Frances Kelsey

Where are the modern-day Kelsey’s when you need them?

Fifty years ago, Frances Kelsey revolutionised the regulation of prescription drugs. As a new FDA employee, she reviewed Kevadaon, known as thalidomide. She questioned the drug's safety:  "It just came with so many extravagant claims that I didn't believe," she said.

Kelsey took a stance against inadequate testing and corporate pressure, refusing to approve thalidomide’s release in the US. Her stance came in the first month of her job at the FDA; it was her first assignment. In 1960, Kelsey was concerned by data suggesting dangerous side effects in those who took the drug repeatedly.

"We were concerned about the non-absorption," said Kelsey. 

"That you could give enormous amounts, both to animals and humans, without toxicity. We felt that there might be conditions, illnesses, or other drugs that might change the absorption, and toxic effects might appear." 

"The clinical reports were more on the nature of testimonials, rather than the results of well-designed, well-executed studies,"

But K…