Dr. Frances Oldham Kelsey, then a pharmacologist at the Food and Drug Administration, holds three packages of Contergan, the German brand of thalidomide, on October 15, 1962. Kelsey blocked the FDA from approving the drug for general use in the United States.
William J. Smith/AP
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William J. Smith/AP
When Cincinnati-based pharmaceutical company William S. Merrell sought Food and Drug Administration approval for a German-made sedative in the late 1960s, it expected the application to go through the process and be on store shelves in time for Christmas.
The drug, thalidomide, was not approved that year or the following year. A persistent medical reviewer at the FDA prevented the drug from being approved for general use. Dr. Frances Oldham Kelsey’s actions fundamentally changed the agency’s testing and approval process, leading to the strict regulations that exist today.
President John F. Kennedy publicly praised Kelsey for sparing “this terrible human tragedy that has befallen families in Germany.”
Except that wasn’t entirely true.
Doctors are already administering thalidomide to thousands of American patients, including pregnant women. Some children whose mothers received this medication during pregnancy have been born with severely deformed limbs.
These children are now adults and they want the federal government to officially recognize their existence.
“We’re seeing doctors today who say this didn’t happen here in the United States. Oh yes, it happened,” said Gwen Riechmann, born with phocomelia, the iconic shortened limb deformity caused by thalidomide.
Phocomelia is rare, but slightly more common outside the United States, in countries like Britain and Germany, where thalidomide was more widely sold.
When Riechmann’s mother was pregnant with her in the early 1960s, the doctor gave her a new sedative to ease her nausea. She involuntarily participated in an unregulated US clinical trial of thalidomide.
Merrell distributed thousands of unlabeled doses, telling doctors they were perfectly safe to treat a range of problems from insomnia to morning sickness, according to Jennifer Vanderbes, whose book Wonder drug details the history of thalidomide. She said the company does not require doctors to track the drug or report side effects.
“It was such a botched investigation,” said John Swann, a retired FDA senior historian.
As the FDA dug through Merrell’s records, Swann said, the amount of thalidomide that couldn’t be explained was striking.
“When you have a problem product, you trace it back to where it was distributed,” Swann said. When the FDA did this, it discovered, “and certainly the company had admitted, that there was still a lot that was missing.”
“It’s probably the most iconic toxic drug of all time because of its characteristic injuries,” Vanderbes said. “It transformed the FDA because it made clear that larger, more serious drug testing needed to take place before drugs went to market.”
Doctors did not tell the women they were taking thalidomide or document it in their medical records, Vanderbes said. The women “did not have a piece of paper indicating their prescription. They did not have bottles with a label.”
Many have had children born with truncated limbs.
But even after those babies were born, and even after the scientific community understood the dangers of thalidomide, doctors did not disclose that they had given the drug to their patients, Vanderbes said. Some women were specifically told that they had not taken it.
Years later, many of these women’s children were also told that they could not have survived thalidomide, because their doctors believed that the United States had escaped the thalidomide scandal.
Vanderbes estimates there could be as many as 100 American survivors.
Swann, the former FDA historian, said it is difficult to know the exact number of babies born in the United States whose mothers took the drug, but it is certainly higher than the 17 officially recognized by the FDA.
In 2018, Riechmann co-founded the advocacy group USA Thalidomide Survivors. The group of about 100 people, which includes allies as well as survivors, is pushing Congress to pass a bill that would formally recognize America’s thalidomide survivors and give each $150,000, with the possibility of additional funding in the future.
“The United States is the only country that has not provided any form of support or even acknowledged that they have thalidomide survivors,” she said. “We’re looking for, first, recognition that yes, we exist. And then, second, support.”
Survivors age and their health deteriorates, Riechmann said, but they can’t give up, although they can’t wait long either.
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