In the 1950s, a German company, Chemie Grünenthal, developed thalidomide, which was marketed in Europe as the first safe sleeping pill and was seen as a highly effective treatment for pregnant women with morning sickness.
The drug enjoyed such widespread success that in some European countries it became almost as popular as aspirin.But thalidomide was far from safe. Although the cause was not realized until later, the first known victim of thalidomide was a girl born with no ears on Christmas Day in 1956 — a daughter of a Grünenthal employee.
In time, thousands of children around the world whose mothers took the drug while pregnant were born with severe physical disabilities, including flipper-like arms and legs.
Thalidomide affected children were in some instances rejected by their parents and institutionalized. Others had their flippers amputated to accommodate prostheses for arms and legs. In one extreme case, a young mother and her doctor were charged with the mercy killing of her deformed infant. But in the United States things were different, thanks to one of those little known heroes who simply did her job well, and in the process, prevented the drug from being approved.
In September 1960, Dr. Frances Oldham Kelsey, a young pharmacologist who had just started working at the Food and Drug Administration, was asked to review the drug for approval but became alarmed by what she saw as the lack of rigorous scientific research supporting the drug’s safety done by Grünenthal and William S. Merrell, the United States distributor.
Once she examined the research carefully, the case for thalidomide quickly unraveled. She kept asking the company for more data, delaying approval. In late November 1961, long-ignored evidence became public in Germany linking thalidomide to birth defects. Grünenthal, which in a court case years later blamed causes like nuclear fallout or botched home abortions for the children’s deformities, did not apologize to the victims and their families until last year.
Because of Dr. Kelsey’s perseverance, the drug never received F.D.A. approval and in 1962, the drug was banned worldwide. But almost as important, it marked the beginning of a new era for the F.D.A. Major regulatory reforms were finally forced on the pharmaceutical industry, many of the same federal guidelines that we live under today.
Thalidomide is one principal reason United States drug laws are so strict.
But this was not the end of thalidomide. In the early 1990s, researchers discovered that the same properties of the drug that restrict blood vessel growth and resulted in the stunted limbs, were useful in treating a number of medical disorders, including some cancerous tumors, like multiple myeloma, Crohn’s disease and multiple sclerosis.
While the medication now carries a strict warning that it is not to be taken by pregnant women, in Brazil, where it is used extensively to treat leprosy, a group of researchers report that as many as 100 children have been disabled by thalidomide since 2005.
Winerip, Michael. “The Death and Afterlife of Thalidomide.” The New York Times, The New York Times, 23 Sept. 2013, www.nytimes.com/2013/09/23/booming/the-death-and-afterlife-of-thalidomide.html.