The thalidomide scandal broke in the early 1960s, with the horrifying news that large numbers of infants in Europe whose mothers had taken a new — and heavily marketed — sedative had been born with severe limb deformities. In particular, multiple infants with the shortened “seal-like” limbs of phocomelia, previously a very rare syndrome, were being reported in Germany and England.
Thalidomide, to this day, stands as a major cautionary tale of corporate greed and shoddy — or absent — research, and of the importance of testing and regulating new drugs. In “Wonder Drug: The Secret History of Thalidomide in America and its Hidden Victims,” Jennifer Vanderbes relates the efforts by Frances Kelsey at the Food and Drug Administration that prevented the drug’s approval in the United States. But she also reconstructs a largely untold and deeply disturbing story of how thalidomide was introduced into medical offices across the United States anyway, as an experimental drug given free to patients who in many cases had no idea what they were taking. And then, when the dangers of the medication became known, the authorities — including the FDA — failed to track down the drug, the patients who had taken it and the children who might have been affected.
Vanderbes gives us the voices of some of those families, including the articulate and intelligent children, now adults. Peggy Martz was born in May 1962 in Fort Thomas, Ky., “missing a lot of bones.” She has two fingers on her left arm, and on her right, just a thumb. The doctors, Martz told Vanderbes, “wouldn’t let my mom see me right away. They tried to convince her that because I was misformed on the outside, I was misformed on the inside. They wanted her to give me up. But she insisted on seeing me.” These narratives are woven into the story of drug marketing, medical research and regulation, reminding the reader of what is truly at stake in human terms.
Thalidomide had been developed in Germany by Chemie Grünenthal, a company with a dark Nazi past. But it was the context of the postwar world that made this drug so valuable: Thalidomide initially seemed to be a sedative without the negative effects of barbiturates. In the 1950s, when anxiety was increasingly identified as a problem — and was increasingly medicated — thalidomide’s selling point, paradoxically, was its safety, with Grünenthal claiming that even at very high doses, it did no damage to animals — which was not true.
The drug was marketed widely in Europe. In the United States, the William S. Merrell Company, based in Cincinnati, submitted an application to the FDA, where Kelsey pointed out the lack of safety data and refused to let it through. But in the meantime, in 1960, Merrell sent out its drug “detail men,” the pharmaceutical representatives who called directly on doctors and urged them to prescribe specific drugs. Because thalidomide had not yet been approved, the goal was to ask doctors, especially at teaching hospitals, to run “clinical trials” of the medication and try it out on their patients. These “trials” were not research — they were a marketing ploy to create demand for the new drug. Patients were not asked for their consent or even necessarily informed what drug they were taking, and no one was tracking where the pills went or to whom they were given. But the detail men recruited more than 1,200 doctors, who gave thalidomide to more than 20,000 Americans.
“Wonder Drug” is a story with real heroes — and real villains. Kelsey, the detail-oriented and rigorous doctor-scientist at the FDA, read the research submitted in support of this new tranquilizer and demanded more evidence that it was safe in humans. When the limb deformities associated with thalidomide were discovered, Kelsey was awarded a medal by President John F. Kennedy. She was celebrated in the American press as the woman who had saved American babies — which was certainly true. Kelsey also worked with the crusading Sen. Estes Kefauver of Tennessee in his long legislative battle to regulate the powerful pharmaceutical industry — which finally, drawing on the horrors of the thalidomide story, resulted in a bill being passed in 1962 that increased oversight of new drugs, required animal testing before human use and required patient consent for unapproved drugs.
Widukind Lenz, a pediatrician and geneticist in Germany, went house to house investigating babies with phocomelia. William McBride, an obstetrician in Australia who had delivered multiple infants with limb malformations, was determined to prove the connection to thalidomide. Helen Taussig, a pioneering American pediatric cardiologist, heard about the epidemic of children with limb anomalies and immediately set off for Germany to seek answers. Journalists got the story out, notably Elinor Kamath in Germany and Morton Mintz at The Washington Post. There were parents, like Karl and Linde Schulte-Hillen in Germany, who worked with Lenz, finding the families, battling in court for some compensation for their son, Jan, and extracting a penalty from the drug companies.
Vanderbes quotes pharmaceutical company memos, in Germany and in the United States, and traces the corporate efforts to generate positive medical articles about thalidomide’s safety and to suppress information about negative effects, which initially concerned nerve damage in adults who took it. But with the increasing number of affected infants, the alarm was raised, and the drug was pulled from the market in England and in Germany in November 1961. Still, Merrell did not withdraw its application in the United States for another three months — and it did not contact all the doctors who had been enlisted to distribute the drug.
Even when the effects of thalidomide were acknowledged, even when the children with phocomelia in Europe were well-documented, no one tracked down many of the people who had been exposed in the United States through that network of clinical trials. Kennedy said FDA inspectors were on the case but advised American women to check their medicine cabinets. “For six months the U.S. government had known that the drug, distributed nationwide, was linked to birth defects,” Vanderbes reports. “For six months, it had done nothing in response to the report of its own overseas attachés. Yet, on that August day, Commissioner Larrick and President Kennedy put forth a story of robust FDA action. Which was false.”
Many parents in the United States were refused compensation because of that same lack of documentation and struggled for years to establish that they had been exposed to the drug. In her first nonfiction book, Vanderbes — whose previous books include the novels “Easter Island” (2003) and “The Secret of Raven Point” (2014) — reclaims and reconstructs the hidden history of the American thalidomide victims and details their struggles with passion and compassion. By the end of the book, the heroes include the children themselves — now in their 60s — many of whom are carrying on this effort. In a moving final chapter, Vanderbes brings the daughters of Frances Kelsey to a 2019 thalidomide survivors conference. “They sense that their mother would want them here,” she writes.
“Wonder Drug” will leave you grateful for strong-minded scientists and epidemiology nerds — people who actually take the time to look at the data — and for dedicated pediatricians, parents who won’t take no for an answer and curious, persistent, investigative journalists like Vanderbes who can follow even long-buried and carefully hidden stories that need to be told.
Perri Klass, a professor of journalism and pediatrics at New York University, is the author of “The Best Medicine: How Science and Public Health Gave Children a Future.”
The Secret History of Thalidomide in America and Its Hidden Victims
Random House. 432 pp. $28.99
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