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

The Directors: NCORP PIs discuss the growing complexity of regulatory oversight in clinical cancer research

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 [https://www.cancer.gov/research/infrastructure/clinical-trials/ncorp] 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.

As FDA’s wheels almost entirely come off, NCI remains sturdy—a cancer moonshot may even be on the horizon

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 cancer [https://cancerletter.com/the-cancer-letter/20260522_1/] * Marcel van den Brink: Microbiome research is now in “critical phase” where evidence points to therapeutic use [https://cancerletter.com/conversation-with-the-cancer-letter/20260522_2/] * NCI’s Letai gets softball questions from Senate appropriators at an otherwise contentious hearing [https://cancerletter.com/nci/20260522_3/] * USPSTF leaders John Wong and Esa Davis fired by Kennedy, leaving the panel rudderless [https://cancerletter.com/capitol-hill/20260522_4/] * UMGCCC neuro-oncologist navigates the reality of his father’s pancreatic cancer [https://cancerletter.com/guest-editorial/20260522_5/] * FDA’s acting drug chief, acting vaccines chief, and chief of staff ousted in the wake of Makary departure [https://cancerletter.com/cancer-policy/20260522_6a/]

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/