The Lab · Autumn 1960 · The US Food and Drug Administration
Frances Kelsey and thalidomide: approve it, or ask again?
What do you do?
The case
Told from where the person who decided stood. In the game each line is written into a drawing as you tap.
- You are a doctor, one month into a new job checking drugs for the government. They give you an easy file to start with.
- It is a sleeping pill, already sold across Europe and in Canada. Doctors give it to pregnant women for morning sickness.
- The law gives you sixty days. If you raise no objection, the drug is approved without you.
- The company’s evidence is thin: doctors’ praise, few real studies. Nothing shows it is dangerous. The company’s men call, visit, and complain to your boss.
The two calls
- Approve it.Millions take it already. You have no evidence against it, and the pressure stops.
- Ask for more data.Again, for as long as it takes. You cannot say what is wrong with it. The company is furious.
Make the call in the game Free. No account. Two minutes.
What happened
Frances Kelsey kept asking for data, for more than a year. The drug was thalidomide.
In November 1961 thalidomide was linked to severe birth defects and withdrawn in Germany. It was never approved in the United States.
In 1962 the President gave Kelsey the country’s highest award for a civil servant.
Source: University of Chicago Medicine (2015). How a courageous physician-scientist saved the U.S. from a birth-defects catastrophe. www.uchicagomedicine.org/forefront/biological-sciences-articles/courageous-physician-scientist-saved-the-us-from-a-birth-defects-catastrophe
How to read this
History is not an answer key. This page says what was done and what came of it. Whether it was right is the question the case leaves with you.
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