Thalidomide

Thalidomide is a pharmaceutical product that was synthesized in West Germany in 1953 and sold as an antinausea drug and sleep aid under a number of different brand names beginning in 1957. Because it was believed to be nontoxic and to have no side effects, it was widely prescribed to pregnant women for relief of morning sickness and insomnia. However, thalidomide proved to be anything but nontoxic; more than 10,000 women who took the drug during pregnancy gave birth to children with severe birth defects. The best-known sign of prenatal thalidomide exposure was phocomelia (misshapen limbs), but children exposed to thalidomide before birth (commonly referred to as ‘thalidomide babies’) suffered many other birth defects, including missing limbs, cleft palate, spinal cord defects, missing or abnormal external ears, and abnormalities of the heart, kidneys, genitals, and digestive system. Some women who took thalidomide also reported abnormal symptoms, including peripheral neuropathy. Thalidomide was removed from the market in most countries in 1961, and the events surrounding its approval and release are considered perhaps the worst case of insufficient pharmacological oversight in the modern world. In particular, thalidomide had not been tested on humans at the time of its release, and its pharmacological effects were poorly understood.

Thalidomide was never approved by the Food and Drug Administration (FDA) for sale in the United States, so the impact of the drug was much less in this country than in Europe and other countries. However, the experience of seeing thousands of ‘thalidomide babies’ born in countries where the drug had been approved for general sale led to strengthening of several protections in the U.S. drug approval process. The major changes were incorporated in the KefauverHarris Amendment, passed in 1962, which required that new pharmaceutical products had to be demonstrated as both safe and effective and required that adverse reactions to prescription drugs be reported to the FDA.

Although thalidomide should not be taken by pregnant women, it has legitimate medical uses and is used in some countries to treat serious conditions such as cancer, leprosy, and AIDS. Because of thalidomide's history, any use of the drug today is controversial and some medical professionals believe that the drug should be banned entirely, while others feel that it is the best available drug to treat certain specific conditions.

One primary medical use of thalidomide today is in the treatment of leprosy, in particular to treat the symptoms of erythema nodosum leprosum. Thalidomide is also used in some cancer therapies and has become a common treatment for multiple myeloma. Thalidomide is also used to treat AIDS patients, in particular to fight mouth ulcers and wasting syndrome. Theoretically, the therapeutic use of thalidomide is carefully supervised and monitored; in practice, however, the risk of improper use remains (e.g., a thalidomide baby was born in Brazil in 1995), and this potential harm must be weighed against the benefits achieved by wider use of this drug.