In last week’s issue of The Cancer Letter, the cover story featured coverage of Kalshi, an online prediction market exchange, launching a pilot program in which one can place bets on both outcomes of trials and FDA decisions. 

In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher with The Cancer Letter, and Jacquelyn Cobb, associate editor, discuss the Kalshi’s entrance into betting on clinical trials and drug development. 

“This is worth reading. I mean, this is, for those who still drink, definitely an excellent accompaniment to a Scotch. It will go well with Scotch,” Paul said. “Even though I prefer vodka, this will go with Scotch.”

A big chunk of the story about Kalshi was made up of the answers to a three-question survey that The Cancer Letter administered to members of the oncology community. 

In the podcast, Jacquelyn and Paul recalled one answer they found particularly enjoyable.

“Prediction markets are another opportunity to violate the law, but, if used correctly, there should not be a problem. Overall, I don’t think this is problematic for society, but certainly creates another opportunity for my colleagues to lose money and go to jail,” Mark Ratain, director of the Center for Personalized Therapeutics, the Leon O. Jacobson Professor of Medicine, chief hospital pharmacologist at University of Chicago Medicine, said to The Cancer Letter in last week’s cover story. 

This episode is sponsored by City of Hope. Learn more at www.cityofhope.org.

Stories mentioned in this podcast include:

• Prediction markets now allow betting on clinical trial results, FDA decisions It’s a high-risk bet: Insider trading, equipoise, integrity of research, public trust are at stake 

• Trump plans a 200% tariff on imported generic drugs by 2029, raising fears of cancer drug shortages

• Retraction is not refutation: Why chrono-immunotherapy still deserves scientific investigation 

• Joseph F. Fraumeni Jr., inventor of molecular epidemiology, was a “gentle giant” who “bet on the good people” Chanock and Brawley reflect on their illustrious mentor 

• FDA’s OCE publishes three final guidances to increase clinical trial enrollment

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260805-predictionmarkets/ 

Last week, the Pentagon posted a video on X announcing they will be mandating testosterone screening for troops in the military aged 30 and above. If they test low, they will be offered voluntary testosterone replacement therapy.

At the same time, FDA has announced it will be loosening safety warnings on the labels for testosterone replacement therapy. The primary evidence base to guide that decision is cited as the 2023 TRAVERSE trial.

However, screening experts, endocrine specialists, and even the first author of the TRAVERSE study said that this trial was not designed to study the effectiveness of long-term TRT use. It was designed to look primarily at cardiovascular risk.

The big issue isn’t TRT use itself, it is the overinterpretation of evidence to broaden the use of TRT therapy in people who may not need it. 

“The risks of over testing, over treatment, over diagnosis—cannot be overstated,” said Claire Marie Porter, a reporter with The Cancer Letter. 

Should one screen an asymptomatic population for a condition that no major medical society recommends screening for? That's where many experts draw the line. 

In this episode of The Cancer Letter Podcast, Claire and Jacquelyn Cobb, associate editor of The Cancer Letter, discuss the implications of overuse of TRT, in oncology and otherwise.

“Anxiety is not the only consequence of overscreening,” Jacquelyn said. “There are actually potential health outcomes that could come from over screening. And I think that's sort of the missing link, that there could be harm introduced that was not necessary.”

Some of those harms could include fertility decrease, prostate changes, hormone suppression, and more. 

“If you are on testosterone replacement therapy for long periods of time, your pituitary glands will stop making it,” Claire said. “Increased PSA testing will likely happen—the Endocrine Society recommends it—which means more biopsies, more false positives, more anxiety, and just decades of treatment beginning in your thirties.”

TRT has an accepted role for men with diagnosed hypogonadism, but population-wide testing is a very different policy, experts say. 

“Many sources were like, this is basically an uncharted, natural, human experiment,” Claire said.

This episode is sponsored by the American Society of Clinical Oncology. Learn more at asco.org/ascoaction.

Stories mentioned in this podcast include:

• Cancer hospitals brace for impact, as CMS moves to slash 340B payments by 33%

• Hegseth orders testosterone testing for troops as FDA moves to loosen TRT prostate cancer warnings

• The Susan Wojcicki Foundation pushes for rethinking of strategies for early lung cancer detection

• Gary Morrow, a pioneer in supportive oncology, dies of prostate cancer complications at 82

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260729-trt/

FDA has been taking a look at psychedelics as a potential treatment for psychiatric and substance abuse disorders, recently publishing a final guidance for drug sponsors conducting clinical trials of psychedelics, including psilocybin, LSD, and MDMA. 

