Click here if you don’t see subscription options
Rhoda FengSeptember 13, 2023

It was touted as a sedative with no hangover. It was hailed as non-addictive. It was rumored to present no side effects. It was trumpeted in medical journal ads as “astonishingly safe” and “completely non-poisonous.”

In hindsight, such claims about the safety and efficacy of thalidomide were dreadfully inaccurate: The teratogenic drug has a devastating impact on fetal development, causing severe limb abnormalities and other birth defects.

Wonder Drugby Jennifer Vanderbes

Random House
432p $29


Thalidomide, or the “wonder drug” that gives Jennifer Vanderbes’s terrific new book its name, was first developed in West Germany in 1954 by Chemie Grünenthal, a pharmaceutical company run by two brothers who had previously been associated with the Nazi Party. Synthesizing in-depth research and interviews with hundreds of survivors along with scientists, lawyers and doctors, Vanderbes’s Wonder Drug: The Secret History of Thalidomide in America and Its Hidden Victims provides a sweeping account of the drug’s invention, its shadow distribution in the United States, where it was not legally sold, and the terrible consequences on the people who were its unwitting guinea pigs.

That thalidomide was never made available for sale in the United States was due largely to the efforts of one indefatigable F.D.A. medical reviewer, Frances Oldham Kelsey.

After it was invented in Germany, thalidomide was introduced in other countries, including Canada, Britain, New Zealand, Japan, Italy and the United States, under various brand names like Contergan, Kevadon and Distaval. Its sedative properties made it especially appealing; as Vanderbes relates, the 1950s saw a vogue for anti-anxiety meds, with the likes of Lauren Bacall and Lucille Ball praising tranquilizers like Miltown. However, it was not long before serious concerns arose about the drug—first relating to peripheral neuritis, a condition that “begins as numbness or prickling in the hands and feet” before “escalating to painful stabbing, burning, or tingling,” and later, to women who gave birth to babies with shortened limbs or seal-like appendages.

Karl-Hermann Schulte-Hillen, a German father whose son was born with stumps instead of arms, was one of the first parents to sound the alarm over thalidomide. When baby Jan was born in 1961, the hospital’s doctor was quick to chalk up his defects to genetics, but Karl-Hermann was unconvinced; after all, a dozen women in their neighborhood, including Karl-Hermann’s sister, had recently given birth to babies with similar deformities. Over several chapters, Vanderbes movingly recounts how Karl-Hermann and his wife Linde resolved to raise their baby with “no shame, no guilt” while trying to unravel the cause of their son’s condition.

When an investigation by the Public Health Service was unforthcoming, Karl-Hermann took it upon himself to “find out what had harmed his son.” He gumshoed with Widukind Lenz, a German pediatrician and geneticist, just as more reports about babies with phocomelia (or born without arms) were making the rounds. The pair published ads in several newspapers, seeking to collect more information about mothers who gave birth to similarly afflicted babies. One thing ran through the mothers’ stories like a bright red thread: thalidomide.

The drug-maker Chemie Grünenthal was far from ignorant of thalidomide’s neurotoxic effects. As early as 1956, a doctor from Berlin noted the drug’s “absolute intolerability” in humans, only to be rebuffed (he was told that he had administered improper doses). The next year, a researcher at Edinburgh University determined that thalidomide inhibited thyroid activity and deemed it “unjustifiable” for use in the absence of “more detailed study of its long-term effects in a larger series of patients.” His research was later watered down in the British Medical Journal.

In 1958, a German doctor relayed his concerns to Grünenthal about “giddiness and balance disturbances in elderly patients”; the firm disavowed any connection between the symptoms and its drug. The following year saw more complaints about constipation and nerve damage as well as severe side effects, as reported by 20 doctors in Switzerland. Still nothing.

In an act of brazen disregard, Chemie Grünenthal partnered with the Cincinnati-based William S. Merrell Company in 1959 to distribute millions of samples of the drug in so-called experimental trials in the United States. “Detail men,” forerunners of pharmaceutical sales reps, tirelessly peddled thalidomide as a low-risk treatment for insomnia, headaches and morning sickness. Soon, more than a thousand obstetricians and other doctors were dispensing “Kevadon,” as the drug was commonly called in the United States, to their patients in unmarked envelopes. They were sowing the seeds for one of the biggest drug disasters involving children.

Even after the dangers of taking thalidomide were more widely recognized, “doctors had no obligation to alert patients to what drug they had been given,” Vanderbes writes. “Names of trial doctors, forever guarded, meant that patients might never know they’d been used as guinea pigs. On all sides, the law shielded doctors, leaving patients defenseless.”

Even after the dangers of taking thalidomide were more widely recognized, “doctors had no obligation to alert patients to what drug they had been given,” Vanderbes writes.

