Federal policy changes implemented by the Trump administration have impacted childhood cancer research and the availability of clinical trials, particularly for diffuse intrinsic pontine glioma (DIPG), a highly fatal brain tumor.
Impact on Patients and Families
Jenn Janosko, a former pediatric oncology nurse, sought clinical trials for her four-year-old daughter, Izzy, who was diagnosed with DIPG. A trial designed by Izzy's neurosurgeon at Memorial Sloan Kettering was halted due to administrative changes. Nikki Owens faced similar challenges in securing trials for her nine-year-old daughter, Kinlee, also diagnosed with DIPG, following reported NIH funding cuts.
Policy Changes and Their Consequences
Key policy shifts and events contributing to the research challenges include:
- Project 2025: A report by the Heritage Foundation advocated for significant changes, including a reduction in the National Institutes of Health's (NIH) role in directing research.
- Budgetary Leadership: Russell Vought, appointed as the government's top budget official, implemented policies affecting the NIH.
- Spending Bill Failure: Public statements by Elon Musk preceded the failure of a bipartisan spending bill in Congress, leading to the removal of provisions that would have increased child cancer research funding.
- Funding Freeze: A funding freeze was imposed on federal agencies, including the NIH, resulting in the cancellation of hundreds of medical grants and disruption to clinical trials for various conditions.
- Grant Approval Rates: The approval rate for peer-reviewed federal research grant applications was reduced from the top 9% to 4%.
- Consortium Closure: In August, the Trump administration announced the withdrawal of support from the Pediatric Brain Tumor Consortium (PBTC), an alliance of 16 leading children's hospitals in the US and Canada. All funding for PBTC is scheduled to end in March, stopping many promising clinical trials for new patients.
Research and Trial Setbacks
These policy changes have resulted in several research setbacks:
- Souweidane's Trial: Dr. Mark Souweidane's catheter delivery trial for DIPG, which had shown promising early results, was among seven cutting-edge clinical trials closed to new patients due to the PBTC's closure.
- Car T-cell Therapy: Janosko encountered closed doors for Car T-cell therapy trials for DIPG. A trial at Texas Children’s Cancer Center was suspended, Stanford Medicine was accepting only one new patient per month, and Seattle Children’s hospital had a waiting list of over 50 children.
- mRNA Vaccine Research: Dr. Eugene Hwang and Elias Sayour's mRNA vaccine research for DIPG, which showed tumor reduction and destruction in mouse models, faced setbacks after their grant application, originally in the top 7%, fell outside the new 4% approval threshold.
- Flag 3 Drug: Flag Therapeutics' experimental drug, Flag 3, cancelled plans for a clinical trial due to the loss of a funding stream from a voucher scheme that failed to pass Congress.
- Laboratory Impact: Research laboratories across the country reported hiring freezes, affecting their capacity to analyze clinical trial data and address critical research questions.
- Communication Challenges: Scientists privately circulated advice to avoid using the term