Betting platforms Kalshi and Polymarket are now taking wagers on whether the FDA will approve treatments for lung, breast, pancreatic and blood cancers this year, with Kalshi also planning to let users bet on clinical trial outcomes.
Kalshi launched the pilot July 16, starting with 13 contracts tied to trials and FDA decisions for drugmakers including Sanofi and Gilead Sciences. Specific markets include whether AR1001’s Polaris-AD Phase 3 trial will meet its primary endpoint in early Alzheimer’s disease, whether the FDA will approve Gilead and Arcellx’s anito-cel for relapsed or refractory multiple myeloma, and whether the agency will approve camizestrant for advanced breast cancer.
The move has drawn pushback from researchers, physicians and patients, who argue the markets could compromise study integrity, invite undetected insider trading and erode public trust in the drug development process, according to a July 28 New York Times report. Former FDA Commissioner Robert Califf, MD, told The Times allowing betting on an active randomized trial amounts to a breach of scientific conduct, warning that a public market signaling a study is likely to fail could prompt participants to drop out or unconsciously influence trial staff behavior.
Kalshi said it is restricting bets to late-stage trials that have finished enrollment, verifying traders’ employers, and barring wagers by trial staff, data monitors, FDA regulators, drugmaker employees and enrolled patients, according to its release. However, critics countered that Kalshi lacks access to full trial staffing rosters, leaving gaps in enforcement.
The debate comes as the Commodity Futures Trading Commission, under a Trump administration seen as broadly permissive toward prediction markets, weighs new rules for blocking wagers deemed contrary to the public interest.
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