That thalidomide was never made available for sale in the United States—that it did not reach even more people than it did through unscrupulous trial doctors—was due largely to the efforts of one indefatigable F.D.A. medical reviewer, Frances Oldham Kelsey. As Vanderbes meticulously documents, the Canadian-American pharmacologist and physician refused to buckle under immense pressure from Merrell to approve the drug posthaste; instead, she thoroughly reviewed every aspect of the drug’s application, flagging inconsistencies, asking for more information at critical junctures, raising trenchant questions about the drug’s effect on pregnant subjects and on fetuses and conducting her own research.

From the time that Merrell submitted its application to the F.D.A. in 1960 to sell thalidomide, Kelsey was not swayed by overheated claims of the drug’s magical properties—one brochure boasted that it was impossible to determine thalidomide’s lethal dose, making it unprecedentedly safe. When she learned of reports coming out of Germany that the drug might be linked to severe birth defects, her suspicions mounted.

Her decision not to approve the drug for sale was later vindicated as more news of thalidomide’s toxicity came to light. Major news outlets quickly anointed Kelsey a civic hero; a front-page tribute in The Washington Post by Morton Mintzbegan: “This is the story of how the skepticism and stubbornness of a government physician prevented what could have been an appalling American tragedy, the birth of hundreds or indeed thousands of armless and legless children.”

For her uncompromising integrity and her championing of evidence over anecdote, Kelsey received several awards, including a President’s Award for Distinguished Federal Civilian Service in 1962. That same year saw the passage of the Kefauver-Harris amendments to the Food, Drug, and Cosmetic Act, which mandated that drugs had to be both safe and effective before they could be marketed. Her work also paved the way for the creation of institutional review boards “to approve the how, who, and where of clinical trials before they started.”

Kelsey’s legacy as a vigilant and conscientious regulator has had such a remarkable impact on drug approval procedures and patient safety that it has paradoxically threatened to obscure the stories of American “thalidomiders,” or children born to mothers who often unknowingly took the sedative. The official narrative for several years was that because thalidomide was never officially sold in the United States, the country had been spared the worst of the drug’s consequences.

One of the most chilling statistics of this book, which fairly brims with them, is that to this day, the F.D.A. recognizes only nine thalidomide babies, including two stillborn ones. “In sixty years, the agency has never amended its victim count,” Vanderbes writes. “This erasure from history seems a cruel irony for people prevented, in many ways, from fading into the background.”

Equally damning is the fact that the United States is the only developed nation that doesn’t subsidize care for thalidomide victims. Whereas countries like Britain, Spain, Denmark, Sweden, Japan and Italy have covered some of the care costs for survivors, the United States absolved the guilty-as-sin Merrell “of any criminal accountability and essentially dodges any responsibility of its own on a technicality”: that thalidomide was made freely available rather than being sold.

Perhaps the greatest contribution of this urgent and engrossing book is the space it accords to the criminally undercounted survivors: Their testimonies are interleaved between chapters like so many intervertebral disks, forming the book’s moral spine. The final section of Wonder Drug recounts a 2019 “U.S. Thalidomide Survivors Conference” in San Diego organized by thalidomiders. Many of the attendees had first found one another through a Facebook group for thalidomide survivors, which became a valuable hub for those seeking a sense of community as well as information about ongoing lawsuits against companies that distributed Kevadon.

Meeting one other face-to-face for the first time at the conference proved epiphanic. One woman, surrounded by a roomful of people with atypical limbs, tells them “that seeing people who look like her has finally allowed her to abandon the need to perform.” Yet the battle for justice continues; for a whole slew of complicated reasons having to do with statutes of limitations, costs of filing a claim, lack of drug documentation and difficulties in tracing a case to a specific clinical investigator, “the deck [is] stacked overwhelmingly against any American victims.” What it will take to turn the tide is anyone’s guess, but Vanderbes’s book is a vital contribution to that effort.

The latest from america

Somerset Maugham's short story “The Letter” serves as the linchpin of Tran Twan Eng’s third novel, “The House of Doors,” which was selected for the 2023 Booker Prize long list.
Diane ScharperApril 05, 2024
A newly available compilation of Rahner’s writings on the arts, edited and translated from the original German by Gesa Thiessen, traces Rahner’s thinking about the phenomenon of inspired enthusiasm.
Benjamin IvryMarch 22, 2024
Paul Lynch’s 'Prophet Song' was inspired by the Syrian Civil War and the plight of those seeking refuge from the destruction and death occurring in Syria.
Diane ScharperMarch 14, 2024
Some of Jimmy Breslin’s best work has now been collected and edited by one of Breslin’s true heirs, The New York Times correspondent Dan Barry.
Tom DeignanMarch 14, 2024