It’s the early 1960s, and Widukind Lenz, a German pediatrician, is going door to door in his efforts to find out what is causing an epidemic of babies born with shortened limbs and other serious medical conditions.In the U.S. the drug company Richardson-Merrell is battling with Frances Oldham Kelsey at the Food and Drug Administration about the pending approval of thalidomide. She’s asking for data that show it’s safe to use during pregnancy (spoiler alert: it’s not).Meanwhile Merrell continues to send what will add up to millions of thalidomide pills to doctors in so-called clinical trials. In November 1961 Lenz goes public with the results of his medical sleuthing and, as host Katie Hafner puts it, “the proverbial shit hits the proverbial fan.”
In the fall of 1961, Frances Kelsey was still jousting with Merrell’s liaison, Joseph Murray, about the safety of thalidomide during pregnancy. Kelsey, with her background in studying drug effects on embryos, was rightfully cautious about approving the drug without sufficient evidence of its safety. Merrell, on the other hand, was eager to bring the drug to market quickly.
As the investigation unfolded in Europe with Lenz’s discoveries, the pressure on Grünenthal to withdraw thalidomide intensified. Once the connection between the drug and birth defects became clear, Grünenthal finally took action to remove the drug from the market. The urgency to protect pregnant women from the harmful effects of thalidomide was evident.
The story of thalidomide sheds light on the importance of thorough testing and evaluation of drugs, especially when it comes to their effects on vulnerable populations such as pregnant women and developing embryos. The courage and dedication of individuals like Widukind Lenz and Frances Kelsey in uncovering the dangers of thalidomide demonstrate the critical role of science and regulatory oversight in protecting public health.
This cautionary tale serves as a reminder of the need for rigorous scientific inquiry and ethical considerations in the approval and monitoring of pharmaceuticals. The tragic consequences of the thalidomide crisis highlight the potential risks associated with inadequate testing and oversight in the pharmaceutical industry, emphasizing the importance of prioritizing patient safety and well-being above all else.
