The Unseen Survivors of Thalidomide Want to Be Heard

By | March 24, 2020

The man on the bus was staring at her. Carolyn Farmer, 17, noticed him as she closed the Leon Uris novel “Exodus” and gathered her things.

It was 1979, and she knew what it was like to have strangers gawk at her: She had been born with shortened arms and fingers missing on each hand.

“Are you a thalidomide baby?” he asked as she waited to get off.

Confused, she said no. But on the walk home in her close-knit suburb of St. Paul, Minn., she repeated this word she had never heard before: tha-lid-o-mide.

Thalidomide, a sedative sold by a German drugmaker, was said to relieve everything from anxiety to morning sickness, but it led to perhaps the greatest pharmaceutical scandal of all time. About 10,000 babies, many in Germany, Britain and Australia, were born with severe defects in the 1950s and 1960s after their mothers took it. Some babies had no arms or legs. Others had no ears or malformed kidneys.

The scandal briefly flared in the United States, where the drug was given to about 20,000 Americans in loosely run clinical trials sponsored by two American drug makers. The crisis led to passage of modern drug safety laws in the United States that required pharmaceutical companies to prove their medicines worked through rigorous clinical trials.

But the babies whose mothers took thalidomide in the United States were largely forgotten. Today, more than half a century later, people who believe they are the U.S. survivors of thalidomide have found one another through Google searches and Facebook groups, joining forces to fight for justice, recognition and compensation.

Historians say the lesson of thalidomide is one that society is still learning the hard way. Hundreds of thousands of Americans have died in an opioid epidemic that has its roots in the Food and Drug Administration’s approval of the painkiller OxyContin and dishonest, aggressive marketing of the drug by its maker, Purdue Pharma.

Today, as the coronavirus circles the globe — claiming thousands of lives — there is a renewed push to rush potential cures to market, even if it means bypassing the checks and balances that were thalidomide’s legacy.

Jennifer Vanderbes, who is researching a book about the history of thalidomide in the United States, said society owed the survivors in America a debt of gratitude.

“They took a pharmaceutical bullet for all of us, not choosing to,” she said. “But without them, we don’t have the safeguards that we have today.”

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Credit…Jenn Ackerman for The New York Times

Carolyn was just a year old in 1963 when her father, a Konica salesman and freelance wedding photographer, posed her for a portrait, a teddy bear obscuring her weaker, shorter left arm. It was one of many props he used to hide her birth defect as she grew up: cuddling a bear, seated behind her baby sister, in profile against a tree.

Her disability was like that — seen, yet unseen — for much of her childhood.

Her mother, Marilyn, was 22 when she gave birth in March 1962. The nurses did not tell her about her newborn’s defects right away. They presented the baby in a tight swaddle, her too-short limbs tucked under a blanket.

Her mother, whose last name is now Martin, had heard about thalidomide, but said she didn’t connect it to Carolyn’s defects.

Her doctor had given her a packet of pills early in her pregnancy that were for headaches, not morning sickness. Besides, the doctor had assured her they were safer than Alka-Seltzer, and she had taken only one or two, she said.

Carolyn’s arms were shorter, and she was missing fingers, but “it wasn’t the horrific deformities that they were telling about or showing,” Ms. Martin recalled.

Nevertheless, she set the pills aside, just in case.

Carolyn, the eldest of four children, was expected to do the same chores as everyone else, washing dishes after dinner and changing her sheets every Friday.

But she couldn’t hold hands on Sundays at church or when her third-grade class learned to square dance. She remembers visits to doctors, including to a surgeon who fashioned a working thumb out of one of her index fingers. She endured taunts at school.

Her siblings had to answer prying questions. “My mom would say, ‘Well, tell your friends that’s how God made her,’” Patty Westcott, Carolyn’s younger sister, recalled.

