There was a time in the 1960s when the Canadian-born pharmacologist and physician, Frances Oldham Kelsey (1914-2015), was among the most famous women in America. She had blocked the approval of thalidomide in the United States, thereby sparing the lives and limbs of countless infants–a tragedy that was keenly felt in Britain, Germany, Canada, and elsewhere. She had managed to accomplish that singular feat by reading the evidence, sticking to her understanding of scientific principles, and defying drug companies, politicians, and her own superiors at the FDA. It wasn’t easy. And it wasn’t her only battle.
A child of unconventional, British-born parents, raised in the bucolic countryside of Vancouver Island, British Columbia, her relentless pursuit of science began in a love of animals, carrying her through two Canadian universities to a University of Chicago PhD in pharmacology and tenuous postdoctoral positions investigating the pituitaries of whales and armadillos. The research sent her to sea with grudging whalers and to inhospitable deserts by night. She married fellow pharmacologist Ellis Kelsey, followed him for his work, and became a mother of two daughters. Lack of paid opportunities for a woman scientist sent her commuting to medical school in Chicago where she obtained an MD degree in 1950 at age 36, while her husband kept the home and family together. She was working as a G.P. locum tenens and as an editor for JAMA. After a stint in South Dakota, the family relocated to Washington in 1960 where she began her lengthy career in the FDA, rising through the ranks to positions of prominence. Not long after the move, her stance on thalidomide earned her the Distinguished Federal Service Award of 1962, presented by President John F. Kennedy. It also brought widespread admiration, mountains of fan mail, several other honours, and the resentment of male colleagues. Ellis died suddenly in 1966, but she kept working into her 90s, taking on the public-health challenges of other notorious “remedies” seeking approval. Kelsey’s fame eventually subsided but rose again in 2015 with late honours and her death at 101 years of age.
Cheryl Krasnick Warsh, who lives and works on Kelsey’s parental home of Vancouver Island, has given us a wonderful biography. With many previous publications in gender history and the history of alcohol and other drugs, Warsh is well placed to handle this vast and multifaceted topic, sensitive to the misogyny of Kelsey’s century and with expertise on the nature and fortunes of licit and illicit substances.
In twenty short chapters, Warsh divides this long life into three segments– before, during, and after thalidomide– and identifies her subject in three different ways. She describes “Frankie’s” early years in simple prose, reminiscent perhaps of Gertrude Stein or Emily Carr. Quirks and disputes in the Oldham home become evidence of a high-functioning, dysfunctional family. As a young woman, “Frances Oldham” delved into science studies at what would become University of Victoria and McGill in Montreal but made the trip back home every summer. She slipped into the laboratory of distinguished pharmacologist E.M.K. Geiling at the University of Chicago, when he believed the applicant was male. Despite his initial skepticism, Geiling fostered her career and supervised her doctorate. In 1937, she worked on the lethal side-effects of elixir sulfanilamide and determined that the solvent was responsible. At that time, she also became interested in researching harmful effects of pharmaceuticals on pregnancy and explored the legal protections (or lack thereof) for their consumers. With Geiling and Ellis Kelsey, Frances Oldham wrote a pharmacology textbook, one of the first in America, that went into four editions. These experiences, her medical degree and the work with JAMA were excellent preparations for her concerns about thalidomide. Now she was “Dr Kelsey,” one of two in the same home.
Kelsey first doubted the value of this new drug when the side effect of peripheral nerve damage seemed to have been excluded from the incomplete applications and their inadequate trials. Further delay allowed for the early reports of fetal damage (coming from newspapers rather than manufacturers) to add to the concerns. While she succeeded in blocking the approval of thalidomide, it had managed to make its way into the US anyway, in the form of free samples given to practitioners sloppily engaged as researchers in shoddy “clinical trials.” Warsh carefully tracks the resultant American harm through reports of at least 56 damaged or dead infants documented in a survey of city health officers in 1962—probably merely the tip of an iceberg. She also probed the tragedy’s impact on attitudes to abortion, respect for the disabled, and increasing caution over medications.
Beyond the thalidomide story, this biography provides a good sense of the evolving field of pharmacology and interesting chapters on the thorny history of several famous drugs–Krebiozen, laetrile, dimethyl sulfoxide (DMSO), artificial sweeteners, and diethylstilbestrol (DES)–and the harmful impact of Xrays on the pregnant belly. Kelsey found support from other women scientists, in particular Barbara Moulton and Helen Taussig, who became her friends.
Warsh has tapped into a wealth of sources—extending well beyond the numerous publications, FDA documents, and newspaper reports. She interviewed Kelsey, aged 99, in 2014 and spoke with her colleagues, daughters and other family members. She made excellent use of the personal papers, sorted by the pharmacologist herself with the help of FDA historian John Swann; they contain more than 78,000 items and occupy more than 100 feet of shelving in the Library of Congress. Moreover, Warsh follows the court decisions, changing legislation and rules governing not only drug approvals but also the ordering of female lives in terms of employment and reproductive freedoms. Yet she handles all this information with a deft light touch, accessible language and playful humour.
A great read about a great scientist and a fascinating era in biomedical science.
Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide
Warsh, Cheryl Krasnick
Oxford University Press.
New York, 2024-03-15
Photos of Frances Oldham Kelsey from Wikicommons
