Ohio Drug Company Handed Out Unlabeled Thalidomide to Thousands in the US While the Government Took Credit for Blocking It

The textbook version of the thalidomide story is a triumph: an FDA pharmacologist named Dr. Frances Oldham Kelsey blocked a dangerous sedative from ever reaching American shelves, sparing the United States the birth-defect catastrophe that hit Germany, Britain and dozens of other countries. President John F. Kennedy publicly praised her in 1962 for sparing "us this terrible human tragedy which has been visited on families in Germany."

But the federal government's role in stopping thalidomide masks a darker reality: a Cincinnati pharmaceutical company distributed roughly 5 million unlabeled doses across the country while the drug remained technically unapproved.

A company that didn't wait for approval

William S. Merrell, a pharmaceutical company based in Cincinnati, applied to the FDA in late 1960 to sell the German-made sedative thalidomide in the United States, expecting quick approval in time for the holiday season, according to NPR. Kelsey, the FDA reviewer assigned to the file, kept raising questions and never let the drug reach general approval.

Merrell proceeded with distribution while the paperwork stalled. Between 1959 and 1962, the company distributed thalidomide across the country under the cover of a so-called clinical trial, according to reporting from Ohio State's student newspaper, The Lantern. Author Jennifer Vanderbes, who wrote "Wonder Drug: The Secret History of Thalidomide in America and its Hidden Victims," says Merrell handed out roughly 5 million doses to doctors nationwide.

Those doses were unlabeled. Doctors were told the drug had already been tested and was safe, and that they didn't need to track patients or report side effects, Vanderbes said. Some women were simply told they were getting a vitamin or a supplement for morning sickness or insomnia.

"This was such a sloppy investigation," said John Swann, a retired FDA senior historian. When the FDA later tried to trace where the drug had gone, Swann said, the company itself admitted a large amount of it was unaccounted for.

No paper trail, no proof

Because the doses weren't labeled or logged, the women who took them had nothing to point to afterward. "They had no slips of paper that showed their prescription. They had no bottles with a label," Vanderbes said. When babies were born with truncated or missing limbs, a condition called phocomelia, doctors often didn't connect it to the drug, and mothers were rarely told the truth even after the thalidomide scandal became public, according to Vanderbes.

Gwen Riechmann was one of those babies. Her mother was given the sedative in the early 1960s for nausea, unaware she'd been enrolled in an unregulated experiment. Riechmann, who still lives in the Cincinnati home she grew up in, says the denial has followed her for decades. "We go to doctors today who say it didn't happen here in the United States. Oh yeah, it did," she told NPR.

In 2018, Riechmann helped found USA Thalidomide Survivors, a group pushing for federal recognition. Nobody knows exactly how many American survivors are still alive; the group's own estimate puts the number at roughly 100.

The hard part: proving it decades later

Because Merrell never required doctors to document who received the drug, there is often no medical record connecting a specific birth defect to thalidomide exposure sixty-plus years later. That absence of a paper trail is exactly why some doctors and officials have told survivors the U.S. simply wasn't part of the thalidomide story. It's a fair, practical objection: government programs generally need documentation to verify a claim, and this one was designed by the company itself to leave none.

That doesn't mean the underlying injury isn't real. Phocomelia has a distinct, recognizable clinical signature, and the historical record, including the FDA's own admission that large quantities of distributed drug went untracked, backs up the survivors' account of what happened. The dispute isn't over whether thalidomide reached the U.S. It reached the U.S. The dispute is over how to formally verify, compensate or even count individual survivors when the company that caused the harm made sure there was nothing to verify with.

Other countries handled this differently. Germany, the United Kingdom and Canada set up formal compensation funds for thalidomide victims decades ago. No comparable federal program exists in the United States. USA Thalidomide Survivors continues to press Congress and the Department of Health and Human Services for formal recognition and support, according to NPR and its affiliate stations. As of now, no such federal acknowledgment program has been established, and no congressional hearing on the issue has been scheduled.