Setting Our Story Straight
The true story of thalidomide distribution in the United States was buried in FDA documents and a Library of Congress archive for decades.
A reconstruction of the events of 1956-1965 is now possible thanks to the tireless efforts of several people who sought to uncover the truth.
A feature story by New York Times reporter Katie Thomas, published on March 24, 2020 touches on some recent revelations. A forthcoming book by Jennifer Vanderbes will reveal much more detail. Random House expects to publish the book sometime in 2022.
Feature story published in the New York Times on March 24, 2020 (Photo courtesy Carolyn Farmer Sampson.)
Grünenthal headquarters in Stolberg Germany. (Photo courtesy Norbert Schnitzler)
THE THALIDOMIDE Disaster in Germany
In November 1961, German citizens were shocked to learn about thousands of babies born with severe birth defects in their country.
Most of the babies were born with deformities of the arms and/or legs (phocomelia). Additional injuries to the kidneys, heart, gastrointestinal tract, reproductive organs, ears and eyes were sometimes not discovered until decades later.
Some doctors suspected that thalidomide, a popular remedy for insomnia, headaches, “tension” and nausea, caused the birth defects. Unfortunately, the drug manufacturer, Chemie Grünenthal (now Grünenthal) rejected the doctors’ suspicions as unproven speculation.
The sedative, a non-barbiturate alternative to Valium, had been sold for five years by the time Chemie Grünenthal reported the suspected dangers. By then, thalidomide had been sold by prescription or over-the-counter under many brand names, including Distival and Contergan, in forty-six countries.
FALSE NARRATIVE IN The United States
Decades later, people who recall headlines from 1962 often say, “thalidomide was never available in the United States.” Their recollection was probably skewed by a story that emerged slowly over a tumultuous two year period in U.S. History.
When news of the tragedy in Europe broke in April 1962, the American media reported that the U.S. Food and Drug Administration (FDA) had never approved thalidomide for sale in the United States.
Although American pharmaceutical company Richardson Merrell filed a New Drug Application (NDA) for thalidomide in September 1960, Dr. Frances Kelsey declined to approve it. With doctoral degrees in both medicine and pharmacology, Dr. Frances Kelsey, a new FDA employee, knew that drugs can cross the placental barrier and harm an unborn baby.
Dr. Kelsey requested proof of experiments on pregnant animals. Richardson Merrell resubmitted the NDA several times without ever providing the information she sought.
When it became clear that the drug would be recalled, Richardson Merrell quietly withdrew the pending NDA on March 8, 1962.
Original Life magazine cover, (Photo courtesy Carolyn Farmer Sampson.)
A seized bottle of thalidomide, known as Mer-30 or Kevadon in clinical trials (Photo courtesy of the US FDA)
THE THALIDOMIDE PROMOTION SCHEME
In April 1962, the FDA finally revealed that thalidomide had been distributed widely as samples in a clinical trial. Even then, the information was treated as a minor event in American newspapers, apparently because the FDA said no women who took the medication had so far delivered a baby with birth defects. They were wrong.
Details emerged over the coming months and in early August 1962, newspapers reported that Richardson Merrell distributed more than 2.5 million doses of thalidomide to more than 1,200 U.S. doctors. By the time the company filed the NDA, its clinical trial had evolved into an unauthorized marketing program.
In spite of an FDA rule prohibiting drug companies from distributing marketing materials before the NDA was approved, Richardson Merrell promoted the samples as a safer alternative to other sedatives. Company executives believed the drug would be approved by November 1960. They hoped to advance awareness of the new tranquilizer and maximize the number of prescriptions written during the most anxious time of the year: the Christmas and New Year’s holidays.
According to an internal FDA memo dated October 2, 1962, the “Manual” used by salesmen “shows that the doctor was provided with information assuring him of the safety of the drug and reveals the presence of a physician’s sample promotion scheme rather than a bonafide investigational program.”
