April 22, 2024
Makena, once the only available treatment to prevent preterm birth, has had its share of controversy. A yearslong debate over the drug’s effectiveness led the Food and Drug Administration to withdraw its approval of the product and demand it be pulled from the market after a confirmatory trial couldn’t replicate the results of a key study.
But while the story of Makena’s rise and fall may be well known, one aspect of the drug’s legacy has gone untold. A widely cited study that supported Makena’s approval mixed up the names of two distinct molecules: 17P and progesterone. That error, which reverberated through dozens of papers, caused some women to mistakenly be given injections of high doses of progesterone to reduce their risk of preterm birth — an untested treatment — though it’s unclear precisely how many people were affected.
It wasn’t a prominent professor, a clinician, or a scientific watchdog who has driven the push to get the issue corrected — it was a lab manager, Tara Skopelitis, who was determined to leave no stone unturned in trying to solve the puzzle of her daughter’s illness.
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