Pro Publica: Why Drug Testing’s Omission of Pregnant Women May Have Led to Zofran Birth Defect Injuries

California Parents File Zofran Lawsuit Against GlaxoSmithKline

Pro Publica has published a lengthy article exploring how the medical establishment’s long-standing approach to “protecting” fetuses by restricting testing on pregnant women has resulted in a critical shortfall of knowledge. While the intention was mostly good — to protect women and babies from the kind of severe birth defects and other harm caused by thalidomide and other drugs in the 1960s and ‘70s (but also to protect pharmaceutical companies from legal liability for those injuries) — the result is less certain. By excluding women — and pregnant women in particular — from clinical trials, doctors have been forced into prescribing untried medications “off-label” to pregnant women, with results that can lead to serious negative health consequences for mothers, and birth defects for babies. [Read more…]