John Stanford

speaker
1,479 appearances 11 recordings 1 series first heard May 2026 last heard 13 Aug

John Stanford’s voice in public audio — every appearance, attributed to the second.

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recordings per month · last 12 months
4 · Jul OctJan 26AprJulnow

Recordings per month over the last 12 months — 11 in all, peaking in Jul 2026 with 4.

Appearances

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His name was Francis Oldham Kelsey.
A pharmaceutical company repeatedly sought permission to sell thalidomide in the United States as a sedative.
Kelsey was unconvinced by the safety evidence and resisted pressure to approve it.
Overseas, thalidomide was linked to severe birth defects in thousands of children.
But Kelsey's insistence on better evidence largely kept the drug off the American market.
The episode led to the nineteen sixty two Cafauver Harris Amendments, which required manufacturers to provide substantial evidence that medicines were not only safe, but effective.
This sets the groundwork for what we talk about today.
How many times on making medicine has a guest talked about safety and efficacy?
It's really telling to think back to that moment in time.
When this became a real part of how we think about medicine today.
And it's an important part of the story.
Regulation and innovation are not necessarily opposites.
Trustworthy standards can make innovation more valuable by giving patients confidence that a medicine has been seriously evaluated.
So we should be grateful as we walk through this history lesson about the time and energy Francis Kelsey must have taken.
And pushed back to prevent a drug that actually had devastating consequences on children from making it to the American market.
It was an important time for those standards to be taking shape, because at the exact same time, medicine was beginning to accomplish things that earlier generations might simply have called miracles.
Consider diabetes.
Before insulin, a child with type one diabetes was often placed on a near starvation diet in an attempt to prolong life.
The treatment could buy time, but frequently only months.
The disease was effectively a death sentence.
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