Trump FDA Uses TreeScan in 10-Week Mifepristone Review as Secrecy Draws Fire
Updated
Updated · POLITICO · Oct 15
Trump FDA Uses TreeScan in 10-Week Mifepristone Review as Secrecy Draws Fire
1 articles · Updated · POLITICO · Oct 15
Summary
A court filing last week showed the FDA is using TreeScan to review mifepristone safety through 70 days of gestation, part of a Trump administration study launched more than a year ago.
TreeScan mines Sentinel electronic health records and insurance-billing data for unexpected adverse-event signals, letting the agency search broadly rather than testing only preselected side effects.
Martin Kulldorff, the software’s developer, is known for opposing Covid-19 mitigation measures; it is unclear whether he has any direct role in the abortion-pill review.
Experts said the approach could be comprehensive, but Sentinel relies heavily on insurance claims and any safety signal would still need follow-up study to rule out confounding factors.
The disclosure came in Louisiana litigation over FDA mifepristone rules, amid pressure from anti-abortion activists seeking tighter limits and criticism from both sides over the review’s secrecy.