If you’ve never heard of the Thalidomide tragedy, listen up.
Thalidomide is an immunomodulator used to treat a number of conditions, which was first marketed in West Germany in 1957. Today it is prescription-only and well regulated, but originally it was sold over the counter to treat anxiety, sleeping trouble, and most notably pregnancy nausea. It was discovered in 1961 that Thalidomide causes serious birth defects and was therefore removed from European markets. This discovery came too late, however, and an estimated 10,000 babies were born with serious birth defects, and approximately 40% of them died around the time of birth.
This tragedy was averted in the United States, however, thanks to the efforts of Dr. Frances Oldham Kelsey.
Dr. Kelsey was born in 1914, acquired her PhD from the University of Chicago in 1938, married and had two children with Dr. Fremont Kelsey (a fellow faculty member), and then earned her medical degree at University of Chicago Medical School. What is relevant to this story, however, is that in 1960 she began working at the FDA. She later became the chief of the Division of New Drugs, deputy for Scientific and Medical Affairs at the Office of Compliance, and the director of the Division of Scientific Investigations. Her role in this story starts when she had just been hired to the FDA, however.
Dr. Frances Oldham Kelsey was assigned to review an application for the distribution of Thalidomide in the United States. At this point, Thalidomide had been approved in more than 20 other large countries, and the FDA was greatly underfunded (only eleven full and part-time physicians worked on in the review department), and the drug was expected to pass. Kelsey, however, refused to approve the drug, due to concerns raised by a study from England which documented peripheral neuritis in some. The manufacturer continued to pressure her, but she continued to request data to prove the drug was not harmful to the fetus. A year later, the horrific side effects became apparent in Europe, and was discontinued.
Dr. Kelsey was lauded as a hero, and was the second woman ever to receive the President’s Award for Distinguished Federal Civilian Service, among many other awards. She was promoted to a powerful role in the FDA, and continued her work there, creating the 1962 amendments. She instituted stricter requirements for the testing and distribution of drugs, a requirement that drugs be proven effective before marketing, and many other policies which we think of as obvious basic requirements now.
Sometimes the stringent safety requirements of the FDA may seem overbearing; when a vaccine to combat a pandemic is being developed, for example. However, it is important to remember the dangers unregulated drugs can pose; we know from history that those dangers won’t always dissuade a company from attempting to sell them. Even today, manufacturers try to hide side effects. The opioid crisis can be partially blamed on manufacturers understating or ignoring opioids’ addictive properties.
Never underestimate peoples’ willingness to do harm to pursue profit, but never forget that scientists will call them out.