Wonder Drug

Wonder Drug

One

Rain pounded the hood of Frances Kelsey’s car as she inched through the downtown Washington, D.C., traffic. She’d be late, again. For the past five weeks, every morning had been a struggle to get to work on time. Because she was not a woman short on accomplishment—she had two advanced degrees and a scientific textbook to her name—her lateness had become a family joke. Even though Mom had won national research prizes and harpooned sperm whales, she was being bested by traffic, unable to make it from the family’s new house in Chevy Chase to the National Mall in under an hour.

Today Frances was driving through the fringes of Hurricane Donna, with rain dousing the Northeast. High-speed winds bent and rustled trees along the road. Excitement was in the air, if not in Frances’s life.

It was September 12, 1960, and the forty-six-year-old married mother of two had just moved halfway across the country for a position at the Food and Drug Administration. After decades of hands-on lab research with beavers and armadillos and summer boating trips to collect massive whale gland specimens, Frances was now an FDA medical reviewer: a doctor who assessed paperwork, not patients. A bureaucrat. It was not the profession she’d trained for, but she knew it was important work, and a necessary concession to her husband’s new job.

Three years before the publication of The Feminine Mystique launched the feminist revolution, Frances was an oddity of her day: She held both an MD and a PhD and had forged a career in the hard sciences while married with children. She wasn’t emotive. She wasn’t frilly. She relegated makeup to special occasions and ignored the gray in her blunt-cut chin-length hair. Born in rural Canada, Frances—a solid five foot seven—remained tomboyish well into adulthood, fishing, clam digging, lugging her stick out to a field for a game of hockey whenever the air was crisp. She neither cooked nor cleaned house, but she knew that to keep her family running smoothly she had to relinquish some professional ground to Ellis. In seventeen years of marriage, Frances had moved states, shifted careers, earned degrees, and secured freelance work a half dozen times to oblige his career.

But this nine-to-five FDA desk job was a jolt for the normally bustling Frances. For the past seven years, living in South Dakota, where Ellis had chaired the university’s pharmacology department, Frances had juggled a host of on-the-go jobs. In addition to her university lab research with beaver thyroids, she had regularly hopped the overnight train to Chicago to secure her radioisotope diagnostics license. She had spent a full year commuting to Yankton for a hospital medical internship, leaving Ellis to cook dinners and put the girls to bed. Frances also zipped across the state for weeks at a time to fill in for vacationing small-town physicians. Often the first female doctor to grace the Badlands outposts, Frances made headlines: “Lemmon Patients Are Treated by Lady Physician,” boasted a local newspaper. So remote was the town of Lemmon that Frances had been dropped there by a chartered prop plane.

Frances had loved juggling emergencies in these remote South Dakota communities. Births, burst appendixes. Any “hectic series of crises” fascinated her, and she proudly embraced the grisly. One story she often recounted was of the hunter she tended upon her arrival in Lemmon—a man blasted in the abdomen by an antelope rifle in a hunting accident.

Back at home with daughters Susan and Christine, Phillip the Siamese cat, and their Saint Bernard, George, Frances tried to make the most of university-town life. She and Ellis, a hulking charmer of a man, socialized at the Vermillion Eagles Club and religiously played bridge. Brilliant, fun-loving, and quick-witted, the duo shared a zest for life that earned them a reputation as bon vivants. “Frankie and Kelse” were known for their well-stocked bar and the lively parties around the fireplace of their white clapboard colonial home. The parties were so lively that, before they began, the whole family laughingly tugged closed the “Weeks curtains”—thick drapes the couple had installed on their dining room windows after discovering that the dour man living next door was university president I. D. Weeks. Frankie and Kelse had “borrowed” a reel-to-reel audio device from the university and set it up behind the couch to record the gatherings. The girls spent the night crisscrossing the crowd of adults, carrying platters of olives and soda crackers and bacon-wrapped chicken livers.

