The Shadow of the Thalidomide Tragedy | Retro Report | The New York Times
The New York Times・9 minutes read
Thalidomide caused birth defects, leading to a global crisis, but Dr. Kelsey's vigilance prevented a tragedy in the US. The thalidomide scandal spurred regulatory reforms and survivors faced lifelong challenges, although the drug was eventually banned but found new uses in treating diseases.
Insights
- Dr. Kelsey's caution at the FDA prevented a potential disaster in the US by holding back thalidomide's approval due to incomplete safety information.
- The thalidomide scandal sparked widespread regulatory changes in the pharmaceutical sector globally, following President Kennedy's involvement, impacting drug approval processes and patient safety measures.
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Recent questions
What caused severe birth defects in children?
Thalidomide
Who delayed thalidomide's approval in the US?
Dr. Kelsey
What led to significant regulatory reforms in the pharmaceutical industry?
Thalidomide scandal
What was the global impact of thalidomide?
Birth defects and regulatory reforms
When was thalidomide eventually banned globally?
1962
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Summary
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Thalidomide: Tragedy, Regulation, and Medical Advances
- Thalidomide, a drug introduced in the 1960s, caused severe birth defects in children, leading to a global medical crisis.
- The drug was initially marketed as safe, even for pregnant women, but its dangers were soon revealed, prompting strict drug laws in the US.
- Dr. Kelsey's vigilance at the FDA prevented a tragedy in the US by delaying thalidomide's approval due to insufficient safety data.
- Thalidomide's impact extended worldwide, affecting individuals like Jazelle Cole in Trinidad and Tobago, born with limb deformities.
- The thalidomide scandal led to significant regulatory reforms in the pharmaceutical industry, influenced by President Kennedy's efforts.
- Survivors of thalidomide faced lifelong challenges, with some families resorting to extreme measures due to the drug's effects.
- Despite legal battles and delayed apologies, thalidomide was eventually banned globally in 1962, but later found new uses in treating various diseases, including cancer.
