Medical Ethics in Drug Trials
Thousands of people voluntarily enroll in clinical drug trials every year. They are putting their health and safety at risk by participating in a drug trial. One would think they would be doing this to promote medical advancement, but in all actuality, it is for the high dollar amounts they receive for compensation. People that frequently enroll in drug trials are often called “guinea pigs.” The monetary amount people are paid can go as high seventy-five hundred dollars. The more invasive the procedure is the higher the compensation. These “Guinea pigs” are required to pay taxes on the money they do make. (Elliott, 2008)
Reasons for Drug Trials
Clinical trials are designed to test the safety and efficiency of potential interventions in humans. Trials of treatments, prevention modalities, medical devices, and other interventions are the fastest, safest, and best way to determine the failure or success of the product being tested. Treatment trials are experimental treatments. They test new drugs, new combinations of drugs; as well as, approaches to surgery and/or radiation therapy. This is the fastest way to discover the possible therapeutic options. Prevention trials test medicines, vaccines, vitamins, or lifestyle changes.
History of drug Trials
The largest drug-testing site, a 675-bed motel in Miami-Dade County, Florida was demolished in 2006. The participants were undocumented immigrants who were paid minute amounts as compensation. Conditions at the site were deplorable and the living conditions were repulsive. The paint was peeling from the ceilings and half a dozen, or more, individuals were forced to endure their trials in one room. Lisa Krinsky, a Miami native, the medical director who managed this facility was not licensed to practice in the United States. She was previously employed as a licensed clinical laboratory technician after receiving a medical degree from Spartan Health Sciences University, a medical school on the Caribbean Island of St. Lucia. As the owner of a commercial ethical review board and wife of the South Florida Bioavailability Committee (SFBC) vice president, she approved many of the studies brought to the board.
Due to the fact that because drug trials were poorly regulated in the early 1970’s Phase I research was conducted on prisoners. The FDA was granted authority to monitor research that involved humans in the 1978; at which time, the FDA ordered each institution to devise an Institutional Review Board (IRB). The IRB was to generate and monitor the rules of the trials on all studies done within the universality. The IRB was comprised of faculty members who volunteered to evaluate their colleagues’ studies. Unfortunately, before 2005, FDA inspectors’ primary focus was on verifying the clinical trial data, not the human subjects involved in them.
Benefits of Drug Trials
Who Enrolls in Drug Trials? Healthy experienced testers are used during Phase I where the...