Author estimates around 100 actual U.S. survivors
An advocacy group of roughly 100 U.S. thalidomide survivors and their allies is urging Congress to pass legislation that would formally recognize American survivors of the drug and provide each with $150,000, with the possibility of additional money in the future, the group’s co-founder said in an NPR interview. Riechmann said the U.S. is the only country that has not provided recognition or support to thalidomide victims.
The campaign comes more than six decades after Cincinnati-based pharmaceutical company William S. Merrell distributed thousands of unlabeled doses of the sedative to doctors for use by pregnant women in the early 1960s, according to historical research detailed in the NPR report. The FDA has formally acknowledged only 17 American survivors, while author and researcher Jennifer Vanderbes estimates there could be around a hundred U.S. survivors. John Swann, a retired FDA senior historian, said it is hard to know an exact number but that the count was certainly more than the 17 formally acknowledged.
“We are looking for, first, recognition that, yes, we do exist. And then, secondly, support,” said Gwen Riechmann, who was born with phocomelia — the signature shortened-limb deformity caused by thalidomide — and co-founded USA Thalidomide Survivors in 2018. When Riechmann’s mother was pregnant in the early 1960s, her doctor gave her a new sedative to treat nausea, and she was unwittingly part of what the report described as an unregulated U.S. clinical trial for the drug.
Riechmann and other survivors say medical professionals continue to doubt that thalidomide injuries occurred domestically. “We go to doctors today who say it didn’t happen here in the United States. Oh yeah, it did,” Riechmann said.
The drug was developed in Germany as a sedative, and Merrell applied for FDA approval in late 1960. The application was not approved that year or the next. Dr. Frances Oldham Kelsey, a medical reviewer at the agency, repeatedly raised safety concerns about the drug. President John F. Kennedy publicly praised Kelsey for sparing us “this terrible human tragedy which has been visited on families in Germany.” Kelsey’s actions fundamentally changed the agency’s testing and approval process and led to the more rigorous drug-safety regulations in place today.
That official account omitted what was already underway in the United States. Merrell had distributed thousands of unlabeled doses of the drug to doctors, telling them it was safe for treating conditions from insomnia to morning sickness, according to Jennifer Vanderbes, author of “Wonder Drug,” a history of thalidomide. The company did not require doctors to track the medication or report side effects, Vanderbes said.
“This was such a sloppy investigation,” said John Swann, a retired FDA senior historian. When the FDA traced where the drug had been distributed, the company had admitted there was “just a great deal that was unaccounted for,” Swann said.
The women who received thalidomide were not told what they were taking and had no prescription slips or labeled bottles, Vanderbes said. Some were specifically told they had not taken the drug even after the scientific community understood its dangers, and many survivors were later told they could not be thalidomide survivors because their doctors believed the U.S. had escaped the scandal.
“It’s probably the most iconic toxic drug of all time because of its signature injuries,” Vanderbes said. “It transformed the FDA because it made clear that more significant and serious drug testing had to take place before drugs were released on the market.”
Phocomelia is rare but slightly more common outside the United States, particularly in countries such as Britain and Germany where thalidomide was more widely sold. “The U.S. is the only country that has not provided any kind of support or even recognition that they have thalidomide survivors,” Riechmann said.
Survivors are aging and their health is deteriorating, Riechmann said, making the legislative campaign time-sensitive.