Thalidomide and birth defects
Thalidomide is a sedative that was prescribed to pregnant women in the late 1950s and early 1960s to alleviate morning sickness, but it was later discovered to cause severe birth defects when taken during a critical period of fetal development. The drug was associated with serious deformities, including limb malformations, affecting an estimated 5,000 to 10,000 newborns worldwide, primarily in Western Europe, Canada, Australia, and Japan. The thalidomide tragedy highlighted the necessity for stringent drug testing and regulatory oversight to prevent similar public health disasters. In the United States, Dr. Frances Kelsey notably resisted pressure to approve thalidomide, resulting in only a few cases of related deformities occurring in the country. The subsequent Kefauver-Harris Amendment of 1962 established stricter requirements for drug approval, ensuring that medications could only be marketed after proving their safety and efficacy through rigorous testing. Today, thalidomide is approved for limited medical uses, including the treatment of leprosy-related complications and certain cancers. In recent years, Australia has taken steps to acknowledge the impact of thalidomide by issuing formal apologies and providing support to affected individuals. The legacy of thalidomide serves as a reminder of the importance of safeguarding maternal and fetal health through careful drug regulation.
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Thalidomide and birth defects
DEFINITION: Sedative drug prescribed for pregnant women in the late 1950s and early 1960s to combat morning sickness until it was found to cause serious physical deformities during fetal development.
SIGNIFICANCE: When taken by pregnant women between the twentieth and fortieth days of gestation, thalidomide caused severe birth defects. The thalidomide tragedy showed that governments need to be scrupulous in determining the possible risks posed by new drugs before granting permission to manufacturers to market those drugs. Forensic scientists must investigate unusual medical conditions that appear in the population as rapidly as possible so that regulations can be put in place to avert disaster.
Prior testing of thalidomide had been seriously flawed when the drug was introduced into West Germany during the late 1950s, marketed vigorously as an antidote against a variety of human ailments, including morning sickness. By 1959, an estimated one million Germans were using the drug on a daily basis, and some German pharmacies allowed the purchase of thalidomide without a prescription. An advertisement by the German company selling the drug misleadingly declared that thalidomide was an antidote for morning sickness, that it relieved tensions associated with pregnancy, that it could be taken as often as necessary, and that it would harm neither pregnant women nor their unborn children.
Discovering Deformities
In December 1961, William McBride, an Australian physician, reported in a major medical journal that he had attended the births of a number of babies who showed severe physical abnormalities and whose mothers had used thalidomide. Shortly thereafter, German physicians reported similar outcomes and presented pictures of newborns with various deformities, including some with finlike appendages attached to their shoulders instead of arms and hands.
At that time, thalidomide was being sold in forty-six countries under fifty-one different brand names. It has been estimated that between five thousand and ten thousand newborns throughout the world suffered serious defects as a result of their mothers’ use of thalidomide. The injuries occurred primarily in western Europe, Canada, Australia, and Japan. In West Germany, after prolonged court hearings, more than 2,800 people received compensation for the harm they suffered as a result of the use of thalidomide
In the United States, the drug company Richardson-Merrell applied to the Food and Drug Administration (FDA) in 1960 for approval to market thalidomide. The application went to Dr. Frances Kelsey, who possessed a doctorate in pharmacology and a medical degree but had been working at the FDA for only a month. Kelsey was pressured by her superiors and by the drug company to approve thalidomide, but she insisted that better test results had to be obtained before she would recommend approval. As a result of Kelsey’s stance, only seventeen cases of thalidomide-related deformity among newborns occurred in the United States. In 1962, Kelsey was awarded the President’s Award for Distinguished Federal Civilian Service for her firm stand against federal approval of thalidomide.
Remedial Actions
The powerful lesson that emerged from the dire consequences of the failure to block the marketing of thalidomide outside the United States was that governments must be vigilant in monitoring new products produced by drug companies and should strongly resist companies’ efforts to enhance their profits by bringing drugs into the marketplace prematurely. In addition, forensic specialists need to analyze the reported results of tests on new drugs carefully to ensure that the testing has been conducted on adequate samples of animals and humans and that the results are accurately presented.
Following the thalidomide disaster, an important step was taken toward protecting the public in the United States with the passage in 1962 of the Kefauver-Harris Amendment, a measure that had been languishing in congressional committees through many sessions. The bill eliminated a previous provision of US law that allowed drug companies to sell new drugs to the general public if the FDA did not say otherwise for six months after the drugs were submitted to the FDA for approval. Since passage of the amendment, drug companies can sell new drugs only after the FDA has affirmed that the products are safe and effective on the basis of “substantial evidence.” Such evidence must include the results of carefully conducted scientific trials using matched groups where possible; that is, during the testing of a new drug, persons in one group undergo treatment with the drug while those in another are given a placebo, a harmless pill that resembles the drug being tested.
In 1998, the FDA approved thalidomide for limited uses. It has been shown to provide dramatically effective treatment for complications of Hansen’s disease (leprosy); trials found relief of symptoms in more than 70 percent of those given the drug, compared with only 2.5 percent of those who were administered a placebo. Thalidomide has also been approved for use in the treatment of the symptoms of acquired immunodeficiency syndrome (AIDS), some forms of cancer, and various skin conditions.
In 2023, the government of Australia formally issued a national apology to all citizens affected by the tragedy. The government reopened its Australian Thalidomide Survivors Support Program to ensure that anyone who was affected by thalidomide can secure access to support. Additionally, Australia unveiled a national memorial in Canberra to survivors of the thalidomide incident.
Bibliography
Brynner, Rock, and Trent Stephens. Dark Remedy: The Impact of Thalidomide and Its Revival as a Vital Medicine. Basic Books, 2001.
Mason, David. Thalidomide: My Fight. Allen and Unwin, 1976.
McBridge, Emma. "National Apology to Thalidomide Survivors and Their Families." Australian Department of Health and Aged Care, 29 Nov. 2023, www.health.gov.au/ministers/the-hon-mark-butler-mp/media/national-apology-to-thalidomide-survivors-and-their-families. Accessed 16 Aug. 2024.
Roskies, Ethel. Abnormality and Normality: The Mothering of Thalidomide Children. Cornell UP, 1972.
Sjöström, Henning, and Robert Nilsson. Thalidomide and the Power of the Drug Companies. Penguin Books, 1972.
Teff, Harvey, and Colin R. Munro. Thalidomide: The Legal Aftermath. Saxon House, 1976.
Winerip, Michael. "The Death and Afterlife of Thalidomide." The New York Times, 23 Sept. 2013, www.nytimes.com/2013/09/23/booming/the-death-and-afterlife-of-thalidomide.html. Accessed 16 Aug. 2024.