History Of Thalidomide

The novel chemical compound alpha-phthalimido glutarimide (thalidomide) was first synthesized by Ciba in 1952 but found to be ineffective in the animal models tested and was ultimately discarded. Then in 1957, the German manufacturer Chemie Grunenethal in West Germany bought the patent for the chemical, which contained the active pharmaceutical drug substance thalidomide. The initial indication of the novel medication was for use as an anticonvulsant but early studies suggested that it was not effective for this condition; however, it did show positive results for use as a sedating agent. Earlier research of thalidomide showed several unusual properties, one of which was in the fact that an overdose of the medication did not appear to cause …show more content…
Manufactures of new medicines and therapies during across Europe during this period of time were able to capitalize on regulations that lacked adequate protocols, standards or controls over the way in which animal and clinical trial models were performed as well as deficient regulations requiring manufacturers to provide comprehensive safety information on their products before it was available to the general public. The lack of regard by pharmaceutical manufactures during this period for the safety of the general population would ultimately become the platform for which reform was targeted in hopes to avoid future catastrophic tragedies such as the thalidomide incident. During this period, thalidomide became the preferred choice of pregnant women who were suffering from morning sickness all across Europe, mostly due to the fact that thalidomide was initially marketed as a medication free of any side effects and could be taken safety by expecting mothers5. Thousands of babies were born during this time in Europe and Australia to unsuspecting mothers seeking treatment for their symptoms through the use of thalidomide, only to find out this medication would be the cause of severe birth abnormalities as well the ultimate demise of their baby …show more content…
Multiple health organizations during this time were issuing responses to thalidomide in hopes of stopping its use. Several organizations were created to help in dealing with the situation and in July of 1962, the College of General Practitioners created the Register of Unexpected Toxicity and a committee was set up by the Association of the British Pharmaceutical Industry to help aid in immediately dealing with the catastrophic fetal effects of thalidomide1. The committee’s findings on thalidomide ultimately led to the issuance of the Cohen report in 1963 that recommended all new medications be subject a Committee on the Safety of Drugs, which would include multiple expert reviews on the toxicology, clinical trials, therapeutic efficacy and any adverse reactions or events associated1. The report also disseminated concern on other concerns that were not covered in the committee’s remit such as: the quality of drugs being manufactured, control of medications that were available over-the-counter, the use of approved names and regulating the therapeutic claims, which would be implemented in the years