But by 1956, three years into their South Dakota stint, Frankie and Ellis had overstayed their welcome. “This is a desolate area,” Ellis wrote to a friend, “from the standpoint of professional colleagues.” In Vermillion, egos were fragile and résumés flimsy, and the couple became the target of spiteful gossip. A university dean advised colleagues to shun the Kelseys, warning that anyone foolish enough to collaborate with them would be “left out in the cold” when they made off with “all of the data.” Frances—who, as a woman, had been sidelined her whole career—shrugged off the drama. Having just become a U.S. citizen, she toyed with a career move—and Washington, D.C., where their former graduate school adviser had just moved, brimmed with scientific government jobs. Every night, she and Kelse ogled D.C. real estate listings. They planned their South Dakota exit with the patience and intensity of a small prison break.

After a three-year bureaucratic slog, mailing applications across the country, Ellis had finally secured a National Institutes of Health job when a man at the Food and Drug Administration contacted him. Ralph Smith, who had met Ellis at a pharmacology conference, now helmed the FDA’s New Drug Branch. He wanted to hire “a man with a PhD as well as an MD” as an FDA medical officer.

Ellis, who merely held a PhD, confessed his limits. But he offered the name of a brilliant MD and PhD—his wife, Dr. Frances Kelsey.

At the National Mall, at Jefferson Drive and Seventh Street, Frances finally pulled into the parking lot of the shabby, unmarked FDA building, a deteriorating, prefab army structure from World War II. Compared to the Capitol’s marble grandeur, this agency looked like the government’s armpit.

The Food and Drug Administration had earned its name in 1930. It was a rebranding of the Bureau of Chemistry, a Civil War–era creation that had monitored the nation’s food, chemicals, and medicine for over seventy years. When the FDA was initially christened, food was its chief focus; the drug sector at that time—composed of small, regional apothecaries–turned–pharmaceutical firms—barely dented the nation’s gross domestic product. But wartime subsidies had expanded those firms into national corporations. By 1960—the year Frances arrived in Washington, D.C.—drugs were the country’s most profitable industry, to the tune of $2.7 billion in annual sales. The Goliath sector was overseen by one very underfunded federal agency: Frances’s new employer, the Food and Drug Administration.

Tasked with monitoring all food, drugs, cosmetics, and medical devices throughout the United States, the FDA Washington headquarters coordinated eighteen regional offices and inspectors in forty-one cities. But budget cuts under the Truman and early Eisenhower administrations had crippled the bureau so that by the mid-1950s, fewer than nine hundred employees struggled to keep pace with its massive mandate. When American drug firms submitted a staggering 369 applications to market new products in 1959—essentially proposing a patented drug each day—the agency scrambled to find more doctors to review all the scientific paperwork. Enter Frances.

Frances worked out of room 2605, a run-down office on the second floor. The green paint was peeling, the wooden floor was bare, and a long metal table pushed against the wall had been anointed her “desk” by some government furniture provisioner wrestling with the agency’s shoestring budget. Frances was highly credentialed but unpretentious, so the setting didn’t trouble her. And this morning she was giddy. After a monthlong orientation of slideshows and lectures, today she would dive into actual work. On the table sat her assignment: New Drug Application (NDA) 12-611—a few phone books’ worth of data, letters, and reports, bound in blue folders, submitted by a Cincinnati pharmaceutical company for a new sedative called Kevadon.

The cover page described the drug as an unusually safe, nonbarbiturate hypnotic already sold in over forty-six countries. The application, submitted by the William S. Merrell Company, brimmed with praise from American doctors who had used Kevadon in clinical trials, hailing it as “highly encouraging” and “superior to other sleep-inducing agents.” Drafts of research papers—soon to be published—indicated similarly rave conclusions. It seemed her bosses had lobbed her an easy one.

A few hundred pages of the application, in German, came from Chemie Grünenthal, the overseas firm that had invented the drug. Frances could read only rudimentary German, but Merrell—which had licensed the product from Chemie Grünenthal—had summarized the European research, which also seemed to celebrate the sedative as effective and harmless.