For this week’s post, I focused on the 4 phases of the IRB and the real-life scenarios where these trials have actually gone awry. I found a story from about a month ago of a drug trial in France. The article states that the drug was a “cannabis-based painkiller” was conducted in a private lab without the approval of the French health ministry, while another source says that the lab was in full regulation. This is under investigation. 90 volunteers took the drug, 5 of those volunteers were hospitalized and one brain dead. According to NBC News “…the accident affected a Phase 1 trial” of the drug. The man that was brain dead ending up dying shortly after and BBC states that “New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in 2018”.
Another incident was with Dan Markingson, a boy who participated in a clinical trial at the University of Minnesota. In the trial, Dan compared Seroquel, Risperdal & Zyprexa for schizophrenia. He was given 800 mg of the drug and though “70% of the patients in the trial dropped out”, Markingson remained in the trial for five months. If he refused the drug and dropped out of the trial, he would be put in a treatment facility. On May 8th, 2004, he killed himself with a box cutter. Through an investigation it has been found that Markingson was coerced, he was incompetent to consent, the university ignored warnings that he was suicidal, and many more.
This is not to say that I don’t think clinical trials are 100% necessary for the research of a drug, but I do think that those who are going to be subjected to this should be in their right mind. In Markingson’s case, the University of Minnesota was aware of his condition and denied the risk. For the most recent case in France, I think that maybe more efforts could have been done by the French health ministry to combat a trial they did not agree to. Or if they did, to have researched more carefully. I believe that trials are very important to drugs and oftentimes they are effective, but I think that those who participate should be able to give consent to the trials. Otherwise, the trials are very dangerous, even though their goal is to not cause harm.
Two links to the incident in France: