SQ Online By Student
Consider this: you have been working in a lab for a few years, and you think that you have discovered a new drug to combat adolescent depression. Now, you have to test the efficacy and safety of the drug in a series of clinical trials in order to obtain FDA approval for it to go on the market. Of course, most people know that getting FDA approval for a drug requires several stringent guidelines to be met, and that meeting these guidelines is no easy task. However, this was not always the case. Before the 1960s, the FDA existed in name, but its regulatory functions were lax at best, and negligent at worst. The turning point occurred in the early 1960s after the thalidomide tragedy, a disaster which demonstrates the importance of regulating the pharmaceutical industry.
The thalidomide tragedy occurred in the 1950s, a time when the standards of regulation in the pharmaceutical industry were not nearly as rigorous as they are today. Thalidomide was first marketed in Germany during the mid-1950s as a drug to aid with sleeping problems and insomnia. The drugâs safety was emphasized heavily, and it was advertised as being acceptable for anyone to ingest, including pregnant women and children. In fact, the drugâs developers confidently proclaimed that they ââcould not find a dose [of thalidomide] high enough to kill a rat.ââ Thalidomide sales skyrocketed, and by 1960, the drug was marketed in 46 countries. At this time, research on thalidomide had begun to show the drugâs effectiveness in alleviating nausea in pregnant women, and many physicians started prescribing the drug off-label as a treatment for morning sickness. Not long after thalidomide started being used for this purpose, scientists began to observe birth defects in children born to mothers who had taken thalidomide during their pregnancy; studies showed that exposure was particularly dangerous for infants born to mothers that had used the drug approximately 20â34 days post-fertilization. Common birth defects seen in these children included deletion of the ears, deafness, severe underdevelopment or absence of the arms, defects in the femur and tibia (bones of the legs), and many more. More than 10,000 children around the world were born with thalidomide-related birth defects, and tragically, many of these children, now adults, still suffer from the effects of thalidomide…
