A pharmaceutical company distributed thousands of unlabeled doses of thalidomide to U.S. doctors in the early 1960s, even as the Food and Drug Administration’s medical reviewer Dr. Frances Oldham Kelsey worked to prevent the drug’s general approval. The company provided no labeling or requirement for doctors to track the medication or report side effects, according to FDA senior historian John Swann, who characterized the effort as “such a sloppy investigation.” Large quantities of the drug could not be accounted for when the FDA examined Merrell’s records.
Despite the drug never receiving approval for general use, physicians administered thalidomide to thousands of patients, including pregnant women seeking relief from morning sickness and insomnia. Women were not informed they were taking the drug, and it was not documented in their medical records. Some women were later specifically told they had not taken thalidomide. Children born with the drug’s signature deformity, phocomelia—severely shortened limbs—were sometimes told they could not be thalidomide survivors because the condition was believed not to have occurred in the United States.
The FDA has formally acknowledged 17 American thalidomide survivors, though experts estimate the actual number could be around a hundred. Thalidomide survivors and advocates have formed organizations pushing Congress to pass legislation that would officially recognize American survivors and provide each with $150,000 in compensation, with the possibility of additional support later. These aging survivors emphasize that the United States remains the only country that has not provided recognition or support to its thalidomide-affected population, even as their health continues to deteriorate.
Article Attribution | Read More at Article Source
Article summary produced by Claude AI