We all know that placebos are commonly used in clinical trials and are occasionally used as actual interventions. The placebo effect occurs when a patient who has been given a placebo treatment has an actual response to the placebo, whether this response be positive or negative. When developing a new surgical treatment double-blind surgical placebo-based trials (SPTs) are normally done to assess the safety of the new procedure (Polgar & Mohamed, 2019). When it comes to Parkinson's disease, SPTs have been used to study stem cell-based therapies (Polgar & Mohamed, 2019). The purpose of using STPs in this instance is to reduce the likelihood of false positives (Polgar & Mohamed, 2019). Neuroscientists and bioethicists have deemed STPs as necessary when looking at potential cellular therapies (Polgar & Mohamed, 2019). Even though these trials may be necessary, are they ethical?
Participants who volunteer to be part of a STP are undergoing surgery without receiving the potential therapeutic effects of the surgery. There has been a sign of the placebo effect occurring in STPs for Parkinson’s disease, but the results are highly variable and lacking a statistically significant difference (Polgar & Mohamed, 2019). STPs do not provide the most clinically valuable and applicable results compared to alternative control groups and improved outcome measures (Polgar & Mohamed, 2019). STPs have been viewed as unethical in the regards that performing a surgery that does not have a chance of resulting in the expected benefit of the actual surgery does not comply with the ethical principle of nonmaleficence making sure the risk to patients is minimized (Polgar & Mohamed, 2019). Using STPs also does not ensure the moral responsibility to treat seriously ill patients (Polgar & Mohamed, 2019). As a future healthcare professional would you feel as though you are upholding the 4 main ethical principles if you were part of a team conducting a placebo-based trial?
Reference: Polgar, S. & Mohamed, S. (2019). Evidence-Based Evaluation of the Ethics of Sham Surgery for Parkinson’s Disease. Journal of Parkinson’s Disease(9), 565-574. http://doi.org/10.3233/JPD-191577
Hi Madison,
ReplyDeleteThis is a very interesting topic. It seems as though this is a very controversial topic for many researchers. One group has argued that STP is beneficial due to it alleviates a lot of psychosomatic effects on treatment studies, while the opponents discuss about how if there is an effective therapy, then a placebo should not be given to the participants. For me, both sides sound very convincing. When looking at the 4 main ethical principles, Utilitarianism is a big proponent on why we should continue STP. By providing a conformation with placebo on a small group of people, this provides that the actually therapy works and benefits a larger group of people as well. This also correlated with justice, the idea of fairness and trying to help the people. When looking at it from the other side as an opponent, I believe we see non-maleficence and Beneficience. As we looking at it, we want to try and do no harm for any of the patience and try to do good for them. By providing the placebo, we are inherently not doing any good for these participants and may even do more harm than neutral as well. As a result, the STP may not be the most beneficial way to go. For me, I could see both sides of the story and it is really hard to decide!
Stang, A., Hense, H., Jöckel, K., Turner, E., & Tramèr, M. (2005, March). Is it always unethical to use a placebo in a clinical trial? Retrieved November 16, 2020, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1069666/