Thalidomide: A Nightmare Revisited

Spet. 20, 2013

By Medical Discovery News

While thalidomide is now being tapped for its cancer-fighting properties, it has a more notorious history. Starting in 1957, doctors recommended thalidomide as a mild over-the-counter sleeping pill supposedly safe enough for even pregnant women. That it also reduced morning sickness made it even more popular. The company that made thalidomide aggressively marketed the drug in 46 countries even after the wife of an employee who took the drug before its release gave birth to a child with no ears. Within two years, an estimated 1 million people in West Germany were taking the drug daily. However, thousands of babies born with severely malformed limbs revealed that this drug was not safe, but that connection was not made until 1961.

German pharmaceutical company Chemie Grünenthal GmbH originally developed thalidomide to treat convulsions, but users reported feeling sleepy. During testing, the company discovered that it was almost impossible to take enough thalidomide to be fatal. The company did not test the drug’s effects during pregnancy. Though approved for use in Germany and elsewhere in Europe, a U.S. Food and Drug Administration medical officer named Frances Oldham Kelsey denied its license because there was insufficient clinical evidence about its side effects. This decision limited the impact of the drug in America. In 1962, President John F. Kennedy awarded Kelsey the President’s Medal for Distinguished Federal Civilian Service. 

Warnings of the drug’s possible toxicity began to emerge in 1959. Adults taking the drug reported peripheral neuritis or inflammation of the nerves and the resulting nervous system damage. Even after an Australian and a German physician independently linked thalidomide to birth defects in 1961, it was four months before the company withdrew the drug from the market, and it was banned even later in some countries. It is thought that at least 100,000 pregnant women were affected by the drug leading to more than 90,000 miscarriages. Even a single dose of thalidomide during early pregnancy may cause severe birth defects. About 40 percent of babies exposed to the drug die before or soon after delivery. Over 10,000 children were born with thalidomide-related birth defects such as missing or shortened limbs. Still others were born deaf and blind, some had curved spines and some had damaged hearts and brains and many other abnormalities.

The company refused to pay compensation for many years until 1970 when they established a $28 million fund in return for legal immunity. When those funds were depleted, the German government paid compensation to victims. In 2009, Grünenthal provided another $63 million in compensation. The company did not publicly apologize for its actions until August 2012.  However, dissatisfaction with that statement and the level of compensation by the company continues.

Researchers are actively seeking drugs that work similarly to thalidomide but without the side effects. The thalidomide tragedy prompted creation of and reforms in the laws and policies that govern drug testing and approval, reducing the chances of another such incident, but it must not be forgotten lest history repeats itself.

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