About Thalidomide

Wiki Thalidomide

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Thalidomide was sold in a number of countries across the world from 1957 until 1961 when it was withdrawn from the market after being found to be a cause of birth defects in what has been called "one of the biggest medical tragedies of modern times".

It is not known exactly how many worldwide victims of the drug there have been, although estimates range from 10,000 to 20,000.

In the late 1950s and early 1960s, more than 10,000 children in 46 countries were born with deformities such as phocomelia, as a consequence of thalidomide use. The Australian obstetrician William McBride and the German pediatrician Widukind Lenz suspected a link between birth defects and the drug, and this was proved by Lenz in 1961.

The impact in the United States was minimized when pharmacologist and M.D. Frances Oldham Kelsey refused Food and Drug Administration (FDA) approval for an application from the Richardson-Merrell company to market thalidomide, saying further studies were needed. And although thalidomide was never approved for sale in the United States, millions of tablets had been distributed to physicians during a clinical testing program. It was impossible to know how many pregnant women had been given the drug to help alleviate morning sickness or as a sedative.


Wiki Frances Oldham Kelsey

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In 1960, Kelsey was hired by the FDA in Washington, DC. At that time, she "was one of only seven full-time and four young part-time physicians reviewing drugs" for the FDA. One of her first assignments at the FDA, was to review application by Richardson Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquiliser and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Even though it had already been approved in Canada and over 20 European and African countries, she withheld approval for the drug, and requested further studies. Despite pressure from thalidomide's manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.

Kelsey's insistence that the drug should be fully tested prior to approval was dramatically vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy. Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects in infants. She was hailed on the front page of The Washington Post as a heroine for averting a similar tragedy in the US. Morton Mintz, author of The Washington Post article, said "[Kelsey] prevented ... the birth of hundreds or indeed thousands of armless and legless children." The public outcry was swift and drug testing reforms were passed unanimously by Congress a few months later. The drug testing reforms required "stricter limits on the testing and distribution of new drugs" to avoid similar problems. The amendments also, for the first time, recognized that "effectiveness [should be] required to be established prior to marketing."