I attended Good Clinical (Trial) Practice course over the last few days and I learnt a few interesting facts and events that led to the development of current protocols on medical studies and patients’ protection.
TUSKEGEE SYPHILIS STUDY 1932-1972
Year 1932, in Tuskegee, Alabama, US Public Health Service initiated a study to determine the natural course of untreated syphilis.
Of course, these ‘objectives’ were not that clearly spelled out for the 400 already infected + 200 not infected (control) subjects recruited for the study. These black people were poor, vulnerable, don’t know what syphilis is and don’t know they are having it or not. With inadequate information and human respect, these subjects were led into believing that they were getting free treatment, and enticed with assurance of meals, burial insurance,etc.
The bigger problem appeared later. Year 1947, ta-dah. Penicillin became available and penicillin IS the treatment of syphilis.Uh-oh, researchers faced cross road. This Tuskegee became (in)famous today because at that point of time, researchers/authorities decided that completion of the study as per achieving the objectives is more important than treating these blacks and terminating the study just like that. So they withhold treatment from the subjects.
The damage? 28 died of syphilis, 100 others due to related complications, infected wives and babies born with syplilis. This went on until whistle blowers leaked the story to the press, led to protest and finally termination of the study.
Year 1997, Clinton made a presidential apology.
Studies like this (including Nuremberg Trial 1947) rang alarms on human rights and patients protection, leading to Declaration of Helsinki 1964 (rev 2008), Belmont Report 1979, etc.
On a different note, I cannot deny how important clinical trials are, because every single piece of tablet/ capsule/ injections had gone through trials before deemed safe (or not) and ended up in our medication shelf at home~ And today, a proper clinical trial is structured to protect the patients. That’s why a 3 days course on Good Clinical Practice for potential researchers. That also covers the very basics only =) Every studies involving human subjects must be registered and obtained ethical clearance.
And on another different note, if anyone has a chance to participate in a study, read the fine prints, check the protection and consider going for it =)