” Sara said. “And it's the type of fire that people are still dealing with the ramifications of today, whether those are people living in LA because they're rebuilding or there was exposure to smoke from their homes. And then of course, the people that had the highest concentration of exposure were firefighters on the front line breathing in that smoke.”

These early results come at a time when the culture of firefighting is beginning to shift, Sara said. Respirators—which, counterintuitively, have only just become legal to use in some wildfire settings and are still restricted—are becoming more utilized with the involvement of firefighters in research design.

“There were just really rich stories about how this culture shift is happening and what firefighters themselves are saying and thinking and how that is informing the research,” Sara said. “There's this tension that one of the firefighters was talking about, which is that researchers don't get it, or policy makers don't get it, and there's that disconnect. But at the same time, firefighters are getting involved in research in a way that has not happened before. And I'm talking about firefighters being PIs on research papers—not just research participants, their biospecimens. They're getting in there.”

But the culture of firefighting remains distinctly its own. 

“Content warning for anybody who's reading the article,” Sara said. “There are quite a few F bombs in there, just letting you guys know, because that is how firefighters talk. This was just one of the most amazing parts of reporting. The story was talking to firefighters, and I mean, once you get them going, they're going. They have strong opinions, and they were definitely documented in the story. 

Stories mentioned in this podcast include: 

• A year after LA wildfires, early data reinforce anxieties over firefighters’ cancer risks—Respirators (restricted by federal regulation) may or may not be the answer

• NIH Director Bhattacharya named acting CDC director in latest public health shakeup—The temporary appointment concentrates vast authority in the hands of one person

• Malcolm V. Brock on his journey from Bermuda to Japan to the U.S. to England–and from Japanese studies to thoracic oncology. 

• Sustaining community oncology through nonprofit structures and shared technology infrastructure

• California Institute of Regenerative Medicine and Cancer Research: A promise broken?

• At Friends meeting, Pazdur, Woodcock lament FDA’s failure to protect the agency staff from political interference, warn of “lasting implications”

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260225-firefighters/   

Malcolm V. Brock, director of Clinical and Translational Research in Thoracic Surgery at Johns Hopkins Kimmel Comprehensive Cancer Center, grew up on the island of Bermuda. His father insisted that his children branch outside the island’s small footprint—the country has a population of just over 60,000 people—and challenge themselves abroad.

“My father said to me, ‘Look, you're not going to do much sitting here in a 20-square-mile place,’” Brock said. “He had a plan. [To] all of us, at about 15-and-a-half or 16-years old, he said, ‘You need to leave and go to a place where they don't speak the language. No English.’”

So, Brock applied for and was awarded a Rotary Exchange Scholarship and decided on his next stop: Japan. To prepare, Brock studied Japanese with a teacher who came to his house in Bermuda. He learned to read and write in Japanese during his time in the country, and eventually earned a degree in Japanese studies at Princeton University.

Still, the idea of becoming a physician remained appealing to Brock.

“I also wanted to be a doctor because I had an influence, a surgeon, who I grew up with who took care of me when I actually had an accident,” Brock said. “I was little, and I was always inspired by the guy.”

Brock faced a fork in the road: he became both a Rhodes Scholar and got a deferred admission to the Johns Hopkins School of Medicine. Brock ended up doing two years of Japanese Research at Oxford University and wrote a book in Japanese called “Biotechnology in Japan.” 

Brock was widely encouraged by his colleagues at Oxford to leave behind his medical career to continue at Oxford, get his PhD, join the faculty, and pursue a career in Japanese studies. 

As he was facing this decision, Brock gave a lecture for the Japanese Ambassador to the United Kingdom. Afterwards, the ambassador offered Brock advice that altered the course of his career.

“He basically pulled me aside, took me outside, and said, ‘What are you doing?’” He said, ‘You've learned our language, you're obviously a talented guy in terms of being able to do this in such a short period of time. You can read and write. Why are you going to spend your life essentially studying people like me?’” Brock recalled. “He said, ‘You go out and make a name for yourself, you go and make the world work. You don't watch other people making the world work.’”

The next day, Brock sent a message to Johns Hopkins to say he was coming to enroll in the School of Medicine, and the rest is history. 

Brock shared his start in medicine with Robert A. Winn, director and Lipman Chair in Oncology at VCU Massey Comprehensive Cancer Center in honor of Black History Month.

Winn is The Cancer Letter’s guest editor for Black History Month.

A transcript of this episode is available: https://cancerletter.com/black-history-month/20260220_3/ 

With NCI Director Anthony Letai in Milan supporting his daughter, Julie, at the 2026 Winter Olympics, Douglas R. Lowy, principal deputy director of NCI, took on the job of delivering detailed remarks and fielding questions at the inaugural meeting of the NCAB’s ad hoc working group on Extramural Research Concepts and Programs.

