In the final years of the 1950’s, European doctors began recommending the drug thalidomide. It was supposed to be a wonder drug, used to treat anxiety, pain and insomnia. It was also given to pregnant women to suppress morning sickness and nausea. In addition to Europe, thalidomide was also widely recommended for use in Canada, Australia, Japan, as well as parts of Africa and Asia. For the next five years, despite growing concerns about the safety of the drug, doctors continued to suggest thalidomide to patients.
In 1960, it became quite clear that an unusually high number of babies were being born with severe deformities and birth defects. Growth of the arms and legs were stunted and misshapen. Hundreds of babies were born deaf and with unformed ears. There were also heart defects, blindness, malformed bladders, mental impairment and a condition called anal atresia, in which a child in utero fails to develop an anus, thus preventing proper bowel elimination.
Once reports of these defects began to spread, doctors had no choice except to find the cause. The first physician to suggest a causal link between thalidomide use and birth defects, Dr. Widukin Lenz also discovered that the severity of a baby’s defects could be traced back to the stage of development in which the mother took the drug. It was determined by Dr. Lenz that a fetus was most susceptible to damage from thalidomide when the mother used it 34 to 51 days following her last menstruation, or 20 to 37 days post-conception.
Despite overwhelming evidence that suggested thalidomide was dangerous, the manufacturer, Grunenthal, created promotions for the drug. In 1960, Grunenthal mailed over 250,000 flyers reiterating its claim that thalidomide was not harmful to children and could be taken safely for a long period of time.
When 1961 came to a close, the proof of the horror caused by thalidomide could no longer be denied. The drug was finally pulled from the market. It was too little, too late for the over 8,000 babies born under the influence of thalidomide. In 45 countries, babies were born with thalidomide related defects. The rate of stillbirth during the thalidomide years strongly suggests that nearly as many babies were born dead as were born alive with defects.
In the years that followed the withdrawal of thalidomide, Grunenthal found itself being indicted on the grounds of involuntary manslaughter and intentional infliction of harm. Eventually, Grunenthal and the prosecution agreed to drop the charges in exchange for a financial settlement. Grunenthal paid out over $31 million to children damaged by thalidomide.
More recently, thalidomide use has resumed in certain situations and under highly supervised conditions. Patients with leprosy have seen improvement with the drug, the use of which requires adherence to strict guidelines. Studies are being conducted to determine if thalidomide may have useful applications in the treatment of certain cancers, as well as tuberculosis and macular degeneration.
The unfortunate reality is that the dark years of thalidomide use stands as a harsh reminder of what can happen when a drug is not properly tested or implemented. The nightmare of thalidomide provided a completely new way of thinking about how substances taken by pregnant women can and do affect fetal development. While nothing can undo the damage already inflicted, the lessons learned from that damage has probably saved countless children conceived since that time.