October 24, 2018

Milestones in Pharmaceutical History: Frances Kelsey and the “Thalidomide Tragedy”

Written by Garret Weigel | Pharmacy Safety

October is American Pharmacists Month – time to recognize pharmacists’ contributions to health care and all they do for their communities. To celebrate, we’re publishing a series of posts this month about milestones in pharmaceutical history that have immeasurably advanced drug safety and improved public health. In this post, we take a look at the “thalidomide tragedy” that launched the drug approval and monitoring systems in place at the Food and Drug Administration (FDA) today.

 

Thalidomide on the Global Market

Immediately after the stressful years of the Great Depression and WWII, Americans and Europeans reported an increase in insomnia. To prevent sleeplessness, tranquilizers and sleeping pills were prescribed worldwide more than ever before. By the mid-20th century, one out of seven Americans regularly took some form of sedative.

 

In 1957, thalidomide first entered the German market as an over-the-counter remedy, based on the manufacturer’s unproven health claims that the drug was completely safe for the general population. At the time, it was the only non-barbiturate sedative available, which gave the drug massive public appeal. By 1960, thalidomide was marketed in 46 countries, with sales rivaling aspirin. Primarily prescribed as a sedative, thalidomide was falsely advertised to cure anxiety and gastritis as well.

 

The Tragedy of Birth Defects

Making matters much worse, an Australian obstetrician, William McBride, discovered that thalidomide also alleviated morning sickness, and began recommending its off-label use, setting a worldwide trend. Thousands of pregnant women eagerly took the drug to relieve their symptoms, although medications taken during pregnancy back then were not strictly controlled and not tested for potential harm to the baby. That’s because scientists had not yet discovered that drugs could pass across the placental barrier to harm the developing fetus.

 

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In 1961 McBride noticed a correlation between thalidomide use by his pregnant patients and severe defects in their babies that he delivered. The drug disrupted their normal development, causing a condition called phocomelia, resulting in short or absent limbs. Other birth defects included blindness, deafness, and deformed organs. Experts estimate that more than 10,000 children worldwide were born with birth defects because of thalidomide use, resulting in more than 2,000 fatalities. By November, thalidomide was taken off the market due to public outrage.

 

Frances Kelsey: An FDA Hero

Amazingly, thalidomide was never approved within the U.S., despite pressure from manufacturer Richardson-Merrell and the FDA. We owe that heroic decision to Frances Kelsey, an FDA inspector who believed that the application for approval lacked sufficient data on its safety for a developing fetus, as well as any results from clinical trials – which at the time were not subject to FDA oversight. Kelsey’s wise refusal of approving thalidomide for the American pharmaceutical market quickly led to profound changes in the FDA.

 

After Kelsey was featured in the Washington Post, John F. Kennedy hailed her as a hero, and in 1962 presented her the President’s Award for Distinguished Federal Civilian Service at a special ceremony. The Kennedy administration used this public relations opportunity to pass stronger drug regulations. That same year, Congress quickly passed the Kefauver-Harris Drug Amendments Act, which had five requirements for any drug sold in the U.S.:

  • A rigorous FDA drug approval process, including clinical trials
  • Proof from manufacturers of the drug’s safety and effectiveness prior to marketing
  • Disclosure of side effects
  • FDA inspection of manufacturing practices at industry facilities
  • FDA control of prescription drug advertising

 

Also, in 1962, the FDA created a new department to test and regulate drugs, with Kelsey at the helm. Later, she was promoted to director of the FDA Office of Scientific Investigations. In her distinguished 45-year career, the rules she wrote for American medical-testing regulations have been adopted worldwide, strengthening protections for patients and restricting conflicts of interest between pharmaceutical marketing and public health.

 

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