Photo Credit: Frances Oldham Kelsey, MD, PhD, receives the President’s Award for Distinguished Federal Civil Service from President John F. Kennedy in 1962. Photo credit: Special Collections Research Center/The University of Chicago Library
When I first learned of Dr. Frances Oldham Kelsey, my immediate thought was that she embodied this month’s tenet: “We recognize and follow our intuitive internal compass to speak and act with integrity.” I vaguely remember my mother talking about the drug Thalidomide and the birth defects it caused, but it wasn’t until about a year ago that I learned how this one woman’s determination was primarily responsible for keeping this dangerous drug off the U.S. market.
A quick internet search about Thalidomide leads to numerous articles about Dr. Kelsey. The drug originated in Germany, and was subsequently introduced to the U.K. and other countries. It was promoted as a sleep aid and to help combat morning sickness. It was apparently effective for both conditions, but with initially unforeseen devastating consequences for pregnant women. Thousands of their babies died in utero, and an estimated 8,000 to 10,000 children were born with varying deformities, very often missing or malformed limbs.
Dr. Kelsey had been hired by the Food and Drug Administration to review new drug applications. Manufacturers were required by law to provide evidence of a drug’s safety before it could go on the market. One of her first assignments, within her first month on the job, was to evaluate the application that an American distributor had made for this drug. She was very concerned with the lack of medical evidence supporting its safety record, so she rejected the application. And she kept rejecting it, in spite of the company’s pressure and insistence that it was safe. Fortunately, her superiors backed her decision, and eventually the company withdrew its application after substantial proof was finally found during the ensuing period that this drug was what had caused so much damage in the twenty countries where it had been distributed.
Dr. Kelsey pointed out that it was not solely because of her efforts that this drug was not approved in the U.S., but by following her own internal compass and holding fast to her integrity she undoubtedly helped save thousands of babies and spared all those mothers the devastating heartbreak that would have occurred. And shortly after this, a new law was signed that required FDA approval of new drugs and more regulated trials were required before approval.
Most of us will not have the opportunity to make such a huge impact in this world, but each of us can follow the course we know to be right.