Policy by way of podcaster—FDA issues priority vouchers after Joe Rogan episode on psychedelics

Policy by way of podcaster—FDA issues priority vouchers after Joe Rogan episode on psychedelics

In this week's episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher, and Sara Willa Ernst, reporter, go on a trip into the world of federal health policy surrounding psychedelic medicine.  In April, FDA issued National Priority Vouchers to three companies conducting clinical trials of psilocybin for treatment-resistant depression and major depressive disorder, and methylone for PTSD, as well as an IND to study ibogaine for treatment of alcohol use disorder. This came after the president issued an executive order vowing to accelerate drug approvals of psychedelic drugs.  “One thing that they seem to want to do is reverse Nixon's War on Drugs, which stopped all of the psychedelic drugs research in its tracks in the '70s,” Paul said.  Some oncologists are not opposed to this reversal, particularly as clinical trials evaluating psilocybin as a treatment for cancer-related anxiety, depression, demoralization, fear of recurrence, and other psychological conditions have been ongoing since 2008 [https://jamanetwork.com/journals/jamapsychiatry/fullarticle/210962]. But the story behind the policy change is cause for concern.  At a press conference in the Oval Office, President Donald Trump sat next to Joe Rogan, comedian and host of “The Joe Rogan Experience" podcast. Just two and half weeks before, Rogan published a two-hour long interview on ibogaine.  Rogan texted Trump about the psychadelic’s promise as a treatment for drug addiction, brain trauma, and cognitive decline.  “The text message came back: ‘Sounds great, do you want FDA approval?’ It was literally that quick,” Rogan said at a subsequent press conference [https://www.youtube.com/shorts/VFO6Gcrcz4c] with Trump in the Oval Office.  “This is a very unscientific way to roll back the scientific kibosh,” Paul said.  The policy change didn’t appear to come from scientific consensus by an expert panel brought together by FDA or NIH.  “When the President of the United States can text you saying, ‘Would you like an FDA approval?’ I worry about prescribing, but especially off label,” said Paul, editor and publisher of The Cancer Letter. “This thing is not approved, by the way, to give credit to FDA right now.” Stories mentioned in this podcast include: * Is psilocybin heading to a cancer clinic near you? [https://cancerletter.com/regulatory-news/20260618_1/] * What NHS-Galleri taught us—and what it didn’t [https://cancerletter.com/trials-and-tribulations/20260618_2/] * The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies [https://cancerletter.com/trials-and-tribulations/20260618_3/] * FDA clears a way for dramatic reduction in animal toxicology studies in cancer [https://cancerletter.com/news-analysis/20260618_4/] * Proposed OMB rule aims at the heart of the U.S. research enterprise—and scientists are fighting back [https://cancerletter.com/the-cancer-letter/20260612_1/]