By the time the man on the bus asked about thalidomide, Carolyn’s parents were divorcing. Her mother said she wasn’t sure what the cause was, but ended the conversation. It wasn’t the right time to ask questions no one felt like answering.

When Carolyn was old enough to get a job, no one wanted to hire her. She was turned down at a fast-food chain because she couldn’t hold the fry basket. At a department store lunch counter, she was told she wouldn’t be able to balance large trays of food. She was fired from a gas station after being wrongly accused of making errors at the cash register.

Carolyn married at age 19 and quickly had two girls. Angered by her poor job prospects, she consulted a lawyer to look into the thalidomide story.

This time, she pinned her mother down, and to her surprise, her mother handed over the old pills. Her lawyer sent them to a lab, but the tests could not determine whether they were thalidomide, and they were not returned.

Carolyn divorced, becoming a single mother.

As she got older, she learned to slip her arms into her sleeves at job interviews, revealing her disability only after she was hired. A career in public relations followed, and she dabbled in local Democratic politics.

In 2008, as she prepared for her daughter Angie’s summer wedding, Carolyn agonized over what to wear. A long-sleeved jacket would be too hot, yet she cringed when she imagined the photograph hanging on her wall, her arms exposed every time she walked by. She bought a sleeveless dress anyway.

Similarly emboldened, in 2011, Carolyn typed the words “thalidomide victim” into Google. Decades of burying her feelings had caught up with her, and she was struggling with depression and anxiety. She needed to understand what had happened.

Her Google search led her to a Facebook group for international survivors of thalidomide, and she learned there that a lawsuit was being prepared on behalf of American victims.

That fall, she reached out to the lawyers bringing the suit, and one of them returned her call at work. She walked to the parking lot to talk.

The lawyer told her about the American clinical trials, and that the drugs had been dispensed in paper packages, without labels.

“I was just pacing around the parking lot, like, ‘Oh my gosh, I can’t believe it,’” Carolyn said. “My whole life kind of flipped upside down.”

In 1957, thalidomide arrived in German pharmacies as a sedative sold by Chemie Grünenthal, whose head of research, Dr. Heinrich Mückter, was a Nazi war criminal.

The drug, approved in Germany without testing in pregnant women, was sold as a safe alternative to overdose-prone sedatives. Soon, Grünenthal and its overseas partners were selling thalidomide for a range of ailments, including morning sickness in pregnant women.

Two American companies explored bringing thalidomide to the United States. In 1956 and 1957, the Philadelphia drugmaker Smith, Kline & French distributed it to dozens of doctors through a clinical trial. Doctors were not initially told it was thalidomide; the pills instead carried the label SK&F #5627, according to federal court documents. The company’s researchers concluded it was not effective and decided not to pursue an application for approval.

But Richardson-Merrell, a Cincinnati company that was selling thalidomide in Canada under the name Kevadon, began a more aggressive, sloppily run trial to prepare for what the company assumed would be an easy approval in the United States.

One part of the campaign, run by its marketing department, instructed salesmen to assure doctors they didn’t have to keep track of which patients took it. “Do not sacrifice having an important man evaluate Kevadon for the sake of case histories,” according to a handbook later turned over to Congress for Senate hearings that took place in 1962.

Internal F.D.A. reports, obtained through a recent public records request, show just how chaotic the distribution of thalidomide had been.

The tablets came in a variety of shapes and colors, from yellow to pink to white.

In one case, a boy with birth defects was born to a Maryland woman who had been given the drug by her mother, whose psychiatrist issued it “to allay her nervousness,” according to an F.D.A. memo from August 1962.

A Chicago-area doctor told investigators that a colleague had given him 400 pills, according to another memo. He heard of the drug’s problems only from later news reports.

In the United States, thalidomide was never approved for sale because a drug reviewer at the F.D.A., Dr. Frances Kelsey, successfully delayed an application by Richardson-Merrell over concerns that the drug could be unsafe.

