As reports about alleged corruption in science surface, following news over the years of the disturbing side effects of potent pharmaceuticals, it is really heartwarming to read the story of Frances Kelsey, US FDA drug regulator, who recently died.
Merrell, an Ohio company, licensed thalidomide from Grünenthal of Germany and it had been available in Europe for years; Merrell expected its application for US approval would be swiftly rubber-stamped, as did Kelsey’s bosses.
After asking ‘questions that regulators elsewhere failed to’ as the FT put it, she became concerned about the lack of evidence to prove the safety of using thalidomide when prescribed to pregnant women for morning sickness.
She was still demanding answers when reports started to emerge from Europe of a link to infants born with missing or deformed limbs. The earliest case involved a girl born with no ears on Christmas Day 1956 — the daughter of a Grünenthal employee. Eventually thalidomide caused birth defects in more than 10,000 people around the world.
Wiki: “Mercédes Benegbi, a thalidomide victim and the head of the Thalidomide Victims Association of Canada, praised Dr. Kelsey for showing strength and courage by refusing to bend to pressure from drug company officials, and said “To us, she was always our heroine, even if what she did was in another country.”
The FT reports that Jerry Avorn, professor at Harvard Medical School, says thalidomide showed the need for regulators to maintain a sceptical approach in the face of industry pressure. “She was vilified as a pointy-headed bureaucrat; someone pushing a pencil and stifling innovation.”
He fears that renewed pharma lobbying to relax regulation is threatening Kelsey’s legacy.