Thoughts for Unethical Conduct in Tuskegee Study
It is the need of the mankind to try and find new ways to treat major diseases. Research and clinical trials are the only way to successfully achieve the goals of finding the proper cure for diseases. When pharmaceutical companies forget the rights of the subjects of the trial and start treating then as lab rats for their profits, such tragedies takes place in the history. These companies spend billions of dollars to research one drug, and the only thing that they care is about the profit. ‘Tuskegee Trials’ are one black mark on the history of the clinical research field. Development of one drug costs 2-3 billion dollars and around 10-15 years for the trial to the company.
During this period, the patent of the drug may expire and the generics may take over the drug. Also, there is no guarantee that the trials will be successful. So, the companies would want to expedite the trial in any way possible to get the approval from the FDA. Sometimes these efforts of fast track trials lead to tragedies like Tuskegee.
Details of the Trials
The study was conducted during 1932 -72. It was funded by U.S. Public Health Service Department. It was race based study as the subjects were African-American with Syphilis. Around 399 subjects were enrolled to assess the natural progression of the disease. However, due to some reasons the funding to the study stopped and the treatment trial became simply observational trial. In fact, the investigators misguided the subjects that they were being treated for the ‘Bad blood.’
Impact of Tuskegee to Clinical Research Field
There were catastrophic results of this highly controversial study. The impacts were also magnificent. The ‘Belmont Report’ came into existence that protects human rights and safety in such clinical trials. Office for Human Research Protection (OHRP) started protecting the safety of human volunteers. Requirement of the ‘Institutional Review Board’ review to conduct any experiments on the human subjects was mandatory before any trials. These were the huge impacts of this study to the profession.
The Strong need of Ethical Conduct
The history speaks for itself. Tuskegee trials are one of the many unethical trials conducted in the past. During that time the governing bodies were not that strict and the education and awareness was not there with the subjects. The pharmaceutical companies were giving more importance to the efficacy of the drug rather than safety of the subject. Hence, it is strongly advisable to have vigilant review board and external auditing committee to oversee the progress of the clinical trials. Starting from the informed consent of the subjects till the submission of the documents to the FDA, each process should be monitored carefully. This is the only way to ensure the safety of the human kind.
(2013, Sep. 24 ). In U.S. Public Health Service Syphilis Study at Tuskegee. Retrieved Jun. 19, 2014, from http://www.cdc.gov/tuskegee/timeline.htm
(Year, Month. Day ). In Tuskegee Syphilis Study. Retrieved Jun. 19, 2014, from http://www.sciencemuseum.org.uk/broughttolife/tech