On this day in medical history: Honoring the courage of Frances Oldham Kelsey and Alice Augusta Ball

Born on July 24, 1914, on Vancouver Island, British Columbia, Canada, Frances Oldham Kelsey, MD, PhD, is acclaimed for her refusal to approve the release of thalidomide in the United States. Thalidomide had been used as a sleeping aid, and caused thousands of birth defects worldwide. With her refusal to approve it, Dr. Kelsey is credited with circumventing certainly disastrous effects on children in the United States, and the thousands of potential miscarriages and severe deformities that thalidomide may have caused.

In 1960, Dr. Kelsey moved to Washington, DC, and began working at the Food and Drug Administration (FDA). She later became the chief of the Division of New Drugs, director of the Division of Scientific Investigations, and deputy for Scientific and Medical Affairs, Office of Compliance.

After only 1 month at the FDA, Dr. Kelsey took a stand refusing to approve the release of thalidomide. Upon her review of the drug, which was already widely used in Europe, Dr. Kelsey became concerned that some of the data suggested serious side effects in patients who repeatedly took it.

Thalidomide had been on the market in other countries, ranging from Germany to Australia, for 4 years. It was marketed to pregnant women as a cure for morning sickness and insomnia.

But in November 1961, reports from Germany and the United Kingdom came out that some mothers who had taken thalidomide during their pregnancies were having babies with severe birth defects. In Europe, approximately 4,000 children were affected. In all, at least 10,000 children in 46 countries were born with severe deformities, some missing limbs and others with phocomelia—the development of seal-like flippers. In some, organs, tissues, eyes, and ears did not develop properly.

When given the application for thalidomide, Dr. Kelsey was unhappy with the incomplete studies on its absorption and toxicity. She rejected the application several times, always requesting more data. She was concerned that Merrell, thalidomide’s manufacturer in the US, had failed to report adverse reactions to the FDA, as well as their lack of studies in pregnant animals.

With the testimony of Helen Taussig, MD—who was also investigating thalidomide—before the Senate, Dr. Kelsey was able to ban thalidomide in the United States.

In 1962, the Washington Post ran an article about Dr. Kelsey on the front page titled “’Heroine’ of FDA keeps bad drug off the market.”

Dr. Kelsey received the President’s Award for Distinguished Federal Civilian Service on August 7, 1962, from President John F. Kennedy, becoming only the second woman to ever receive this award.

“Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States. Through high ability and steadfast confidence in her professional decision, she has made an outstanding contribution to the protection of the health of the American people,” said President Kennedy.

Dr. Kelsey also helped amend the laws governing FDA drug regulation to protect patients in drug studies, requiring that the drugs be proven to be both safe and effective, that informed consent be obtained from patients in clinical trials, and that adverse reactions be reported to the FDA. These new regulations are still in force today.

In 2000, Dr. Kelsey was inducted into the National Women’s Hall of Fame. She died at the age of 101 in London, Ontario, on August 7, 2015, less than 24 hours after Elizabeth Dowdeswell, Ontario’s Lieutenant-Governor, came to her home to present her with the insignia of Member of the Order of Canada.

Alice Augusta Ball

Also on this day, Alice Augusta Ball, a pharmaceutical chemist from Seattle, WA, was born in 1892. Ball developed a water-soluble, injectable form of chaulmoogra oil used to relieve the symptoms of leprosy. She was the first woman and first African American to graduate from the University of Hawaii, as well as the first woman to teach in the University of Hawaii’s chemistry department.

While at the University of Hawaii, Ball was assigned a research project that involved studying the effects of intravenously administered chaulmooga oil on patients with leprosy. Her research findings helped develop a successful treatment for leprosy, but she did not live to see them come to fruition. Tragically, Ball became ill and died at the age of 24, on December 31, 1916.

Until the 1940s, the “Ball method” was the most effective treatment available for leprosy, and it was still being used as late as 1999 to treat patients in remote areas. Interestingly, leprosy patients had a new treatment option made available to them when, in July 1998, thalidomide was approved for use by the FDA for certain leprosy lesions and complications.

Ball posthumously received the Regents Medal of Distinction from the University of Hawaii. On February 29, 2000, the governor of Hawaii declared it to be “Alice Ball Day,” and fittingly, a bronze plaque honoring her was mounted on the base of the only chaulmoogra tree on campus.

Sources:

Ball, Alice Augusta. BlackPast.org. http://www.blackpast.org/aaw/ball-alice-augusta-1892-1916. Accessed July 19, 2018.

Ball, Alice Augusta. ScholarSpace. https://scholarspace.manoa.hawaii.edu/handle/10125/1837. Accessed July 19, 2018.

Bernstein A, Sullivan P. “Frances Oldham Kelsey, FDA scientist who kept thalidomide off US market, dies at 101.” Washington Post. August 7, 2015. https://www.washingtonpost.com/national/health-science/frances-oldham-kelsey-heroine-of-thalidomide-tragedy-dies-at-101/2015/08/07/ae57335e-c5da-11df-94e1-c5afa35a9e59_story.html?utm_term=.80bf008e5717. Accessed July 19, 2018.

Frances Oldham Kelsey. Changing the face of Medicine.com. National Library of Medicine, National Institutes of Health. https://cfmedicine.nlm.nih.gov/physicians/biography_182.html. Accessed July 19, 2018.

Thalidomide. FDA. https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107296.htm. Accessed July 20, 2018.