Aggregated News
A momentous act of prudence stands out as the US Food and Drug Administration’s shining hour. In 1962, pharmacologist Dr. Frances Oldham Kelsey refused to approve the German drug thalidomide for the prevention of insomnia and morning sickness in pregnant US women, even though it had been distributed in Europe since 1957 by the German drug firm Grünenthal. Kelsey, now 96, gave thalidomide a thumbs-down because she determined that the safety tests had been performed incorrectly. In doing so, she - and a supportive FDA - defied Merrell-Richardson, the pharmaceutical company that wanted to market it to the lucrative US market and threatened lawsuit in response.
Kelsey was correct. Thalidomide proved horribly unsafe, a teratogen that crosses the placental barrier and caused birth defects in 10,000 children in 46 countries. The children of women who took thalidomide were born with gross injuries including phocomelia, which is characterized by internal organ damage and missing or dramatically shortened limbs.
But only 16 American children suffered phocomelia, and the FDA takes justified pride in having saved Americans from sharing in this global tragedy....
Kelsey was correct. Thalidomide proved horribly unsafe, a teratogen that crosses the placental barrier and caused birth defects in 10,000 children in 46 countries. The children of women who took thalidomide were born with gross injuries including phocomelia, which is characterized by internal organ damage and missing or dramatically shortened limbs.
But only 16 American children suffered phocomelia, and the FDA takes justified pride in having saved Americans from sharing in this global tragedy....