“This is of interest to psycho-oncologists that have been looking into this question for at least two decades around cancer-related anxiety, depression, and PTSD,” said Sara Willa Ernst, a reporter with The Cancer Letter. “Could psilocybin specifically be a treatment to help cancer patients and cancer survivors deal with psychological distress that comes from a cancer diagnosis?”

However, regulatory challenges emerge when FDA is tasked with evaluating a treatment that may (or may not) rely on both a drug and a psychotherapy component to improve outcomes. In this episode of The Cancer Letter Podcast, Sara and Paul Goldberg, editor and publisher of The Cancer Letter, discuss the tricky regulatory landscape facing psycho-oncologists. 

“FDA does not regulate psychotherapy,” Sara said. “I think a lot of the sources, the clinical trialists I talked to said, admittedly, ‘This is kind of a weird space for FDA to approve or not approve.’”

But psycho-oncology experts with experience administering psychedelic therapy are almost uniformly convinced that the psychotherapy component is critical to the treatment’s efficacy. Most of Sara’s sources ended up “echoing the same thing—that the psychotherapy component is very crucial,” she said. 

While FDA is staying in its lane and remaining agnostic to a question for which there is not yet satisfying data, Sara said her sources are concerned about what that might mean for the development of the field.

“FDA has opened the door—at least in the final guidance—to applications that kind of de-emphasize the psychotherapy aspect. So, that might be a whole lot cheaper for a pharmaceutical company that is trying to bring a drug to market to go in that direction as opposed to the real hefty lift of a factorial design trial [to demonstrate the role of psychotherapy],” Sara said.

“A lot of methodologists are having a lot of fun deciphering this,” Paul said. “How do you go forward with this? Could be very interesting.”

This episode is sponsored by the University of Kentucky Markey Cancer Center. Learn more at ukhealthcare.com/markey.

Stories mentioned in this podcast include:

• The Directors: Two leaders in data science have a warp speed vision for AI, with cancer clinical trials leading the way Knudsen and Thoelke

• FDA final guidance on psychedelics opens the door to psycho-oncology research

• OMB proposal to sideline peer review sparks widespread opposition

• Cancer progress is not reaching everyone. Native Nations must be part of the solution.

• The future of oncology: Early-career scientists need mentorship and a new academic model

A transcript of this podcast is available: cancerletter.com/podcastc/20260722-psychedelics/ 

The United States has a translation problem. Scientific breakthroughs in oncology are accelerating, but clinical trial infrastructure hasn’t kept pace. 

The solution: Speed up clinical trial enrollment by using AI to reduce costs and eliminate bureaucratic red tape. Tasks that ordinarily require hours of manual work for each patient in a single study can now be completed for 100,000 patients in a matter of minutes. 

“If we really do have this problem of translating science to people because of the lack of resourcing and efficiency on the clinical trial side, then I don’t view innovation outside the U.S. as a bad thing. I actually think it’s a great thing, and it’s great for people who are getting access to these clinical trials,” Karen Knudsen, CEO of the Parker Institute for Cancer Immunotherapy, said on the July episode of The Directors. 

For years, U.S.-based pharma and biotechnology companies have been offshoring clinical trials to manage labor costs, avoid regulatory burdens, and gain access to larger patient populations that can make recruitment easier. 

In this episode of The Directors, Knudsen and Kent Thoelke, CEO of Paradigm Health, a technology company focused on using AI to enhance clinical trials, discuss the factors that are bottlenecking translation in the U.S. and the promising role of AI in modernizing the U.S. clinical trial infrastructure. 

A transcript is available at https://cancerletter.com/podcastc/20260717_1/

The cover story in last week’s issue of The Cancer Letter featured a retraction of a Nature Medicine paper demonstrating that giving patients immunochemotherapy before 3:00 p.m. led to massive improvements in overall survival and progression-free survival.

In this week's episode of The Cancer Letter Podcast, editor and publisher Paul Goldberg, and associate editor Jacquelyn Cobb revisit the high-profile retraction.

The retracted study, one of the first to provide prospective, randomized data on the topic of chronomedicine in cancer immunotherapy, was retracted due to a litany of errors that began to be flagged by the scientific community nearly immediately after the study was published.

