What if the cure is worse than the disease?
Welcome to “Dumb Ideas that Changed the World.” The views expressed are solely those of the host and do not reflect the opinions of this station or its funders.
Wonder drugs have snuffed out some terrifying diseases. But first they must be approved by the U.S. government’s Food and Drug Administration (FDA). Have you heard of “drug lag”? It’s a complaint when the FDA is too slow to approve a drug with life-changing potential.
An example of drug lag was thalidomide, prescribed to alleviate morning sickness. Low birthweight babies are at high-risk so nobody wants a mother to lose weight during pregnancy. Beginning in 1960 drug maker Grünenthal asked the FDA to approve thalidomide six times, but the agency stubbornly resisted.
The drug received quick approval in Europe and Canada because Grünenthal assured them it could not breach the placenta to the fetus. Tragically, however, thalidomide was a dumb idea. Over four years an estimated 2,000 babies died worldwide, and 10,000 more were born with severe birth defects, such as missing or deformed limbs.
Europe and Canada trusted the drug-maker too much. And the same easily could have happened in the U.S. Enter our hero. A young Dr. Frances Kelsey was the FDA reviewer who insisted on clinical safety trials before granting approval. She felt the burden should be on the drug to prove it would not harm the fetus. As you can imagine, the trials went badly and thalidomide was never approved here for morning sickness. Did I mention that Frances Kelsey was a woman?
Repeatedly pressured to sign-off on thalidomide Dr. Kelsey held firm, never backing down to the men at Grünenthal. For saving thousands from death and tragic birth defects, John F. Kennedy gave her the Presidential Award for Distinguished Civil Service in 1962. That same year Congress unanimously passed a law giving the FDA stronger oversight over drug approvals. Dr. Kelsey’s work at the agency went on for four more decades. She passed away, just a few years ago, at the age of 101.
Thanks to the brilliant Frances Kelsey, America dodged a bullet.
I’m Jeff Gentry
Best reference: Waggoner, M. R., & Lyerly, A. D. (2022). Clinical trials in pregnancy and the “shadows of thalidomide”: Revisiting the legacy of Frances Kelsey. Contemporary Clinical Trials, 119, 106806. https://doi.org/10.1016/j.cct.2022.106806
Dumb Ideas that Changed the World copyright 2023 by Jeff Gentry. All rights reserved.
