When the William S. Merrell pharmaceutical company filed paperwork with the Food and Drug Administration in late 1960, executives in Cincinnati had every reason to expect a quick green light. The product was thalidomide, a sedative already popular in Europe, and Merrell hoped to have it stocked in American stores by Christmas. Instead, the application stalled — first for a year, then for longer.
The delay is now remembered as one of the greatest regulatory saves in American history. Dr. Frances Oldham Kelsey, a medical reviewer at the FDA, repeatedly refused to approve thalidomide for general sale, pressing the company for evidence that the drug was safe. Her insistence spared the United States the scale of the birth-defect catastrophe that was unfolding in Germany, Britain and elsewhere, where the medication had been widely marketed to pregnant women.
President John F. Kennedy later honored Kelsey in a public ceremony, crediting her with preventing "this terrible human tragedy" from reaching American families. Her work reshaped how the agency evaluates drugs and helped usher in the stricter testing and approval rules that still govern the pharmaceutical industry today.
But the familiar story of Kelsey's triumph conceals a more complicated reality. While thalidomide was never cleared for general distribution in the U.S., it was not absent from the country. Under a loophole of the era, drugmakers could supply experimental medications to physicians for research purposes, and doctors were permitted to hand those drugs to patients. Thalidomide flowed through that channel into the hands of thousands of Americans, including pregnant women.
Some of those women were given the sedative without being told what they were taking or that it had not been approved. Others received it as part of what were described as clinical trials. The result, according to advocates and survivors, is a group of Americans born with the signature injuries of thalidomide exposure — people whose existence the federal government has never formally counted.
Those children are now in their sixties. They are pressing for official recognition, arguing that the government's long-standing position — that thalidomide caused almost no domestic cases — is simply wrong. Their campaign challenges a piece of American medical folklore that has been repeated for more than half a century.
Gwen Riechmann is one of them. Born with phocomelia, the distinctive condition in which the limbs are shortened or missing, she has spent years encountering doctors who insist her disability could not have come from thalidomide because the drug never reached the United States. "We go to doctors today who say it didn't happen here in the United States," she said. "Oh yeah, it did."
Phocomelia is uncommon, though it appears somewhat more often outside the U.S., particularly in Britain and Germany, where thalidomide was sold openly and prescribed widely. In those countries, thousands of babies were born with severe limb differences before the drug was withdrawn from the market in the early 1960s. The affected populations there have been documented, compensated and, in many cases, formally apologized to.
In the United States, no comparable accounting has ever taken place. Because thalidomide was distributed mainly through the experimental-use system rather than as an approved product, there was no nationwide registry of patients who received it and no systematic follow-up of the pregnancies involved. Many records were never kept, and some that existed have since been lost or discarded.
That gap in the historical record has made it difficult for survivors to prove what happened to them. Many were told as children that their mothers had taken a vitamin or an unknown medication during pregnancy. In Riechmann's case, her mother was given a new sedative by her doctor in the early 1960s — a detail that fits the pattern described by other American families now coming forward.
Survivors and their advocates say the consequences of that missing history are not merely symbolic. Without official acknowledgment, they argue, patients struggle to obtain accurate medical care, because physicians are trained to regard thalidomide-related birth defects as a foreign phenomenon. Recognition could also open the door to research, support services and, potentially, compensation similar to programs established abroad.
The campaign also raises uncomfortable questions about how the FDA's wartime and postwar arrangements with drug companies were overseen. The experimental-use pathway was intended to speed promising treatments to patients under a doctor's supervision, but critics say it functioned in practice as a shadow distribution system with limited transparency and almost no tracking of outcomes.
For the survivors, the request is narrow: an admission that they are here, that their disabilities have a documented cause, and that the comforting narrative of America's narrow escape from thalidomide is incomplete. Until that happens, they say, each visit to a skeptical doctor becomes another round of having to prove their own history.
More than six decades after Kelsey blocked thalidomide's approval, her legacy remains secure. What remains unsettled is the fate of the Americans who were exposed anyway — and whether the government that once celebrated its success in keeping the drug out will now acknowledge those it did not keep safe.
(0)