In November 1961, Grünenthal announced it was pulling thalidomide from the German market because of questions about whether the drug was causing birth defects. Richardson-Merrell later withdrew its application.

Alarm in the United States crescendoed in the summer of 1962, when a Washington Post article revealed Dr. Kelsey’s role. Other reports followed, including news about the clinical trials in the United States. President John F. Kennedy warned women to check their medicine cabinets and not to use the drug.

The F.D.A. initiated an investigation into whether any American babies had been harmed, sending a “rush” assignment to each of its field offices.

Over the next months, investigators struggled to document the drug’s toll because of the casual way it had been distributed, according to hundreds of pages of government and company documents uncovered through court filings and public records requests made by The New York Times, as well as those who believe they were harmed by the drug

The federal government, citing limited resources, did not try to track down all of the affected babies, focusing instead on ones who would build their case against Richardson-Merrell.

Estimates of how many American babies were affected by thalidomide have varied. A lead F.D.A. investigator said in a 1964 report that 17 infants had been harmed. Investigators in the agency’s Cincinnati office later pursued reports of about 40 births associated with one obstetrician, Dr. Ray O. Nulsen of Cincinnati. Dr. Nulsen, who had been one of the chief doctors in the Richardson-Merrell trial, declined to cooperate, according to F.D.A. reports. The agency later said it could not verify that number, but found that he had delivered at least five malformed infants.

By the fall of 1962, F.D.A. officials concluded that Richardson-Merrell had most likely broken the law several times over. An agency memo described how the company emphasized “selling the product” even though it had never been approved. The officials also said that company lawyers appeared to have cleared their records of incriminating internal memos for the years after 1960, when Richardson-Merrell was pursuing approval.

In September 1964, federal prosecutors declined to press charges. Some of the company’s activities had “questionable overtones,” prosecutors said, but the evidence did not warrant criminal charges.

F.D.A. officials later noted that prosecutors had made a critical error when they said only one baby had been born in the United States with defects from thalidomide.

But by then, the public had moved on.

The children of thalidomide are now in their late 50s and early 60s.

In 2011, the lawyers who had contacted Carolyn Sampson were planning to sue Grünenthal, which is still in business, and GlaxoSmithKline and Sanofi, the successors to Smith, Kline & French and Richardson-Merrell.

To avoid the long-expired statute of limitations, the lawyers would have to prove their clients had a new claim, based on new information.

One of the lawyers, Peter Gordon, had filed a class-action suit in Australia, arguing that a larger group had been affected than those who had previously received government compensation, and citing recent research that changed the understanding of how thalidomide caused defects.

The question of who is a thalidomide survivor has persisted since the earliest days of the crisis.

Infants injured by thalidomide suffered a range of ailments, but the focus was on the most severe cases. European researchers settled on a set of attributes that would guide who could be compensated, including people with symmetrical defects — that they were missing both arms, for example.

Lawyers in the recent cases have cited newer research. It posits that thalidomide could have interfered with embryonic growth in many ways, including stopping the creation of blood vessels, which halted the formation of limbs. This would mean thalidomide survivors could have a wider range of defects.

“Thalidomide was a wrecking ball to the embryo, but the early medicine got it wrong,” said Mr. Gordon, whose Australian lawsuits were settled in 2014 for more than 100 million Australian dollars, tripling the number of people in Australia and New Zealand who were recognized as survivors, to about 150 from 45.

Neil Vargesson, a professor of developmental biology at the University of Aberdeen in Scotland, who has studied the effects of thalidomide, said that while the precise cause of the damage was still unclear, “I honestly think there are way more people affected.”

Beginning in 2011, lawyers for Ms. Sampson and about 50 other American plaintiffs filed suit. But those recent cases have largely failed. In 2015, a federal judge in Philadelphia fined the Seattle firm that helped bring the suits, Hagens Berman Sobol Shapiro, for employing “bad faith and dishonesty.” The judge, Paul S. Diamond of the Eastern District of Pennsylvania, concluded that the lawyers should have known the cases, filed after the statute of limitations expired, would fail.

