Study Links Type 2 Diabetes With Higher Risk Of Cancer (++)

Study Links Type 2 Diabetes With Higher Risk Of Cancer A Danish study looked at 27 years of data and found an increase of cancers related to obesity, like colorectal cancer and postmenopausal breast cancer, in people with Type 2 diabetes, Newsweek reported. Between 2010 and 2022, obesity-related cancers were 45% higher in men and 30% higher in women with Type 2 diabetes than those without. Plus: birth control for men, BuzzBallz, peripheral artery disease, and more. https://kffhealthnews.org/morning-breakout/public-health-093026/ Viewpoints: The Current State Of The World Is Wearing Down Our Health; Coal's Real Comeback? Black Lung Disease https://kffhealthnews.org/morning-breakout/viewpoints-the-current-state-of-the-world-is-wearing-down-our-health-coals-real-comeback-black-lung-disease/

GAO: Trump Can't Void Millions That Congress OK'd Spending On HHS Programs (+++)

GAO: Trump Can't Void Millions That Congress OK'd Spending On HHS Programs Following President Donald Trump's Friday announcement that he'd use a “pocket rescission” to cancel more than $800 million in spending approved by Congress for immigrant services and diversity-focused initiatives, the Government Accountability Office let lawmakers know that he's not allowed to withhold funds beyond the end of the fiscal year ending Wednesday, AP reported. Most of the cuts are aimed at Health and Human Services programs that serve refugees and unaccompanied minors accused of being in the country illegally. https://kffhealthnews.org/morning-breakout/immigration-and-race-093026/ Former House Majority Leader Eric Cantor Takes Helm At Powerful Pharma Lobby Group The trade group Pharmaceutical Research and Manufacturers of America has tapped Cantor, a Republican, as its next president, Politico reported. Also: Lawmakers urge the Trump administration to rethink a new federal rule that could keep Americans from getting Canadian meds. https://kffhealthnews.org/morning-breakout/pharma-and-tech-093026/ Despite Safety Claims, Six Flags Shuts Down Thrill Ride Some Allege Caused Brain Injuries The X2 roller coaster at California's Magic Mountain was retired a week after three people sued Six Flags and S&S Worldwide, The New York Times reported. The companies previously settled lawsuits with the families of two people who died after riding the X2. Plus, an Ohio woman has sued Selby General Hospital and her doctors for gross negligence, battery, and reckless conduct after the wrong leg was amputated during surgery. https://kffhealthnews.org/morning-breakout/state-watch-093026/

Health Secretary RFK Jr. Says AI Will 'Free Us From Medical Tyranny' (++)

Health Secretary RFK Jr. Says AI Will 'Free Us From Medical Tyranny' On Tuesday at a MAHA conference, Health and Human Services Secretary Robert F. Kennedy Jr. claimed that artificial intelligence is "better informed than any doctor in the country." He also allegedly agreed with OpenAI CEO Sam Altman, who claimed it would be malpractice for a doctor to make a diagnosis without consulting AI, The New York Times reported. https://kffhealthnews.org/morning-breakout/artificial-intelligence-093026/ Preventive Services' Guidance On Cervical Cancer Screening Was Quashed, Ex-Chair Says "Despite the efforts, the task force has been blocked from publishing even a single recommendation since July 2025," Michael Silverstein wrote in the Annals of Internal Medicine. "This means that primary care providers across the country may be following cancer, heart disease, or other prevention guidelines that are based on outdated evidence, and Americans are possibly being denied insurance coverage for highly effective services." https://kffhealthnews.org/morning-breakout/more-administration-news-093026/

KFF HEALTH NEWS ORIGINAL STORIES (++++)