The meeting was the first time the field was able to publicly communicate with NCI leadership since President Trump signed the FY26 funding bill.

On this week’s episode, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, talk about last week’s deep dive into the inaugural meeting of the ad hoc working group, which replaced the Board of Scientific Advisors. 

“This is the first public display from NCI, from Letai, from Lowy, after they actually have their appropriation, they know what they're actually getting from Congress,” Jacquelyn said. “I think that I went into this thinking that we were going to have a lot of answers, and in some ways we did. We know about the funding numbers of course, and we know about the forward funding caps, etc., indirect cost caps. We know a lot of the stipulations that were included in the funding bill, but there are important caveats that Lowy talked about.” 

One of the key concerns brought up at the meeting was the fact that although NCI will still rank award applications using percentiles, NCI is no longer “allowed to make awards exclusively on the basis of payline,” Lowy said.

Instead, NCI has been tasked with considering other factors when reviewing grant applications, which has sparked concern from some members of the working group about political interference in grant making.

“This presidential appointee [that will have final review over grant decisions] is Dr. Letai, and I think Lowy was smart to remind everybody of that,” Jacquelyn said. “Not that people legitimately forget, but I think to have that center of mind—that we are in good hands, we're in expert hands, we're in hands that the field agrees are very capable. So, that was very, I think reassuring.”

Stories mentioned in this podcast include: 

• CBER Director Vinay Prasad sidelined staff to jettison Moderna’s mRNA flu shot

• Olopade: “The genetic basis of every cancer, or everything we do, starts in Africa.”

• NCAB ad hoc group approves seven new, reissue concepts

• Science is winning the war on cancer—CMS shouldn’t disarm

• Why infection and immunity matter for Florida’s cancer patients

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260218-ncab-working-group/ 

When The Cancer Letter founder Jerry Boyd carried the first print run of his little eight page oncology newsletter into an NCAB meeting in 1973, he certainly could not have predicted that, half a century later, his experiment would branch out into this thing called “podcasts.”

On this week's episode, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, celebrate the one year anniversary of The Cancer Letter Podcast.

Boyd understood that oncology was a community, and a community is engaged in storytelling. Once you get past the sci-fi hurdle of explaining podcasting to a time traveler from the 70s, he would have seen the impact it could have.

“When you publish a story, there is, you hope, conversation. And this way, we can be part of the conversation,” Paul said. 

For Paul, who started at The Cancer Letter when it was still a "Washington newsletter" and watched it grow over the proceeding three decades into what we now describe as a magazine. The Cancer Letter Podcast is the next iteration of this continuous experimentation with storytelling.

"We started doing that some years ago. So, it's always experimentation and storytelling. There's really nothing more complicated or more important than storytelling, so here we are," Paul said.

The Cancer Letter Podcast began last year after Donald Trump began his second term, with two regular segments: In the Headlines, like this episode, and The Directors, a monthly series where Paul asks directors of cancer centers what is keeping them up at night.

The Directors, in particular, plays an important role in the current political climate, creating a space for leaders in the field to address the significant changes and challenges that have emerged under the MAHA agenda.

But for Boyd, time traveling from 1973, the most shocking realization would have been that the oncology community is still around, and still relevant. An optimist, he strongly hoped that, through the great efforts of the War on Cancer, the disease would long since have been eradicated—and The Cancer Letter with it.

This episode of The Cancer Letter Podcast was sponsored by City of Hope. Learn more at http://www.cityofhope.org. 

Stories mentioned in this podcast include: 

• On Day 2 as director of NYU Perlmutter, Anirban Maitra talks about the advantages of running a matrix cancer center

• Letai: NCAB's ad hoc working group plays major role in advising NCI on extramural research

• Black History Month: Otis Brawley shares how lessons learned in West Side Detroit shape his stance on cancer prevention

• The National Highway Traffic Safety Administration has a profound, albeit not immediately obvious, impact on cancer 

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260211-anniversary/   

Growing up in inner-city Detroit, Otis Brawley had a thriving community made up of his parents, Jesuit priests, friends, and neighbors encouraging him that he could do anything he put his mind to. 

Brawley’s parents worked at the local Veteran’s Hospital, his father in janitorial services and his mother in food services. Neither graduated from high school, but they had high aspirations for their son, and would not take no for an answer. 

“I can remember in 1970, when I was 11 years old, the census taker came to the house,” Brawley said. “She was a Black woman, and she was surprised that my father expected me to go to college. He got very upset. The idea that I would not go to college was just not acceptable.”

Brawley, now the associate director of Community Outreach and Engagement at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, shared this story in a recent conversation with Robert A. Winn in honor of Black History Month.

Winn, who is director and Lipman Chair in Oncology at VCU Massey Comprehensive Cancer Center, is The Cancer Letter’s guest editor for Black History Month.

A transcript of this episode is available: https://cancerletter.com/black-history-month/20260206_3/