FDA records obtained by a survivor through a Freedom of Information Act (FOIA) request in 2011 also document that German pharmaceutical company Chemie Grünenthal (now known as Grünenthal) licensed American companies Smith Kline and French (now GlaxoSmithKline) to manufacture thalidomide from 1956-1958 and Richardson-Merrell (now Sanofi), to produce it from 1958-1962.
Contrary to popular belief, thalidomide was not primarily a morning sickness remedy. The medication was referred to in FDA documents and the media as a sedative, tranquilizer or sleeping pill. Both companies distributed samples to doctors for testing on men, women and children for various symptoms including nausea.
FAILURE TO PROSECUTE RICHARDSON MERRELL
Many additional details about the FDA investigation were recorded in thousands of pages but never reported to the media. After receiving high praise for protecting thousands of babies from serious birth defects, no individual had both the power and the political will to release the truth that gradually unfolded. There was no way to know the exact number of “thalidomide babies” born in the U.S., much less find them all.
By the time the FDA investigation concluded, the official number of thalidomide babies born in the United States was seventeen. Only nine of the mothers received thalidomide as a sample in this country. The other eight mothers said they obtained the drug in Europe or from a family member who had traveled out of the country.
While the exact number will never be known, FDA records suggest there were many more than nine or even seventeen.
Dr. Kelsey’s valiant effort to find the children damaged by thalidomide was hampered by a Richardson Merrell executive who threatened to sue for libel. In the end, U.S. Attorney General Nicholas Katzenbach (1965-1966) declined to prosecute the pharmaceutical company or the executives responsible for this preventable tragedy. His review of the information gathered by the FDA and decision not to prosecute were never made public.
Nicholas Katzenbach, U.S. Attorney General 1965-1966 (Photo courtesy of the John F. Kennedy Library and Museum.)
FINDING OUR TRIBE
Through social media, dozens of thalidomide survivors born in the U.S. began finding each other in 2016. When a small group of us gathered for a weekend two years later, it was a shock to meet others who shared our life experience. (Read about that meeting.)
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.
HOW MANY BABIES WERE Maimed by Thalidomide samples distributed to pregnant women by AMERICAN DRUG COMPANIES?
Almost every available source, published from 1962 through 2019, states that seventeen “thalidomide babies” were born in the U.S.
Shockingly, the FDA never publicly revealed that the number 17 was certainly an enormous undercount. Their records suggest there could be dozens or hundreds of babies whose mothers received thalidomide samples from American drug companies. These babies, now adults, have never been counted, recognized or compensated for their enormous losses.
With an estimated 40% infant death rate and an unknown number of miscarriages, the damage caused by the reckless distribution of thalidomide samples to pregnant women in the United States is staggering.
Personal book collection (Photo courtesy of Jose G. Calora.)
Jennifer Vanderbes, author of “The Gatekeeper: Dr. Frances O. Kelsey and the Band of Unlikely Heroes Who Foiled the Greatest Pharmaceutical Scandal of the 20th Century”
NEW BOOK FROM RANDOM HoUSE WILL TELL The TRUE STORY Of thalidomide in the United States FOR THE FIRST TIME
In an uncanny coincidence, award-winning author Jennifer Vanderbes contacted one of our members in February 2018, the same month some of us met for the first time. She had been awarded a grant from the Alfred P Sloan Foundation and a publishing contract with Random House and HarperCollins UK to write a book about Dr. Frances Kelsey.
Dr. Kelsey, an FDA employee, prevented thalidomide from being approved for use in the United States. While researching the book, Vanderbes learned of our existence.
“THE GATEKEEPER: Dr. Frances O. Kelsey and the Band of Unlikely Heroes Who Foiled the Greatest Pharmaceutical Scandal of the 20th Century” reveals the whole truth about thalidomide in the United States for the first time.
Vanderbes was named a 2019-2020 National Endowment for the Humanities Public Scholar for her work on “THE GATEKEEPER.”
More than fifty-nine years after the International thalidomide disaster shocked the world, American thalidomide survivors will finally be acknowledged. The book release is expected in 2022.
Subscribe to find out the book release date later this year!