A special master appointed by the judge is investigating a range of claims against the firm, including that it misled plaintiffs about their chances for success.

Ms. Sampson has dropped Hagens Berman as her representative and testified against the firm at a hearing before the special master last May.

“I feel manipulated by everyone,” she said.

Nick Styant-Browne, a lawyer for Hagens Berman, said that “the firm would like to respond to these issues, but, in 2013, Judge Diamond directed the parties not to make any further public statements about the cases.”

With the lawsuits in tatters, those who considered themselves the American survivors of thalidomide met on a late winter weekend in 2018 at a Holiday Inn near the Atlanta airport.

It was part reunion, part battle planning.

The men and women — about a dozen in all — had never met in person, having connected on a Facebook group set up by Ms. Sampson. They talked for hours at the hotel restaurant, gesturing with arms and hands of all shapes and sizes as waiters brought fresh glasses of beer. Some had shortened legs and used wheelchairs. Others had eye problems, ear problems, a cleft palate, no toes.

Some had driven for hours, while others had flown across the country. One woman took Greyhound from Cincinnati in her power wheelchair, a 12-hour ordeal that involved a broken-down bus and a midnight arrival at the Atlanta bus depot.

She and another woman from Cincinnati ordered “pop” at the bar in their flat Ohio accents; another spoke with the drawl of Monroe, her Louisiana hometown. There was a shy nurse from Missouri whose voice cracked when he spoke of his family.

For the first time, they watched as others who looked like them raised glasses, brushed away hair, scrolled through Instagram. They compared notes from a lifetime of compensating for malformed limbs: chronic back pain, worn-out joints.

By the end of the weekend, they resolved to form a nonprofit, US Thalidomide Survivors, to press for their needs and to initiate a campaign to draw attention to their story.

Around the world, thalidomide survivors have been making a renewed push for recogition. In Australia, that has meant the legal settlement. In 2015, Canadians persuaded the government to increase its compensation payments, and the Canadian government enhanced its assistance to survivors again in 2019.

The Americans who believe they are survivors say they want to spread the word that thalidomide harmed babies in the United States, too. They want better medical information and research about the way their bodies were damaged. They want to remove statutes of limitations that have prevented them from successfully suing. And they are planning to campaign for compensation, inspired by the success of Canadian survivors.

Dorothy Hunt-Honsinger, of Cortland, Ohio, said her mother was given pills for anxiety and morning sickness in Pennsylvania in 1960. She believes someone must be held accountable for the trials, even if thalidomide was never approved in the United States.

“I would like compensation,” said Ms. Hunt-Honsinger, who has malformed arms and legs as well as heart problems. “More than that, I would like recognition that it did happen.”

As part of her quest to understand her story, Ms. Sampson asked the F.D.A. for the list of American doctors who distributed thalidomide. Soon she was turning through the roughly 1,200 doctors who worked with Richardson-Merrell, and nearly 70 who received the drug through Smith, Kline & French.

She was searching for her mother’s obstetrician. Discovering whether he had been part of the trial might offer her one more clue to her story. The names beginning with H, the first letter of his name, ran for four pages. But he was not there.

Another dead end.

Today, Ms. Sampson receives federal disability assistance as a result of chronic back, neck and arm pain that she says results from her defects. She works part time designing websites for businesses and nonprofits around Minneapolis, and volunteers as the communications director of the nonprofit she helped to found.

She said she had struggled to make peace with the idea that she would never know for sure whether she is a thalidomide survivor.

That ambiguity is built into the story of thalidomide in the United States. Richardson-Merrell’s slapdash clinical trial and the flawed investigation by the F.D.A. most likely mean the drug’s true toll will never be known.

“I can’t tell you how angry that makes me,” Ms. Sampson said.

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