Today’s strict regulation of drug application through the Food and Drug Administration (FDA) did not come in an easy way. Back in the early days when female scientists were less valued, Dr. Frances Oldham Kelsey, a Canadian born medical reviewer, proved her worth by preventing thalidomide from going into the US market.

In 1960, a new drug called thalidomide was widely distributed in many countries, acting as a sedative to treat anxiety and insomnia. It had also been prescribed for pregnant women to treat nausea and morning sickness. However, Kelsey, who joined the FDA the same year, refused to approve thalidomide due to the lack of safety evidence.

Dr Kelsey reshaped American drug safety rules. (Photo credit: Associated press/New York Times)
Dr Kelsey reshaped American drug safety rules. (Photo credit: Associated press/New York Times)

Hence, the US escaped from the crisis when severe birth defects caused by thalidomide became an epidemic in other countries, including Canada, Great Britain and West Germany, and affected thousands of infants between 1957 and 1962.

Becoming a novice medical reviewer

After receiving her doctorate in pharmacology at the University in Chicago in 1950, Kelsey worked as an editorial associate for the American Medical Association Journal. She also worked as a professor and family doctor later before she joined the FDA to work as a medical reviewer for New Drug Applications (NDA).

Kelsey worked with a chemist, Lee Geismar and a pharmacologist, Oyam Jiro to determine a drug’s safety for public consumption. Her duty was to review animal trials that testify whether the drug was safe whereas chemists reviewed the chemical makeup of the drug and how the manufacturer maintained the consistency.

In her memoir “Autobiographical Reflections”, Kelsey admitted the challenges faced by the pharmaceutical industry and the defect of 60-day window for approving or rejecting drugs. If the 60th day passed, the drugs would automatically go to market.

Keeping the relentless lobbying at bay

When the drug manufacturer, Richard Merrell, sent his licence application for thalidomide to the FDA – Kelsey and other reviewers did not pass the drug. Even though the application seemed routine in Europe, Kelsey remained skeptical about the safety of thalidomide.

Other than pharmacological issues, Kelsey also discovered that there were insufficient clinical trials to provide scientific evidence. As a result, she rejected the application.

Kelsey requested for more information from Merrell on the toxicity, strength and purity of thalidomide. As Merrell was desperate to enter the US market, the negotiation process between the two was tense. The company continued to pressure Kelsey with letters, calls and visits. Nevertheless, Kelsey’s stood firm on her refusal due to insufficient proof which was described as fussy and unreasonable by Merrell.

In December 1960, a doctor’s letter in The British Medical Journal reported that thalidomide might lead to the side effect of peripheral neuritis, causing nerve inflammation. Kelsey became more alert and concerned with the foetuses of pregnant women taking the drug.

A year later, a tragedy took place in Europe and Canada. Physicians discovered mothers who had taken thalidomide during early pregnancy gave birth to babies with birth defects. During that time, it was estimated that 10,000 infants were affected across the world, and countless might have died in uterus.

Only 17 cases of birth defect in the US

Eventually, Merrell withdrew the application in 1962. However, according to the FDA historian, John Swann, the drug had been distributed to “more than 1200 physicians, about 15,000 to 20,000 patients—of whom over 600 were pregnant.”

In the US, only 17 cases of birth defects were reported. Swann said in an email, “that could have been thousands had the FDA not insisted on the evidence of safety required under the law (despite ongoing pressure from the drug’s sponsor).”

In light of this incident, the Congress amended the law to pass stricter drug regulations. In the meantime, Kelsey was hailed as a heroine with her continuous efforts to seek long-term benefits of the public health as one of the pioneering female doctors.

In 1962, President John F. Kennedy honoured Kelsey for her work blocking the marketing of thalidomide. (Photo credit: FDA/
In 1962, President John F. Kennedy honoured Kelsey for her work blocking the marketing of thalidomide. (Photo credit: FDA/

In 1962, US President John F. Kennedy awarded Kelsey the President’s Award for Distinguished Federal Civilian Service. She was the second woman to receive such an honour. Kelsey said in her memoir that the honour did not just belong to her.

She wrote, “I thought that I was accepting the medal on behalf of a lot of different federal workers. This was really a team effort.”

Kelsey continued her service at the FDA until she retired at the age of 90, as the director of the Office of Science Investigation. She lived until the age of 101, and passed away in 2015. MIMS

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