Clinical Trials

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” wmerp22222222as 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 mdang 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:

http://www.nbcnews.com/health/health-news/france-clinical-trial-goes-awry-leaving-one-volunteer-brain-dead-n497191

http://www.bbc.com/news/world-europe-35337671

 

Dan Markingson:

https://www.psychologytoday.com/blog/side-effects/200906/when-drug-trials-go-terribly-wrong-lessons-bereaved-mother

http://markingson.blogspot.com/

-Gabriella Feltman

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6 thoughts on “Clinical Trials

  1. I completely agree with you! They should have taken the consent before the trial. I feel that we still see unethical behavior like this because most of the people are doing research with a money motif. The momey motif has definitely overpowered the original motif of research- to make a better world. Cases like this should be made aware of. People should really change their attitude they have about research. I really liked your post!
    A M Ovini H Amarasinghe

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  2. Seems like we only want to focus on the failures of the system. Maybe we should read up on the successes of the system. How many of us are here, because Amoxicillin was tested on humans. Prior to World War II your body beat a bacterial infection or your died or were crippled. Many of us are here today, because of the sacrifices paid by folks like Dan. Thanks to Dan this medicine will likely not go on the market.

    Mike Cappel

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  3. This was a cool read. It makes me think about why people will just openly jump into participating in a clinical trial. I really liked your post!

    Becca Roberts

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  4. Your post is amazing. I also wonder how children medicine goes through 4 phases of IRB. I appreciate the fact that I have more kinds medicine available for diseases. However, I also think legal protection should provided to participants when it comes to pharmaceutical trials. I think it is not only researchers are money motif driven, but often participants are.

    Jisung Yu

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  5. This is a great post. I agree that they should have gotten consent before the the trial. Hopefully the process to test drugs becomes even more strict due to situations like these. Also, people will think harder about joining a clinical trial on a drug.

    Andrew Traicoff

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  6. I never knew this was how some clinicals operated. I agree with you 100%, consent of a “normal” (health wise) person should be clear and understood before any type of clinal testing is started. That is terrible what happened to that patient, I wonder if that was his mental state before the clinicals and then it worsened or if the clinicals were the sole cause of him being suicidal.

    -Skylar Barkley

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