KFF HEALTH NEWS ORIGINAL STORIES KFF Health News and AP: Rural MAHA Followers Say Trump Health Policies Haven’t Reached Their Communities President Donald Trump has championed sprawling health policy changes under the Make America Healthy Again movement, but a KFF-Associated Press survey of rural voters found people aren’t seeing the initiatives reach their communities. (Swenson, Tribble, and Sanders, 9/30) https://kffhealthnews.org/rural-health/kff-ap-poll-rural-voters-maha-make-america-healthy-again-local-impact-midterms/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--mCZg8wNam2KKOdNMSat2ew-bSh9dX9XSGK9RCrY0sdgOT70NMWBgORssX8AkQRY05v7FOhLdXs3V4WBCdPre-mXHN6w&_hsmi=441803617&utm_content=441803617&utm_source=hs_email KFF Health News: Drugs Are Widely Used To Sedate Dementia Patients. Her Sons Wanted To Keep Her Off Them In December 2024, Marjorie Tingley’s adult sons received an urgent email from the dementia care unit at Vista Grande Villa, a Michigan senior living community. They were told that their 85-year-old mother was a major safety threat. On at least 10 days the previous month, Tingley had hit, kicked, or elbowed aides when they were trying to help change her briefs, get dressed, bathe, or go to the bathroom, according to Vista Grande behavior logs. Vista Grande wanted permission to sedate her. (Rau, 9/30) https://kffhealthnews.org/aging/dementia-drugs-antipsychotic-dangers-memory-care-seniors-alzheimers-michigan/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-8amkn8j2btRbpAT64xxlhn7pfHY613va06Rq_24qHB2sgFRda2Hl9OQgrruAiWWY4qRZxMigg2akaEWC8KC4Vd2w_P1A&_hsmi=441803617&utm_content=441803617&utm_source=hs_email KFF Health News: US Poised To Boot Legal Immigrants From Medicaid, Including Refugees And Sex-Trafficking Victims Hundreds of thousands of immigrants with legal status are at risk of losing government health coverage starting Oct. 1, state data shows, signaling that the impact of Medicaid changes in President Donald Trump’s signature legislation from 2025 may be greater than anticipated. Many lawfully present immigrants will be among the first people to lose Medicaid coverage under congressional Republicans’ One Big Beautiful Bill Act, which is expected to cut spending by more than $900 billion through 2034 for the state-federal health program for people with low incomes or disabilities. The law will strip many more immigrants of their Affordable Care Act plan subsidies and Medicare coverage next year. (Galewitz, Jones and Boyd-Barrett, 9/30) https://kffhealthnews.org/health-industry/immigrants-kicked-off-medicaid-refugees-asylum-seekers-trump-big-beautiful-bill-cbo-2/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--eb3Ur0WyJ1q9CvijtiooQrlqVlKLhf-72KGeB-3WE6z8HDCobCItrgSnFGqGSM_O-ojlzDkdI_hlwzkBR28K60KEjuw&_hsmi=441803617&utm_content=441803617&utm_source=hs_email KFF Health News: These 100 Nursing Homes Face Perilous Flood Risk. Minnesota Shows What Can Happen Floodwater seeped through the nursing home’s front door just before sunrise. Inside the New Richland Care Center, staff members rushed to move 36 residents out of the building on Sept. 19 while they still could. They pushed elderly residents in wheelchairs through 4-inch-deep water to buses waiting in the parking lot, said nursing home administrator Robert Johannsen. (Kelman, Hacker, Chang, McLister and Rantala, 9/30) https://kffhealthnews.org/public-health/nursing-home-flood-risk-analysis-minnesota-evacuation/?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-83DCLRY6Yd1K5dm0qNsKxjOjqCy9trXwZG5kv0X4LikRcnbjESAciPVgwgAro8C3WxMeQO9ZvCGBzCCf5ap_KVHMnFDw&_hsmi=441803617&utm_content=441803617&utm_source=hs_email

Advancing Regulatory Science (+++++) INFORMATION ABOUT FDA'S REGULATORY SCIENCE RESEARCH

Advancing Regulatory Science https://www.fda.gov/science-research/science-and-research-special-topics/advancing-regulatory-science?utm_medium=email&utm_source=govdelivery Regulatory Science is a field of scientific research focused on developing the tools, standards, and approaches needed to generate the data and information on which FDA assesses the safety, efficacy, quality, and performance of FDA-regulated products. Advances in regulatory science are critical to support regulatory decision-making and to help enable the translation of discoveries in science and technology into safe and effective medical products. FDA: Overview of our Role Regulating and Approving Drugs | Video Series https://www.fda.gov/drugs/information-consumers-and-patients-drugs/overview-our-role-regulating-and-approving-drugs-video-series?utm_medium=email&utm_source=govdelivery FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. Learn more. CDER Office of New Drugs- Regulatory Science Research https://www.fda.gov/about-fda/cder-offices-and-divisions/office-new-drugs-regulatory-science-research The Office of New Drugs (OND)-led regulatory science research projects are designed to address knowledge gaps identified during regulatory review of investigational or new drug applications. Learn more. CDER Office of Generic Drugs- Science and Research https://www.fda.gov/drugs/generic-drugs/science-research?utm_medium=email&utm_source=govdelivery The Office of Research and Standards within the FDA's Office of Generic Drugs (OGD) supports the Science and Research program established under the Generic Drug User Fee Amendments (GDUFA). In collaboration with industry and the public, FDA creates an annual list of its regulatory science initiatives on generic drugs. Learn more. Research Tools and Resources https://www.fda.gov/drugs/science-and-research-drugs/research-tools-and-resources?utm_medium=email&utm_source=govdelivery Developing and sharing knowledge and scientific resources with researchers in the public and private sectors is at the heart of what CDER scientists do. Learn more.

A Novel Stratum-Specific Trial Design Improves Statistical Power for Rare Diseases with Heterogenous Clinical Symptoms September 22, 2026

https://www.fda.gov/drugs/regulatory-science-action/impact-stories?utm_medium=email&utm_source=govdelivery A Novel Stratum-Specific Trial Design Improves Statistical Power for Rare Diseases with Heterogeneous Clinical Symptoms Clinical trials for rare diseases face significant statistical challenges: small patient populations limit enrollment and the heterogeneous clinical presentations common to many rare diseases further reduce statistical power by making it difficult to identify a single primary endpoint applicable to all participants. Traditional trial designs either enroll all patients using uniform endpoints regardless of their symptoms or restrict enrollment to patients experiencing all symptoms under investigation — both approaches can substantially limit a trial's power. To address these challenges, CDER statisticians developed a novel stratum-specific trial design in which patients are grouped into subpopulations based on the symptoms they experience at baseline, and treatment efficacy is evaluated using only the endpoints relevant to each patient's subpopulation. Using computer simulations, researchers compared this design against traditional global test approaches and found substantial gains in statistical power for a given subpopulation size — meaning fewer total patients are needed to achieve the same level of evidence as a traditionally designed trial. When followed by the Hochberg method for multiple testing correction, the design also maintained reasonable power to draw conclusions about treatment effects on specific symptoms. The stratum-specific design has important limitations, including a weaker interpretation of significant global test results compared to traditional trials, and an assumption of well-defined, accurately categorized subpopulations at baseline that does not account for patient misclassification or post-randomization symptom changes. Despite these limitations, CDER researchers suggest this framework offers a valuable and flexible paradigm for rare disease drug development, with the potential to support more efficient clinical trials and strengthen the evidence base for regulatory approval of effective therapies. Sponsors are encouraged to explore this design further through FDA's Complex Innovative Trial Design Meeting Program and the LEADER 3D initiative. Advancing Regulatory Science https://www.fda.gov/science-research/science-and-research-special-topics/advancing-regulatory-science?utm_medium=email&utm_source=govdelivery

C3TI Demonstration Program CDER Center for Clinical Trial Innovation (C3TI) (+...)

https://www.fda.gov/about-fda/cder-center-clinical-trial-innovation-c3ti/c3ti-demonstration-program?utm_medium=email&utm_source=govdelivery CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program Fosters Early Engagement with Drug Developers on Innovative Clinical Trial Approaches The CDER Center for Clinical Trial Innovation (C3TI) Demonstration Program provides an opportunity for drug developers to test and scale the integration of innovative approaches to clinical trial design and conduct. In this program, clinical trial sponsors can engage early with CDER review teams and subject matter experts in a structured and direct manner on innovative trial elements. A key objective of the C3TI Demonstration Program is to share insights related to the innovative elements of selected trials with the broader clinical trial community. To support this goal, participating sponsors and FDA will agree on what aspects of the development program can be shared publicly. Generally, participating sponsors will be expected to share select details of their clinical trials and the implementation of innovative approaches as the trials progress. This may include updates and insights that focus on general principles and innovative aspects while maintaining the necessary confidentiality of proprietary or sensitive information. The Demonstration Program accepts projects on a rolling basis and is open to selected sponsors conducting innovative clinical trials under a pre-investigational new drug application (pre-IND) or IND with CDER. These trials should be intended to support new drug approvals or changes to approved drug labeling. C3TI currently has three demonstration project areas: Bayesian Statistical Analysis Selective Safety Data Collection Streamlined Trials Embedded in clinical Practice More information about C3TI and its demonstration program, including eligibility criteria and how to submit a proposal, is available on the C3TI webpage. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti?utm_medium=email&utm_source=govdelivery