“When you come up with results, which these folks did, that are really just unbelievably cool and immediately in principle applicable in the clinic, of course, everybody's going to check them. And if you have any booboos in there, they'll find them,” Paul said. 

While the cover story in last week’s issue ended up including a sort of “love letter to the scientific process,” with sources Jedd D. Wolchok and Rachel Humphrey proclaiming that the snafu was in fact a signal that the scientific process is working, Paul had his own take on the issue.

“My question with something like that always is the same. And I've done a lot of stories about these kinds of booboos and retractions,” Paul said. “The question is the process works, as you say, but sometimes the process really should be prevented from having to work, because if you've got ... What's the French word? Dreck, that should be obviously found in peer-review. Just leave the process, let the process concentrate on something bigger, which I think is what we had here. And as you guys were rhapsodizing about how wonderfully the process worked, my kishkes were grinding. And that's another French word, I'm sorry.”

“Rachel talks about this, how you throw it out to the community. But I think there's a hygiene question. What do you throw out to the community? Sometimes you want to spare the community. I do believe that in this case we see ... This is just my opinion, I think we see a failure of Nature Medicine to properly peer review this thing and save embarrassment to the investigators who sound like reasonable people. And the community. I mean, of course, ultimately it's really sparing the patients the nonsense.”

This episode is sponsored by City of Hope. Learn more at www.cityofhope.org.

Stories mentioned in this podcast include:

• A chronotherapy study in Nature Medicine showed dramatic results. Then it was retracted. The phase III trial claimed a staggering boost to OS and PFS when immunochemotherapy was given before 3 p.m.

• OMB’s plan to increase political control of science faces stiff opposition on Capitol Hill

• Saving Western Kenya’s pediatric blood cancer patients How flow cytometry is changing the diagnostic landscape

• The challenge of making the move from conversational AI to autonomous scientific discovery Advancing from level II to level III AI agents in precision medicine

• The long life of a clinical trial How JCO sustains landmark oncology research

• FDA halts public release of Complete Response Letters, following citizen petition 

A transcript of this podcast is available: cancerletter.com/podcastc/20260715-retraction/  

In this week's episode of The Cancer Letter Podcast, editor and publisher Paul Goldberg, and associate editor Jacquelyn Cobb revisit two of last week’s most-read stories: the growing recognition that early-onset colorectal cancer requires a new diagnostic mindset, and the life and legacy of Maura Gillison, the scientist whose discovery that most head and neck cancers are driven by HPV transformed the field. 

The cover story follows Jenna Scott, who was diagnosed with stage 4 colorectal cancer a year after giving birth to her son. Her cancer was repeatedly missed because its symptoms—rectal bleeding, abdominal pain, nausea—overlapped with those of pregnancy and the postpartum period. Researchers say her experience is indicative of a larger phenomenon: early-onset colorectal cancer increasingly appears to be a biologically distinct disease, affecting younger, otherwise healthy patients and often presenting at a more advanced stage.  

“It's a time of patient advocacy, which has been going on really through most of my career, but patient stories really need to get out and be told,” Paul said. “I think that is a bit of a change now because at this time when science is in jeopardy, hearing from patients is very, very important.”

This episode of the podcast also covers the legacy of Maura Gillison, who died on June 21 at age 61. Her groundbreaking research established that HPV causes the majority of head and neck cancers, fundamentally changing how those cancers are understood and treated. 

“I'm going to steal a factoid that you mentioned earlier, Paul, but it's like 70% of head and neck cancers are caused by HPV. So, the magnitude of the effect is really huge here. The numbers are huge,” said Jacquelyn.

Stories mentioned in this podcast include:

• Early-onset colorectal cancer is behaving like a new, biologically distinct disease, researchers note. One woman’s pregnancy shows how this distinction matters

• Maura Gillison, who identified the role of HPV in head and neck cancer, changing the standard of care, dies at 61

• Is it time to re-assess the practice and practicality of screening colonoscopy? Modeling data in ACS guideline support greater use of noninvasive tests to ease system strain, save lives

• More than 50 million Americans remain unscreened for colon cancer. New guidelines offer another option

A transcript of this podcast is available: cancerletter.com/podcastc/20260708-legacy/ 

In this week’s episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Sara Willa Ernst, reporter, break down HHS’ latest vision for the future: Operation Trailblazer. 

The report is titled: “HHS Roadmap to Maintaining U.S. Leadership in Early Clinical Research and Development.”

