In the mid 1900s, sleepless worriers full of post-war anxiety needed an easy way to fall asleep. In rushed the drug market, who could could easily target this anxiety-ridden population, where one out of seven American adults took sleeping pills every night (Fintel, 2009). Thalidomide seemed like an easy, unassuming miracle pill. It was so safe, in fact, that the company targeted pregnant women, saying that there were no effects on the child or the mother. This worldwide drug was sold to numerous countries in Australia, Africa, Europe, and North America (Decarvalho Anderson, 2013), and affected the lives of 10,000 children and their families over a short period of time.
In a toxicology report done by Professor Florian Basserman, it is seen …show more content…
Trials started only two years before the release, while most drug trials take 8 times longer than that in order to be proven as safe (CCFA, 2016). This is a “Type I error”, which means that the drug was approved as safe to use and was later found to be harmful (Philipson, 2012). Chemie Grünenthal tried to make a deal with an American company, which was rejected, and so eventually made an arrangement with the William S Merrell company in the United States. Chemie Grünenthal should have taken the rejection from the first company as a warning that the drug should not be marketed as safe for even pregnant women. This drug caused many birth defects that resulted in emotional and physical pain and displacement. Chemie Grünenthal did not apologize until 50 years after the incident, making this pharmaceutical sale a serious ethical issue.
Because of thalidomide, the FDA has made a stricter drug-authorization regime. In 1962, the FDA passed the Kefauver Harris amendment, which made stricter regulations on drugs sold in the United States. This has caused other tragedies that have happened elsewhere to be protected in the United States (Philipson, 2012). This drug now is back to treat leprosy, AIDS, cancer, and multiple myeloma, which greatly helps these weak populations (NCBI,
In a toxicology report done by Professor Florian Basserman, it is seen …show more content…
Trials started only two years before the release, while most drug trials take 8 times longer than that in order to be proven as safe (CCFA, 2016). This is a “Type I error”, which means that the drug was approved as safe to use and was later found to be harmful (Philipson, 2012). Chemie Grünenthal tried to make a deal with an American company, which was rejected, and so eventually made an arrangement with the William S Merrell company in the United States. Chemie Grünenthal should have taken the rejection from the first company as a warning that the drug should not be marketed as safe for even pregnant women. This drug caused many birth defects that resulted in emotional and physical pain and displacement. Chemie Grünenthal did not apologize until 50 years after the incident, making this pharmaceutical sale a serious ethical issue.
Because of thalidomide, the FDA has made a stricter drug-authorization regime. In 1962, the FDA passed the Kefauver Harris amendment, which made stricter regulations on drugs sold in the United States. This has caused other tragedies that have happened elsewhere to be protected in the United States (Philipson, 2012). This drug now is back to treat leprosy, AIDS, cancer, and multiple myeloma, which greatly helps these weak populations (NCBI,