On August 7, 2015, Dr. Frances Oldham Kelsey passed away at the age of 101. Dr. Kelsey—a true hero of science and democracy—championed science-based policies that protected public health and safety throughout her life. Most famously, her actions preventing the FDA approval of thalidomide—a drug that causes birth defects—stopped what could have been a devastating tragedy for Americans. As my colleague Celia Wexler wrote, “The lesson of thalidomide is that regulations matter.”
Dr. Kelsey also became a scientist and a medical doctor (she earned both a Ph.D. in pharmacology and an M.D. from the University of Chicago) at a time when few women entered STEM professions. Her legacy, in ways not often fully appreciated, also speaks to science and social justice—and to why diverse perspectives matter in science as in society.
Not without evidence
As a newly hired medical officer at the U.S. Food and Drug Administration (FDA) in 1960, Dr. Kelsey was responsible for reviewing drug manufacturer Richardson-Merrell’s application for thalidomide approval in the U.S. Thalidomide was to be sold as a sedative specifically recommended for pregnant women to ease morning sickness. Although doctors had already begun prescribing it in Canada, Europe, and Africa, Dr. Kelsey had questions that she believed the company had not adequately answered, and she refused to approve it without stronger evidence for its efficacy and safety.
At the time, drug companies had to submit applications for approval of new drugs to the FDA, but if the agency didn’t act within 60 days to deny the application, approval was automatic. Under constant pressure from the drug manufacturer, Dr. Kelsey remained steadfast—even as company executives complained to her supervisors. Every 60 days, she returned the company’s application with a request for more evidence, which the company failed to provide. As reports began emerging of babies born without arms or legs—or with flipper-like appendages and deformed internal organs—linked to thalidomide in countries where the drug was legal, the company abruptly withdrew its FDA application in 1961.
Dr. Frances Kelsey refused to approve the drug thalidomide for use in the United States, likely preventing thousands of cases of birth defects. Photo: Flickr User Duckwailk
A year later, following a story in the Washington Post hailing Dr. Kelsey as a “heroine,” Congress unanimously passed the Kefauver Harris Amendment, a law which updated and greatly strengthened the 1938 Federal Food, Drug, and Cosmetic Act. Among other improvements, the Kefauver Harris Amendment required new drugs to pass more rigorous trials and gave the FDA full authority to approve or deny new drug applications. President John F. Kennedy awarded Dr. Kelsey the Medal for Distinguished Federal Civilian Service for her role in improving drug safety.
Difficult decisions, disproportionate impacts
Of the estimated 10,000 “thalidomide babies” born outside the U.S., only around 40 percent survived. In the U.S., some physicians had received supplies of thalidomide with its approval still pending; fortunately, only 17 births were affected. Now in their fifties, thalidomide survivors have struggled with life altering disabilities, as well as major health problems now being exacerbated by age.
Once the dangers of thalidomide became public, pregnant women who had taken the drug faced the difficult decision of whether knowingly to bring children into the world that would face a lifetime of suffering. The burden of deciding what to do and then living with the consequences of their decisions disproportionately fell to women. While ethical considerations were complex—and painful and private and deeply personal for any woman—a complicating factor in the U.S. was that abortion was still illegal in 1961.
What that meant is that women who wanted to end affected pregnancies faced extraordinary obstacles. In a well-publicized case, Sherri Chessen (a.k.a. Sherri Finkbine)—a mother of four in Phoenix, Arizona, pregnant with her fifth child—took thalidomide her husband had obtained during a trip to England. An abortion was quietly arranged by her doctor at a local hospital. Hoping to alert other women who might have unknowingly taken the drug, Sherri—the Phoenix area host of the popular children’s TV show Romper Room—told her story to the press before the procedure was performed. Fearing negative publicity and potential litigation, the hospital withdrew its permission, a judge denied an appeal, and Sherri ended up travelling to Sweden to have the abortion. The aborted fetus was missing both arms and both legs.
Had thalidomide been more widely distributed in this country, other white, financially secure women like Sherri Chessen likely would have made similar trips. As painful as their decisions would have been, it is difficult to speculate on the even greater consequences for poor women—especially poor women of color—who were already disproportionately affected by anti-abortion laws.
Diversity in science and why it matters
By preventing approval of thalidomide in the U.S., Frances Oldham Kelsey not only spared countless children from birth defects or death, she also spared their mothers.
Although Dr. Kelsey rarely spoke about how gender had affected her own career, she did offer a few clues in her “Autobiographical Reflections.” Of her decision to get an M.D. after already earning a Ph.D., she said, “[As] a woman, I needed the extra credentials. Let us face it, I needed all the help I could get.”
When Dr. Kelsey was offered a job as a research assistant at the University of Chicago—a job that paved the way for her to attend graduate and medical school there—the offer letter was addressed to “Mr. Oldham.” Instead of correcting the mistake and informing her would-be employer she was a woman, she simply signed the letter and showed up. Of that experience in 1936, she said, “to this day, I do not know if my name had been Elizabeth or Mary Jane, whether I would have gotten that first big step up. My professor at Chicago to his dying day would never admit one way or the other.”
Nor will we ever know how much her life experiences as a woman influenced her decisions around thalidomide, but she did reflect, “I was very cautious about using drugs during my own pregnancies.”
Dr. Kelsey receiving the Medal for Distinguished Federal Civilian Service from President Kennedy. Photo: FDA.
Dr. Kelsey’s legacy teaches us that this must change. The point of diversity in science, as elsewhere in our society, is not only to create opportunities for underrepresented groups but also to expand our collective understanding by including and embracing a multitude of experiences and perspectives. Only in doing so can we ever hope to progress toward the democratic ideals of equality, freedom, and justice for all.