“The U.S. is apparently losing its leadership in INDs and early phase research,” Paul said. “Some of it is true and also it does not help that the whole enterprise of cancer research right now is in, if not disarray, then at least a kind of mental and spiritual discombobulation.”

Most notable were proposed changes to FDA, including an expedited Investigational New Drug program, which would use expertise outside FDA to help prepare INDs before submission, and a lower threshold—just one high-quality late-stage—for confirmatory evidence, which is already common practice in oncology. 

Paul checked in with sources about the report after it was released. What he heard with his ear to the ground: It’s unclear whether the plans in the report will amount to policy. 

“We don't know whether it's going to happen and there is a problem right now in that FDA really took a hit in terms of staffing,” Paul said. “At the moment, there is no permanent FDA commissioner. Having leadership that's deeply destabilizing was really a problem.”

“FDA really right now needs to get its house in order or as the industry says, ‘right the ship,’” he continued. “A rudderless FDA for a while there was a step in the wrong direction. So, they're going to have to clean this up and maybe they will. Let's hope they do.

“That's what I'm hearing from folks as I call them. But it was important to get [the news] out on paper even though the story certainly has a large number of caveats.”

Stories mentioned in this podcast include:

• The Directors: Directors of two Midwestern cancer centers tell us about the challenging healthcare economics in rural areas

• To keep the early clinical trial enterprise in the U.S., HHS pledges to simplify regulatory requirements

• Joe Fraumeni, founder of molecular epidemiology, dies at 93

• Karen Huntsman’s vision gave shape to the Huntsman Cancer Institute

• Robert Mayer tells us about pancreatic cancer’s hopeless past as new data shows promise

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260701-operation-trailblazer/

“Institutions are feeling crunched at so many different directions”

How’s this for a paradox:

The better cancer centers become at keeping patients alive, the more expensive cancer care becomes.

This brutal tradeoff hits harder in rural areas, where the cancer burden is higher and the investigator and clinical trial representation is lower. The federal budget introduced last summer dealt Medicaid a mighty blow, which is expected to cause a spike in the number of uninsured Americans over the next decade (The Cancer Letter, July 3, 2025). 

In the June episode of The Directors, two Midwestern cancer center directors, University of Iowa Holden Comprehensive Cancer Center Director Mark Burkard, and University of Minnesota Masonic Cancer Center Director Jeffrey Miller, discussed the financial and logistical challenges confronting cancer care outside major metropolitan hubs. 

“We had a Medicaid expansion in Iowa, and that supported what's called the directed payment program (Medicaid State Directed Payments) and that's being phased out over 10 years,” Burkard said. “I think it's going to affect rural hospitals and hospitals in underserved areas even more. And some money was put back into the rural transformation funds of which our state got $209 million. But we're looking at, basically, over the next 10 years, it's a billion-dollar cut from our health system. So, we're trying to figure out how to tighten our belts to make up for that difference as a health system.”

Driven by the One Big Beautiful Bill Act and subsequent CMS regulations, these changes cap supplemental payments and are expected to significantly reduce federal Medicaid spending over the next decade.

The effect of the financial tightening is systemic. Even the paths taken by junior faculty members are affected.

“It used to be that you could creatively dabble as a junior faculty, and then figure out how to develop your career,” Miller said. “But now, they want you to do it in pretty much three years. You get three years of unrestricted time, and then you’ve got to go out into the world and say, ‘How am I going to support my salary?’"

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. 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 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.”

This episode is sponsored by ASCO. Learn more at asco.org/ascoaction

Stories mentioned in this podcast include:

• Is psilocybin heading to a cancer clinic near you?

• What NHS-Galleri taught us—and what it didn’t

• The NHS-Galleri trial has and will continue to provide critical insights to refine future MCED studies

• FDA clears a way for dramatic reduction in animal toxicology studies in cancer

• Proposed OMB rule aims at the heart of the U.S. research enterprise—and scientists are fighting back

  
  
  

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

• House bill gives NCI $7.4 billion in FY 2027—$110 million above current budget 

• As his Senate testimony alleged danger from mRNA COVID vaccine, El-Deiry had an offer to run NCI Frederick lab

• Lessons from the AIDS Quilt: what the cancer world can learn from AIDS advocacy 

• Former NCI official's nonprofit seeks to tell the stories of cancer patients 

A transcript of this podcast is available: https://cancerletter.com/podcastc/20260617-petergarrett/