Peter F. Garrett to people with cancer: Your story has power

This Pride Month, Peter F. Garrett appeared on The Cancer Letter Podcast to talk about what his experience during the HIV/Aids crisis has taught him about effective healthcare communication and advocacy. Garrett spoke with Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor.  In the 1980s, Garrett was a closeted gay man in his twenties. He met his now-husband, Ken, who was open, and through him was introduced to a network of people who were openly gay. They became Garrett’s “instant-friends.” “All of a sudden I knew all these great people,” Garrett said on this week’s episode of In the Headlines. “But they then were also dying.” That time period was characterized by an “overwhelming sense of fear and constant anxiety,” Garrett said. “It was so mysterious at first. Nobody knew what was going on. They didn't know if it was an infectious thing, if it was a cancer related to poppers, or some sort of environmental thing,” Garrett said. “So, it was just this very scary feeling that you never knew what a phone call was going to be. Phone calls—I remember being kind of terrifying, (these would've been landline phones, obviously) because it just seemed like bad news was coming in, and so forget about doctor's appointments… Right now, everybody's getting hay fever and allergies. That terrified you. If you had a sore throat, colds, anything with a fever, you just assumed you had HIV/AIDS.” This experience was formative for Garrett, who later became the director of External Affairs at NCI. Garrett has since founded Patient Action for Cancer Research, an advocacy organization that aims to organize and amplify patient voices in an effort to protect life-saving health research. “It was really, really scary. I found myself at the epicenter of something that was happening very quickly to a certain population but was really being talked about broadly, and that very much framed the way I think about disease in general,” Garrett said. “This is really about a pandemic, a disease like cancer that, unlike cancer, which has been around forever, was all of a sudden there, but like cancer in many ways, it had a stigma. And I think that stigma associated with disease is something that is part of what you have to think about when you're talking with patients about what they've experienced in their cancer journey.” Garrett had a message for people with cancer: Stories have power. “It's about people coming to the table and realizing that their story, should they decide to tell it, has a lot of power,” Garrett said. “Whether they tell it to their neighbor or their church community or their local reporter or The New York Times or whomever or a member of Congress, I think it's all powerful. Because it just reminds us that this is not just about science. Science is cool, but this is about being healthier.” Stories mentioned in this podcast include: * Proposed OMB rule aims at the heart of the US research enterprise—and scientists are fighting back [https://cancerletter.com/the-cancer-letter/20260612_1/] * House bill gives NCI $7.4 billion in FY 2027—$110 million above current budget  [https://cancerletter.com/capitol-hill/20260612_2/] * As his Senate testimony alleged danger from mRNA COVID vaccine, El-Deiry had an offer to run NCI Frederick lab [https://cancerletter.com/the-cancer-letter/20260612_3/] * Lessons from the AIDS Quilt: what the cancer world can learn from AIDS advocacy  [https://cancerletter.com/trials-and-tribulations/20260612_4/] * Former NCI official's nonprofit seeks to tell the stories of cancer patients [https://cancerletter.com/the-cancer-letter/20251003_1/]  A transcript of this podcast is available: https://cancerletter.com/podcastc/20260617-petergarrett/

Pancreatic cancer breakthrough came from smart scientists making smart bets—not from politicization of science

The oncology community is still riding the high of the success of daraxonrasib—the first drug to show real promise in treating metastatic pancreatic cancer. The drug doubled overall survival for patients in the phase III RASolute-302 trial. At the same time, science continues to become increasingly politicized. The White House Office of Management and Budget released a 412-page proposal May 29 that inserts political appointees into all stages of reviewing and awarding of federal research grants, centralizes OMB control over awarding federal funds, lists “specific principles” that must be applied to review of research programs of all federal entities, including NIH. In this episode of In the Headlines, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, talk about how these two stories are inseparable. Political review could put future breakthroughs like daraxonrasib in jeopardy when politicization of science is rooted in distrust. “I was actually thinking of talking to someone who understands Project 2025 to talk about the roots of this kind of dislike for science, which is…I mean, what's not like? Is a treatment for pancreatic cancer a bad thing?” Paul said. Daraxonrasib’s success is thanks to the decades of basic, translational, and clinical research that preceded it, largely funded by federal research dollars. Indeed, the NCI RAS Initiative jumpstarted the field of RAS in 2013.  “To me, the best part of the story, your story, was going back to the link to the NCAB-BSA joint meeting where you could see these guys, with Harold Varmus presiding, deciding what they want to do with the RAS Initiative. By then, you had a pretty good idea that RAS mattered and that it was worth studying. There were already drugs and it was happening.” “It was not a waste of time, but it was also a bet. And it was a smart bet that only NCI could place, and that's why we need to have political appointees—on either party, I don't even care—to look at the entire process, lest those intellectuals get into their idiot heads to cure some other cancer. I mean, my God, that would be awful.” Stories mentioned in this podcast include: * Pancreatic cancer finally starts to budge as daraxonrasib doubles overall survival [https://cancerletter.com/clinical/20260605_1/] * The story of daraxonrasib is the ultimate hero’s journey: A narrative curve with twists, turns, intrigue, drama—and a blow to a mighty foe  [https://cancerletter.com/trials-and-tribulations/20260605_2/] * Political appointees to be inserted into all stages of making research funding awards if OMB rule becomes final  [https://cancerletter.com/the-cancer-letter/20260605_3/] * At Senate hearing, Brown’s El-Deiry and other witnesses say they were targeted for arguing that mRNA vaccine may be linked to cancer [https://cancerletter.com/the-cancer-letter/20260605_4/] * Eric Small, ASCO's immediate past president, speaks on the toll of toxicity—financial, emotional, physical—in cancer [https://cancerletter.com/the-cancer-letter/20260605_5/] * Cancer patients could be exempted from Medicaid work requirements if they prove they are “medically frail”  [https://cancerletter.com/cancer-policy/20260605_7a/] * Richard Pazdur joins Friends board [https://cancerletter.com/cancer-policy/20260605_7b/] A transcript of this podcast is available: https://cancerletter.com/podcastc/20260610-omb/

