Thalidomide Tragedy Essay

There are many stakeholders involved in the thalidomide disaster, however, none more important than the infants born to mothers that had taken thalidomide amid their pregnancy. The babies born during this time were the only stakeholders involved in this tragedy, not presented with the choice of whether or not ingest thalidomide as a therapeutic remedy. The babies born to mothers taking thalidomide during this time period represent the most helpless victims who would have to eventually bear the consequences of the choices made by their unsuspecting mothers. Even though this tragedy would ultimately lead to more stringent regulations placed on the reporting and gathering of information related to the safety and efficacy of new medicines created …show more content…
The United States was able to narrowly escape the full effects of this tragedy, majorly due to the efforts of the FDA reviewer, Dr. Frances Kelsey. Other countries, however, did experience a massive incidence of birth defects to babies born to mothers who had ingested thalidomide during their pregnancy. Several lessons were learned during this tragedy with respect to the toxicological effects that would shape the process of developing medicines that spans drug development up to marketing and post approval monitoring trials. The first important lesson to be learned by toxicologists was that pharmaceutical products should be systematically tested for developmental effects prior to marketing . Other lessons learned through the thalidomide tragedy was in the gain of knowledge that there are differences in species sensitivity and manifestations of developmental toxicity and thirdly, that the use of a second species or more thoroughgoing interpretation of results in a single species (taking pharmacokinetics into consideration) are important considerations in drug …show more content…
It seems like many new regulations and changes to how we discover, manufacture and market new medications are in direct response to adverse effects and not put in place to prior to major tragedies to public health. Medicines play a unique role in our society in the fact that all medications inevitably have side effects but it is in the interest of doctors, manufacturing companies, and patients alike to measure the adverse effect against the benefit. In some cases, however, patients are not afforded the opportunity to weight such options if experiencing life-threatening conditions, so they ultimately put all their trust in the product and in the drug development process that allowed that medication to be sold to the general