Thalidomide in the US
US Thalidomide Survivors lifelong search for the truth
Although almost every source states that 17 Thalidomide Babies were born in the U.S, only 9 of their mothers received thalidomide as a sample in this country. The other eight mothers obtained the drug from sources in Europe, some directly and others from a family member who had traveled out of the country.
Evidence shows there were likely dozens or hundreds more babies born in the United States whose mothers received thalidomide samples from American drug companies.
How many of those babies died at birth, or in the years since, and how many are still living?
In November 1961, the world was shocked to learn that thousands of babies had been born with serious birth defects over the previous five years in Germany, England and many other countries. The birth defects, including phocomelia (shortened or missing arms, legs, fingers and toes) and other deformities were caused by their mothers taking thalidomide, a popular sleeping pill sold in many countries under various brand names including Distival, Contergan and Kevadon.
Initially, the American public was assured that the drug was primarily sold in Europe and never approved for use in the United States. But in April 1962, the US Food and Drug Administration (FDA) finally revealed that thalidomide had been distributed as samples in a clinical trial during and prior to the manufacturer submitting a New Drug Application.
According to FDA documents obtained by a survivor in 2012 through a Freedom of Information Act (FOIA) request, more than 2.5 million doses of thalidomide were distributed to more than 1,300 U.S. doctors by Smith Kline and French (now GlaxoSmithKline), Richardson-Merrell (now Sanofi-Aventis) and several Richardson-Merrell subsidiaries to be used in clinical trials.
The American pharmaceutical companies had been licensed to manufacture and distribute the drug by its patent owner, German pharmaceutical company Chemie Grünenthal (now known as Grünenthal).
Although the exact number of thalidomide babies born in the United States will never be known, the FDA records indicate the number was likely much higher. Dozens of children born with thalidomide injuries were never told their mothers took the drug handed to them as a sample medication by a doctor or nurse with no written record.
Many additional details about the clinical trial were recorded in thousands of pages of FDA records but never revealed to the public. After receiving high praise for preventing thousands of babies from serious birth defects, few had the power or political will to release the whole truth: there was no way to know exactly how many babies had been injured much less find them all.
Through social media, dozens of Thalidomide Babies born in the U.S. began finding each other in 2011. Unlike thalidomide survivors in Germany, England, Canada, Australia, Japan and other countries, many survivors in the U.S. grew up never knowing the cause of our birth defects or meeting others like us. Shamed into silence, we rarely spoke of our isolating experiences, even to our closest friends and family.
When a dozen of us met in 2018, it was the first time some had ever known another person who shared our life experience.
Many of our parents were reluctant to come forward for fear of intense media scrutiny. As a result, most of us grew up having no idea that our injuries were not “the way God made us” as we had been told.
Together we are working to correct the false narrative created in 1961 by Richardson-Merrell, Smith Kline and French, and Chemie Grünenthal. That story, repeated by journalists and doctors for decades, prevented most of us from knowing the cause of our birth defects and seeking compensation for the ongoing damage done to our health, self-image, relationships and economic security.
Although Dr. Frances Kelsey and her FDA colleagues did their best to find the children damaged by thalidomide, their efforts were hampered by pharmaceutical executives who threatened to sue for libel, and other political pressures. In the end, the U.S. Justice Department declined to prosecute those responsible for this preventable tragedy.
Once we learned our injuries might have been caused by thalidomide, there was little we could do as individuals. In most cases, the statute of limitations for us to take legal action against the pharmaceutical companies had expired.
Many of our mothers denied having taken thalidomide even when the evidence was overwhelming, or admitted it only recently. Almost every one of us has been told by a doctor, hospital or clinic that our medical records were “lost”.
The FDA documents reveal that many doctors who received thalidomide samples refused to allow FDA inspectors to review their patients’ records. Some admitted having shared the samples with other doctors, nurses, pharmacists and even a charity hospital in Africa.
While the drug manufacturers deny our claims against them by stating that we cannot prove our mothers took thalidomide, there’s plenty of proof that they have no idea who received the drug, when, where or how. In spite of the FDA’s valiant effort to track and recall the dangerous medication, tens of thousands of pills were never accounted for.
Today we are fighting to hold the pharmaceutical companies and the U.S. and German governments accountable for telling the truth and finally fulfilling their moral obligation to ensure our physical, emotional and financial security as we age much more quickly than our able-bodied peers.
Overcoming the Challenges
Although hundreds of newspaper and magazine articles published from 1961-1964 did not reveal the full story, one thing is clear. Our parents worried about our future prospects for work and family.
But we are strong individuals with current or past professions such as
Most of us have a current or past spouse or partner, children
One Little Pill
In the last decade, most of us were shocked to learn more about our history, such as thalidomide’s connection to Nazi Germany, as documented in the September 2012 issue of Newsweek magazine. The doctors who claimed to have discovered thalidomide had served time in prison as Nazi war criminals.
Thalidomide was said to have amazing potential as a sleeping pill with no hangover effect or possibility of accidental overdose. The doctors are now suspected of having tested thalidomide on prisoners in Nazi concentration camps.
We also learned about research that shows thalidomide only causes malformations in a fetus from day 35 to day 54 of gestation, when limbs, digits, eyes, ears and internal organs are forming.
Perhaps the biggest shock was learning that just one pill taken by a pregnant woman affected whatever was developing during the next 24-hour period. Just one little pill.
When a dozen of us met in 2018, it was the first time some had ever known another person who shared our life experience. Here are some photos of that life-changing experience plus others provided by our members.