Former White House economist: science has delivered a cancer detection revolution, now the FDA must keep pace

Cancer claims the lives of more than half a million Americans each year, a sobering statistic made even more tragic by the fact that most cancers are discovered too late for effective treatment. Routine screening programs for only a handful of cancers account for less than 10% of all cancer diagnoses in the United States. Nearly 70% of cancer deaths occur in individuals with no recommended screening test available.

Pancreatic, ovarian, liver, stomach, esophageal, and blood cancers are notorious for presenting symptoms only after the disease has advanced, leaving limited treatment options.

New multi-cancer early detection (MCED) tests aim to address this dire situation by analyzing blood samples for signals associated with various cancers, providing a comprehensive screening approach. The FDA will soon decide how to evaluate these novel tests, such as GRAIL's Galleri blood test. While these tests are not perfect, they have demonstrated a much lower false-positive rate (0.4%) and a positive predictive value (60%) compared to established single-cancer screens.

Critics argue that the FDA should demand proof that MCED tests reduce cancer mortality before widespread adoption. However, this standard should not apply to diagnostic tools, as their primary function is to provide accurate information for better decision-making by doctors and patients. Evaluating a diagnostic test based on its ability to improve patient outcomes, rather than merely reducing mortality, is more appropriate.

Moreover, traditional single-cancer screening has not been held to the same standard before adoption. Rigidly applying this standard to MCED tests could stifle progress and harm patients by discouraging the adoption of potentially life-saving information. The questions to consider regarding MCED tests include their ability to detect cancer early, catch diseases before symptoms appear, increase detection in early stages when treatment is more effective, and assess their safety for widespread use.

The potential economic benefits of finding cancer earlier, leading to more manageable treatment and avoiding costly hospitalizations, should also be taken into account.

Ultimately, embracing earlier cancer detection can shift the medical paradigm from a reactive, "wait for disease to declare itself" approach to one that prioritizes prevention, prediction, and early intervention. Armed with earlier knowledge, doctors and patients can act proactively, potentially saving lives and improving outcomes.