NFL Cheerleader → Clinician → Media. Writing on health, culture, ambition + incentives to help you build a life with more options. Content @JoinCrowdHealth
> Meet Frances Kelsey
> Joined the FDA in 1960
> Got assigned a drug application
> For a product sold worldwide
> Thalidomide
> The company wanted American approval
> Said the evidence supported its safety
> Kelsey wasn't convinced
> Asked for scientifically reliable data
> The company kept pushing
> Sent more material
> Pressured her to approve it
> She kept asking for evidence
> Kept the application from going through
> Researchers then found a devastating link
> Thousands of babies had severe birth defects
> Their mothers had taken thalidomide
> The US marketing application never passed
> 1962, President Kennedy honors her work
> Her stand helped change drug regulation
An FDA reviewer asking for better evidence helped prevent a far larger American tragedy.