Daraxonrasib’s success in treating pancreatic cancer is a reminder that clinical cancer researchers are heroes

At the American Society of Clinical Oncology annual meeting, the plenary sessions are one of the main events. A handful of clinical research studies are chosen from the thousands that are presented at the conference to represent the biggest achievements from the field in the last year.  This year, results from the phase III RASolute-302 trial were the unequivocal highlight of the plenary hall. With an extended standing ovation, the results showed that patients with metastatic pancreatic cancer who were given daraxonrasib, sponsored by Revolution Medicines, had a median overall survival of 13.2 months compared to a 6.7-month OS for those given chemotherapy. A story about the trial will be in the upcoming issue of The Cancer Letter. But in this week’s In the Headlines, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, talk about the buzz that these results are generating. Paul has seen the prognosis of other cancer types—such as  melanoma and multiple myeloma—completely transform after the development of effective drugs.  “I was there when people were saying, ‘Oh, melanoma, forget it.’ But then, suddenly, there was stuff [treatment options]. Melanoma, multiple myeloma—my God, what catastrophe that was. And look at what's happening now. I mean, there's a lot to be said.” Paul said that this is a reminder of the importance of the biomedical research enterprise, and of clinical cancer researchers specifically. In last week’s issue of The Cancer Letter, the cover story was an episode of The Directors, a special segment of The Cancer Letter Podcast, where Paul spoke with two principle investigators of NCI Community Oncology Research Program, or NCORP, sites.  “This is the week where we better take a good look at how well we are treating our clinical researchers. And we better keep looking at it… Seriously, these folks are heroes,” Paul said. “They should be treated well and respected and well funded because guess what? You cannot do ... NCORP brings in about a third of the clinical trials participants. You wouldn't be able to answer the questions we're answering and we better come up with more money for them and continue to come up with more money for them. “You can write about all the rogues in the field all you want, but you know what? There are some really great people who are really moving this field forward and we're all lucky to see this and covering this is a privilege,” Paul said. Stories mentioned in this podcast include: * The Directors: NCORP PIs discuss workforce shortages, expanding workload, and crushing burden of regulatory oversight  [https://cancerletter.com/podcastc/20260529_1/] * When CAM is added to standard therapies, survival rates drop, observational study finds  [https://cancerletter.com/clinical/20260529_2/] * As rural cancer disparities persist, aligning policy with care delivery models can close the gap [https://cancerletter.com/trials-and-tribulations/20260529_3/] * UK Markey’s Denise Fabian: Theranostics lets us pair a diagnostic with a radioactive therapeutic that target the same molecule  [https://cancerletter.com/sponsored-article/20260529_4/] * A modest proposal from a former FDA commissioner: Add antidepressants to the nation’s water supply Warning: This is not a public health recommendation. Do not implement. [https://cancerletter.com/guest-editorial/20240705_3/] A transcript of this podcast is available: https://cancerletter.com/podcastc/20260603-daraxonrasib/

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.