The Cancer Letter

The Cancer History Project debuts first de novo book; meanwhile, FDA snafus continue

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 [https://cancerhistoryproject.com/primary-source/backwater-to-blockbuster-st-jude-children-research-hospital/]. “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 process [https://cancerletter.com/podcastc/20260515_1/] * FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications [https://cancerletter.com/clinical/20260515_2/] * After a year-long reign over tumult at FDA, Makary heads for the exit [https://cancerletter.com/regulatory-news/20260515_3/] A transcript of this podcast is available: https://cancerletter.com/podcastc/20260520-vapes-and-FDA/

Prasad’s “deceit,” plus, ODAC’s tough decision against biomarker-based progression assessment (for now)

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 ODAC [https://cancerletter.com/regulatory-news/20260508_1/] * Vinay Prasad’s CV inaccurately claims past membership on the President’s Cancer Panel [https://cancerletter.com/the-cancer-letter/20260508_2/] * J. Craig Venter’s work was foundational to cancer advancement of the past 25 years [https://cancerletter.com/letter-to-the-editor/20260508_3/] * Trump changes pick for Surgeon General, nominating Nicole Saphier [https://cancerletter.com/cancer-policy/20260508_5a/] A transcript of this podcast is available: https://cancerletter.com/podcastc/20260513-prasad-and-odac/

Reforms pending at USPSTF, plus, FDA rejects promising melanoma drug for the second time

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 [https://cancerletter.com/regulatory-news/20260313_3/], 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 [https://www.wsj.com/health/healthcare/why-the-fda-blocked-modernas-new-flu-shot-84fdaab6?gaa_at=eafs&gaa_n=AWEtsqdGe8EXfIX6h8XJGW6czZKj86sfoOKymP5DNvTaYJr1cxpFqBLoSmZzivzzaLA%3D&gaa_ts=69b4473e&gaa_sig=8f5MDtqadmtF-pjeLHUdlo9xlwoKLIIypTayP9EgpNMh2eMatkzhAVlH6POSX81r_X0E97JjF-2BrYM8nszabg%3D%3D].  Stories mentioned in this podcast include: * By adding specialists to USPSTF, Kennedy would reshape the functioning and decisions of the influential health panel [https://cancerletter.com/the-cancer-letter/20260501_1/] * FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients [https://cancerletter.com/regulatory-news/20260501_2/] * Benjamin Ebert, Amy Gladfelter, Stephen Liberles, and Pardis Sabeti are among new members of the National Academy of Sciences [https://cancerletter.com/the-cancer-letter/20260501_3/] A transcript of this podcast is available: https://cancerletter.com/podcastc/20260506-hhs/

On the joys of reporting on art as a tool for cancer education

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 [https://www.globalonc.org/comic-book],” 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 open [https://cancerletter.com/podcastc/20260424_1/] * At AACR, Letai announces prevention and screening project for southern Appalachia, describes a future without paylines [https://cancerletter.com/nci/20260424_2/] * Problem: Misinformation and stigma prevent uptake of HPV vaccines and screening. Solution: A comic book [https://cancerletter.com/clinical/20260424_3/] * Directing the narrative of your survival: How The Remission Film Festival centers survivorship stories [https://cancerletter.com/guest-editorial/20260424_4/] * Forty years after Chernobyl: Little evidence to show that radiation released from the accident increased cancers globally [https://cancerletter.com/guest-editorial/20260424_5/] A transcript of this podcast is available: https://cancerletter.com/podcastc/20260429-art/

The Directors: Byrd and Chapman speak about avoiding catastrophism and using bridge funding to keep labs open

In recent months, several directors of cancer centers, appearing on The Directors segment of The Cancer Letter Podcast, mentioned that their institutions are increasingly providing small grants—typically in the range of $50,000—to scientists to enable them to keep their labs open. Andrew Chapman, director of the Sidney Kimmel Cancer Center at Jefferson, said he and other officials at Jefferson designed a bridge funding mechanism that applies to oncology as well as to other therapeutic areas. John Byrd, director of UPMC Hillman Cancer Center, said bridge funding at his institution was started by Kathryn Schmitz [https://hillmanresearch.upmc.edu/researchers/kathryn-schmitz-75f2f776-3a0b-6923-6dde-5a8aa5cb], who served as the interim director before he started his job last November. Chapman and Byrd appeared together on The Directors, a monthly podcast series that focuses on the problems that keep directors of cancer centers up at night. The extent of reliance on bridge funding at NCI grantee institutions hasn’t been studied systematically, but in recent months, it has come up regularly on The Directors. As cancer centers strategize amid this time of uncertainty, many are tapping into their resources to keep their labs and federally-funded programs going—in essence becoming short-term lenders to the government and placing a bet that the money will soon begin to flow. This may be a sound strategy if the problem is limited to temporary constriction of federal funds—and assuming that Congress will continue to provide robust funding to NIH and NCI. A transcript of this episode is available: https://cancerletter.com/podcastc/20260424_1/ [https://cancerletter.com/podcastc/20260424_1/]